NCT05107778CompletedPhase 2
Study to Evaluate Safety and Efficacy of ASC42 Combined With ETV and PEG-IFN α-2a in Subjects With HBV
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
Source: ClinicalTrials.gov · Last updated 4 Apr 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 43 (actual)
- First submitted
- 26 Oct 2021
- Start date
- 10 Jan 2022
- Primary completion date
- 14 Nov 2023
- Lead sponsor
- Ascletis Pharmaceuticals Co., Ltd.
- Diseases
- Hepatitis B
- NCT number
- NCT05107778
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 43
- From 10 Jan 2022 to the primary completion date, 14 Nov 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previously received FXR therapy;
Other illness
- Chronic HBV with unexplained portal hypertension;
Lab values
- Subjects with liver cancer or serum AFP \>1×ULN;
Who the study is looking for
- 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;
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Nanfang Hospital of Southern Medical University Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.