At a glance

ClinicalIndex Comparison Record

Phase 3Completed· 98 enrolled

Drug / intervention

Pegylated Interferon α2 +1 moredrug

Likely dose

Pegylated Interferon α2 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/NCT03090035

NCT03090035Phase 3Completed

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Impact of Interleukin 28B (rs12979860) Genotype on Virological Responses in Chronic Hepatitis C Treatment

Sheikh Zayed Medical College·interventional·Posted Mar 24, 2017·Updated Apr 25, 2017

In Brief

A Phase 3 clinical trial evaluating Pegylated Interferon α2 and Ribavirin for Hepatitis C and Hepatitis C Relapse. Completed, enrolled 98 participants across 1 site.

Detailed Summary

Objective: Pegulated Interferon α2 plus ribavirin is a treatment of choice in patients with chronic hepatitis C infection. This study was conducted to find out the frequency of different IL-28B (rs12979860) genotypes in patients with chronic hepatitis C (HCV genotype type 2 \& 3) infection treated with Pegulated Interferon α2 plus ribavirin and to evaluate the role of IL-28B genotypes in achieving Sustained Virological Response (SVR). Methods: In this non-randomized observational study, ninety eight (98) patients with diagnosis of chronic hepatitis C were included. In all patients, Peg-IFN plus Ribavirin were given in standard doses for 24 weeks. End treatment response, sustained virological response, and relapse rate were the primary endpoints of this study. Analysis of IL28B (rs12979860) polymorphism (CC, CT and TT) was performed by PCR-RFLP protocol.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsHepatitis C, Hepatitis C Relapse

CountriesPakistan

Collaborators--

Timeline

Phase 3CompletedFinished

2014201520162017201820192020202120222023202420252026

Enrollment StartJan 2014

Primary CompletionJul 2014

Study CompletionDec 2014

First PostedMar 2017

TodayJul 2026

First PostedMar 24, 2017

Enrollment StartJan 1, 2014

Primary CompletionJul 1, 2014

Study CompletionDec 31, 2014

TodayJul 2, 2026

Enrollment to primary: 6 monthsPosted 9.3 years ago

Interventions

Pegylated Interferon α2drug

Peg-INF was given in a dose of 180 μg/week

Ribavirindrug

ribavirin 1200 mg/day to every patient for the period of 24 weeks for HCV genotype 2 \& 3