Clinical trial NCT03118843: Safety And Efficacy of Sofosbuvir/Velpatasvir/Voxilaprevir Fixed-Dose Combination for 12 Weeks in Adults Who Participated in a Prior Gilead-Sponsored HCV Treatment Study
Official title: An Open-Label Study to Evaluate the Safety And Efficacy of Sofosbuvir/Velpatasvir/Voxilaprevir Fixed-Dose Combination for 12 Weeks in Subjects Who Participated in a Prior Gilead-Sponsored HCV Treatment Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hepatitis C Virus Infection
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2017-04-18
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary objectives of this study are to determine the efficacy, safety, and tolerability of treatment with sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) fixed-dose combination (FDC) for 12 weeks in participants with chronic hepatitis C virus (HCV) infection with or without cirrhosis, who did not achieve sustained viral response (SVR) after receiving prior treatment in a Gilead-sponsored HCV treatment study of direct-acting antiviral (DAA)-containing regimens.


Eligibility criteria: Key Inclusion Criteria:

* Chronically HCV-infected males and non-pregnant/non-lactating females aged 18 years or older who did not achieve sustained virologic response (SVR) in a prior Gilead-sponsored HCV treatment study

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

Primary outcomes:
measure: Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)
timeFrame: Posttreatment Week 12
measure: Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
timeFrame: Up to Week 12
Secondary outcomes:
measure: Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4)
timeFrame: Posttreatment Week 4
measure: Percentage of Participants With HCV RNA < LLOQ On Treatment
timeFrame: Weeks 2, 4, 8, and 12
measure: Percentage of Participants With Virologic Failure
timeFrame: Up to Posttreatment Week 12
measure: Change From Baseline in HCV RNA
timeFrame: Baseline; Weeks 2, 4, 8, and 12
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Ruane Clinical Research Group Inc.
state: California
city: Los Angeles
country: United States
facility: Cedars Sinai Medical Center
state: California
city: Palo Alto
country: United States
facility: Stanford Hospital and Clinics
state: California
city: Rialto
country: United States
facility: Inland Empire Liver Foundation
state: California
city: San Diego
country: United States
facility: Kaiser Permanente
state: California
city: Aurora
country: United States
facility: University of Colorado Denver (Leprino Building)
state: Colorado
city: Orlando
country: United States
facility: Orlando Immunology Center
state: Florida
city: Atlanta
country: United States
facility: Emory Hospital Midtown Infectious Disease Clinic
state: Georgia
city: Marietta
country: United States
facility: Gastrointestinal Specialists of Georgia
state: Georgia
city: Saint Louis
country: United States
facility: Saint Louis University, Gastroenterology & Hepatology, Clinical Research Unit
state: Missouri
city: New York
country: United States
facility: NYU Langone Medical Center
state: New York
city: New York
country: United States
facility: Columbia University Medical Center/ New York Presbyterian
state: New York
city: Pittsburgh
country: United States
facility: Center for Liver Diseases, Oakland
state: Pennsylvania
city: Providence
country: United States
facility: University Gastroenterology
state: Rhode Island
city: Germantown
country: United States
facility: Gastro One
state: Tennessee
city: Knoxville
country: United States
facility: New Orleans Center for Clinical Research
state: Tennessee
city: Seattle
country: United States
facility: University of Washington/Harborview Medical Center
state: Washington
city: Camperdown
country: Australia
facility: Royal Prince Alfred Hospital
state: New South Wales
city: Darlinghurst
country: Australia
facility: Translational Research Centre
state: New South Wales
city: Edmonton
country: Canada
facility: Kay Edmonton Clinic
city: Toronto
country: Canada
facility: Toronto Centre for Liver Disease (TCLD), Toronto General Hospital
city: Rouen cedex
country: France
facility: Centre Hospitalier Universitaire de Rouen
city: Berlin
country: Germany
facility: Leber- and Studienzentrum am Checkpoint
city: Bonn
country: Germany
facility: Universitatsklinikum Bonn
city: Grafton
country: New Zealand
facility: Auckland Clinical Studies Ltd
state: Auckland
city: Christchurch
country: New Zealand
facility: Christchurch Clinical Studies Trust, Ltd
city: London
country: United Kingdom
facility: Kings College Hospital NHS Trust
Study officials:
affiliation: Gilead Sciences
name: Gilead Study Director
role: STUDY_DIRECTOR
References:
citation: Ruane P, Strasser SJ, Gane EJ, Hyland RH, Shao J, Dvory-Sobol H, et al. Retreatment with Sofosbuvir/Velpatasvir/Voxilaprevir for 12 weeks is safe and effective for patients who have previously received Sofosbuvir/Velpatasvir or Sofosbuvir/Velpatasvir/Voxilaprevir [Abstract LBO-06]. 16th International Symposium on Viral Hepatitis and Liver Diseases (ISVHLD); 2018 14-17 June; Toronto, Canada