Status:
UNKNOWN
Evaluate the Efficacy and Safety of HLX10 in Chronic Hepatitis B Patients
Lead Sponsor:
Henlix, Inc
Conditions:
Hepatitis B, Chronic
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
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.
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 ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
- 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.
Key Trial Info
Start Date :
December 31 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 30 2022
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT04133259
Start Date
December 31 2019
End Date
July 30 2022
Last Update
October 20 2020
Active Locations (3)
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1
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, Taiwan
2
China Medical University Hospital
Taichung, Taiwan
3
National Taiwan University Hospita
Taipei, Taiwan