CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 383 enrolled
Drug / intervention
peginterferon alfa-2a [Pegasys]drug
Likely dose
peginterferon alfa-2a [Pegasys] 180 microgramsfrom 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/NCT00927082
NCT00927082Phase 4Completed
CompareCT.gov

A Follow-up Study to Evaluate the Long-term Post Treatment Effects of Peginterferon Alfa-2a (PEG-IFN) in Patients With HBeAg Positive Chronic Hepatitis B From the Original Study WV19432(NEPTUNE).

Hoffmann-La Roche·interventional·Posted Jun 24, 2009·Updated Mar 9, 2016

In Brief

A Phase 4 clinical trial evaluating peginterferon alfa-2a [Pegasys] for Hepatitis B, Chronic. Completed, enrolled 383 participants across 31 sites in 10 countries.

Detailed Summary

This study is a long-term post-treatment follow-up to study WV19432, which evaluated the efficacy and safety of PEGASYS in patients with HBeAg positive chronic hepatitis B (CHB).Patients who received treatment with PEGASYS, and completed follow-up, are eligible to enter this post-treatment follow-up study. The anticipated time on study was 5 years, and the target sample size is 100-500 individuals.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis B, Chronic
CountriesAustralia, Brazil, China, Hong Kong, New Zealand, Russia, Singapore, South Korea, Taiwan, Thailand
Collaborators--

Timeline

Phase 4CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedJun 24, 2009
Enrollment StartApr 1, 2009
Primary CompletionNov 1, 2014
TodayJul 2, 2026
Enrollment to primary: 5.6 yearsPosted 17.0 years ago

Interventions

peginterferon alfa-2a [Pegasys]drug

90 or 180 micrograms/week sc for 24 or 48 weeks in original study (WV19432). No study treatment in long-term post-treatment follow-up study (MV22430)