Clinical Trials List
Protocol NumberHLX10/HBV-01
NCT Number(ClinicalTrials.gov Identfier)NCT04133259
2019-08-01 - 2021-11-03
Phase II
Recruiting3
ICD-10B18.1
Chronic viral hepatitis B without delta-agent
ICD-9070.32
Viral hepatitis B without mention of hepatic coma, chronic, without mention of hepatitis delta
An Exploratory Study to Evaluate the Efficacy And Safety of HLX10, A Humanized Monoclonal Antibody Targeting Programmed Death-1 (PD-1) Protein In Chronic HepatitisB Patients
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Trial Applicant
PROTECH PHARMASERVICES CORPORATION
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Sponsor
Henlius Biotech Co., Ltd.
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Trial scale
Taiwan Multiple Center
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Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
- Hung-Yao Chen Division of General Internal Medicine
- Tsung-Yu Tsai Division of General Internal Medicine
- Hung-Wei Wang Division of General Internal Medicine
- Wei-Fan Hsu Division of General Internal Medicine
- Hsueh-Chou Lai Division of General Internal Medicine
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 楊宏志 Division of General Internal Medicine
- 曾岱宗 Division of General Internal Medicine
- Chun-Jen Liu Division of General Internal Medicine
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Wan-Long Chuang Digestive System Department
- Jee-Fu Huang Digestive System Department
- Ming-Lung Yu Digestive System Department
- 黃駿逸 Digestive System Department
- Chung-Feng Huang Digestive System Department
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Chronic Hepatitis B
Objectives
Primary objective
• To investigate the efficacy of HLX10 for treatment of chronic hepatitis B.
Secondary objectives
• To investigate the proportion of subjects with chronic hepatitis B that achieve HBs
antigen seroclearance after receiving treatment with HLX10.
• To investigate the safety of HLX10 in subjects with chronic hepatitis B.
• To investigate the population pharmacokinetics and immunogenicity of HLX10 in
subjects with chronic hepatitis B.
Exploratory objectives
• To explore the potential biomarkers for the response to HLX10 in subjects with chronic
hepatitis B.
Test Drug
HLX10
Active Ingredient
HLX10
Dosage Form
Intravenous Infusion
Dosage
100 mg/10 mL/vial
Endpoints
Primary endpoints
• The proportion of the subjects who achieve one log decline in HBsAg log10 IU/mL from baseline to at 24th week after the last dose of HLX10.
Secondary endpoints
• The proportion of subjects who achieve HBsAg loss at 24th week after the last dose of HLX10.
• The HLX10-related toxicity profile, including but not limited to immune-related hepatitis and hepatitis B flare in subjects with chronic hepatitis B.
Exploratory endpoints
• The relationship between various viral and immune biomarkers and efficacy of HLX10 in chronic hepatitis B.
• The proportion of the subjects who achieve one log decline in HBsAg log10 IU/mL from baseline to at 24th week after the last dose of HLX10.
Secondary endpoints
• The proportion of subjects who achieve HBsAg loss at 24th week after the last dose of HLX10.
• The HLX10-related toxicity profile, including but not limited to immune-related hepatitis and hepatitis B flare in subjects with chronic hepatitis B.
Exploratory endpoints
• The relationship between various viral and immune biomarkers and efficacy of HLX10 in chronic hepatitis B.
Inclution Criteria
1. Eligible subjects must be 18 years of age or older or per local regulation AND younger than 80 years old age.
2. Subjects with chronic hepatitis B infection and HBsAg level must be >100 IU/mL.
[Chronic hepatitis B infection /carrier status must be confirmed by at least two
laboratory results of persistent HBV infection (positive HBs antigen or HBV DNA)
collected 6 months apart before the first infusion of HLX10.]
3. HBV DNA level (checked within 4 weeks before the first dose of HLX10) must be lower than 2000 IU/mL
4. 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).
5. HBe antigen (checked within 4 weeks before the first dose of HLX10) must be negative.
6. Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1 at the time of study entry.
7. Able to provide informed consent.
8. 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.
9. Adequate hepatic function defined by: a normal total bilirubin level, alanine
transaminase (ALT) level and a prothrombin time of INR <1.5 times normal.
10. Adequate renal function, as defined by the creatinine clearance rate ≥ 50 mL/minute
calculated using Cockcroft-Gault formula. In patient with extreme body weight (BMI
< 18.5 or > 30), estimated glomerular filtration rate (eGFR) > 50mL/min calculated
using Modification of Diet in Renal Disease (MDRD) formula is acceptable.
