Study to Evaluate Safety and Efficacy of ASC42 Combined With ETV and PEG-IFN α-2a in Subjects With HBV
NCT ID: NCT05107778
Last Updated: 2024-04-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
43 participants
INTERVENTIONAL
2022-01-10
2023-12-14
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Queue ASC42 10mg
ASC42 10mg, ih PEG-IFN α-2a and ETV for 12 weeks.
ASC42 10mg
ASC42 10mg orally once daily;
ih PEG-IFN α-2a
ih PEG-IFN α-2a 180μg subcutaneous injection once a week.
Entecavir
Entecavir 0.5 mg orally once daily.
Queue ASC42 15mg
ASC42 15mg , ih PEG-IFN α-2a and ETV for 12 weeks.
ASC42 15mg
ASC42 15mg orally once daily.
ih PEG-IFN α-2a
ih PEG-IFN α-2a 180μg subcutaneous injection once a week.
Entecavir
Entecavir 0.5 mg orally once daily.
Queue Placebo
Placebo, ih PEG-IFN α-2a and ETV for 12 weeks.
ih PEG-IFN α-2a
ih PEG-IFN α-2a 180μg subcutaneous injection once a week.
Entecavir
Entecavir 0.5 mg orally once daily.
Placebo
Placebo orally once daily.
Interventions
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ASC42 10mg
ASC42 10mg orally once daily;
ASC42 15mg
ASC42 15mg orally once daily.
ih PEG-IFN α-2a
ih PEG-IFN α-2a 180μg subcutaneous injection once a week.
Entecavir
Entecavir 0.5 mg orally once daily.
Placebo
Placebo orally once daily.
Eligibility Criteria
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Inclusion Criteria
* 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
* Subjects with liver cancer or serum AFP \>1×ULN;
* Previously received FXR therapy;
18 Years
65 Years
ALL
No
Sponsors
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Ascletis Pharmaceuticals Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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NanFang Hospital of Southern Medical University
Guangzhou, Guangdong, China
Countries
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Other Identifiers
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ASC42-201
Identifier Type: -
Identifier Source: org_study_id
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