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

NCT04133259 | Unknown Phase 2 DMC

• 1 other identifier: HLX10/HBV-01
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Hepatitis B, Chronic

Keywords

Hepatitis B, Chronic; Monoclonal antibody

Outcome Measures

Primary Outcomes (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

  12 week

Secondary Outcomes (3)

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

  24 weeks

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

  9 months

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

  9 months

Study Arms (1)

HLX10, in patients with CHB

EXPERIMENTAL

HLX10: 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.

Drug: Recombinant anti-programmed death-1 (PD-1) humanized monoclonal antibody; Drug: Nucleoside/nucleotide analogues

Interventions

Recombinant anti-programmed death-1 (PD-1) humanized monoclonal antibody DRUG

Treatment of CHB patient with HLX10

Also known as: HLX10 for Injection, HLX10

HLX10, in patients with CHB

Nucleoside/nucleotide analogues DRUG

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

Also known as: Entecavir, Tenofovir disoproxil fumarate

HLX10, in patients with CHB

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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;
• 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.

Sponsors & Collaborators

• Henlix, Inc: lead

Study Sites (3)

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, Taiwan

RECRUITING

China Medical University Hospital

Taichung, Taiwan

RECRUITING

National Taiwan University Hospita

Taipei, Taiwan

RECRUITING

MeSH Terms

Conditions

Hepatitis B, Chronic

Interventions

Antibodies, Monoclonal, Humanized; Injections; Nucleosides; entecavir; Tenofovir

Condition Hierarchy (Ancestors)

Hepatitis B; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Drug Administration Routes; Drug Therapy; Therapeutics; Glycosides; Carbohydrates; Nucleic Acids, Nucleotides, and Nucleosides; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Jia-Horng Kao, MD, PhD

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

• Cheng-Yuan Peng, MD, PhD

  China Medical University Hospital

  PRINCIPAL INVESTIGATOR

• Chia-Yen Dai, MD, PhD

  Kaohsiung Medical University Chung-Ho Memorial Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jia-Ling Lee

CONTACT

+886-2-792-7927; jlee@henlix.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Simon's Two-Stage Optimal design

Study Record Dates

• First Submitted: October 1, 2019
• First Posted: October 21, 2019
• Study Start: December 31, 2019
• Primary Completion: April 30, 2022
• Study Completion: July 30, 2022
• Last Updated: October 20, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

TW (3)