CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 93 enrolled
Drug / intervention
Pegylated Interferon alfa-2b +3 moredrug
Likely dose
Simeprevir 150 mgfrom 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/NCT02168361
NCT02168361Phase 4Completed
CompareCT.gov

The SIM-SOF Trial: A Randomized Trial Comparing Simeprevir-Sofosbuvir Versus Peginterferon/Ribavirin/Sofosbuvir for the Treatment of Chronic Hepatitis C Genotype-1a-infected Patients With Cirrhosis

Center For Hepatitis C, Atlanta, GA·interventional·Posted Jun 20, 2014·Updated Mar 14, 2016

In Brief

A Phase 4 clinical trial evaluating Pegylated Interferon alfa-2b, Simeprevir, and 2 other interventions for Chronic Hepatitis C. Completed, enrolled 93 participants across 1 site.

Detailed Summary

Randomized trial of Hepatitis C-genotype 1-infected patients with compensated cirrhosis comparing the standard of care (Peginterferon/Ribavirin/Sofosbuvir) versus the off-label combination of simeprevir+ sofosbuvir without Ribavirin.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Hepatitis C
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJun 20, 2014
Enrollment StartDec 1, 2013
Primary CompletionDec 1, 2014
Study CompletionApr 1, 2015
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 12.0 years ago

Interventions

Pegylated Interferon alfa-2bdrug

1.5 ugm/kg/week subcutaneously injected along with ribavirin and sofosbuvir for 12 weeks total

Simeprevirdrug

150 mg daily orally along with pegylated interferon and sofosbuvir for a total of 12 weeks

Ribavirindrug

1000-1200 mg daily divided twice daily for 12 weeks in combination with pegylated interferon and sofosbuvir

Sofosbuvirdrug

12 weeks of combination sofosbuvir and simeprevir