drugset / Trial / NCT02360592
Combination Therapy With Interferon Plus Interleukin 2 and Hepatitis B Vaccine in Chronic Hepatitis B Patients
Phase 4
Completed
94 enrolled
Tongji Hospital
Beijing Kawin Technology Share-Holding Co., Ltd. · collabFujian Cosunter Pharmaceutical Co. Ltd · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
This study is a multi-center, randomized, prospective, open-label Phase IV Clinical trial to evaluate efficacy and safety of interferon alfa-2b therapy combinated with interleukin 2 and hepatitis B therapeutic vaccine versus interferon alfa-2b alone in chronic hepatitis B patients with entecavir achieving HBeAg seroclearance. Patients were randomized to one of 3 groups to receive different antiviral treatment.
Timeline
- Start
- 2013-06
- Primary completion
- 2016-12
- Completion
- 2017-04
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Entecavir | Small molecule | 0.5 mg | Oral |
| Subject | Hepatitis B vaccine | Vaccine | 60 ug | Intramuscular |
| Subject | aldesleukin | Protein / enzyme biologic | 25 unknown | Other |
| Subject | interferon alfa-2b | Protein / enzyme biologic | 600 unknown | Other |