CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 180 enrolled
Drug / intervention
Peg-Interferon Alpha-2A +1 moredrug
Likely dose
Peg-Interferon Alpha-2A 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/NCT02761629
NCT02761629Phase 4Completed
CompareCT.gov

Randomized, Multi-Center, Phase IV, Comparative Study to Assess the Efficacy and Safety of Combined Peg-Interferon Alpha-2a (40 kD) With Ribavirin Combined Therapy for 48 or 72 Weeks of Treatment and 24 Weeks of Follow-Up in Patients With Chronic Hepatitis C, Genotype 1, Co-Infected With Human Immunodeficiency Virus

Hoffmann-La Roche·interventional·Posted May 4, 2016·Updated Aug 16, 2016

In Brief

A Phase 4 clinical trial evaluating Peg-Interferon Alpha-2A and Ribavirin for Hepatitis C, Chronic. Completed, enrolled 180 participants across 17 sites.

Detailed Summary

This randomized, multi-center, Phase IV, comparative study will assess the efficacy and safety of combined peg-interferon alpha-2a (Peg-IFN-Alpha-2A) and ribavirin therapy for 48 or 72 weeks of treatment and 24 weeks of follow-up in participants with Genotype 1 chronic hepatitis C (CHC), co-infected with human immunodeficiency virus type 1 (HIV-1).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis C, Chronic
CountriesBrazil
Collaborators--

Timeline

Phase 4CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 4, 2016
Enrollment StartApr 1, 2005
Primary CompletionMay 1, 2008
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 10.2 years ago

Interventions

Peg-Interferon Alpha-2Adrug

Peg-IFN-Alpha-2A will be administered at 180 micrograms (mcg) once weekly via subcutaneous injection.

Ribavirindrug

Ribavirin will be administered as either 1000 milligrams (mg) (2\*200 mg tablets in morning and 3\*200 mg tablets in evening) for participants weighing less than (\<) 75 kilograms (kg) or as 1200 mg (3\*200 mg tablets in morning and 3\*200 mg tablets in evening) for participants weighing greater than or equal to (\>/=) 75 kg.