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

Primary Purpose

Hepatitis B, Chronic

Status

Active

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

ASC42 10mg

ASC42 15mg

ih PEG-IFN α-2a

Entecavir

Placebo

About this trial

This is an interventional treatment trial for Hepatitis B, Chronic focused on measuring Hepatitis B, Chronic, ASC42

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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;

Sites / Locations

NanFang Hospital of Southern Medical University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

Queue ASC42 10mg

Queue ASC42 15mg

Queue Placebo

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Serum HBsAg change compared with baseline

Serum HBV pgRNA change compared with baseline

Secondary Outcome Measures

Serum HBsAg change compared with baseline

Serum HBV pgRNA change compared with baseline

Full Information

NCT ID

NCT05107778

First Posted

October 26, 2021

Last Updated

February 21, 2023

Sponsor

Ascletis Pharmaceuticals Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT05107778

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

January 10, 2022 (Actual)

Primary Completion Date

February 28, 2023 (Anticipated)

Study Completion Date

February 28, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Ascletis Pharmaceuticals Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hepatitis B, Chronic

Keywords

Hepatitis B, Chronic, ASC42

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

43 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Queue ASC42 10mg

Arm Type

Experimental

Arm Description

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

Arm Title

Queue ASC42 15mg

Arm Type

Experimental

Arm Description

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

Arm Title

Queue Placebo

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

ASC42 10mg

Intervention Description

ASC42 10mg orally once daily;

Intervention Type

Drug

Intervention Name(s)

ASC42 15mg

Intervention Description

ASC42 15mg orally once daily.

Intervention Type

Drug

Intervention Name(s)

ih PEG-IFN α-2a

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Entecavir

Intervention Description

Entecavir 0.5 mg orally once daily.

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo orally once daily.

Primary Outcome Measure Information:

Title

Serum HBsAg change compared with baseline

Time Frame

Week 12 of intervention\Week 24 of follow-up

Title

Serum HBV pgRNA change compared with baseline

Time Frame

Week 12 of intervention\Week 24 of follow-up

Secondary Outcome Measure Information:

Title

Serum HBsAg change compared with baseline

Time Frame

Week 2, 4 ,8 of intervention\Week 4,12 of follow-up

Title

Serum HBV pgRNA change compared with baseline

Time Frame

Week 2, 4 ,8 of intervention\Week 4,12 of follow-up

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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;

Facility Information:

Facility Name

NanFang Hospital of Southern Medical University

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510000

Country

China

12. IPD Sharing Statement

Learn more about this trial

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

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