drugset / Trial / NCT05244057
A Study of Hepalatide Combined With TAF and PEG-IFN as Finite Treatment of Chronic Hepatitis B Patients
Phase 2
Completed
8 enrolled
Shanghai HEP Pharmaceutical Co., Ltd.
Shanghai East Hospital · collabShanghai Tong Ren Hospital · collab
RandomizedParallel-groupTriple-blindTreatment
Summary
The study is designed to assess efficacy of a finitie treatment in Chronic Hepatitis B patients who had stable treatment of NAs for ≧ 2 years， which is compared hepalatide in combination with Pegylated Interferon + TAF with Pegylated Interferon +TAF. Subjects will be randomly assigned to the hepalatide or placebo groups , 15 subjects in each group . Subjects will receive hepalatide+Pegylated Interferon +TAF treatment for 48 weeks or placebo +PegylatedInterferon +TAF treatment for 48 weeks , Then, stopping hepalatide and Pegylate Interferon treatments and followed with further 8 weeks follow-up.
Timeline
- Start
- 2022-08-23
- Primary completion
- 2024-06-24
- Completion
- 2024-06-24
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Hepalatide | Protein / enzyme biologic | 6.3 mg | Subcutaneous |
| Background | Peginterferon alfa-2a | Protein / enzyme biologic | 90 ug | Subcutaneous |
| Background | tenofovir alafenamide | Small molecule | 25 mg | Oral |