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

Ascletis

Status and phase: Completed; Phase 2

Conditions: Hepatitis B, Chronic

Treatments: Drug: ih PEG-IFN α-2a; Drug: Placebo; Drug: ASC42 15mg; Drug: ASC42 10mg; Drug: Entecavir

Study type: Interventional

Funder types: Industry

Identifiers

NCT05107778

ASC42-201

Details and patient eligibility

About

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.

Enrollment: 43 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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43 participants in 3 patient groups, including a placebo group

Queue ASC42 10mg

Experimental group

Description:

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

Treatment:

Drug: ih PEG-IFN α-2a

Drug: ASC42 10mg

Drug: Entecavir

Queue ASC42 15mg

Experimental group

Description:

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

Treatment:

Drug: ih PEG-IFN α-2a

Drug: ASC42 15mg

Drug: Entecavir

Queue Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: ih PEG-IFN α-2a

Drug: Placebo

Drug: Entecavir