Hepatitis BPhase 2NCT03361956
An Efficacy, Safety, and Pharmacokinetics Study of JNJ-56136379 in Participants With Chronic Hepatitis B Virus Infection
A Phase 2 study testing JNJ-56136379 and NA (ETV or TDF) in people with Hepatitis B, run by Janssen Sciences Ireland UC at 76 sites in 19 countries.
Trial summary
The main purpose of this study is to evaluate efficacy of 24 weeks of study treatment, in terms of changes in hepatitis B surface antigen (HBsAg) levels. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hepatitis B
- What is being tested?
- JNJ-56136379 and NA (ETV or TDF)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 232 participants
- Where
- 76 sitesin 19 countries
- Study dates
- 13 Feb 2018to 13 Aug 2020
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must have a body mass index (weight in kilogram (kg) divided by the square of height in meters) of 18.0 to 35.0 kilogram / square meter (kg/m^2), extremes included
- Participants must have chronic hepatitis B virus infection (CHB) infection documented by: Serum hepatitis B surface antigen (HBsAg)-positive at screening and serum HBsAg- or hepatitis B virus (HBV) deoxyribonucleic acid (DNA)-positive at least 6 months prior to screening; Serum immunoglobulin M (IgM) anti- hepatitis B core-related (HBc) antibody negative at screening
- In participants currently not being treated (Treatment Arms 1-2-3 and 6-7-8): Participants must not be receiving any CHB treatment at screening, that is, Have never received treatment with HBV antiviral medicines, including NAs or interferon (IFN) products, OR Have not been on treatment with HBV antiviral medicines, including nucleos(t)ide analog (NA)s or IFN products within 6 months prior to baseline (first intake of study drugs), and participants must be HBeAg-positive and have HBV DNA greater than or equal to (>=) 20,000 International Units Per Milliliter (IU/mL), OR be hepatitis B e antigen (HBeAg)-negative and have HBV DNA >=2,000 IU /mL at screening, and participants must have HBsAg greater than (>) 250 IU/mL at screening, and participants must have alanine aminotransferase (ALT) > upper limit of normal (ULN) and less than or equal to (<=) 5 * ULN at screening, determined in the central laboratory
- In virologically suppressed participants (Treatment Arms 4-5 and 9-10): Participants must be virologically suppressed by current NA treatment (entecavir (ETV) or tenofovir disoproxil fumarate (TDF)) as defined by HBV DNA less than (<) 60 IU/mL at screening and at least 6 months prior to screening, and participants must be on the same NA treatment (ETV or TDF) and the same dose for >=12 months prior to screening, and participants must have HBsAg > 250 IU/mL at screening, and participants must have ALT <=2*ULN at screening
- Participants must have: A liver biopsy result classified as Metavir F0-F2 within 1 year prior to screening or at the time of screening, OR FibroScan liver stiffness measurement <8.0 kilopascal (kPa) within 6 months prior to screening or at the time of screening
Who cannot join
- Main Study:
- Participants who test positive for anti-hepatitis B surface (HBs) antibodies
- Participants with current hepatitis A virus infection (confirmed by hepatitis A antibody immunoglobulin M [IgM]), hepatitis D virus (HDV) infection (confirmed by HDV antibody), hepatitis E virus infection (confirmed by hepatitis E antibody IgM), or human immunodeficiency virus (HIV)-1 or HIV-2 infection (confirmed by antibodies) at screening; participants with a history of or current HCV infection (confirmed by HCV antibody). Evidence of other active infection (bacterial, viral, fungal, including acute tuberculosis) deemed clinically relevant by the investigator that would interfere with study conduct or its interpretation will also lead to exclusion
- Participants with any evidence of hepatic decompensation at any time point prior to or at the time of screening: Direct bilirubin >1.2* ULN, or International normalized ratio (INR) >1.5* ULN, or Serum albumin < lower limit of normal (LLN), or documented history or current evidence of variceal bleeding, ascites, or hepatic encephalopathy
- Participants with a history of cardiac arrhythmia (example, extrasystoli, tachycardia at rest), history of risk factors for Torsades de Pointes syndrome (example, hypokalemia, family history of long QT syndrome) or history or other clinical evidence of significant or unstable cardiac disease (example, angina, congestive heart failure, myocardial infarction, diastolic dysfunction, significant arrhythmia, coronary heart disease, and/or clinically significant 12 lead electrocardiograms (ECGs) abnormalities), moderate to severe valvular disease, or uncontrolled hypertension at screening
- Participants with contraindications to the use of ETV or TDF per local prescribing information
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- Substudy:
- Presence of coagulopathy or hemoglobinopathy (including sickle cell disease, thalassemia)
- Use of any anti-coagulant, anti-platelet, or non-steroidal anti-inflammatory drug medications from 10 days before until 5 days after each liver biopsy
- Presence of ascites, focal liver lesions, and other findings that would be contraindications for liver biopsies
Trial locations and contacts
76 sites in 19 countries.
76 sites in 19 countries
United States7 sites
The Office of Franco Felizarta, MD
Bakersfield, California, 93301
Rush University Medical Center
Chicago, Illinois, 60612
I.D. Care, Inc.
Hillsborough, New Jersey, 08844
Tulane Medical Center (TMC)
New Orleans, Louisiana, 70112
NYU Hepatology Associates
New York, New York, 10016
Orlando Immunology Center
Orlando, Florida, 32803
UPMC Center For Liver Diseases
Pittsburgh, Pennsylvania, 15213
Canada5 sites
University of Calgary
Calgary, Alberta, T2N 1N4
McGill University Health Centre
Montreal, Quebec, H3H 2R9
Toronto General Hospital
Toronto, ON M5G 2C4
Vancouver ID Research and Care Centre Society
Vancouver, British Columbia, V6Z 2C7
GI Research Institute (G.I.R.I.)
