drugset / Trial / NCT02366247
Phase Ⅲ Trial for Combination Treatment of PEG-Tα1 and Adefovir for HBeAg-positive Chronic Hepatitis B
Phase 3
Unknown
463 enrolled
Jiangsu Hansoh Pharmaceutical Co., Ltd.
Nanjing Medical University · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
This trial is to assess the efficacy and safety of Polyethylene Glycol thymosin alpha1 (PEG-Tα1), a new long immunomodulator (Category 1.1 of Chemical Drugs) being developed from Hansoh Pharmaceutical of China, in combination with adefovir in HBeAg-positive patients with chronic hepatitis B.
Timeline
- Start
- 2013-08
- Primary completion
- 2015-12
- Completion
- 2016-02
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | PEG-Tα1 | Unknown | 3.2 mg/ml | Subcutaneous |
| Background | Adefovir | Unknown | 10 mg | Oral |