NCT03036852

Brief 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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
59

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Mar 2017

Geographic Reach
6 countries

22 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 27, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 30, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

March 22, 2017

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 13, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 7, 2018

Completed
1 year until next milestone

Results Posted

Study results publicly available

November 12, 2019

Completed
Last Updated

March 6, 2020

Status Verified

November 1, 2019

Enrollment Period

1.4 years

First QC Date

January 27, 2017

Results QC Date

August 12, 2019

Last Update Submit

February 18, 2020

Conditions

Chronic Hepatitis C

Outcome Measures

Primary Outcomes (2)

  • Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)

    SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ; ie, 15 IU/mL) 12 weeks after stopping the study treatment.

    Posttreatment Week 12

  • Percentage of Participants Who Permanently Discontinued the Study Drug Due to an Adverse Event

    First dose date up to Week 12

Secondary Outcomes (13)

  • Percentage of Participants With Sustained Virologic Response 4 Weeks After Discontinuation of Therapy (SVR4)

    Posttreatment Week 4

  • Percentage of Participants With Sustained Virologic Response 24 Weeks After Discontinuation of Therapy (SVR24)

    Posttreatment Week 24

  • Change From Baseline in HCV RNA

    Baseline; Weeks 2, 4, 6, 8, and 12

  • Percentage of Participants With HCV RNA < LLOQ on Treatment

    Weeks 2, 4, 6, 8, and 12

  • Percentage of Participants With Virologic Failure

    Baseline to Posttreatment Week 24

  • +8 more secondary outcomes

Study Arms (1)

SOF/VEL

EXPERIMENTAL

SOF/VEL for 12 weeks

Drug: SOF/VEL

Interventions

SOF/VELDRUG

400/100 mg fixed-dose combination (FDC) tablet(s) administered orally once daily

Also known as: GS-7977/GS-5816, Epclusa®
SOF/VEL

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (22)

Royal Adelaide Hospital

Adelaide, South Australia, 5000, Australia

Location

Kaye Edmonton Clinic

Edmonton, Alberta, Canada

Location

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

Vancouver, British Columbia, BC V5Z 1M9, Canada

Location

William Osler Health System- Brampton Civic Hospital

Brampton, Ontario, Canada

Location

Hamilton Health Sciences - McMaster University Medical Centre Site

Hamilton, Ontario, ON L8V, Canada

Location

Ottawa Hospital Research Institute

Ottawa, Ontario, K1H 8L6, Canada

Location

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

Montreal, Quebec, H2X 3J4, Canada

Location

Shaare Zedek Medical Center

Jerusalem, 9103102, Israel

Location

The Chaim Sheba Medical Centre

Ramat Gan, 52173, Israel

Location

Tel Aviv Sourasky Medical Center

Tel Aviv, 64239, Israel

Location

Auckland City Hospital

Grafton, Auckland, 1010, New Zealand

Location

Hospital Universitario Fundación Alcorcón

Alcorcón, Madrid, 28922, Spain

Location

Hospital Universitari Vall d'Hebron

Barcelona, 08035, Spain

Location

Hospital Universitario Puerta de Hierro - Majadahonda

Majadahonda, 28222, Spain

Location

Hospital Universitario Virgen del Rocío

Seville, 41013, Spain

Location

Gartnavel General Hospital

Glasgow, G12 0YN, United Kingdom

Location

Barts Health NHS Trust

London, E1 1BB, United Kingdom

Location

King's College Hospital

London, SE5 9RS, United Kingdom

Location

Chelsea and Westminster Hospital

London, SW10 9NH, United Kingdom

Location

Imperial College Healthcare NHS Trust

London, W2 1NY, United Kingdom

Location

Nottingham University Hospitals NHS Trust

Nottingham, NG5 1PB, United Kingdom

Location

Derriford Hospital

Plymouth, PL6 8DH, United Kingdom

Location

Related Publications (2)

  • 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.

    RESULT

  • 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.

    PMID: 31195062DERIVED

MeSH Terms

Conditions

Hepatitis C, Chronic

Interventions

sofosbuvir-velpatasvir drug combination

Condition Hierarchy (Ancestors)

Hepatitis CBlood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitis, ChronicHepatitisLiver DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Gilead Clinical Study Information Center
Organization
Gilead Sciences
GileadClinicalTrials@gilead.com
1-833-445-3230 (GILEAD-0)

Study Officials

  • Gilead Study Director

    Gilead Sciences

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 27, 2017

First Posted

January 30, 2017

Study Start

March 22, 2017

Primary Completion

August 13, 2018

Study Completion

November 7, 2018

Last Updated

March 6, 2020

Results First Posted

November 12, 2019

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
18 months after study completion
Access Criteria
A secured external environment with username, password, and RSA code.
More information

Locations

AU(1)NZ(1)GB(7)ES(4)IL(3)CA(6)