Vancouver, British Columbia, V6Z 2K5
Japan5 sites
Hiroshima University Hospital
Hiroshima, 734-8551
Musashino Red Cross Hospital
Musashino, 180-8610
National Hospital Organization Nagasaki Medical Center
Nagasaki, 856-8562
Nagoya City University Hospital
Nagoya, 467-8602
Osaka University Hospital
Suita-shi, 565-0871
Spain5 sites
Hosp. Clinic I Provincial de Barcelona
Barcelona, 8028
Hosp. Univ. Vall D Hebron
Barcelona, 8035
Hosp. Univ. Ramon Y Cajal
Madrid, 28034
Hosp. Univ. Marques de Valdecilla
Santander, 39008
Hosp. Virgen Del Rocio
Seville, 41013
China4 sites
Peking University People's Hospital
Beijing, 100034
Beiijing Friendship Hospital, Capital Medical University
Beijing, 100050
The First Hospital of Jilin University
Changchun, 130021
Nanfang Hospital
Guangzhou, 510515
France4 sites
Hôpital Beaujon
Clichy, 92110
Hopital de La Croix Rousse
Lyon, 69004
Hopital Saint-Antoine
Paris, 75012
Hopital Paul Brousse
Villejuif, 94800
Germany4 sites
Zentrum für Infektiologie Berlin Prenzlauer Berg GmbH
Berlin, 10439
Universitatsklinikum Essen
Essen, 45122
Universitätsklinikum Johann Wolfgang Goethe- Universität Frankfurt Medizinische Klinik 1
Frankfurt, 60590
Asklepios Klinik St. Georg, Haus Lifi - Studien und Projekte GmbH
Hamburg, 20099
Poland4 sites
Szpital Specjalistyczny w Chorzowie
Chorzów, 41-500
Wojewodzki Szpital Zespolony
Kielce, 25-317
ID Clinic
Mysłowice, 41-400
SP ZOZ Wroclawskie Centrum Zdrowia
Wroclaw, 50-136
Russia4 sites
Medical Center SibNovoMed LLC
Novosibirsk, 630005
Medical Company Hepatolog Ltd
Samara, 443063
Stavropol State Medical University
Stavropol, 355017
Sverdlovsk Regional Clinical Hospital #1
Yekaterinburg, 620102
South Korea4 sites
Pusan National University Hospital
Busan, 49241
Seoul National University Hospital
Seoul, 03080
Severance Hospital, Yonsei University Health System
Seoul, 03722
Asan Medical Center
Seoul, 05505
Taiwan4 sites
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, 80756
Taichung Veterans General Hospital
Taichung, 40705
National Cheng Kung University Hospital
Tainan, 70403
Chang Gung Memorial Hospital Linkou Branch
Taoyuan, 333
Thailand4 sites
King Chulalongkorn Memorial Hospital
Bangkok, 10500
Siriraj Hospital
Bangkok, 10700
Chiang Mai University Hospital
Chiang Mai, 50200
Prince Of Songkla University
Songkhla, 90110
Turkey (Türkiye)4 sites
Istanbul University Cerrahpasa Medical Faculty
Istanbul, 34098
Saglık Bilimleri University Şişli Trainig and Research Hospital,Department of Gastroenterology
Istanbul, 34371
Ege University Medical of Faculty, Department of Gastroenterology
Izmir, 35100
Karadeniz Teknik University Medical Faculty
Trabzon, 61080
Ukraine4 sites
Kharkiv National Medical University, Regional Clinical Infectious Hospital
Kharkiv, 61000
SE 'National institute therapy named L.T. Maloi NAMS of Ukraine'
Kharkiv, 61039
Odessa Regional Clinical Hospital
Odesa, 65025
Vinnytsia City Clinical Hospital #1, Department of Infectious Diseases #1
Vinnytsia, 21021
United Kingdom4 sites
North Manchester General Hospital
Crumpsall, M8 5RB
Grahame Hayton Unit
London, E1 1BB
Newcastle upon Tyne Hospitals NHS Foundation Trust
Newcastle upon Tyne, NE7 7DN
Nottingham University Hospitals NHS Trust
Nottingham, NG7 2UH
Belgium3 sites
SGS Clinical Pharmacology Unit (located in ZNA Stuivenberg)
Antwerp, 2060
Cliniques Universitaires Saint-Luc
Brussels, 1200
UZ Antwerpen
Edegem, 2650
Italy3 sites
Irccs Ospedale Maggiore Di Milano
Milan, 20122
ASST Grande Ospedale Metropolitano Niguarda
Milan, 20162
Azienda Ospedaliero Universitaria Pisana
Pisa, 56124
Hong Kong2 sites
Queen Mary Hospital, University of Hong Kong
Hong Kong
The Chinese University of Hong Kong
Shatin
Malaysia2 sites
Hospital Sultanah Bahiyah
Alor Star, 05460
University Malaya Medical Centre
Kuala Lumpur, 59100
About this study
Official title: A Phase 2a, Randomized, Partially-blind, Placebo-controlled Study to Assess the Efficacy, Safety, and Pharmacokinetics of Treatment With Multiple Doses of JNJ-56136379 as Monotherapy and in Combination With a Nucleos(t)Ide Analog in Subjects With Chronic Hepatitis B Virus Infection
The main purpose of this study is to evaluate efficacy of 24 weeks of study treatment, in terms of changes in hepatitis B surface antigen (HBsAg) levels.
Read the detailed description
The main study consists of 2-parts and each part will consist of 2 types of Chronic Hepatitis B-infected participant populations. Each part of the study will consist of screening phase (up to 8 weeks), treatment phase (24 weeks or 48 weeks, depending on treatment response), and post-treatment follow-up phase (24 weeks or 48 weeks, depending on treatment response). The duration of individual participation will be up to approximately 56 weeks (participants not eligible to continue treatment in extension phase), up to 80 weeks (participants continuing treatment in extension phase but not meeting treatment completion criteria), or up to 104 weeks (participants meeting treatment completion criteria). The safety and efficacy will be monitored throughout the study. In a separate substudy, at selected clinical sites, percutaneous core liver biopsy will be performed to evaluate changes of intrahepatic viral parameters.
- Conditions
- Hepatitis B
- Being tested
- JNJ-56136379, Placebo, NA (ETV or TDF)
- Medical subject headings
- Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JNJ-56136379Drug
Also called JNJ-6379
Participants will receive JNJ-56136379 tablet orally.
PlaceboDrug
Participants will receive matching placebo tablet orally.
NA (ETV or TDF)Drug
Participants will receive NA (ETV or TDF) tablet orally as per approved label.
| Study group | Role | What they receive |
|---|---|---|
| Part A: Arm 1 (JNJ-56136379 or NA) (open label) | Experimental | Participants with hepatitis B virus (HBV) currently not being treated and receiving JNJ-56136379 tablet (at a lower dose) orally for 24 weeks, will stop further dosing with JNJ-56136379 and start treatment with nucleos(t)ide analog (NA) (entecavir [ETV] or tenofovir disoproxil fumarate [TDF]), and enter the 24 week post treatment follow-up phase. Receives: Drug: JNJ-56136379; Drug: NA (ETV or TDF) |
| Part A: Arm 2 (Placebo+NA [ETV] or [TDF]) | Placebo comparator | Participants with HBV currently not being treated will receive matching placebo along with NA (ETV or TDF) tablets orally for 24 weeks. The eligible participants may enter the extension phase and will continue study drugs up to 48 weeks. Receives: Drug: Placebo; Drug: NA (ETV or TDF) |
| Part A: Arm 3 (JNJ-56136379 + NA [ETV or TDF]) | Experimental | Participants with HBV currently not being treated will receive JNJ-56136379 along with NA (ETV or TDF) tablet orally for 24 weeks. The eligible participants may enter the extension phase and will continue study drugs up to 48 weeks. Receives: Drug: JNJ-56136379; Drug: NA (ETV or TDF) |
| Part A: Arm 4 (Placebo + NA [ETV or TDF]) | Placebo comparator | Virologically suppressed participants will receive matching placebo along with NA (ETV or TDF) tablets orally for 24 weeks. The eligible participants may enter the extension phase and will continue study drugs up to 48 weeks. Receives: Drug: Placebo; Drug: NA (ETV or TDF) |
| Part A: Arm 5 (JNJ-56136379 + NA [ETV or TDF]) | Experimental | Virologically suppressed participants will receive JNJ-56136379 along with NA (ETV or TDF) tablets orally for 24 weeks. The eligible participants may enter the extension phase and will continue study drugs up to 48 weeks. Receives: Drug: JNJ-56136379; Drug: NA (ETV or TDF) |
| Part B: Arm 6 (JNJ-56136379 + NA [ETV or TDF]) (open label) | Experimental | Participants with HBV currently not being treated will receive JNJ-56136379 tablet at a high dose, orally for 24 weeks. The eligible participants may enter the extension phase and will receive JNJ-56136379 along with NA (ETV or TDF) from Week 24 to Week 48. Receives: Drug: JNJ-56136379; Drug: NA (ETV or TDF) |
| Part B: Arm 7 (placebo + NA [ETV or TDF]) | Placebo comparator | Participants with HBV currently not being treated will receive matching placebo along with NA (ETV or TDF) tablets orally for 24 weeks. The eligible participants may enter the extension phase and will continue study drugs up to 48 weeks. Receives: Drug: Placebo; Drug: NA (ETV or TDF) |
| Part B: Arm 8 (JNJ-56136379 + NA [ETV or TDF]) | Experimental | Participants with HBV currently not being treated will receive JNJ-56136379 tablet at a high dose along with NA (ETV or TDF) tablets orally for 24 weeks. The eligible participants may enter the extension phase and will continue study drugs up to 48 weeks. Receives: Drug: JNJ-56136379; Drug: NA (ETV or TDF) |
| Part B: Arm 9 (placebo + NA [ETV or TDF]) | Placebo comparator | Virologically suppressed participants will receive matching placebo along with NA (ETV or TDF) tablets orally for 24 weeks. The eligible participants may enter the extension phase and will continue study drugs up to 48 weeks. Receives: Drug: Placebo; Drug: NA (ETV or TDF) |
| Part B: Arm 10 (JNJ-56136379 + NA [ETV or TDF]) | Experimental | Virologically suppressed participants will receive JNJ-56136379 tablet at a high dose along with NA (ETV or TDF) tablets orally for 24 weeks. The eligible participants may enter the extension phase and will continue study drugs up to 48 weeks. Receives: Drug: JNJ-56136379; Drug: NA (ETV or TDF) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Hepatitis B Surface Antigen (HBsAg) Levels in Currently Not Treated Population at Week 24
Change from baseline in HBsAg levels in currently not treated population at Week 24 based on Hepatitis B e Antigen (HBeAg) status was reported. Currently not treated population defined as participants who didn't receive any hepatitis B virus (HBV) treatment 6 months prior to baseline.
Measured: Baseline and Week 24
Change From Baseline in HBsAg Levels in Virologically Suppressed Population at Week 24
Change from baseline in HBsAg levels in virologically suppressed population at Week 24 based on HBeAg status was reported. Virologically suppressed population defined as participants who were on entecavir (ETV) or tenofovir disoproxil fumarate (TDF) for at least 12 months prior to screening and had HBV deoxyribonucleic acid (DNA) <60 IU/mL. This outcome measure was planned to be analyzed for specified arms only.
Measured: Baseline and Week 24
Secondary outcomes (32)
Number of Participants With Treatment- Emergent Adverse Events (AEs)
An AE is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. Treatment-emergent AEs were AEs with onset during the treatment phase or that worsened since baseline.
Measured: Up to Week 48
Number of Participants With Serious Adverse Events (SAEs)
A SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Measured: Up to Week 80
Number of Participants With Clinically Significant Changes in Vital Signs, Physical Examinations, Electrocardiogram (ECG), and Clinical Laboratory Tests
Number of participants with clinically significant changes in vital signs, physical examinations, ECG, and clinical laboratory tests (including hematology, blood biochemistry, blood coagulation, and urinalysis) were reported.
Measured: Up to Week 80
Change From Baseline in HBsAg Levels in Currently Not Treated Population Over Time
Change from baseline in HBsAg levels in currently not treated population based on HBeAg status was reported.
Measured: Weeks 24, 48 and Follow-up Week 24
Change From Baseline in HBsAg Levels in Virologically Suppressed Population Over Time
Change from baseline in HBsAg levels in virologically suppressed population based on HBeAg status was reported. This outcome measure was planned to be analyzed for specified arms only.
Measured: Weeks 24, 48 and Follow-up Week 24
Percentage of Participants With HBsAg Levels Less Than (<) 1,000 or <100 International Units Per Milliliter (IU/mL) in Currently Not Treated Population
Percentage of participants with HBsAg levels <1,000 or <100 IU/mL in currently not treated population based on their HBeAg status were reported.
Measured: Weeks 24, 48 and Follow-up Week 24
Percentage of Participants With HBsAg Levels <1,000 or <100 IU/mL in Virologically Suppressed Population
Percentage of participants with HBsAg levels <1,000 or <100 IU/mL in virologically suppressed population based on their HBeAg status were reported. This outcome measure was planned to be analyzed for specified arms only.
Measured: Weeks 24, 48 and Follow-up Week 24
Percentage of Participants With Greater Than (>) 0.5 log10 IU/mL or >1 log10 IU/mL Reduction in HBsAg From Baseline in Currently Not Treated Population
Percentage of participants with >0.5 log10 IU/mL or >1 log10 IU/mL reduction in HBsAg from baseline in currently not treated population based on their HBeAg status were reported.
