- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03036852
Sofosbuvir/Velpatasvir in Adults With Chronic Hepatitis C Virus Infection Who Are on Dialysis for End Stage Renal Disease (SOF/VEL ESRD)
February 18, 2020 updated by: Gilead Sciences
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
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
59
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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South Australia
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Adelaide, South Australia, Australia, 5000
- Royal Adelaide Hospital
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Alberta
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Edmonton, Alberta, Canada
- Kaye Edmonton Clinic
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British Columbia
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Vancouver, British Columbia, Canada, BC V5Z 1M9
- Gordon and Leslie Diamond Health Care Center, Vancouver General Hospital, UBC Division of Gastroenterology
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Ontario
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Brampton, Ontario, Canada
- William Osler Health System- Brampton Civic Hospital
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Hamilton, Ontario, Canada, ON L8V
- Hamilton Health Sciences - McMaster University Medical Centre Site
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Ottawa, Ontario, Canada, K1H 8L6
- Ottawa Hospital Research Institute
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Quebec
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Montréal, Quebec, Canada, H2X 3J4
- Centre de Recherche du Centre Hospitalier de l'Université de Montreal (CRCHUM)
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Jerusalem, Israel, 9103102
- Shaare Zedek Medical Center
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Ramat Gan, Israel, 52173
- The Chaim Sheba Medical Centre
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Tel Aviv, Israel, 64239
- Tel Aviv Sourasky Medical Center
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Auckland
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Grafton, Auckland, New Zealand, 1010
- Auckland City Hospital
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Barcelona, Spain, 08035
- Hospital Universitari Vall d'Hebron
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Majadahonda, Spain, 28222
- Hospital Universitario Puerta de Hierro - Majadahonda
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Sevilla, Spain, 41013
- Hospital Universitario Virgen del Rocio
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Madrid
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Alcorcón, Madrid, Spain, 28922
- Hospital Universitario Fundacion ALcorcon
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Glasgow, United Kingdom, G12 0YN
- Gartnavel General Hospital
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London, United Kingdom, SE5 9RS
- King's College Hospital
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London, United Kingdom, SW10 9NH
- Chelsea And Westminster Hospital
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London, United Kingdom, E1 1BB
- Barts Health NHS Trust
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London, United Kingdom, W2 1NY
- Imperial College Healthcare Nhs Trust
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Nottingham, United Kingdom, NG5 1PB
- Nottingham University Hospitals NHS Trust
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Plymouth, United Kingdom, PL6 8DH
- Derriford Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Key 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.
NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: SOF/VEL
SOF/VEL for 12 weeks
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400/100 mg fixed-dose combination (FDC) tablet(s) administered orally once daily
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)
Time Frame: Posttreatment Week 12
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SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) 12 weeks after stopping the study treatment.
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Posttreatment Week 12
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Percentage of Participants Who Permanently Discontinued the Study Drug Due to an Adverse Event
Time Frame: First dose date up to Week 12
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First dose date up to Week 12
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants With Sustained Virologic Response 4 Weeks After Discontinuation of Therapy (SVR4)
Time Frame: Posttreatment Week 4
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SVR4 was defined as HCV RNA < LLOQ 4 weeks after stopping study treatment.
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Posttreatment Week 4
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Percentage of Participants With Sustained Virologic Response 24 Weeks After Discontinuation of Therapy (SVR24)
Time Frame: Posttreatment Week 24
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SVR24 was defined as HCV RNA < LLOQ 24 weeks after stopping study treatment.
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Posttreatment Week 24
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Change From Baseline in HCV RNA
Time Frame: Baseline; Weeks 2, 4, 6, 8, and 12
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Baseline; Weeks 2, 4, 6, 8, and 12
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Percentage of Participants With HCV RNA < LLOQ on Treatment
Time Frame: Weeks 2, 4, 6, 8, and 12
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Weeks 2, 4, 6, 8, and 12
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Percentage of Participants With Virologic Failure
Time Frame: Baseline to Posttreatment Week 24
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Virologic failure was defined as:
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Baseline to Posttreatment Week 24
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Number of Participants Who Develop Viral Resistance (as Assessed by Presence of HCV NS5A and NS5B Genes) to SOF and VEL During Treatment and After Discontinuation of Treatment
Time Frame: First dose date up to Posttreatment Week 24
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Baseline deep sequencing of the HCV NS5A and NS5B genes was performed for all participants.
For all participants with virologic failure, deep sequencing was performed at the first time point after virologic failure if the plasma or serum sample was available and HCV RNA was > 1000 IU/mL.
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First dose date up to Posttreatment Week 24
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Pharmacokinetic (PK) Parameter: AUCtau of SOF
Time Frame: Sparse PK samples at Weeks 6, 8, and 12 (all participants). Intensive PK samples at predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose once at Week 6, 8, or 12 (participants who enrolled in the optional PK substudy (N=1))
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AUCtau is defined as the population PK derived area under the concentration versus time curve of the drug over the dosing interval.
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Sparse PK samples at Weeks 6, 8, and 12 (all participants). Intensive PK samples at predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose once at Week 6, 8, or 12 (participants who enrolled in the optional PK substudy (N=1))
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PK Parameter: AUCtau of GS-331007 (Metabolite of SOF)
Time Frame: Sparse PK samples at Weeks 6, 8, and 12 (all participants). Intensive PK samples at predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose once at Week 6, 8, or 12 (participants who enrolled in the optional PK substudy (N=1))
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AUCtau is defined as the population PK derived area under the concentration versus time curve of the drug over the dosing interval.
