CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 62 enrolled
Drug / intervention
Entecavir +2 moredrug
Likely dose
Entecavir 0.015 milligramsfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02263079
NCT02263079Phase 3Completed
CompareCT.gov

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

Hoffmann-La Roche·interventional·Posted Oct 13, 2014·Updated Aug 24, 2020

In Brief

A Phase 3 clinical trial evaluating Entecavir, Lamivudine, and 1 other intervention for Pediatric Immuno-Tolerant Chronic Hepatitis B. Completed, enrolled 62 participants across 25 sites in 12 countries.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPediatric Immuno-Tolerant Chronic Hepatitis B
CountriesAustralia, Belgium, Germany, Italy, Malaysia, Romania, Russia, Taiwan, Turkey (Türkiye), Ukraine, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedOct 13, 2014
Enrollment StartJun 16, 2014
Primary CompletionJan 29, 2020
TodayJul 2, 2026
Enrollment to primary: 5.6 yearsPosted 11.7 years ago

Interventions

Entecavirdrug

Participants will receive entecavir, either as a film-coated tablet or oral solution, once daily at a dose of 0.015 milligrams per kilogram (mg/kg) (maximum daily dose of 0.5 mg).

Lamivudinedrug

Participants will receive lamivudine, either as a film-coated tablet or oral solution, once daily at a dose of 3 mg/kg (maximum daily dose of 100 mg).

Pegylated Interferon Alfa-2Adrug

Participants will receive pegylated interferon-alfa-2A at a body surface area (BSA) based dose of 180 micrograms per 1.73 square meter (mcg/1.73m\^2) BSA.