Measured: Weeks 24, 48 and Follow-up Week 24
Percentage of Participants With >0.5 log10 IU/mL or >1 log10 IU/mL Reduction in HBsAg From Baseline in Virologically Suppressed Population
Percentage of participants with >0.5 log10 IU/mL or >1 log10 IU/mL reduction in HBsAg from baseline in virologically suppressed population based on their HBeAg status were reported. This outcome measure was planned to be analyzed for specified arms only.
Measured: Weeks 24, 48 and Follow-up Week 24
Change From Baseline in Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Levels in Currently Not Treated Population
Change from baseline in HBV DNA levels in currently not treated population based on their HBeAg status was reported.
Measured: Baseline up to Weeks 24, 48 and Follow-up Week 24
Change From Baseline in HBV DNA Levels in Virologically Suppressed Population
Change from baseline in HBV DNA levels in virologically supressed population based on their HBeAg status was reported. This outcome measure was planned to be analyzed for specified arms only.
Measured: Baseline up to Weeks 24, 48 and Follow-up Week 24
Percentage of Participants With Undetectable HBV DNA Levels in Currently Not Treated Population
Percentage of participants with undetectable HBV DNA levels in currently not treated population based on their HBeAg status was evaluated.
Measured: Weeks 24, 48 and Follow-up Week 24
Percentage of Participants With Undetectable HBV DNA Levels in Virologically Suppressed Population
Percentage of participants with undetectable HBV DNA levels in virologically suppressed population based on their HBeAg status were reported. This outcome measure was planned to be analyzed for specified arms only.
Measured: Weeks 24, 48 and Follow-up Week 24
Change From Baseline in HBeAg Levels in Currently Not Treated Population
Change from baseline in HBeAg levels in HBeAg positive currently not treated population was reported.
Measured: Baseline up to Weeks 24, 48 and Follow-up Week 24
Change From Baseline in HBeAg Levels in Virologically Suppressed Population
Change from baseline in HBeAg levels in HBeAg positive virologically suppressed population was reported. This outcome measure was planned to be analyzed for specified arms only.
Measured: Baseline up to Weeks 24, 48 and Follow-up Week 24
Percentage of Participants With >0.5 log10 IU/mL and >1 log10 IU/mL Reduction in HBeAg From Baseline in Currently Not Treated Population
Percentage of participants with >0.5 log10 IU/mL and >1 log10 IU/mL reduction in HBeAg from baseline in HBeAg positive currently not treated population was reported.
Measured: Weeks 24, 48 and Follow-up Week 24
Percentage of Participants With >0.5 log10 IU/mL and >1 log10 IU/mL Reduction in HBeAg From Baseline in Virologically Suppressed Population
Percentage of participants with >0.5 log10 IU/mL and >1 log10 IU/mL reduction in HBeAg from baseline in HBeAg positive virologically suppressed population was reported. This outcome measure was planned to be analyzed for specified arms only.
Measured: Weeks 24, 48 and Follow-up Week 24
Percentage of Participants With HBsAg Seroclearance in Currently Not Treated Population
Percentage of participants with HBsAg seroclearance in currently not treated population based on their HBeAg status were reported. Seroclearance at Week 24/48 of the treatment defined as a confirmed loss of HBsAg at Week 24/48. Loss is defined as a baseline HBsAg with a repeat reactive, confirmed or positive result and a post-baseline assessment with a negative result. This outcome measure was planned to be analyzed at specified timepoints only.
Measured: Weeks 24 and 48
Percentage of Participants With HBsAg Seroclearance in Virologically Suppressed Population
Percentage of participants with HBsAg seroclearance in virologically suppressed population based on their HBeAg status were reported. Seroclearance at Week 24/48 of the treatment defined as a confirmed loss of HBsAg at Week 24/48. Loss is defined as a baseline HBsAg with a repeat reactive, confirmed or positive result and a post-baseline assessment with a negative result. This outcome measure was planned to be analyzed for specified arms and specific timepoints only .
Measured: Weeks 24 and 48
Percentage of Participants With HBsAg Seroconversion in Currently Not Treated Population
Percentage of participants with HBsAg seroconversion in currently not treated population based on their HBeAg status were reported. Seroconversion at Week 24/48 of the treatment defined as a confirmed loss of HBsAg at week 24/48 of the treatment and an appearance of Anti-HBs. This outcome measure was planned to be analyzed for specified timepoints only.
Measured: Weeks 24 and 48
Percentage of Participants With HBsAg Seroconversion in Virologically Suppressed Population
Percentage of participants with HBsAg seroconversion in virologically suppressed population based on their HBeAg status were reported. Seroconversion at Week 24/48 of the treatment defined as a confirmed loss of HBsAg at week 24/48 of the treatment and an appearance of Anti-HBs. This outcome measure was planned to be analyzed for specified arms and specified timepoints only.
Measured: Weeks 24 and 48
Percentage of Participants With Normalized Alanine Aminotransferase (ALT) Levels in Currently Not Treated Population
Percentage of participants with normalized ALT levels in currently not treated population, whose ALT levels were above upper limit of normal at baseline based on their HBeAg status were reported.
Measured: Weeks 24, 48 and Follow-up Week 24
Percentage of Participants With Normalized ALT Levels in Virologically Suppressed Population
Percentage of participants with normalized ALT levels in virologically suppressed population, whose ALT levels were above upper limit of normal at baseline based on their HBeAg status were reported. This outcome measure was planned to be analyzed for specified arms only.
Measured: Weeks 24, 48 and Follow-up Week 24
Percentage of Participants With Virological Breakthrough in Currently Not Treated Population
Percentage of participants with virological breakthrough in currently not treated population based on their HBeAg status was reported. Virological breakthrough defined as confirmed on treatment HBV DNA increase by >1 log10 from nadir level or confirmed on treatment level >200 IU/mL in participants who had HBV DNA level below the lower limit of quantification (LLOQ) of the HBV DNA assay.
Measured: Weeks 24 and 48
Percentage of Participants With Virological Breakthrough in Virologically Suppressed Population
Percentage of participants with virological breakthrough in virologically suppressed population based on their HBeAg status was reported. Virological breakthrough defined as confirmed on treatment HBV DNA increase by >1 log10 from nadir level or confirmed on treatment level >200 IU/mL in participants who had HBV DNA level below the lower limit of quantification (LLOQ) of the HBV DNA assay. This outcome measure was planned to be analyzed for specified arms only.