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Sparse PK samples at Weeks 6, 8, and 12 (all participants). Intensive PK samples at predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose once at Week 6, 8, or 12 (participants who enrolled in the optional PK substudy (N=1))
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PK Parameter: AUCtau of VEL
Time Frame: Sparse PK samples at Weeks 6, 8, and 12 (all participants). Intensive PK samples at predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose once at Week 6, 8, or 12 (participants who enrolled in the optional PK substudy (N=1))
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AUCtau is defined as the population PK derived area under the concentration verses time curve of the drug over the dosing interval.
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Sparse PK samples at Weeks 6, 8, and 12 (all participants). Intensive PK samples at predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose once at Week 6, 8, or 12 (participants who enrolled in the optional PK substudy (N=1))
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PK Parameter: Cmax of SOF
Time Frame: Sparse PK samples at Weeks 6, 8, and 12 (all participants). Intensive PK samples at predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose once at Week 6, 8, or 12 (participants who enrolled in the optional PK substudy (N=1))
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Cmax is defined as the population PK derived maximum concentration of the drug.
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Sparse PK samples at Weeks 6, 8, and 12 (all participants). Intensive PK samples at predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose once at Week 6, 8, or 12 (participants who enrolled in the optional PK substudy (N=1))
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PK Parameter: Cmax of GS-331007 (Metabolite of SOF)
Time Frame: Sparse PK samples at Weeks 6, 8, and 12 (all participants). Intensive PK samples at predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose once at Week 6, 8, or 12 (participants who enrolled in the optional PK substudy (N=1))
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Cmax is defined as the population PK derived maximum concentration of the drug.
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Sparse PK samples at Weeks 6, 8, and 12 (all participants). Intensive PK samples at predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose once at Week 6, 8, or 12 (participants who enrolled in the optional PK substudy (N=1))
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PK Parameter: Cmax of VEL
Time Frame: Sparse PK samples at Weeks 6, 8, and 12 (all participants). Intensive PK samples at predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose once at Week 6, 8, or 12 (participants who enrolled in the optional PK substudy (N=1))
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Cmax is defined as the population PK derived maximum concentration of the drug.
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Sparse PK samples at Weeks 6, 8, and 12 (all participants). Intensive PK samples at predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose once at Week 6, 8, or 12 (participants who enrolled in the optional PK substudy (N=1))
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PK Parameter: Ctau of VEL
Time Frame: Sparse PK samples at Weeks 6, 8, and 12 (all participants). Intensive PK samples at predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose once at Week 6, 8, or 12 (participants who enrolled in the optional PK substudy (N=1))
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Ctau is defined as the population PK derived concentration of the drug at the end of a 24 hour dosing interval.
The 24 hour Ctau is estimated based on the combination of sparse PK samples collected at random times across the dosing interval as well as intensive PK samples collected for up to 12 hours post-dose.
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Sparse PK samples at Weeks 6, 8, and 12 (all participants). Intensive PK samples at predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose once at Week 6, 8, or 12 (participants who enrolled in the optional PK substudy (N=1))
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Borgia SM, Dearden J, Lurie Y, Shafran SD, Brown A, Hyland RH, et al. Sofosbuvir/Velpatasvir for 12 Weeks Is Safe and Effective in Patients Undergoing Dialysis. American Association for the Study of Liver Diseases (AASLD); 2018 09-13 November; San Francisco, CA.
- Borgia SM, Dearden J, Yoshida EM, Shafran SD, Brown A, Ben-Ari Z, Cramp ME, Cooper C, Foxton M, Rodriguez CF, Esteban R, Hyland R, Lu S, Kirby BJ, Meng A, Markova S, Dvory-Sobol H, Osinusi AO, Bruck R, Ampuero J, Ryder SD, Agarwal K, Fox R, Shaw D, Haider S, Willems B, Lurie Y, Calleja JL, Gane EJ. Sofosbuvir/velpatasvir for 12 weeks in hepatitis C virus-infected patients with end-stage renal disease undergoing dialysis. J Hepatol. 2019 Oct;71(4):660-665. doi: 10.1016/j.jhep.2019.05.028. Epub 2019 Jun 11.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 22, 2017
Primary Completion (Actual)
August 13, 2018
Study Completion (Actual)
November 7, 2018
Study Registration Dates
First Submitted
January 27, 2017
First Submitted That Met QC Criteria
January 27, 2017
First Posted (Estimate)
January 30, 2017
Study Record Updates
Last Update Posted (Actual)
March 6, 2020
Last Update Submitted That Met QC Criteria
February 18, 2020
Last Verified
November 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Kidney Diseases
- Urologic Diseases
- Liver Diseases
- Renal Insufficiency
- Flaviviridae Infections
- Hepatitis, Viral, Human
- Enterovirus Infections
- Picornaviridae Infections
- Renal Insufficiency, Chronic
- Hepatitis
- Hepatitis A
- Hepatitis C
- Hepatitis, Chronic
- Kidney Failure, Chronic
- Hepatitis C, Chronic
- Anti-Infective Agents
- Antiviral Agents
- Sofosbuvir
- Sofosbuvir-velpatasvir drug combination
- Velpatasvir
Other Study ID Numbers
- GS-US-342-4062
- 2016-003625-42 (EudraCT Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Yes
IPD Plan Description
Qualified external researchers may request IPD for this study after study completion.
For more information, please visit our website at https://www.gilead.com/science-and-medicine/research/clinical-trials-transparency-and-data-sharing-policy.
IPD Sharing Time Frame
18 months after study completion
IPD Sharing Access Criteria
A secured external environment with username, password, and RSA code.
IPD Sharing Supporting Information Type
- Study Protocol
- Statistical Analysis Plan (SAP)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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