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

NCT05107778 | Completed Phase 2

• 1 other identifier: ASC42-201
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatitis B, Chronic

Keywords

Hepatitis B, Chronic; ASC42

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• 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

Study Arms (3)

Queue ASC42 10mg

EXPERIMENTAL

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

Drug: ASC42 10mg; Drug: ih PEG-IFN α-2a; Drug: Entecavir

Queue ASC42 15mg

EXPERIMENTAL

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

Drug: ASC42 15mg; Drug: ih PEG-IFN α-2a; Drug: Entecavir

Queue Placebo

PLACEBO COMPARATOR

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

Drug: ih PEG-IFN α-2a; Drug: Entecavir; Drug: Placebo

Interventions

ASC42 10mg DRUG

ASC42 10mg orally once daily;

Queue ASC42 10mg

ASC42 15mg DRUG

ASC42 15mg orally once daily.

Queue ASC42 15mg

ih PEG-IFN α-2a DRUG

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

Queue ASC42 10mg; Queue ASC42 15mg; Queue Placebo

Entecavir DRUG

Entecavir 0.5 mg orally once daily.

Queue ASC42 10mg; Queue ASC42 15mg; Queue Placebo

Placebo DRUG

Placebo orally once daily.

Queue Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

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

Sponsors & Collaborators

• Ascletis Pharmaceuticals Co., Ltd.: lead

Study Sites (1)

NanFang Hospital of Southern Medical University

Guangzhou, Guangdong, 510000, China

Location

MeSH Terms

Conditions

Hepatitis B, Chronic

Interventions

entecavir

Condition Hierarchy (Ancestors)

Hepatitis B; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2021
• First Posted: November 4, 2021
• Study Start: January 10, 2022
• Primary Completion: November 14, 2023
• Study Completion: December 14, 2023
• Last Updated: April 4, 2024

Record last verified: 2024-04

Locations

CN (1)