Measured: Weeks 24 and 48
Plasma Concentrations of Entecavir [ETV] in Currently Not Treated Population
Plasma concentrations of ETV administered as monotherapy or co-administered with JNJ-56136379 in currently not treated population was determined. As planned, plasma concentration of ETV co-administered with placebo was analyzed separately for Part A and Part B. Samples were analyzed using POP PK modeling.
Measured: Day 1: 0 hours, 2 hours; Weeks 1, 2, 4, 8, 12, 20, 24, 28, 32, 36, 44, 48: 0 hours; Follow-up: Weeks 2 and 4
Plasma Concentrations of ETV in Virologically Suppressed Population
Plasma concentrations of ETV administered as monotherapy or co-administered with JNJ-56136379 in virologically suppressed population was determined. As planned, plasma concentration of ETV co-administered with placebo was analyzed separately for Part A and Part B. Samples were analyzed using POP PK modeling.
Measured: Day 1: 0 hours, 2 hours; Weeks 1, 2, 4, 8, 12, 20, 24, 28, 32, 36, 44, 48: 0 hours; Follow-up: Weeks 2 and 4
Plasma Concentrations of Tenofovir Disoproxil Fumarate (TDF) in Currently Not Treated Population
Plasma concentrations of TDF administered as monotherapy or co-administered with JNJ-56136379 was determined. As planned, plasma concentration of TDF co-administered with placebo was analyzed separately for Part A and Part B. Samples were analyzed using POP PK modeling.
Measured: Day 1: 0 hours, 2 hours; Weeks 1, 2, 4, 8, 12, 20, 24, 28, 32, 36, 44, 48: 0 hours; Follow-up: Weeks 2 and 4
Plasma Concentrations of TDF in Virologically Suppressed Population
Plasma concentrations of TDF administered as monotherapy or co-administered with JNJ-56136379 was determined. As planned, plasma concentration of TDF co-administered with placebo was analyzed separately for Part A and Part B. Samples were analyzed using POP PK modeling.
Measured: Day 1: 0 hours, 2 hours; Weeks 1, 2, 4, 8, 12, 20, 24, 28, 32, 36, 44, 48: 0 hours; Follow-up: Weeks 2 and 4
Plasma Concentrations of JNJ-56136379 in Currently Not Treated Population
Plasma concentrations of JNJ-56136379 in currently not treated population administered as monotherapy or when co-administered with NA (ETV or TDF) was determined. As planned, the plasma concentration of JNJ-56136379 when co-administered with NA was determined separately for each NA treatment (ETV and TDF). Samples were analyzed using POP PK modeling.
Measured: Day 1: 0 hours, 2 hours; Weeks 1, 2, 4, 8, 12, 20, 24, 28, 32, 36, 44, 48: 0 hours; Follow-up: Weeks 2 and 4
Plasma Concentrations of JNJ-56136379 in Virologically Suppressed Population
Plasma concentrations of JNJ-56136379 in virologically suppressed population administered as monotherapy or when co-administered with NA (ETV or TDF) was determined. As planned, the plasma concentration of JNJ-56136379 when co-administered with NA was determined separately for each NA treatment (ETV and TDF). Samples were analyzed using POP PK modeling.
Measured: Day 1: 0 hours, 2 hours; Weeks 1, 2, 4, 8, 12, 20, 24, 28, 32, 36, 44, 48: 0 hours; Follow-up: Weeks 2 and 4
Number of Participants With Treatment-Associated Mutations
Number of participants with treatment-associated mutations were reported. Viral genome sequence analysis was performed to evaluate emergence of mutations associated with JNJ-56136379 considering 15 HBV core protein positions of interest. This outcome measure was planned to be analyzed for specified arms only.
Measured: From Week 0 to Week 24, From Week 25 to Week 48, Up to Follow-up Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2017
- Study start13 Feb 2018
- Primary completion5 Sep 2019
- Study completion13 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Hepatitis BStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 232 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Sciences Ireland UC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Sciences Ireland UC Clinical Trial, Study director, Janssen Sciences Ireland UC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03361956
- Sponsor's protocol ID
- CR108410
- Other IDs
- 2017-001110-29, 56136379HPB2001, 2017
- Status last verified
- Oct 2022
- First submitted
- 29 Nov 2017
- Last updated
- 17 Nov 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Verbinnen T, Talloen W, Janssen HLA, Zoulim F, Shukla U, Vandenbossche JJ, Biermer M, De Meyer S, Lenz O. Viral sequence analysis of chronic hepatitis B patients treated with the capsid assembly modulator JNJ-56136379 in the JADE phase 2a study. Antiviral Res. 2023 Aug;216:105660. doi: 10.1016/j.antiviral.2023.105660. Epub 2023 Jun 28.
PubMed 37385475Janssen HLA, Hou J, Asselah T, Chan HLY, Zoulim F, Tanaka Y, Janczewska E, Nahass RG, Bourgeois S, Buti M, Lampertico P, Lenz O, Verbinnen T, Vandenbossche J, Talloen W, Kalmeijer R, Beumont M, Biermer M, Shukla U. Randomised phase 2 study (JADE) of the HBV capsid assembly modulator JNJ-56136379 with or without a nucleos(t)ide analogue in patients with chronic hepatitis B infection. Gut. 2023 Jul;72(7):1385-1398. doi: 10.1136/gutjnl-2022-328041. Epub 2023 Jan 25.
PubMed 36697207Berke JM, Dehertogh P, Vergauwen K, Mostmans W, Vandyck K, Raboisson P, Pauwels F. Antiviral Properties and Mechanism of Action Studies of the Hepatitis B Virus Capsid Assembly Modulator JNJ-56136379. Antimicrob Agents Chemother. 2020 Apr 21;64(5):e02439-19. doi: 10.1128/AAC.02439-19. Print 2020 Apr 21.
PubMed 32094138
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2a, Randomized, Partially-blind, Placebo-controlled Study to Assess the Efficacy, Safety, and Pharmacokinetics of Treatment With Multiple Doses of JNJ-56136379 as Monotherapy and in Combination With a Nucleos(t)Ide Analog in Subjects With Chronic Hepatitis B Virus Infection
- ClinicalTrials.gov ID
- NCT03361956
- Acronym / sponsor ID
- CR108410
- Conditions
- Hepatitis B
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 232 participants (actual)
- Lead sponsor
- Janssen Sciences Ireland UCIndustry (pharma, biotech, devices)
- Study start
- 13 Feb 2018 (actual)
- Primary completion
- 5 Sep 2019 (actual)
- Study completion
- 13 Aug 2020 (actual)
- First posted
- 5 Dec 2017 (actual)
- Results
- Posted 17 Nov 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main purpose of this study is to evaluate efficacy of 24 weeks of study treatment, in terms of changes in hepatitis B surface antigen (HBsAg) levels.
