drugset / Trial / NCT04846491
A Study of Peginterferon Alfa-2b Combined With TDF in Patients With Chronic Hepatitis B
Phase 3
Completed
475 enrolled
Xiamen Amoytop Biotech Co., Ltd.
Peking University First Hospital · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
Current clinical practices has shown promising prospects of the therapy strategy of interferon combined with nucleos(t)ides in patients with chronic hepatitis B, but the safety and efficacy has not been fully studied. This study is aimed to exploit the safety and efficacy of the study drug, Peginterferon alfa-2b injection, with nucleos(t)ide (NAs), tenofovir disoproxil fumarate tablets (TDF), in the patients with hepatitis B, who has previously treated with nucleos(t)ides and who are treatment naïve.
Timeline
- Start
- 2019-12-04
- Primary completion
- 2023-11-30
- Completion
- 2023-12-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Peginterferon alfa-2b | Protein / enzyme biologic | — | Subcutaneous |
| Comparator | Tenofovir disoproxil fumarate | Small molecule | — | Oral |