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

Phase 2

Completed

• Conditions: Hepatitis B, Chronic
• Interventions: Drug: ASC42 10mg; Drug: ASC42 15mg; Drug: ih PEG-IFN α-2a; Drug: Placebo; Drug: Entecavir

• Registration Number: NCT05107778
• Lead Sponsor: Ascletis Pharmaceuticals Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-10-26
• Study First Submitted QC: 2021-10-26
• Study First Posted: 2021-11-04
• Study Start: 2022-01-10
• Primary Completion: 2023-11-14
• Study Completion: 2023-12-14
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-03
• Last Update Posted: 2024-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Queue ASC42 10mg	ASC42 10mg	ASC42 10mg, ih PEG-IFN α-2a and ETV for 12 weeks.
Queue ASC42 15mg	ih PEG-IFN α-2a	ASC42 15mg , ih PEG-IFN α-2a and ETV for 12 weeks.
Queue Placebo	ih PEG-IFN α-2a	Placebo, ih PEG-IFN α-2a and ETV for 12 weeks.
Queue ASC42 10mg	ih PEG-IFN α-2a	ASC42 10mg, ih PEG-IFN α-2a and ETV for 12 weeks.
Queue ASC42 15mg	ASC42 15mg	ASC42 15mg , ih PEG-IFN α-2a and ETV for 12 weeks.
Queue Placebo	Placebo	Placebo, ih PEG-IFN α-2a and ETV for 12 weeks.
Queue ASC42 10mg	Entecavir	ASC42 10mg, ih PEG-IFN α-2a and ETV for 12 weeks.
Queue ASC42 15mg	Entecavir	ASC42 15mg , ih PEG-IFN α-2a and ETV for 12 weeks.
Queue Placebo	Entecavir	Placebo, ih PEG-IFN α-2a and ETV for 12 weeks.

Primary Outcome Measures

Name	Time	Method
Serum HBV pgRNA change compared with baseline	Week 12 of intervention\Week 24 of follow-up
Serum HBsAg change compared with baseline	Week 12 of intervention\Week 24 of follow-up

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

NanFang Hospital of Southern Medical University; 🇨🇳 Guangzhou, Guangdong, China