CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 111 enrolled
Drug / intervention
LDV/SOFdrug
Likely dose
Ledipasvir/sofosbuvir 90/400 mg fixed-dose combination tablet orally once dailyAI-extracted
Key inclusion· 4
  • ✓Weight ≥40 kg
  • ✓Chronic genotype 1 or 2 HCV with HBV coinfection
  • ✓Cirrhosis status determined by Fibroscan
  • ✓Screening laboratory values within defined thresholds
Key exclusion· 5
  • ✕Current or prior clinically-significant illness or major medical disorder that may interfere with treatment or compliance
  • ✕Pregnant or nursing female
  • ✕HIV or hepatitis delta virus (HDV) coinfection
  • ✕Hepatocellular carcinoma or other malignancy

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02613871
NCT02613871Phase 3Completed
CompareCT.gov

A Phase 3b Open-Label Study of Ledipasvir/Sofosbuvir Fixed-Dose Combination for 12 Weeks in Subjects With Chronic Genotype 1 or 2 Hepatitis C Virus (HCV) and Hepatitis B Virus (HBV) Coinfection

Gilead Sciences·interventional·Posted Nov 25, 2015·Updated Mar 6, 2020

In Brief

A Phase 3 clinical trial evaluating LDV/SOF for Hepatitis C Virus Infection. Completed, enrolled 111 participants across 8 sites.

Detailed Summary

The primary objectives of this study are to determine the antiviral efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) in adults with chronic genotype 1 or 2 HCV infection who are coinfected with HBV in Taiwan.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis C Virus Infection
CountriesTaiwan
Collaborators--

Timeline

Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedNov 25, 2015
Enrollment StartDec 22, 2015
Primary CompletionJan 4, 2017
Study CompletionNov 7, 2018
TodayJul 2, 2026
Enrollment to primary: 1.0 yearsPosted 10.6 years ago

Interventions

LDV/SOFdrug

90/400 mg FDC tablet administered orally once daily