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Hepatitis B, ChronicPhase 2NCT04133259

Evaluate the Efficacy and Safety of HLX10 in Chronic Hepatitis B Patients

A Phase 2 study testing Recombinant anti-programmed death-1 (PD-1) humanized monoclonal antibody and Nucleoside/nucleotide analogues in people with Hepatitis B, Chronic, run by Henlix, Inc at 3 sites in Taiwan.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

A multiple-center, open-label, Phase II clinical trial to evaluate the safety and the efficacy of HLX10 in chronic hepatitis B patients. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Hepatitis B, Chronic
What is being tested?
Recombinant anti-programmed death-1 (PD-1) humanized monoclonal antibody and Nucleoside/nucleotide analogues
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
44 participants
Where
3 sitesTaiwan
Study dates
31 Dec 2019to 30 Jul 2022
Phase
Phase 2
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 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Eligible subjects must be 18 years of age or older or per local regulations and younger than 65 years.
  • Subjects with chronic hepatitis B infection with serum HBsAg level > 100 IU/mL. [Chronic hepatitis B infection/carrier status must be confirmed by at least two laboratory results of persistent hepatitis B virus (HBV) infection (positive HBs antigen or HBV DNA) collected 6 months apart before the first infusion of HLX10.]
  • Achieved viral suppression, defined as: HBV DNA level (checked within 4 weeks before the first dose of HLX10) lower than 2000 IU/mL.
  • Subjects must be either (1) under nucleoside/nucleotide analogues (NAs) therapy and has achieved viral suppression at the time of study entry or (2) who currently are not taking anti-viral NAs but be able and willing to take one of the designated NAs for a duration of 14 to 22 weeks (2 weeks before the first dose of HLX10, up to 8 weeks during treatment, 12 weeks after the last dose of HLX10).
  • HBe antigen (checked within 4 weeks before the first dose of HLX10) must be negative.
  • Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1 at the time of study entry.
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  • Able to provide informed consent.
  • Adequate hematologic functions, as defined by: a normal white blood cell count, a normal absolute neutrophil count; a hemoglobin level ≥ 10 gm/dL and a platelet count ≥ 100,000/mm3.
  • Adequate hepatic function defined by: a normal total bilirubin level, alanine transaminase (ALT) level and a prothrombin time of INR < 1.5 times normal.
  • Adequate renal function, as defined by the creatinine clearance rate ≥ 50 mL/minute calculated using Cockcroft-Gault formula. In subject with extreme body weight (BMI < 18.5 or > 30), estimated glomerular filtration rate (eGFR) > 50 mL/min calculated using Modification of Diet in Renal Disease (MDRD) formula is acceptable.
  • Adequate cardiac function defined as left ventricular ejection fraction (LVEF) ≥ 50% measured by multigated acquisition (MUGA) scan or cardiac ultrasound.
  • Use of effective contraceptive measures if procreative potential exists .
  • Able to be followed up the procedures as required by the study protocol.

Who cannot join

  • Concurrent unstable or uncontrolled medical conditions which include either one of the followings:
  • Active systemic infections that necessitate antimicrobial therapy;
  • Poorly controlled hypertension (systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥100 mmHg), or poor compliance with anti-hypertensive agents;
  • Acute myocardial infarction within 12 months OR clinically significant arrhythmia, unstable angina pectoris, congestive heart failure (class III or IV of New York Heart Association [NYHA]);
  • Uncontrolled diabetes (HbA1c > 9.5% in past three months) or poor compliance with hypoglycemic agents;
  • The presence of chronically unhealed wound or ulcers;
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  • Other chronic diseases, which, in the opinion of the investigator, could compromise safety of the subject or the integrity of study.
  • Any concurrent malignancy other than basal cell carcinoma or carcinoma in situ of the cervix. (Subjects with a previous malignancy without history of liver involvement and without evidence of disease for ≥ 3 years can participate).
  • Pregnancy (confirmed by urine beta human chorionic gonadotropin [ßHCG]) or breast-feeding.
  • History of human immunodeficiency virus infection (HIV). All subjects must agree to undergone screening for HIV.
  • Subject who has an active or a documented history of autoimmune disease (must be confirmed by negative antinuclear antibodies (ANA), rheumatic factor (RF) and anti-double stranded DNA level (anti-dsDNA)).
  • Subject who currently has hepatitis C (defined as anti-HCV antibody reactive or detectable HCV RNA > 15 IU/L) or hepatitis D (defined as anti-HDV antibody reactive).
  • Subject who has a history of interstitial lung disease.
  • Have a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids and adrenal replacement doses > 10 mg daily prednisone equivalents are permitted in the absence of autoimmune disease.
  • The subject is the investigator, sub-investigator or any one directly involved in the conduct of the study.
  • Subject has a history or current evidence of any condition or disease that could confound the results of the study or is not the best interest of the subject to participate, in the opinion of Investigator.
  • History of alcoholism OR recreational drug use.
  • Preexisting advanced liver disease and cirrhosis subject: advanced hepatic fibrosis and cirrhosis are defined as Fibroscan ≥ 9.5 Kpa or Acoustic radiation force impulse (ARFI) ≥ 1.81 m/sec or Fibrosis-4 (FIB-4) ≥ 3.25 or METAVIR F ≥ 3.