11. Adequate cardiac function defined as left ventricular ejection fraction (LVEF) ≥ 50%
measured by multigated acquisition (MUGA) scan or cardiac ultrasound.
12. Use of effective contraceptive measures if procreative potential exists3.
13. Able to be followed up the procedures as required by the study protocol.
2. Subjects with chronic hepatitis B infection and HBsAg level must be >100 IU/mL.
[Chronic hepatitis B infection /carrier status must be confirmed by at least two
laboratory results of persistent HBV infection (positive HBs antigen or HBV DNA)
collected 6 months apart before the first infusion of HLX10.]
3. HBV DNA level (checked within 4 weeks before the first dose of HLX10) must be lower than 2000 IU/mL
4. 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).
5. HBe antigen (checked within 4 weeks before the first dose of HLX10) must be negative.
6. Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1 at the time of study entry.
7. Able to provide informed consent.
8. 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.
9. Adequate hepatic function defined by: a normal total bilirubin level, alanine
transaminase (ALT) level and a prothrombin time of INR <1.5 times normal.
10. Adequate renal function, as defined by the creatinine clearance rate ≥ 50 mL/minute
calculated using Cockcroft-Gault formula. In patient with extreme body weight (BMI
< 18.5 or > 30), estimated glomerular filtration rate (eGFR) > 50mL/min calculated
using Modification of Diet in Renal Disease (MDRD) formula is acceptable.
11. Adequate cardiac function defined as left ventricular ejection fraction (LVEF) ≥ 50%
measured by multigated acquisition (MUGA) scan or cardiac ultrasound.
12. Use of effective contraceptive measures if procreative potential exists3.
13. Able to be followed up the procedures as required by the study protocol.
Exclusion Criteria
1. 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 antihypertensive 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 patient or the integrity of study.
2. 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 ≥ γ years can participate).
3. Pregnancy (confirmed by urine beta human chorionic gonadotropin [ßHCG]) or breastfeeding.
4. History of human immunodeficiency virus infection (HIV). All subjects must agree to
undergone screening for HIV.
5. Patient who has an active or a documented history of autoimmune disease (must be
confirmed by negative antinuclear antibodies (ANA), rheumatic factor (RF) and antidouble stranded DNA level (anti-dsDNA)).
6. Patient who currently has hepatitis C (defined as anti-HCV antibody reactive or
detectable HCV RNA > 15 IU/L) or hepatitis D.
7. Patient who has a history of interstitial lung disease.
8. 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.
9. The patient is the investigator, sub-investigator or any one directly involved in the
conduct of the study.
10. Patient 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 patient to participate, in the
opinion of Investigator.
11. History of alcoholism OR recreational drug use.
12. Preexisting advanced liver disease and cirrhosis patient : advanced hepatic fibrosis and
cirrhosis are defined as Fibroscan ≥ 9.5 Kpa or ARFI ≥ 1.81 m/sec or FIB-4 ≥ 3.25
.METAVIR F ≥3.
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 antihypertensive 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 patient or the integrity of study.
2. 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 ≥ γ years can participate).
3. Pregnancy (confirmed by urine beta human chorionic gonadotropin [ßHCG]) or breastfeeding.
4. History of human immunodeficiency virus infection (HIV). All subjects must agree to
undergone screening for HIV.
5. Patient who has an active or a documented history of autoimmune disease (must be
confirmed by negative antinuclear antibodies (ANA), rheumatic factor (RF) and antidouble stranded DNA level (anti-dsDNA)).
6. Patient who currently has hepatitis C (defined as anti-HCV antibody reactive or
detectable HCV RNA > 15 IU/L) or hepatitis D.
7. Patient who has a history of interstitial lung disease.
8. 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.
9. The patient is the investigator, sub-investigator or any one directly involved in the
conduct of the study.
10. Patient 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 patient to participate, in the
opinion of Investigator.
11. History of alcoholism OR recreational drug use.
12. Preexisting advanced liver disease and cirrhosis patient : advanced hepatic fibrosis and
cirrhosis are defined as Fibroscan ≥ 9.5 Kpa or ARFI ≥ 1.81 m/sec or FIB-4 ≥ 3.25
.METAVIR F ≥3.
The Estimated Number of Participants
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Taiwan
44 participants
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Global
44 participants
