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Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed-Dose Combination in Participants With Chronic Hepatitis C Virus Infection | Clinical Trials | Clareo Health

COMPLETEDPHASE3

Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed-Dose Combination in Participants With Chronic Hepatitis C Virus Infection

A Phase 3, Open-label Study to Investigate the Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed Dose Combination for 12 Weeks in Subjects With Chronic Hepatitis C Virus (HCV) Infection

NCT02722837•Gilead Sciences

View on ClinicalTrials.gov

Summary

The primary objective of this study is to evaluate the efficacy, safety, and tolerability of treatment with sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) for 12 weeks in participants with chronic hepatitis C virus (HCV) infection.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•HCV RNA ≥ 10\^4 IU/mL at screening
•Chronic HCV infection (≥ 6 months) documented by prior medical history or liver biopsy

Exclusion Criteria

•Any other chronic liver disease
•Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
•Clinical hepatic decompensation
•Prior exposure to SOF or other nucleotide analogue HCV NS5B inhibitor or any HCV NS5A inhibitor

Locations (15)

Krasnoyarsk Regional Center of AIDS Prevention

Krasnoyarsk, Russia

Central Research Institute of Epidemiology

Moscow, Russia

Central Scientific-Research Institute of Epidemiology

Moscow, Russia

City Clinical Hospital # 24

Moscow, Russia

First Moscow Medical University I.M.Sechenov.

Moscow, Russia

First Moscow State Medical University I.M. Sechenov

Moscow, Russia

Limited Liability Company "Clinic Tour"

Moscow, Russia

Scientific Research Institute of Nutrition

Moscow, Russia

Sklifosovsky Scientific Research Institution of Emergency Care

Moscow, Russia

Center for Prevention and Control of AIDS and Infectious Diseases

Saint Petersburg, Russia

Key Dates

Start Date

April 4, 2016

Primary Completion Date

June 26, 2017

Completion Date

September 13, 2017

Last Updated

November 16, 2018

Enrollment

119

ACTUAL participants

Conditions

Hepatitis C Virus Infection

Interventions

SOF/VEL

DRUG

Acceptability of Simultaneous Screening for Viral Hepatitis B, C and HIV Among Drug Users in Non-conventional Structures

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Hepatitis CTransmission, Intravenous Drug Abuser+3 more

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COMPLETED

Relinking Diagnosed But Untreated HCV Patients Back Into Care.

NCT05975216

Hepatitis C Virus Infection

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 16, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed-Dose Combination in Participants With Chronic Hepatitis C Virus Infection

Inclusion Criteria

Exclusion Criteria

Acceptability of Simultaneous Screening for Viral Hepatitis B, C and HIV Among Drug Users in Non-conventional Structures

Relinking Diagnosed But Untreated HCV Patients Back Into Care.

Screening, Treatment, and Eradication of Hep C

Pharmacokinetics of Sofosbuvir/Daclatasvir in HCV-infected Lactating Women

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