Status:
COMPLETED
A Phase II Study of Subcutaneously Injected PD-L1 Antibody ASC22 in Chronic Hepatitis B Patients
Lead Sponsor:
Ascletis Pharmaceuticals Co., Ltd.
Collaborating Sponsors:
Peking University First Hospital
Beijing Clinical Service Center
Conditions:
Chronic Hepatitis b
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
The objective of this study is to evaluate the safety and efficacy of ASC22 in the treatment of chronic hepatitis B after single and multiple drug administration.
Detailed Description
The study consists of two parts: the ASC22 single-dose IIa study and the ASC22 multi-dose IIb study. The IIa study consists of 3 cohorts of 0.3mg/kg, 1.0mg/kg and 2.5mg/kg, and the IIb study consists ...
Eligibility Criteria
Inclusion
- 18-65 years old (including boundary value), gender unlimited；
- Chronic hepatitis B patients with clear diagnosis of Hematology, etiology and clinical (for example: HBsAg positive for more than 6 months);
- HBV-DNA turns negative after treatment with nucleoside (acid) drugs;
- cohort1-5:HBsAg≤ 10000 IU/mL; cohort6: HBsAg≤ 100 IU/mL;
- HBeAg negative;
- The fertile female subjects or the fertile male subjects agreed to take contraceptive measures from 7 days before the first administration until 24 weeks after the end of the administration cycle of ASC22. The serum pregnancy test of fertile female subjects must be negative within 7 days before the first administration.
Exclusion
- Patients with hepatitis a, hepatitis c (HCV RNA\>15IU/L), hepatitis d or HIV infection; Patients with other active infections (e.g., respiratory tract infection, urinary tract infection and herpes simplex, cytomegalovirus, epstein-barr virus);
- Fibrosis stage: Cirrhosis, portal hypertension, or advanced fibrosis (defined as Fibroscan≥9.5kPa or ARFI≥1.81m/sec or Fibrosis-4 (FIB-4)≥3.25 or METAVIR F≥3);
- Liver cancer patients or blood AFP\>1×ULN;
- cohort1-5：Patients who received interferon therapy within 6 months before the first administration; cohort6: Patients who received interferon therapy before the first administration;
- Patients receiving immunosuppressive therapy within 3 months before the first administration (except interferon);
- The investigator judges that the participants are not suitable for this study.
Key Trial Info
Start Date :
July 17 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 9 2024
Estimated Enrollment :
207 Patients enrolled
Trial Details
Trial ID
NCT04465890
Start Date
July 17 2020
End Date
August 9 2024
Last Update
December 2 2024
Active Locations (1)
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1
Peking University First Hospital
Beijing, China