CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 60 enrolled
Drug / intervention
8 weeks SOF/LED +1 moredrug
Likely dose
8 weeks SOF/LED 400 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/NCT02480166
NCT02480166Phase 4Completed
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Comparative Efficacy of Fixed-dose Combination of Sofosbuvir and Ledipasvir for 8 or 12 Weeks for Chronic Hepatitis C Genotype 6

Stanford University·interventional·Posted Jun 24, 2015·Updated Sep 19, 2017

In Brief

A Phase 4 clinical trial evaluating 8 weeks SOF/LED and 12 weeks SOF/LED for PT-NANBH. Completed, enrolled 60 participants across 4 sites.

Detailed Summary

The primary objectives of this study are to describe the efficacy of: 1. 8-week treatment of SOF/LED for treatment-naïve, non-cirrhotic, HCV genotype 6 2. 12-week treatment of SOF/LED for all other HCV-6 populations

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPT-NANBH
CountriesUnited States
CollaboratorsGilead Sciences

Timeline

Phase 4CompletedFinished
20162017201820192020202120222023202420252026
First PostedJun 24, 2015
Enrollment StartJun 1, 2015
Primary CompletionOct 1, 2016
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 11.0 years ago

Interventions

8 weeks SOF/LEDdrug

Eligible and consenting patients will be treated with sofosbuvir 400 mg daily and ledipasvir 90 mg daily for 8 weeks. Patients that are treatment naïve and without cirrhosis will be assigned to 8 weeks of treatment. The drug will be administered orally, per manufacturers' instructions, and can be taken with or without food.

12 weeks SOF/LEDdrug

Eligible and consenting patients will be treated with sofosbuvir 400 mg daily and ledipasvir 90 mg daily for 8 weeks. Patients that are not treatment naïve or have cirrhosis will be assigned to 12 weeks of treatment. The drug will be administered orally, per manufacturers' instructions, and can be taken with or without food.