CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 180 enrolled
Drug / intervention
PegIFN alfa-2adrug
Likely dose
PegIFN alfa-2a 180 μgfrom 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/NCT02594293
NCT02594293Phase 4Completed
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A Prospective, Randomized, Controlled Clinical Trial to Evaluate the Role of Peg-IFN Alfa-2a in Reducing RelapSe Rate in Patients With Hepatitis B e Antigen(HBeAg)-nEgative Chronic Hepatitis B After Discontinuation of NUC Therapy

Huashan Hospital·interventional·Posted Nov 3, 2015·Updated Oct 31, 2022

In Brief

A Phase 4 clinical trial evaluating PegIFN alfa-2a for Chronic Hepatitis B. Completed, enrolled 180 participants across 19 sites.

Detailed Summary

This study evaluates whether Peg-IFN alfa-2a can reduce the recurrence rate of hepatitis B in 96 weeks after nucleoside analogue (NUC) withdrawal. The HBV HBeAg-Negative patients who received NUC anti-virus treatment for 2.5 years and reached stopping rule in 《Chinese chronic hepatitis B prevention and treatment guidelines》(2010) were randomly assigned into three groups: One group discontinue the NUC treatment and follow up for 96 weeks,One discontinue the NUC treatment ,receive Peg-IFN alfa-2a 180 μg by week for 24 weeks and follow up for 72 weeks,The other discontinue the NUC treatment ,receive Peg-IFN alfa-2a 180 μg by week for 48 weeks and follow up for 48 weeks.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Hepatitis B
CountriesChina
Collaborators--

Timeline

Phase 4CompletedFinished
20162017201820192020202120222023202420252026
First PostedNov 3, 2015
Enrollment StartOct 1, 2015
Primary CompletionSep 1, 2022
TodayJul 2, 2026
Enrollment to primary: 6.9 yearsPosted 10.7 years ago

Interventions

PegIFN alfa-2adrug

180 μg/ 0.5 ml ,hypodermic injection once a week