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

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.

Study Overview

• Status: Completed
• Conditions: Hepatitis B, Chronic
• Intervention / Treatment: Drug: ASC42 10mg; Drug: ih PEG-IFN α-2a; Drug: Entecavir; Drug: ASC42 15mg; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 43
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510000
      • Nanfang Hospital of Southern Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / 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: 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: ASC42 15mg; ASC42 15mg 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.

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Ascletis Pharmaceuticals Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2022
• Primary Completion (Actual): November 14, 2023
• Study Completion (Actual): December 14, 2023

Study Registration Dates

• First Submitted: October 26, 2021
• First Submitted That Met QC Criteria: October 26, 2021
• First Posted (Actual): November 4, 2021

Study Record Updates

• Last Update Posted (Actual): April 4, 2024
• Last Update Submitted That Met QC Criteria: April 3, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Hepatitis B, Chronic; ASC42
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Disease Attributes; Liver Diseases; Hepatitis, Viral, Human; Hepadnaviridae Infections; DNA Virus Infections; Enterovirus Infections; Picornaviridae Infections; Hepatitis, Chronic; Chronic Disease; Hepatitis B; Hepatitis; Hepatitis A; Hepatitis B, Chronic; Anti-Infective Agents; Antiviral Agents; Entecavir
• Other Study ID Numbers: ASC42-201

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No