Trial locations and contacts

3 sites in 1 country.

Jia-Ling Lee contact

+886-2-792-7927 ext. 105

jlee@henlix.com

Taiwan3 sites, 3 recruiting

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung City

    Chia-Yen Dai, MD, PhD

    Recruiting

  • China Medical University Hospital

    Taichung

    Cheng-Yuan Peng, MD, PhD

    Recruiting

  • National Taiwan University Hospita

    Taipei

    Jia-Horng Kao, MD, PhD

    Recruiting

Other trials in Taiwan

About this study

Official title: An Exploratory Study to Evaluate The Efficacy And Safety of HLX10, A Humanized Monoclonal Antibody Targeting Programmed Death-1 (PD-1) Protein In Chronic Hepatitis B Patients

A multiple-center, open-label, Phase II clinical trial to evaluate the safety and the efficacy of HLX10 in chronic hepatitis B patients.

Read the detailed description

This study is multiple-center, open-label, Phase II clinical trial and uses Simon's Two-Stage Optimal design. Subjects with chronic hepatitis B (CHB) will be enrolled sequentially and receive up to 3 doses of HLX10 at 1 mg/kg for four weeks apart.

First six subjects will be enrolled in the safety run-in period. If there are no serious adverse events noticed in these 6 subjects up to 6 weeks after the last infusion of HLX10, additional 11 subjects will be enrolled. These 17 subjects (6+11) will be evaluated for efficacy. In the second stage of trial, 27 additional subjects will be enrolled. Total 44 subjects [stage I (n=17) + stage II (n= 27) = total (n=44)] will be accrued in this study.

Being tested
Recombinant anti-programmed death-1 (PD-1) humanized monoclonal antibody, Nucleoside/nucleotide analogues
Keywords
Hepatitis B, Chronic, Monoclonal antibody
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.

  • Recombinant anti-programmed death-1 (PD-1) humanized monoclonal antibodyDrug

    Also called HLX10 for Injection, HLX10

    Treatment of CHB patient with HLX10

  • Nucleoside/nucleotide analoguesDrug

    Also called Entecavir, Tenofovir disoproxil fumarate

    Treatment NAs for chronic hepatitis B subject to achieve adequate HBV viral suppression

Study groups in NCT04133259
Study groupRoleWhat they receive
HLX10, in patients with CHBExperimentalHLX10: 1 mg/kg at 0, 4th, 8th week (maximum 3 doses). Concomitant antiviral medications: take Nucleoside/nucleotide analogues (NAs) starting from at least 2 weeks before the first dose of HLX10 until 12 weeks after the last dose of HLX10 infusion.
Receives: Drug: Recombinant anti-programmed death-1 (PD-1) humanized monoclonal antibody; Drug: Nucleoside/nucleotide analogues

What is being measured

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

  1. The proportion of the subjects who achieve 0.5 log decline in HBsAg log10 IU/mL from baseline

    Efficacy of HLX10 for treatment of chronic HBV

    Measured: 12 week

Secondary outcomes (3)

  1. The proportion of the subjects who achieve 1 log decline in HBsAg log10 IU/mL from baseline

    Efficacy of HLX10 for treatment of chronic HBV

    Measured: 24 weeks

  2. The proportion of subjects with chronic hepatitis B that achieve HBsAg seroclearance after receiving treatment with HLX10.

    HLX10 for curative treatment of chronic HBV

    Measured: 9 months

  3. The proportion of subjects with chronic hepatitis B who suffered from hepatitis flare after receiving HLX10

    Safety of HLX10 in treatment of chronic HBV

    Measured: 9 months

Timeline

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

  1. First posted21 Oct 2019
  2. Study start31 Dec 2019
  3. Primary completion30 Apr 2022 (estimated)
  4. Study completion30 Jul 2022 (estimated)

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Simon's Two-Stage Optimal design
Masking
None (open label)
Enrolment
44 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04133259
Sponsor's protocol ID
HLX10/HBV-01
Status last verified
Oct 2020
First submitted
1 Oct 2019
Last updated
20 Oct 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Recombinant anti-programmed death-1 (PD-1) humanized monoclonal antibody and Nucleoside/nucleotide analogues in people with Hepatitis B, Chronic, run by Henlix, Inc at 3 sites in Taiwan.

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 13 inclusion and 18 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: status not confirmed, as of the sponsor's last update on 20 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Taiwan. 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 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Jia-Ling Lee (+886-2-792-7927 ext. 105, jlee@henlix.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The proportion of the subjects who achieve 0.5 log decline in HBsAg log10 IU/mL from baseline (time frame: 12 week). 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 NCT04133259.

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 20 Oct 2020.

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