Study to Evaluate Safety and Efficacy of ASC42 Combined With ETV and PEG-IFN α-2a in Subjects With HBV

Sponsor

Ascletis Pharmaceuticals Co., Ltd. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05107778

Collaborator

(none)

Enrollment

Location

Arms

13.4

Anticipated Duration (Months)

3.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a phase2, randomized, single-blind, placebo controlled and multi-center study in adults with chronic hepatitis B virus. The study is aimed at evaluating efficacy and safety of ASC42 in combination with entecavir and pegylated interferon α-2a in subjects with chronic hepatitis B virus.

Condition or Disease	Intervention/Treatment	Phase
Hepatitis B, Chronic	Drug: ASC42 10mg Drug: ASC42 15mg Drug: ih PEG-IFN α-2a Drug: Entecavir Drug: Placebo	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

45 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

A Phase II Multi-center, Randomized, Single-blind, Placebo-controlled to Evaluate Safety and Efficacy of ASC42 Tablets in Combination With Entecavir and Pegylated Interferon α-2a in Subjects With Chronic Hepatitis B Virus

Actual Study Start Date :

Jan 10, 2022

Anticipated Primary Completion Date :

Dec 8, 2022

Anticipated Study Completion Date :

Feb 23, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Queue ASC42 10mg ASC42 10mg, ih PEG-IFN α-2a and ETV for 12 weeks.	Drug: ASC42 10mg ASC42 10mg orally once daily; Drug: ih PEG-IFN α-2a ih PEG-IFN α-2a 180μg subcutaneous injection once a week. Drug: Entecavir Entecavir 0.5 mg orally once daily.
Experimental: Queue ASC42 15mg ASC42 15mg , ih PEG-IFN α-2a and ETV for 12 weeks.	Drug: ASC42 15mg ASC42 15mg orally once daily. Drug: ih PEG-IFN α-2a ih PEG-IFN α-2a 180μg subcutaneous injection once a week. Drug: Entecavir Entecavir 0.5 mg orally once daily.
Placebo Comparator: Queue Placebo Placebo, ih PEG-IFN α-2a and ETV for 12 weeks.	Drug: ih PEG-IFN α-2a ih PEG-IFN α-2a 180μg subcutaneous injection once a week. Drug: Entecavir Entecavir 0.5 mg orally once daily. Drug: Placebo Placebo orally once daily.

Arm

Intervention/Treatment

Experimental: Queue ASC42 10mg

ASC42 10mg, ih PEG-IFN α-2a and ETV for 12 weeks.

Drug: ASC42 10mg

ASC42 10mg orally once daily;

Drug: ih PEG-IFN α-2a

ih PEG-IFN α-2a 180μg subcutaneous injection once a week.

Drug: Entecavir

Entecavir 0.5 mg orally once daily.

Experimental: Queue ASC42 15mg

ASC42 15mg , ih PEG-IFN α-2a and ETV for 12 weeks.

Drug: ASC42 15mg

ASC42 15mg orally once daily.

Drug: ih PEG-IFN α-2a

ih PEG-IFN α-2a 180μg subcutaneous injection once a week.

Drug: Entecavir

Entecavir 0.5 mg orally once daily.

Placebo Comparator: Queue Placebo

Placebo, ih PEG-IFN α-2a and ETV for 12 weeks.

Drug: ih PEG-IFN α-2a

ih PEG-IFN α-2a 180μg subcutaneous injection once a week.

Drug: Entecavir

Entecavir 0.5 mg orally once daily.

Drug: Placebo

Placebo orally once daily.

Outcome Measures

Primary Outcome Measures

Serum HBsAg change compared with baseline [Week 12 of intervention\Week 24 of follow-up]
Serum HBV pgRNA change compared with baseline [Week 12 of intervention\Week 24 of follow-up]

Secondary Outcome Measures

Serum HBsAg change compared with baseline [Week 2, 4 ,8 of intervention\Week 4,12 of follow-up]
Serum HBV pgRNA change compared with baseline [Week 2, 4 ,8 of intervention\Week 4,12 of follow-up]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

18-65 years old (including 18 and 65 years old);
Chronic HBV infection confirmed by serological, etiological and clinical diagnosis (HBsAg positive for more than 6 months);
HBV-DNA negative after nucleoside (acid) treatment;
Laboratory test values meet the following requirements :
Liver function : AST, ALT ≤ 3×ULN; serum total bilirubin≤2×ULN; direct bilirubin≤1.5×ULN; serum albumin≥35 g/L (blood collection is not within 2 weeks before transfusion of albumin);
Hematology: white blood cell count>3.0×109/L, ANC>1.5×109/L; platelet>1×ULN; hemoglobin 120g/L. (No blood transfusion (including transfusion of red blood cells and platelets) and EPO, TPO, leukocyte-stimulating factor were required within 2 weeks before blood collection) ;
Renal function: serum creatinine≤1×ULN;
Thyroid function: TSH and T4 in normal range or thyroid function can be completely controlled ;
Determination of serum immunoglobulin : IgM≤ULN;
Coagulation function: International normalized ratio: INR≤1×ULN;