Detailed description
The main study consists of 2-parts and each part will consist of 2 types of Chronic Hepatitis B-infected participant populations. Each part of the study will consist of screening phase (up to 8 weeks), treatment phase (24 weeks or 48 weeks, depending on treatment response), and post-treatment follow-up phase (24 weeks or 48 weeks, depending on treatment response). The duration of individual participation will be up to approximately 56 weeks (participants not eligible to continue treatment in extension phase), up to 80 weeks (participants continuing treatment in extension phase but not meeting treatment completion criteria), or up to 104 weeks (participants meeting treatment completion criteria). The safety and efficacy will be monitored throughout the study. In a separate substudy, at selected clinical sites, percutaneous core liver biopsy will be performed to evaluate changes of intrahepatic viral parameters.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| Part A: Arm 1 (JNJ-56136379 or NA) (open label) | Experimental | Drug: JNJ-56136379, Drug: NA (ETV or TDF)Participants with hepatitis B virus (HBV) currently not being treated and receiving JNJ-56136379 tablet (at a lower dose) orally for 24 weeks, will stop further dosing with JNJ-56136379 and start treatment with nucleos(t)ide analog (NA) (entecavir [ETV] or tenofovir disoproxil fumarate [TDF]), and enter the 24 week post treatment follow-up phase. |
| Part A: Arm 2 (Placebo+NA [ETV] or [TDF]) | Placebo comparator | Drug: Placebo, Drug: NA (ETV or TDF)Participants with HBV currently not being treated will receive matching placebo along with NA (ETV or TDF) tablets orally for 24 weeks. The eligible participants may enter the extension phase and will continue study drugs up to 48 weeks. |
| Part A: Arm 3 (JNJ-56136379 + NA [ETV or TDF]) | Experimental | Drug: JNJ-56136379, Drug: NA (ETV or TDF)Participants with HBV currently not being treated will receive JNJ-56136379 along with NA (ETV or TDF) tablet orally for 24 weeks. The eligible participants may enter the extension phase and will continue study drugs up to 48 weeks. |
| Part A: Arm 4 (Placebo + NA [ETV or TDF]) | Placebo comparator | Drug: Placebo, Drug: NA (ETV or TDF)Virologically suppressed participants will receive matching placebo along with NA (ETV or TDF) tablets orally for 24 weeks. The eligible participants may enter the extension phase and will continue study drugs up to 48 weeks. |
| Part A: Arm 5 (JNJ-56136379 + NA [ETV or TDF]) | Experimental | Drug: JNJ-56136379, Drug: NA (ETV or TDF)Virologically suppressed participants will receive JNJ-56136379 along with NA (ETV or TDF) tablets orally for 24 weeks. The eligible participants may enter the extension phase and will continue study drugs up to 48 weeks. |
| Part B: Arm 6 (JNJ-56136379 + NA [ETV or TDF]) (open label) | Experimental | Drug: JNJ-56136379, Drug: NA (ETV or TDF)Participants with HBV currently not being treated will receive JNJ-56136379 tablet at a high dose, orally for 24 weeks. The eligible participants may enter the extension phase and will receive JNJ-56136379 along with NA (ETV or TDF) from Week 24 to Week 48. |
| Part B: Arm 7 (placebo + NA [ETV or TDF]) | Placebo comparator | Drug: Placebo, Drug: NA (ETV or TDF)Participants with HBV currently not being treated will receive matching placebo along with NA (ETV or TDF) tablets orally for 24 weeks. The eligible participants may enter the extension phase and will continue study drugs up to 48 weeks. |
| Part B: Arm 8 (JNJ-56136379 + NA [ETV or TDF]) | Experimental | Drug: JNJ-56136379, Drug: NA (ETV or TDF)Participants with HBV currently not being treated will receive JNJ-56136379 tablet at a high dose along with NA (ETV or TDF) tablets orally for 24 weeks. The eligible participants may enter the extension phase and will continue study drugs up to 48 weeks. |
| Part B: Arm 9 (placebo + NA [ETV or TDF]) | Placebo comparator | Drug: Placebo, Drug: NA (ETV or TDF)Virologically suppressed participants will receive matching placebo along with NA (ETV or TDF) tablets orally for 24 weeks. The eligible participants may enter the extension phase and will continue study drugs up to 48 weeks. |
| Part B: Arm 10 (JNJ-56136379 + NA [ETV or TDF]) | Experimental | Drug: JNJ-56136379, Drug: NA (ETV or TDF)Virologically suppressed participants will receive JNJ-56136379 tablet at a high dose along with NA (ETV or TDF) tablets orally for 24 weeks. The eligible participants may enter the extension phase and will continue study drugs up to 48 weeks. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Participants must have a body mass index (weight in kilogram (kg) divided by the square of height in meters) of 18.0 to 35.0 kilogram / square meter (kg/m^2), extremes included
- Participants must have chronic hepatitis B virus infection (CHB) infection documented by: Serum hepatitis B surface antigen (HBsAg)-positive at screening and serum HBsAg- or hepatitis B virus (HBV) deoxyribonucleic acid (DNA)-positive at least 6 months prior to screening; Serum immunoglobulin M (IgM) anti- hepatitis B core-related (HBc) antibody negative at screening
