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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02781571
First Posted: May 24, 2016
Last Update Posted: August 4, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Gilead Sciences
  Purpose
This study will 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 Intervention Phase
Hepatitis C Virus Infection Drug: SOF/VEL Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Gilead Sciences:

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

  • Percentage of Participants Who Permanently Discontinued Study Drug Due to any Adverse Event [ Time Frame: Up to 12 weeks ]

Secondary Outcome Measures:
  • Percentage of Participants who Attain Sustained Virologic Response at 4 Weeks After Cessation of the Study Treatment Regimen (SVR4) [ Time Frame: Posttreatment Week 4 ]
    SVR4 is defined as HCV RNA < LLOQ at 4 weeks after stopping study treatment.

  • Percentage of Participants who Have HCV RNA < LLOQ by Visit While on Study Treatment [ Time Frame: Up to 12 Weeks ]
  • Absolute and Change From Baseline/Day 1 in HCV RNA Through Week 12 [ Time Frame: Baseline; Week 12 ]
  • Percentage 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 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


Enrollment: 79
Actual Study Start Date: July 27, 2016
Study Completion Date: July 28, 2017
Primary Completion Date: July 28, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Key Inclusion Criteria:

  • History of chronic HCV prior to liver transplant with HCV reoccurrence post-transplant
  • HCV genotype 1, 2, 3, 4, 5, 6, or indeterminate
  • Individuals ≥ 3 months post-liver transplant with chronic HCV reoccurrence
  • Male and nonpregnant/ non-lactating female individuals without cirrhosis or with compensated cirrhosis
  • Metavir stage 3 or 4 fibrosis/cirrhosis or corresponding fibrosis

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.

NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.

  Contacts and Locations
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
  More Information

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 Submitted: May 20, 2016
First Posted: May 24, 2016
Last Update Posted: August 4, 2017
Last Verified: August 2017

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