drugset / Trial / NCT02893124
The Optimizing Treatment of Peginterferon (PEG IFN) Alpha in Chronic Hepatitis B Virus Patients With Low Level HBsAg
Phase 4
Unknown
200 enrolled
Third Affiliated Hospital, Sun Yat-Sen University
First Affiliated Hospital of Kunming Medical University · collabFirst People's Hospital of Foshan · collabFirst People's Hospital, Shunde China · collabHuazhong University of Science and Technology · collabHuizhou Municipal Central Hospital · collabNanchang University · collabPeking University · collabShenzhen Third People's Hospital · collabTang-Du Hospital · collabYuebei People's Hospital · collab
Non-randomizedParallel-groupOpen-labelTreatment
Summary
HBeAg-negative chronic hepatitis B (CHB) patients with low Level HBsAg and with a history of drug resistance or suboptimal/partial virological response were enrolled. After giving informed consent, patients were treated with nucleoside analog(s) (NAs) once a day and weekly subcutaneous injections of alfa-2a 180 micrograms/week or peginterferon alfa-2b 80 micrograms/week for 12 weeks. 12 weeks later, NAs was stopped, patients were treated with weekly subcutaneous injections of alfa-2a 180 micrograms/week or peginterferon alfa-2b 80 micrograms/week. Treatment endpoint was HBsAg loss(\<0.05 IU/mL).
Timeline
- Start
- 2016-08
- Primary completion
- 2019-08
- Completion
- 2019-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Peginterferon alfa-2a | Protein / enzyme biologic | 180 ug | Subcutaneous |
| Subject | Peginterferon alfa-2b | Protein / enzyme biologic | 80 ug | Subcutaneous |