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Hepatitis B, ChronicPhase 1OSPREYNCT05123599

A Study of JNJ-73763989, JNJ-64300535, and Nucleos(t)Ide Analogs in Virologically Suppressed, Hepatitis B e Antigen (HBeAg)- Negative Participants With Chronic Hepatitis B Virus Infection

A Phase 1 study testing JNJ-73763989, JNJ-64300535 and ETV monohydrate in people with Hepatitis B, Chronic, run by Janssen Research & Development, LLC at 13 sites in 8 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of this study is to evaluate the efficacy of the study intervention based on hepatitis B surface antigen (HBsAg) levels. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Hepatitis B, Chronic
What is being tested?
JNJ-73763989, JNJ-64300535 and ETV monohydrate
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
13 sitesin 8 countries
Study dates
6 Dec 2021to 26 Jun 2024
Phase
Phase 1
Are there results?
None posted in the registry

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 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Participants must be medically stable based on physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at screening. Any abnormalities, must be consistent with the underlying illness in the study population and this determination must be recorded in the participant's source documents and initialed by the investigator
  • Participants must have a body mass index (BMI; weight in kilograms [kg] divided by the square of height in meters) between 19.0 and 32.0 kilograms per meter square (kg/m^2), extremes included
  • A woman of childbearing potential must have a negative highly sensitive serum pregnancy test (beta-human chorionic gonadotropin) at screening and a negative urine pregnancy test on Day 1 before the first dose of study intervention
  • Participants must have chronic hepatitis B virus (HBV) infection. HBV infection must be documented by serum hepatitis B surface antigen (HBsAg) positivity at screening. In addition, chronicity must be documented by any of the following, at least 6 months prior to screening: serum HBsAg positivity, hepatitis B e antigen (HBeAg) positivity or HBV deoxyribonucleic acid (DNA) positivity, alanine aminotransferase (ALT) elevation above upper limit of normal (ULN) without another cause than HBV infection, documented transmission event. If none of the above are available, the following ways of documenting chronicity are acceptable at the time of screening: liver biopsy with changes consistent with chronic HBV, or absence of marker for acute HBV infection such as positive immunoglobulin M (IgM) anti- hepatitis B surface protein (HBs) and anti- hepatitis B core protein (HBc) antibodies. Virologically suppressed participants should: a) be HBeAg-negative and anti- hepatitis B e (HBe) positive, b) be on stable HBV treatment, defined as currently receiving nucleos(t)ide analog (NA) treatment for at least 6 months prior to screening and having been on the same NA treatment regimen (at the same dose) as used in this study for at least 3 months at the time of screening, c) have serum HBV deoxyribonucleic acid (DNA) less than (<) 60 International units per milliliter (IU/mL) on 2 sequential measurements at least 6 months apart (one of which is at screening), and d) have documented ALT values <2.0* ULN on 2 sequential measurements at least 6 months apart (one of which is at screening)
  • Participants must have: a) Fibroscan liver stiffness measurement less than or equal to (<=) 9.0 kPa within 6 months prior to screening or at the time of screening, or b) If a Fibroscan result is not available: a liver biopsy result classified as Metavir F0-F2 within 1 year prior to screening

Who cannot join

  • History or evidence of clinical signs or symptoms of hepatic decompensation, including but not limited to: portal hypertension, ascites, hepatic encephalopathy, esophageal varices
  • Participants with a history of malignancy within 5 years before screening (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy, which are considered cured with minimal risk of recurrence)
  • Participants with any history of or current clinically significant skin disease requiring regular or periodic treatment
  • Participants with clinically relevant alcohol or drug abuse within 12 months of screening
  • Participants who had major surgery (example, requiring general anesthesia), excluding diagnostic surgery, within 12 weeks before screening; or will not have fully recovered from surgery; or have surgery planned during the time of expected participation in the study

Trial locations and contacts

13 sites in 8 countries.

13 sites in 8 countries

Belgium2 sites

  • UZ Antwerpen

    Edegem, 2650

  • UZA-SGS

    Edegem, 2650

Other trials in Belgium

France2 sites

  • Hopital Beaujon

    Clichy, 92110

  • Hopital de La Croix Rousse

    Lyon, 69004

Other trials in France

Italy2 sites

  • Irccs Ospedale Maggiore Di Milano

    Milan, 20122

  • Azienda Ospedaliero Universitaria Pisana

    Pisa, 56124

Other trials in Italy

Spain2 sites

  • Hosp Univ Vall D Hebron

    Barcelona, 08035

  • Hosp. Univ. Marques de Valdecilla

    Santander, 39008

Other trials in Spain

Taiwan2 sites

  • E-DA Hospital

    Kaohsiung City, 82445

  • Chang Gung Memorial Hospital Linkou Branch

    Taoyuan, 333

Other trials in Taiwan

New Zealand1 site

  • New Zealand Clinical Research

    Auckland, 1010

Other trials in New Zealand

Poland1 site

  • ID Clinic

    Mysłowice, 41-400

Other trials in Poland

United Kingdom1 site

  • Kings College Hospital

    London, SE5 9RF

Other trials in United Kingdom

About this study

Official title: A Phase 1b, Open-label, Single-arm, Multicenter Study to Assess Efficacy, Safety, and Tolerability of Treatment With JNJ-73763989, JNJ-64300535, and Nucleos(t)Ide Analogs in Virologically Suppressed, HBeAg-negative Participants With Chronic Hepatitis B Virus Infection

The purpose of this study is to evaluate the efficacy of the study intervention based on hepatitis B surface antigen (HBsAg) levels.

