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

Hepatitis B, Chronic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05107778
• Other study ID #: ASC42-201
• Status: Completed
• Phase: Phase 2
• Start date: January 10, 2022
• Est. completion date: December 14, 2023

Study information

• Verified date: April 2024
• Source: Ascletis Pharmaceuticals Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: December 14, 2023
• Est. primary completion date: November 14, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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;

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B, Chronic

Intervention

Drug:
• ASC42 10mg
ASC42 10mg orally once daily;
• ASC42 15mg
ASC42 15mg orally once daily.
• ih PEG-IFN a-2a
ih PEG-IFN a-2a 180µg subcutaneous injection once a week.
• Entecavir
Entecavir 0.5 mg orally once daily.
• Placebo
Placebo orally once daily.

Locations

Country	Name	City	State
China	NanFang Hospital of Southern Medical University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Ascletis Pharmaceuticals Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum HBsAg change compared with baseline		Week 12 of intervention\Week 24 of follow-up
Primary	Serum HBV pgRNA change compared with baseline		Week 12 of intervention\Week 24 of follow-up
Secondary	Serum HBsAg change compared with baseline		Week 2, 4 ,8 of intervention\Week 4,12 of follow-up
Secondary	Serum HBV pgRNA change compared with baseline		Week 2, 4 ,8 of intervention\Week 4,12 of follow-up