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

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ClinicalTrials.gov Identifier: NCT03036852
Recruitment Status : Completed
First Posted : January 30, 2017
Last Update Posted : December 11, 2018
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Brief Summary:
The primary objectives of this study are to evaluate safety, efficacy and tolerability of treatment with sofosbuvir (Sovaldi®)/velpatasvir (Epclusa®; SOF/VEL) for 12 weeks in adults with chronic hepatitis C virus (HCV) infection who are on dialysis for End Stage Renal Disease (ESRD).

Condition or disease Intervention/treatment Phase
Chronic Hepatitis c Drug: SOF/VEL Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 59 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : March 22, 2017
Actual Primary Completion Date : August 13, 2018
Actual Study Completion Date : November 7, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Sofosbuvir

Arm Intervention/treatment
Experimental: SOF/VEL
SOF/VEL for 12 weeks
Drug: SOF/VEL
400/100 mg fixed-dose combination (FDC) tablet(s) administered orally once daily
Other Names:
  • GS-7977/GS-5816
  • Epclusa®




Primary Outcome Measures :
  1. Proportion of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12) [ Time Frame: Posttreatment Week 12 ]
    SVR12 is defined as HCV RNA < the lower limit of quantitation (LLOQ) 12 weeks following the last dose of study drug.

  2. Proportion of Participants Who Permanently Discontinued the Study Drug Due to an Adverse Event [ Time Frame: Up to Week 12 ]

Secondary Outcome Measures :
  1. Proportion of Participants With Sustained Virologic Response 4 Weeks After Discontinuation of Therapy (SVR4) [ Time Frame: Posttreatment Week 4 ]
    SVR4 is defined as HCV RNA < LLOQ 4 weeks after the last dose of study drug.

  2. Proportion of Participants With Sustained Virologic Response 24 Weeks After Discontinuation of Therapy (SVR24) [ Time Frame: Posttreatment Week 24 ]
    SVR24 is defined as HCV RNA < LLOQ 24 weeks after the last dose of study drug.

  3. Proportion of participants with HCV RNA < LLOQ on treatment [ Time Frame: Up to Week 12 ]
  4. Change From Baseline in HCV RNA [ Time Frame: Up to Week 12 ]
  5. Proportion of Participants With Virologic Failure [ Time Frame: Up to Posttreatment Week 24 ]

    Virologic failure is defined as:

    • On-treatment virologic failure:

      • Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while -on treatment), or
      • Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or
      • Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)
    • Virologic relapse:

      • Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit.

  6. Proportion of Participants Who Develop Resistance to SOF and VEL During Treatment [ Time Frame: Up to Week 12 ]
  7. Proportion of Participants Who Develop Resistance to SOF and VEL After Discontinuation of Therapy [ Time Frame: Up to Posttreatment Week 24 ]
  8. Pharmacokinetic (PK) Parameter: AUCtau of SOF and its metabolites [ Time Frame: Predose and up to 12 hours Postdose ]
    AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval)

  9. Pharmacokinetic (PK) Parameter: AUCtau of VEL [ Time Frame: Predose and up to 12 hours Postdose ]
    AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval)

  10. Pharmacokinetic (PK) Parameter: Tmax of SOF and its metabolites [ Time Frame: Predose and up to 12 hours Postdose ]
    Tmax is defined as the time of Cmax (the maximum concentration of drug)

  11. Pharmacokinetic (PK) Parameter: Tmax of VEL [ Time Frame: Predose and up to 12 hours Postdose ]
    Tmax is defined as the time of Cmax (the maximum concentration of drug)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03036852


Locations
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Australia, South Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia, 5000
Canada, Alberta
Kaye Edmonton Clinic
Edmonton, Alberta, Canada
Canada, British Columbia
Gordon and Leslie Diamond Health Care Center, Vancouver General Hospital, UBC Division of Gastroenterology
Vancouver, British Columbia, Canada, BC V5Z 1M9
Canada, Ontario
William Osler Health System- Brampton Civic Hospital
Brampton, Ontario, Canada
Hamilton Health Sciences - McMaster University Medical Centre Site
Hamilton, Ontario, Canada, ON L8V
Ottawa Hospital Research Institute
Ottawa, Ontario, Canada, K1H 8L6
Canada, Quebec
Centre de Recherche du Centre Hospitalier de l'Universite de Montreal (CRCHUM)
Montréal, Quebec, Canada, H2X 3J4
Israel
Shaare Zedek Medical Center
Jerusalem, Israel, 9103102
The Chaim Sheba Medical Centre
Ramat Gan, Israel, 52173
Tel Aviv Sourasky Medical Center
Tel Aviv, Israel, 64239
New Zealand
Auckland City Hospital
Grafton, Auckland, New Zealand, 1010
Spain
Hospital Universitario Fundación Alcorcón
Alcorcón, Madrid, Spain, 28922
Hospital Universitari Vall d'Hebron
Barcelona, Spain, 08035
Hospital Universitario Puerta de Hierro - Majadahonda
Majadahonda, Spain, 28222
Hospital Universitario Virgen del Rocío
Sevilla, Spain, 41013
United Kingdom
Gartnavel General Hospital
Glasgow, United Kingdom, G12 0YN
Barts Health NHS Trust
London, United Kingdom, E1 1BB
King's College Hospital
London, United Kingdom, SE5 9RS
Chelsea and Westminster Hospital
London, United Kingdom, SW10 9NH
Imperial College Healthcare NHS Trust
London, United Kingdom, W2 1NY
Nottingham University Hospitals NHS Trust
Nottingham, United Kingdom, NG5 1PB
Derriford Hospital
Plymouth, United Kingdom, PL6 8DH
Sponsors and Collaborators
Gilead Sciences
Investigators
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Study Director: Gilead Study Director Gilead Sciences

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT03036852     History of Changes
Other Study ID Numbers: GS-US-342-4062
2016-003625-42 ( EudraCT Number )
First Posted: January 30, 2017    Key Record Dates
Last Update Posted: December 11, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at http://www.gilead.com/research/disclosure-and-transparency.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: 18 months after study completion
Access Criteria: A secured external environment with username, password, and RSA code.
URL: http://www.gilead.com/research/disclosure-and-transparency

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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

Additional relevant MeSH terms:
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Hepatitis C
Hepatitis C, Chronic
Hepatitis
Hepatitis, Chronic
Kidney Diseases
Kidney Failure, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
RNA Virus Infections
Flaviviridae Infections
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Sofosbuvir
Velpatasvir
Sofosbuvir-velpatasvir drug combination
Antiviral Agents
Anti-Infective Agents