Read the detailed description

JNJ-73763989 is a liver-targeted antiviral therapeutic for subcutaneous injection designed to treat chronic hepatitis B virus (HBV) infection via a ribonucleic acid interference (RNAi) mechanism. JNJ-64300535 is a DNA vaccine encoding the core protein and the Polymerase (Pol) protein of HBV. The therapeutic vaccine aims at inducing T-cell-specific immunity against HBV antigens in participants with chronic hepatitis B (CHB). Selected nucleos(t)ide analogs (NAs) used in this study are approved treatments of chronic HBV infection. This study is designed to assess efficacy, safety, and tolerability of a 24-week (Day 1 to Week 24) combination treatment with JNJ-73763989 + NA + JNJ-64300535. The study consists of a Screening phase (4 weeks), Treatment period with JNJ-73763989, NA and JNJ-64300535 (187 days), and a follow-up period (FU Week 1 till FO Week 48). Safety will be assessed by adverse events (AEs), clinical safety laboratory assessments, electrocardiograms (ECGs), vital signs and physical examinations. The total duration of the study is up to 88 weeks (including 4 weeks of screening).

Being tested
JNJ-73763989, JNJ-64300535, ETV monohydrate, Tenofovir disoproxil, TAF
Medical subject headings
Hepatitis B, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • JNJ-73763989Drug

    Also called JNJ-3989

    JNJ-73763989 injection will be administered subcutaneously.

  • JNJ-64300535Biological

    Also called JNJ-0535

    JNJ-64300535 deoxyribonucleic acid (DNA) vaccine injection will be administered intramuscularly.

  • ETV monohydrateDrug

    ETV monohydrate film-coated tablets will be administered orally.

  • Tenofovir disoproxilDrug

    Tenofovir disoproxil film-coated tablets will be administered orally.

  • TAFDrug

    TAF film-coated tablets will be administered orally.

Study groups in NCT05123599
Study groupRoleWhat they receive
JNJ-73763989 plus JNJ-64300535 plus Nucleos(t)ide Analogs (NAs)ExperimentalParticipants will receive JNJ-73763989 subcutaneous (SC) injection once every 4 weeks (q4w), NA (either Entecavir monohydrate [ETV], Tenofovir disoproxil or Tenofovir alafemide [TAF]) oral tablets once daily (qd) and JNJ-64300535 intramuscular (IM) injection q4w. From day 187, participants will receive treatment with NA oral tablets qd up to Week 36.
Receives: Drug: JNJ-73763989; Biological: JNJ-64300535; Drug: ETV monohydrate; Drug: Tenofovir disoproxil; Drug: TAF

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants with a Reduction of at Least 2 log10 International Units per Milliliter (IU/mL) in Hepatitis B Surface Antigen (HBsAg) Levels from Baseline to Week 36

    Percentage of participants with a reduction of at least 2 log10 IU/mL in HBsAg levels from baseline to Week 36 will be reported.

    Measured: Baseline to Week 36 (end of study intervention)

Secondary outcomes (24)

  1. Percentage of Participants with at Least 3-fold Increase in Hepatitis B Virus (HBV)- Specific T-Cell Response Against Vaccine Antigen HBV Core and/or Pol

    Percentage of participants with at least 3-fold increase in HBV-specific T-cell response against vaccine antigen HBV core and/or pol as assessed by enzyme-linked immunospot (ELISpot) will be reported.

    Measured: From Day 103 up to Week 84

  2. Percentage of Responders Against Vaccine Antigen HBV Core and/or Pol

    Percentage of responders against vaccine antigen HBV core and/or Pol as assessed by ELISpot will be reported. A responder is defined as a participant with at least a 3-fold increase in HBV-specific T-cell response from the start of vaccination against the vaccine antigen core and/or pol, at least at the last timepoint during the vaccination period.

    Measured: Week 28

  3. Percentage of Participants with Adverse Events (AEs)

    An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.

    Measured: Up to Week 84

  4. Percentage of Participants with Serious AEs

    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 84

  5. Percentage of Participants with Abnormalities in Clinical Laboratory Tests

    Percentage of participants with abnormalities in clinical laboratory tests (hematology, blood biochemistry, blood coagulation, urinalysis, urine chemistry, and renal biomarkers) will be reported.

    Measured: Up to Week 84

  6. Percentage of Participants with Abnormalities in 12- lead Electrocardiograms (ECGs)

    Percentage of participants with abnormalities in 12- lead ECGs will be reported.

    Measured: Up to Week 84

  7. Percentage of Participants with Abnormalities in Vital Signs

    Percentage of participants with abnormalities in vital signs will be reported.