- In participants currently not being treated (Treatment Arms 1-2-3 and 6-7-8): Participants must not be receiving any CHB treatment at screening, that is, Have never received treatment with HBV antiviral medicines, including NAs or interferon (IFN) products, OR Have not been on treatment with HBV antiviral medicines, including nucleos(t)ide analog (NA)s or IFN products within 6 months prior to baseline (first intake of study drugs), and participants must be HBeAg-positive and have HBV DNA greater than or equal to (>=) 20,000 International Units Per Milliliter (IU/mL), OR be hepatitis B e antigen (HBeAg)-negative and have HBV DNA >=2,000 IU /mL at screening, and participants must have HBsAg greater than (>) 250 IU/mL at screening, and participants must have alanine aminotransferase (ALT) > upper limit of normal (ULN) and less than or equal to (<=) 5 * ULN at screening, determined in the central laboratory
- In virologically suppressed participants (Treatment Arms 4-5 and 9-10): Participants must be virologically suppressed by current NA treatment (entecavir (ETV) or tenofovir disoproxil fumarate (TDF)) as defined by HBV DNA less than (<) 60 IU/mL at screening and at least 6 months prior to screening, and participants must be on the same NA treatment (ETV or TDF) and the same dose for >=12 months prior to screening, and participants must have HBsAg > 250 IU/mL at screening, and participants must have ALT <=2*ULN at screening
- Participants must have: A liver biopsy result classified as Metavir F0-F2 within 1 year prior to screening or at the time of screening, OR FibroScan liver stiffness measurement <8.0 kilopascal (kPa) within 6 months prior to screening or at the time of screening
Key exclusion criteria (10 listed)
- Participants who test positive for anti-hepatitis B surface (HBs) antibodies
- Participants with current hepatitis A virus infection (confirmed by hepatitis A antibody immunoglobulin M [IgM]), hepatitis D virus (HDV) infection (confirmed by HDV antibody), hepatitis E virus infection (confirmed by hepatitis E antibody IgM), or human immunodeficiency virus (HIV)-1 or HIV-2 infection (confirmed by antibodies) at screening; participants with a history of or current HCV infection (confirmed by HCV antibody). Evidence of other active infection (bacterial, viral, fungal, including acute tuberculosis) deemed clinically relevant by the investigator that would interfere with study conduct or its interpretation will also lead to exclusion
- Participants with any evidence of hepatic decompensation at any time point prior to or at the time of screening: Direct bilirubin >1.2* ULN, or International normalized ratio (INR) >1.5* ULN, or Serum albumin < lower limit of normal (LLN), or documented history or current evidence of variceal bleeding, ascites, or hepatic encephalopathy
- Participants with a history of cardiac arrhythmia (example, extrasystoli, tachycardia at rest), history of risk factors for Torsades de Pointes syndrome (example, hypokalemia, family history of long QT syndrome) or history or other clinical evidence of significant or unstable cardiac disease (example, angina, congestive heart failure, myocardial infarction, diastolic dysfunction, significant arrhythmia, coronary heart disease, and/or clinically significant 12 lead electrocardiograms (ECGs) abnormalities), moderate to severe valvular disease, or uncontrolled hypertension at screening
- Participants with contraindications to the use of ETV or TDF per local prescribing information
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JNJ-56136379Also: JNJ-6379Participants will receive JNJ-56136379 tablet orally. | Drug | Part A: Arm 1 (JNJ-56136379 or NA) (open label), Part A: Arm 3 (JNJ-56136379 + NA [ETV or TDF]), Part A: Arm 5 (JNJ-56136379 + NA [ETV or TDF]), Part B: Arm 10 (JNJ-56136379 + NA [ETV or TDF]), Part B: Arm 6 (JNJ-56136379 + NA [ETV or TDF]) (open label), Part B: Arm 8 (JNJ-56136379 + NA [ETV or TDF]) |
| PlaceboParticipants will receive matching placebo tablet orally. | Drug | Part A: Arm 2 (Placebo+NA [ETV] or [TDF]), Part A: Arm 4 (Placebo + NA [ETV or TDF]), Part B: Arm 7 (placebo + NA [ETV or TDF]), Part B: Arm 9 (placebo + NA [ETV or TDF]) |
| NA (ETV or TDF)Participants will receive NA (ETV or TDF) tablet orally as per approved label. | Drug | Part A: Arm 1 (JNJ-56136379 or NA) (open label), Part A: Arm 2 (Placebo+NA [ETV] or [TDF]), Part A: Arm 3 (JNJ-56136379 + NA [ETV or TDF]), Part A: Arm 4 (Placebo + NA [ETV or TDF]), Part A: Arm 5 (JNJ-56136379 + NA [ETV or TDF]), Part B: Arm 10 (JNJ-56136379 + NA [ETV or TDF]), Part B: Arm 6 (JNJ-56136379 + NA [ETV or TDF]) (open label), Part B: Arm 7 (placebo + NA [ETV or TDF]), Part B: Arm 8 (JNJ-56136379 + NA [ETV or TDF]), Part B: Arm 9 (placebo + NA [ETV or TDF]) |
Primary outcome
Change From Baseline in Hepatitis B Surface Antigen (HBsAg) Levels in Currently Not Treated Population at Week 24
Time frame: Baseline and Week 24
Change from baseline in HBsAg levels in currently not treated population at Week 24 based on Hepatitis B e Antigen (HBeAg) status was reported. Currently not treated population defined as participants who didn't receive any hepatitis B virus (HBV) treatment 6 months prior to baseline.
Change From Baseline in HBsAg Levels in Virologically Suppressed Population at Week 24
Time frame: Baseline and Week 24
Change from baseline in HBsAg levels in virologically suppressed population at Week 24 based on HBeAg status was reported. Virologically suppressed population defined as participants who were on entecavir (ETV) or tenofovir disoproxil fumarate (TDF) for at least 12 months prior to screening and had HBV deoxyribonucleic acid (DNA) <60 IU/mL. This outcome measure was planned to be analyzed for specified arms only.
