drugset / Trial / NCT02263079
A Study of Pegylated Interferon Alfa-2A in Combination With Lamivudine or Entecavir Compared With Untreated Control Group in Children With Hepatitis B Envelope Antigen (HBeAg)-Positive Chronic Hepatitis B (CHB) in the Immune-Tolerant Phase
RandomizedParallel-groupOpen-labelTreatment
Summary
This randomized, controlled, parallel group, open-label multicenter study will evaluate the efficacy and safety of a combination of pegylated interferon alfa-2A (Pegasys) plus lamivudine or entecavir compared with an untreated control group in participants with HBeAg positive CHB in the immune tolerant phase. NOTE: STUDY RECRUITMENT HAS BEEN TERMINATED
Timeline
- Start
- 2014-06-16
- Primary completion
- 2020-01-29
- Completion
- 2020-01-29
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Entecavir | Small molecule | 0.015 mg/kg | Oral |
| Subject | Lamivudine | Other / unclassified | 3 mg/kg | Oral |
| Subject | Peginterferon alfa-2a | Protein / enzyme biologic | 180 ug/m2 | Subcutaneous |