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

Pediatric Immuno-Tolerant Chronic Hepatitis B Clinical Trial

Official title:
A Phase IIIb, Randomized, Open-Label Study of Pegylated Interferon Alfa-2A in Combination With Lamivudine or Entecavir Compared With Untreated Control Patients in Children With HBeAg Positive Chronic Hepatitis B in the Immune-Tolerant Phase

Status Completed

Clinical Trial 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

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Hepatitis
Hepatitis A
Hepatitis B
Hepatitis B, Chronic
Hepatitis, Chronic
Pediatric Immuno-Tolerant Chronic Hepatitis B

Clinical Trial Details

NCT number	NCT02263079
Study type	Interventional
Source	Hoffmann-La Roche
Contact
Status	Completed
Phase	Phase 3
Start date	June 16, 2014
Completion date	January 29, 2020

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