MedDataX Logo

Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed-Dose Combination (FDC) and Sofosbuvir/Velpatasvir FDC and Ribavirin in Participants With Chronic Genotype 3 HCV Infection and Cirrhosis

NCT ID: NCT02781558

Last Updated: 2018-11-27

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

204 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-29

Study Completion Date

2017-10-27

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) and SOF/VEL FDC and ribavirin (RBV) for 12 weeks in participants with chronic genotype 3 hepatitis C virus (HCV) infection and compensated cirrhosis.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Sofosbuvir/Velpatasvir Fixed Dose Combination in Participants With Chronic Hepatitis C Virus Infection Who Have Received a Liver Transplant

NCT02781571

Hepatitis C Virus Infection
COMPLETED PHASE2

Comparison of Sofosbuvir/Velpatasvir Fixed Dose Combination for 12 Weeks With Sofosbuvir and Ribavirin for 24 Weeks in Adults With Chronic Genotype 3 HCV Infection

NCT02201953

Hepatitis C Virus Infection
COMPLETED PHASE3

Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed Dose Combination for 12 Weeks in Participants With Chronic HCV

NCT02671500

Hepatitis C Virus Infection
COMPLETED PHASE3

Evaluate the Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed-Dose Combination and Ribavirin for 12 Weeks in Participants With Chronic HCV Infection and Child-Pugh-Turcotte Class C Cirrhosis

NCT02994056

Hepatitis C Virus Infection
COMPLETED PHASE2

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

NCT02722837

Hepatitis C Virus Infection
COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hepatitis C Virus Infection

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

SOF/VEL

SOF/VEL FDC for 12 weeks

Group Type EXPERIMENTAL

SOF/VEL

Intervention Type DRUG

400/100 mg FDC tablet administered orally once daily

SOF/VEL + RBV

SOF/VEL FDC + RBV for 12 weeks

Group Type EXPERIMENTAL

SOF/VEL

Intervention Type DRUG

400/100 mg FDC tablet administered orally once daily

RBV

Intervention Type 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)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

SOF/VEL

400/100 mg FDC tablet administered orally once daily

Intervention Type DRUG

RBV

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)

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

GS-7977/GS-5816 Epclusa®

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Willing and able to provide written informed consent
* Individuals with chronic genotype 3 HCV infection and compensated cirrhosis
* Individuals with or without HIV-1 coinfection

Exclusion Criteria

* History of clinically significant illness or any other medical disorder that may interfere with individual's treatment assessment or compliance with the protocol
* Co-infection with active hepatitis B virus
* Laboratory results outside the acceptable ranges at screening
* Pregnant or nursing female
* Chronic liver disease not caused by HCV
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Gilead Sciences

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Gilead Study Director

Role: STUDY_DIRECTOR

Gilead Sciences

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Hospital Universitario Marques de Valdecilla

