NCT05107778

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 43 (actual)
• Sponsor: Ascletis Pharmaceuticals Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2022-01-10
• Primary completion: 2023-11-14
• Completion: 2023-12-14
• First posted: 2021-11-04
• Last updated: 2024-04-04

Locations

1 site across 1 country: China