32 secondary outcomes
Number of Participants With Treatment- Emergent Adverse Events (AEs)
Time frame: Up to Week 48
Number of Participants With Serious Adverse Events (SAEs)
Time frame: Up to Week 80
Number of Participants With Clinically Significant Changes in Vital Signs, Physical Examinations, Electrocardiogram (ECG), and Clinical Laboratory Tests
Time frame: Up to Week 80
Change From Baseline in HBsAg Levels in Currently Not Treated Population Over Time
Time frame: Weeks 24, 48 and Follow-up Week 24
Change From Baseline in HBsAg Levels in Virologically Suppressed Population Over Time
Time frame: Weeks 24, 48 and Follow-up Week 24
Percentage of Participants With HBsAg Levels Less Than (<) 1,000 or <100 International Units Per Milliliter (IU/mL) in Currently Not Treated Population
Time frame: Weeks 24, 48 and Follow-up Week 24
Percentage of Participants With HBsAg Levels <1,000 or <100 IU/mL in Virologically Suppressed Population
Time frame: Weeks 24, 48 and Follow-up Week 24
Percentage of Participants With Greater Than (>) 0.5 log10 IU/mL or >1 log10 IU/mL Reduction in HBsAg From Baseline in Currently Not Treated Population
Time frame: Weeks 24, 48 and Follow-up Week 24
Percentage of Participants With >0.5 log10 IU/mL or >1 log10 IU/mL Reduction in HBsAg From Baseline in Virologically Suppressed Population
Time frame: Weeks 24, 48 and Follow-up Week 24
Change From Baseline in Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Levels in Currently Not Treated Population
Time frame: Baseline up to Weeks 24, 48 and Follow-up Week 24
Change From Baseline in HBV DNA Levels in Virologically Suppressed Population
Time frame: Baseline up to Weeks 24, 48 and Follow-up Week 24
Percentage of Participants With Undetectable HBV DNA Levels in Currently Not Treated Population
Time frame: Weeks 24, 48 and Follow-up Week 24
Percentage of Participants With Undetectable HBV DNA Levels in Virologically Suppressed Population
Time frame: Weeks 24, 48 and Follow-up Week 24
Change From Baseline in HBeAg Levels in Currently Not Treated Population
Time frame: Baseline up to Weeks 24, 48 and Follow-up Week 24
Change From Baseline in HBeAg Levels in Virologically Suppressed Population
Time frame: Baseline up to Weeks 24, 48 and Follow-up Week 24
Percentage of Participants With >0.5 log10 IU/mL and >1 log10 IU/mL Reduction in HBeAg From Baseline in Currently Not Treated Population
Time frame: Weeks 24, 48 and Follow-up Week 24
Percentage of Participants With >0.5 log10 IU/mL and >1 log10 IU/mL Reduction in HBeAg From Baseline in Virologically Suppressed Population
Time frame: Weeks 24, 48 and Follow-up Week 24
Percentage of Participants With HBsAg Seroclearance in Currently Not Treated Population
Time frame: Weeks 24 and 48
Percentage of Participants With HBsAg Seroclearance in Virologically Suppressed Population
Time frame: Weeks 24 and 48
Percentage of Participants With HBsAg Seroconversion in Currently Not Treated Population
Time frame: Weeks 24 and 48
Percentage of Participants With HBsAg Seroconversion in Virologically Suppressed Population
Time frame: Weeks 24 and 48
Percentage of Participants With Normalized Alanine Aminotransferase (ALT) Levels in Currently Not Treated Population
Time frame: Weeks 24, 48 and Follow-up Week 24
Percentage of Participants With Normalized ALT Levels in Virologically Suppressed Population
Time frame: Weeks 24, 48 and Follow-up Week 24
Percentage of Participants With Virological Breakthrough in Currently Not Treated Population
Time frame: Weeks 24 and 48
Percentage of Participants With Virological Breakthrough in Virologically Suppressed Population
Time frame: Weeks 24 and 48
Plasma Concentrations of Entecavir [ETV] in Currently Not Treated Population
Time frame: Day 1: 0 hours, 2 hours; Weeks 1, 2, 4, 8, 12, 20, 24, 28, 32, 36, 44, 48: 0 hours; Follow-up: Weeks 2 and 4
Plasma Concentrations of ETV in Virologically Suppressed Population
Time frame: Day 1: 0 hours, 2 hours; Weeks 1, 2, 4, 8, 12, 20, 24, 28, 32, 36, 44, 48: 0 hours; Follow-up: Weeks 2 and 4
Plasma Concentrations of Tenofovir Disoproxil Fumarate (TDF) in Currently Not Treated Population
Time frame: Day 1: 0 hours, 2 hours; Weeks 1, 2, 4, 8, 12, 20, 24, 28, 32, 36, 44, 48: 0 hours; Follow-up: Weeks 2 and 4
Plasma Concentrations of TDF in Virologically Suppressed Population
Time frame: Day 1: 0 hours, 2 hours; Weeks 1, 2, 4, 8, 12, 20, 24, 28, 32, 36, 44, 48: 0 hours; Follow-up: Weeks 2 and 4
Plasma Concentrations of JNJ-56136379 in Currently Not Treated Population
Time frame: Day 1: 0 hours, 2 hours; Weeks 1, 2, 4, 8, 12, 20, 24, 28, 32, 36, 44, 48: 0 hours; Follow-up: Weeks 2 and 4
Plasma Concentrations of JNJ-56136379 in Virologically Suppressed Population
Time frame: Day 1: 0 hours, 2 hours; Weeks 1, 2, 4, 8, 12, 20, 24, 28, 32, 36, 44, 48: 0 hours; Follow-up: Weeks 2 and 4
Number of Participants With Treatment-Associated Mutations
Time frame: From Week 0 to Week 24, From Week 25 to Week 48, Up to Follow-up Week 24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37385475Verbinnen T, Talloen W, Janssen HLA, Zoulim F, Shukla U, Vandenbossche JJ, Biermer M, De Meyer S, Lenz O. Viral sequence analysis of chronic hepatitis B patients treated with the capsid assembly modulator JNJ-56136379 in the JADE phase 2a study. Antiviral Res. 2023 Aug;216:105660. doi: 10.1016/j.antiviral.2023.105660. Epub 2023 Jun 28.
- Derived from this study: PubMed 36697207Janssen HLA, Hou J, Asselah T, Chan HLY, Zoulim F, Tanaka Y, Janczewska E, Nahass RG, Bourgeois S, Buti M, Lampertico P, Lenz O, Verbinnen T, Vandenbossche J, Talloen W, Kalmeijer R, Beumont M, Biermer M, Shukla U. Randomised phase 2 study (JADE) of the HBV capsid assembly modulator JNJ-56136379 with or without a nucleos(t)ide analogue in patients with chronic hepatitis B infection. Gut. 2023 Jul;72(7):1385-1398. doi: 10.1136/gutjnl-2022-328041. Epub 2023 Jan 25.
- Derived from this study: PubMed 32094138Berke JM, Dehertogh P, Vergauwen K, Mostmans W, Vandyck K, Raboisson P, Pauwels F. Antiviral Properties and Mechanism of Action Studies of the Hepatitis B Virus Capsid Assembly Modulator JNJ-56136379. Antimicrob Agents Chemother. 2020 Apr 21;64(5):e02439-19. doi: 10.1128/AAC.02439-19. Print 2020 Apr 21.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janssen Sciences Ireland UC Clinical Trial study director
Janssen Sciences Ireland UC
76 sites in 19 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing JNJ-56136379 and NA (ETV or TDF) in people with Hepatitis B, run by Janssen Sciences Ireland UC at 76 sites in 19 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 76 sites in United States, Canada, Japan, Spain, China and 14 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Nov 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Hepatitis B Surface Antigen (HBsAg) Levels in Currently Not Treated Population at Week 24 (time frame: Baseline and Week 24). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03361956, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2022.