Santander, Cantabria, Spain

Site Status

Hospital Universitario de A Coruña

A Coruña, , Spain

Site Status

Hospital Universitario Fundacion Alcorcon

Alcorcón, , Spain

Site Status

Hospital General Universitario De Alicante

Alicante, , Spain

Site Status

Complejo Hospitalario Torrecárdenas

Almería, , Spain

Site Status

Hospital Germans Trias i Pujol

Badalona, , Spain

Site Status

Hospital Universitario Valle Hebron

Barcelona, , Spain

Site Status

Hospital Clínic de Barcelona

Barcelona, , Spain

Site Status

Hospital del Mar

Barcelona, , Spain

Site Status

Hospital Universitari de Bellvitge

Barcelona, , Spain

Site Status

Servei de d'Aparell Digestiu Corporació Sanitària Parc Taulí

Barcelona, , Spain

Site Status

Reina Sofía University Hospital

Córdoba, , Spain

Site Status

Hospital Universitario Donostia

Donostia / San Sebastian, , Spain

Site Status

Hospital Puerta De Hierro Majadahonda

Madrid, , Spain

Site Status

Hospital Ramón y Cajal

Madrid, , Spain

Site Status

Hospital Universitario La Paz

Madrid, , Spain

Site Status

Hospital Universitario Virgen de la Victoria

Málaga, , Spain

Site Status

Hospital Universitario Virgen De La Arrixaca

Murcia, , Spain

Site Status

Hospital Universitario Central de asturias

Oviedo, , Spain

Site Status

Complexo Hospitalario Universitario de Montecelo

Pontevedra, , Spain

Site Status

Hospital Univ. NuestraSeñora Candelaria

Santa Cruz de Tenerife, , Spain

Site Status

Hospital de Valme

Seville, , Spain

Site Status

Hospital Universitario Virgen Del Rocio

Seville, , Spain

Site Status

Hospital Clinico Universitario

Valencia, , Spain

Site Status

Hospital General Valencia

Valencia, , Spain

Site Status

La Fe Hospital

Valencia, , Spain

Site Status

Hospital Universitario Alvaro Cunqueiro

Vigo, , Spain

Site Status

Hospital Clinico Universitario

Zaragoza, , Spain

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Spain

References

Explore related publications, articles, or registry entries linked to this study.

Esteban R, Pineda JA, Calleja JL, Casado M, Rodriguez M, Turnes J, Morano Amado LE, Morillas RM, Forns X, Pascasio Acevedo JM, Andrade RJ, Rivero A, Carrion JA, Lens S, Riveiro-Barciela M, McNabb B, Zhang G, Camus G, Stamm LM, Brainard DM, Subramanian GM, Buti M. Efficacy of Sofosbuvir and Velpatasvir, With and Without Ribavirin, in Patients With Hepatitis C Virus Genotype 3 Infection and Cirrhosis. Gastroenterology. 2018 Oct;155(4):1120-1127.e4. doi: 10.1053/j.gastro.2018.06.042. Epub 2018 Jun 27.

Reference Type DERIVED
PMID: 29958855 (View on PubMed)

