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Sofosbuvir/Velpatasvir in Adults With Chronic Hepatitis C Virus Infection Who Are on Dialysis for End Stage Renal Disease | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Sofosbuvir/Velpatasvir in Adults With Chronic Hepatitis C Virus Infection Who Are on Dialysis for End Stage Renal Disease

A Phase 2, Multicenter, Open-Label Study to Evaluate the Efficacy and Safety of Sofosbuvir/Velpatasvir for 12 Weeks in Subjects With Chronic HCV Infection Who Are on Dialysis for End Stage Renal Disease

NCT03036852•Gilead Sciences

View on ClinicalTrials.gov

Summary

The primary objectives of this study are to evaluate safety, efficacy, and tolerability of treatment with sofosbuvir/velpatasvir (SOF/VEL) for 12 weeks in adults on dialysis for end stage renal disease (ESRD) with chronic hepatitis C virus (HCV) infection of any genotype.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Chronic HCV infected, male and non-pregnant/non-lactating females aged 18 years or older who are on dialysis for ESRD, including adults with HIV co-infection if they are suppressed on a stable, protocol-approved antiretroviral (ARV) regimen for ≥8 weeks prior to screening.

Locations (22)

Royal Adelaide Hospital

Adelaide, South Australia, Australia

Kaye Edmonton Clinic

Edmonton, Alberta, Canada

Gordon and Leslie Diamond Health Care Center, Vancouver General Hospital, UBC Division of Gastroenterology

Vancouver, British Columbia, Canada

William Osler Health System- Brampton Civic Hospital

Brampton, Ontario, Canada

Hamilton Health Sciences - McMaster University Medical Centre Site

Hamilton, Ontario, Canada

Ottawa Hospital Research Institute

Ottawa, Ontario, Canada

Centre de Recherche du Centre Hospitalier de l'Universite de Montreal (CRCHUM)

Montreal, Quebec, Canada

Shaare Zedek Medical Center

Jerusalem, Israel

The Chaim Sheba Medical Centre

Ramat Gan, Israel

Tel Aviv Sourasky Medical Center

Tel Aviv, Israel

Key Dates

Start Date

March 22, 2017

Primary Completion Date

August 13, 2018

Completion Date

November 7, 2018

Last Updated

March 6, 2020

Enrollment

ACTUAL participants

Conditions

Chronic Hepatitis C

Interventions

SOF/VEL

DRUG

Study of the Pharmacokinetic Action of Amantadine and Ribavirin in Chronic Hepatitis C. CINAM

NCT00199719

Chronic Hepatitis C

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COMPLETEDPHASE4

Study of the Efficacy and Safety of Pegnano Plus Barivir (Ribavirin) in Treatment-naïve Patients With Chronic Hepatitis C at KienGiang General Hospital

NCT06922643

Chronic Hepatitis C

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COMPLETEDNA

Changes in Liver Fibrosis, Lipid Profile and Insulin Resistance in HCV Patients Who Received Antiviral Therapy

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: March 6, 2020Data 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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Sofosbuvir/Velpatasvir in Adults With Chronic Hepatitis C Virus Infection Who Are on Dialysis for End Stage Renal Disease

Inclusion Criteria

Study of the Pharmacokinetic Action of Amantadine and Ribavirin in Chronic Hepatitis C. CINAM

Study of the Efficacy and Safety of Pegnano Plus Barivir (Ribavirin) in Treatment-naïve Patients With Chronic Hepatitis C at KienGiang General Hospital

Changes in Liver Fibrosis, Lipid Profile and Insulin Resistance in HCV Patients Who Received Antiviral Therapy

Efficacy and Safety Study of Pegylated Interferon Lambda-1a With Ribavirin and Daclatasvir, to Treat naïve Subjects With Chronic HCV Genotypes 1, 2, 3, and 4 Who Are Co-infected With HIV

Treatment of HCV-Infected Recent Injection Drug Users in U.S. Liver Clinics

A Study to Evaluate Long-term Outcomes Following Treatment With ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 With or Without Ribavirin (RBV) in Adults With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection