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

NCT05107778 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2024-04-04

No results posted yet for this study

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.

Conditions

  • Hepatitis B, Chronic

Interventions

DRUG

ASC42 10mg

ASC42 10mg orally once daily;

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.

DRUG

Placebo

Placebo orally once daily.

Sponsors & Collaborators

  • Ascletis Pharmaceuticals Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-10
Primary Completion
2023-11-14
Completion
2023-12-14

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05107778 on ClinicalTrials.gov