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol: Original

View Document

Document Type: Study Protocol: Protocol Amendment 1

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2016-000417-73

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

GS-US-342-2097

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Sofosbuvir/Velpatasvir Fixed-Dose Combination and Ribavirin for 12 or 24 Weeks in Participants With Chronic Genotype 1 or 2 Hepatitis C Virus Infection Who Have Previously Failed a Direct-Acting Antiviral-Containing Regimen
NCT02822794 COMPLETED PHASE3
Safety and Efficacy of SOF/VEL/VOX FDC for 8 Weeks and SOF/VEL for 12 Weeks in Adults Chronic Genotype 3 HCV Infection and Cirrhosis
NCT02639338 COMPLETED PHASE3
Sofosbuvir/Velpatasvir Fixed-Dose Combination in Adults With Chronic HCV Infection and Child-Pugh Class B Cirrhosis
NCT02201901 COMPLETED PHASE3
Safety and Efficacy of Sofosbuvir/Velpatasvir/Voxilaprevir and Sofosbuvir/Velpatasvir in Adults With Chronic HCV Infection Who Have Not Previously Received Treatment With Direct-Acting Antiviral Therapy
NCT02607800 COMPLETED PHASE3
Safety and Efficacy of Voxilaprevir Plus Sofosbuvir/Velpatasvir Fixed Dose Combination in Adults With Chronic Non-Genotype 1 HCV Infection
NCT02378961 COMPLETED PHASE2
Safety and Efficacy of Voxilaprevir Plus Sofosbuvir/Velpatasvir Fixed Dose Combination in Adults With Chronic Genotype 1 HCV Infection
NCT02378935 COMPLETED PHASE2
Study to Investigate the Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed-Dose Combination for 12 Weeks in Adults With Chronic HCV Infection and Compensated Cirrhosis
NCT04112303 COMPLETED PHASE3
Safety and Efficacy of Sofosbuvir/Velpatasvir/Voxilaprevir Fixed-Dose Combination With or Without Ribavirin in Participants With Chronic Genotype 1 HCV Infection Previously Treated With a Direct Acting Antiviral Regimen
NCT02536313 COMPLETED PHASE2
Study to Investigate the Efficacy and Safety of Sofosbuvir/Velpatasvir (SOF/VEL) Fixed-Dose Combination (FDC) and Sofosbuvir/Velpatasvir/Voxilaprevir (SOF/VEL/VOX ) FDC for 12 Weeks in Adults With Chronic Hepatitis C Virus (HCV) Infection
NCT04211909 COMPLETED PHASE3
Sofosbuvir/Velpatasvir Fixed Dose Combination for 12 Weeks in Adults With Chronic HCV Infection
NCT02201940 COMPLETED PHASE3
Comparison of Sofosbuvir/Velpatasvir Fixed Dose Combination for 12 Weeks With Sofosbuvir and Ribavirin for 12 Weeks in Adults With Chronic Genotype 2 HCV Infection
NCT02220998 COMPLETED PHASE3
Efficacy and Safety of Sofosbuvir/Velpatasvir ± Ribavirin for 12 Weeks in Adults With Chronic HCV Infection and Decompensated Cirrhosis
NCT02996682 COMPLETED PHASE3
Sofosbuvir/Velpatasvir Fixed Dose Combination for 12 Weeks in Adults With Chronic Hepatitis C Virus (HCV) Infection
NCT03074331 COMPLETED PHASE3
Safety And Efficacy of Sofosbuvir/Velpatasvir/Voxilaprevir Fixed-Dose Combination for 12 Weeks in Adults Who Participated in a Prior Gilead-Sponsored HCV Treatment Study
NCT03118843 COMPLETED PHASE3
Safety and Efficacy of Sofosbuvir Plus Velpatasvir With or Without Ribavirin in Treatment-experienced Subjects With Chronic HCV Infection
NCT01909804 COMPLETED PHASE2
Safety and Efficacy of Sofosbuvir + Velpatasvir With or Without Ribavirin in Treatment-Naive Adults With Chronic HCV Infection
NCT01858766 COMPLETED PHASE2
Safety and Efficacy of Sofosbuvir/Velpatasvir/Voxilaprevir in Adults With Chronic HCV Infection Who Have Previously Received Treatment With Direct-Acting Antiviral Therapy
NCT02607735 COMPLETED PHASE3
Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed-Dose Combination (FDC) With and Without Ribavirin for the Treatment of HCV
NCT01701401 COMPLETED PHASE3
Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed Dose Combination for 12 Weeks in Adults With Chronic Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV)-1 Coinfection
NCT02480712 COMPLETED PHASE3
Efficacy And Safety Of Sofosbuvir/Velpatasvir Fixed Dose Combination With Ribavirin in Chronic HCV Infected Adults Who Participated in a Prior Gilead Sponsored HCV Treatment Study
NCT02300103 COMPLETED PHASE2
Efficacy and Safety of Sofosbuvir/Ledipasvir Fixed-Dose Combination ± Ribavirin in Cirrhotic Subjects With Chronic Genotype 1 HCV Infection
NCT01965535 COMPLETED PHASE2
Sofosbuvir Plus Ribavirin, or Ledipasvir/Sofosbuvir in Adults With HCV Infection and Renal Insufficiency
NCT01958281 COMPLETED PHASE2
Sofosbuvir/Velpatasvir Fixed-Dose Combination in Adults With Chronic HCV Infection
NCT02346721 COMPLETED PHASE3
A Randomized, Open-Label Study of Daclatasvir and Sofosbuvir With or Without Ribavirin for 8 Weeks in Treatment-Naïve, Non-cirrhotic Subjects Infected With Chronic Hepatitis C Virus (HCV) Genotype 3
NCT02551861 WITHDRAWN PHASE2
Efficacy and Safety of Ledipasvir/Sofosbuvir, With or Without Ribavirin, in HCV Infected Participants Who Have Failed Prior Treatment With Sofosbuvir-based Therapies
NCT02600351 TERMINATED PHASE3