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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05107778

Enrollment

Registered

2021-11-04

Start date

2022-01-10

Completion date

2023-12-14

Last updated

2024-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis B, Chronic

Keywords

Hepatitis B, Chronic, ASC42

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.

Interventions

DRUGASC42 10mg

ASC42 10mg orally once daily;

DRUGASC42 15mg

ASC42 15mg orally once daily.

DRUGih PEG-IFN α-2a

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

DRUGEntecavir

Entecavir 0.5 mg orally once daily.

DRUGPlacebo

Placebo orally once daily.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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;

Exclusion criteria

* Chronic HBV with unexplained portal hypertension; * Subjects with liver cancer or serum AFP \>1×ULN; * Previously received FXR therapy;

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026