MedTrace Logo

Efficacy and Safety of Oral Regimens for the Treatment of Chronic HCV Infection

NCT02202980 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 273

Last updated 2018-11-16

Study results available
· View outcomes & findings →

Summary

This study will evaluate the antiviral efficacy, safety, and tolerability of combination therapy with oral regimens for the treatment of chronic hepatitis C virus (HCV) infection.

Conditions

  • Chronic Hepatitis C

Interventions

DRUG

LDV/SOF

90/400 mg FDC tablet administered orally once daily

DRUG

RBV

Tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (\< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)

DRUG

SOF/VEL

400/100 mg FDC tablet administered orally once daily

DRUG

VOX

100 mg tablet administered orally once daily with food

Sponsors & Collaborators

Principal Investigators

  • Gilead Study Director · Gilead Sciences

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-08-04
Primary Completion
2016-03-16
Completion
2016-05-09
FDA Drug
Yes

Countries

  • New Zealand

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02202980 on ClinicalTrials.gov