    Measured: Up to Week 84

  8. Percentage of Participants with Abnormalities in Physical Examinations

    Percentage of participants with abnormalities in physical examinations will be reported.

    Measured: Up to Week 84

  9. Percentage of Participants with Solicited Local AEs for JNJ-64300535 up to 7 Days Post Each Vaccination

    Solicited local AEs include (injection site pain/tenderness, erythema and swelling at the study vaccine injection site and the extent (largest diameter) of any erythema and swelling [using the ruler supplied]) will be reported after 7 days of each vaccination.

    Measured: 7 days post each vaccination (Up to Day 194)

  10. Percentage of Participants with Solicited Systematic AEs for JNJ-64300535 up to 7 Days Post Each Vaccination

    Solicited systemic AEs (include body temperature, fatigue, headache, nausea, myalgia) will be reported after 7 days of each vaccination.

    Measured: 7 days post each vaccination (Up to Day 194)

  11. Change from Baseline Over Time in HBsAg Levels

    Change from baseline over time in HBsAg levels will be reported.

    Measured: Baseline up to Week 84

  12. Change from Start of Vaccination Over Time in HBsAg Levels

    Change from start of vaccination over time in HBsAg levels will be reported.

    Measured: From Day 103 up to Week 84

  13. Percentage of Participants with HBsAg, HBV Deoxyribonucleic Acid (DNA) and Alanine Aminotransferase (ALT) Levels Below/Above Different Cut-offs

    Percentage of participants with HBsAg, HBV DNA and ALT levels below/above different cut-offs will be reported.

    Measured: Up to Week 84

  14. Percentage of Participants with HBsAg Seroclearance

    Percentage of participants with HBsAg seroclearance (HBsAg negativity) will be reported.

    Measured: Up to Week 84

  15. Percentage of Participants with HBsAg Seroconversion

    Percentage of participants with HBsAg seroconversion (HBsAg negativity and anti-HBs antibody positivity) will be reported.

    Measured: Up to Week 84

  16. Time to Achieve HBsAg Seroclearance

    Time to achieve HBsAg seroclearance will be reported.

    Measured: Up to Week 84

  17. Time to Achieve HBsAg Seroconversion

    Time to achieve HBsAg seroconversion will be reported.

    Measured: Up to Week 84

  18. Percentage of Participants Meeting Nucleos(t)ide Analog (NA) Treatment Completion Criteria

    Percentage of participants meeting NA treatment completion criteria will be reported.

    Measured: Week 38 and Week 40

  19. Percentage of Participants with Virological Breakthrough

    Percentage of participants with virological breakthrough (confirmed on-treatment HBV DNA increase by greater than [>] 1 log10 IU/mL from nadir or confirmed on-treatment HBV DNA level >200 IU/mL in participants who had HBV DNA level less than [<] lower limit of quantification [LLOQ] of the HBV DNA assay) will be reported.

    Measured: Up to Week 36

  20. Percentage of Participants with HBsAg Seroclearance at Week 60 and Week 84

    Percentage of participants with HBsAg seroclearance at Weeks 60 and 84 (during follow-up period) will be reported.

    Measured: Weeks 60 and 84

  21. Percentage of Participants with HBV DNA <LLOQ at Week 60 and Week 84

    Percentage of participants with HBV DNA <LLOQ at Weeks 60 and 84 (during follow-up period) will be reported.

    Measured: Weeks 60 and 84

  22. Percentage of Participants with Viral Flares

    Percentage of participants with viral flares will be reported.

    Measured: From Week 36 to Week 84

  23. Percentage of Participants with Biochemical Flares

    Percentage of participants with biochemical flares will be reported.

    Measured: From Week 36 to Week 84

  24. Number of TriGrid Delivery System (TDS)-Intramuscular (IM) version 2.0 Device Fault Conditions by Type

    Number of TDS-IM v2.0 device fault conditions by type will be observed. User reported fault conditions will be documented to enable assessment of the device reliability. Device functions to be assessed include electrode/needle deployment, JNJ-64300535 administration, and electroporation application.

    Measured: From Day 103 to Day 187

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Nov 2021
  2. Study start6 Dec 2021
  3. Primary completion31 Jul 2023
  4. Study completion26 Jun 2024

Resources

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 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05123599
Sponsor's protocol ID
CR109042
Other IDs
2020-005584-30, 73763989PAHPB1006
Acronym
OSPREY
Status last verified
May 2025
First submitted
16 Nov 2021
Last updated
26 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson and Johnson is available at www.janssen.com/clinical trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing JNJ-73763989, JNJ-64300535 and ETV monohydrate in people with Hepatitis B, Chronic, run by Janssen Research & Development, LLC at 13 sites in 8 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 5 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 26 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in Belgium, France, Italy, Spain, Taiwan and 3 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Percentage of Participants with a Reduction of at Least 2 log10 International Units per Milliliter (IU/mL) in Hepatitis B Surface Antigen (HBsAg) Levels from Baseline to Week 36 (time frame: Baseline to Week 36 (end of study intervention)). 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 NCT05123599.

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 26 May 2025.

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