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

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ClinicalTrials.gov Identifier: NCT02781571
Recruitment Status : Completed
First Posted : May 24, 2016
Results First Posted : August 21, 2018
Last Update Posted : November 14, 2018
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Brief Summary:
The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of sofosbuvir /velpatasvir (SOF/VEL) fixed-dose combination (FDC) in participants with chronic hepatitis C virus (HCV) who have received a liver transplant.

Condition or disease Intervention/treatment Phase
Hepatitis C Virus Infection Drug: SOF/VEL Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 79 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 Fixed Dose Combination in Subjects With Chronic HCV Infection Who Have Received a Liver Transplant
Actual Study Start Date : July 27, 2016
Actual Primary Completion Date : July 28, 2017
Actual Study Completion Date : July 28, 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Sofosbuvir

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




Primary Outcome Measures :
  1. Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Cessation of Therapy (SVR12) [ Time Frame: Posttreatment Week 12 ]
    SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ) at 12 weeks after stopping study treatment.

  2. Percentage of Participants Who Prematurely Discontinued Study Drug Due to Any Adverse Event [ Time Frame: Up to 12 weeks ]

Secondary Outcome Measures :
  1. Percentage of Participants With Sustained Virologic Response 4 Weeks After Cessation of Therapy (SVR4) [ Time Frame: Posttreatment Week 4 ]
    SVR4 was defined as HCV RNA < LLOQ at 4 weeks after stopping study treatment.

  2. Percentage of Participants With HCV RNA < LLOQ at Week 2 [ Time Frame: Week 2 ]
  3. Percentage of Participants With HCV RNA < LLOQ at Week 4 [ Time Frame: Week 4 ]
  4. Percentage of Participants With HCV RNA < LLOQ at Week 8 [ Time Frame: Week 8 ]
  5. Percentage of Participants With HCV RNA < LLOQ at Week 12 [ Time Frame: Week 12 ]
  6. HCV RNA at Week 2 [ Time Frame: Week 2 ]
  7. HCV RNA at Week 4 [ Time Frame: Week 4 ]
  8. HCV RNA at Week 8 [ Time Frame: Week 8 ]
  9. HCV RNA at Week 12 [ Time Frame: Week 12 ]
  10. Change From Baseline in HCV RNA at Week 2 [ Time Frame: Baseline; Week 2 ]
  11. Change From Baseline in HCV RNA at Week 4 [ Time Frame: Baseline; Week 4 ]
  12. Change From Baseline in HCV RNA at Week 8 [ Time Frame: Baseline; Week 8 ]
  13. Change From Baseline in HCV RNA at Week 12 [ Time Frame: Baseline; Week 12 ]
  14. Percentage of Participants With Virologic Failure [ Time Frame: Up to Posttreatment Week 12 ]

    Virologic failure was defined as

    On-treatment virologic failure:

    • Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ on 2 consecutive measurements 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 12 weeks of treatment)

    Virologic relapse:

    • HCV RNA ≥ LLOQ during the post-treatment period having achieved HCV RNA < LLOQ at end of treatment, confirmed with 2 consecutive values or last available post-treatment measurement



Information from the National Library of Medicine

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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:

  • History of chronic HCV infection (≥ 6 months)
  • HCV genotype 1, 2, 3, 4, 5, 6, or indeterminate
  • Liver transplant ≥ 3 months prior to screening
  • Male and nonpregnant/ non-lactating female individuals without cirrhosis or with compensated cirrhosis

Key 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 HIV or hepatitis B virus
  • Known hypersensitivity to study medication,
  • Use of any prohibited concomitant medications as within with window before the Day 1 visit.
  • De novo or recurrent hepatocellular carcinoma posttransplant

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): NCT02781571


Locations
Spain
Hospital Clínic de Barcelona
Barcelona, Spain
Hospital Universitari Vall d'Hebron
Barcelona, Spain
Reina Sofía University Hospital
Córdoba, Spain
Hospital General Universitario Gregorio Maranon
Madrid, Spain
Hospital Ramón Y Cajal
Madrid, Spain
Hospital Universitario Virgen del Rocío
Sevilla, Spain
La Fe Hospital
Valencia, Spain
Hospital Clinico Zaragoza
Zaragoza, Spain
Switzerland
Universität Bern
Bern, Switzerland
University Hospital Zurich
Zürich, Switzerland
United Kingdom
Cambridge University Hospitals NHS Foundation Trust
Cambridge, United Kingdom
Royal Infirmary of Edinburgh
Edinburgh, United Kingdom
St James University Hospital
Leeds, United Kingdom
Kings College Hospital
London, United Kingdom
Royal Free Hampstead NHS Trust
London, United Kingdom
Sponsors and Collaborators
Gilead Sciences
Investigators
Study Director: Gilead Study Director Gilead Sciences
  Study Documents (Full-Text)

Documents provided by Gilead Sciences:
Study Protocol  [PDF] February 19, 2016
Statistical Analysis Plan  [PDF] August 10, 2017


Publications:
Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT02781571     History of Changes
Other Study ID Numbers: GS-US-342-2104
2016-000416-15 ( EudraCT Number )
First Posted: May 24, 2016    Key Record Dates
Results First Posted: August 21, 2018
Last Update Posted: November 14, 2018
Last Verified: July 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

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:
Hepatitis, Viral, Human
Infection
Communicable Diseases
Hepatitis
Hepatitis C
Virus Diseases
Liver Diseases
Digestive System Diseases
Flaviviridae Infections
RNA Virus Infections
Sofosbuvir
Sofosbuvir-velpatasvir drug combination
Antiviral Agents
Anti-Infective Agents