Clinical trial NCT02300103: Efficacy And Safety Of Sofosbuvir/Velpatasvir Fixed Dose Combination With Ribavirin in Chronic HCV Infected Adults Who Participated in a Prior Gilead Sponsored HCV Treatment Study
Official title: An Open Label Study to Evaluate The Efficacy And Safety Of Sofosbuvir/GS-5816 Fixed Dose Combination With Ribavirin For 24 Weeks In Chronic HCV Infected Subjects Who Participated In A Prior Gilead Sponsored HCV Treatment Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hepatitis C Virus Infection
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2014-11-24
Enrollment: 69
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 objective of this study is to evaluate the efficacy, safety and tolerability of treatment with sofosbuvir/velpatasvir (Epclusa®; SOF/VEL) with ribavirin (RBV) for 24 weeks in adults with chronic hepatitis C virus (HCV) infection who participated in a prior Gilead sponsored study and did not achieve sustained virologic response (SVR).


Eligibility criteria: Key Inclusion Criteria:

* Willing and able to provide written informed consent
* HCV genotype determined by the Central Laboratory
* HCV RNA \> LLOQ at screening
* Participated and completed a Gilead sponsored HCV treatment study of direct acting antiviral (DAA) containing regimens.
* Male and female of childbearing potential must agree to use protocol specified method(s) of contraception

Key Exclusion Criteria:

* Current or prior history: Clinically-significant illness (other than HCV) or any other major medical disorder that may interfere with treatment, assessment or compliance with the protocol; individuals currently under evaluation for a potentially clinically-significant illness (other than HCV) are also excluded.
* Screening ECG with clinically significant abnormalities
* Laboratory results outside of acceptable ranges at screening
* Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)

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

Primary outcomes:
measure: Percentage of Participants With Sustained Virologic Response 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 24 weeks
Secondary outcomes:
measure: Percentage of Participants With Sustained Virologic Response 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
timeFrame: Posttreatment Weeks 4 and 24
measure: Percentage of Participants With HCV RNA < LLOQ On-treatment
timeFrame: Baseline to Week 24
measure: HCV RNA Change From Baseline
timeFrame: Baseline to Week 24
measure: Percentage of Participants With Virologic Failure
timeFrame: Up to Posttreatment Week 24
Other outcomes:
Locations:
city: San Diego
country: United States
state: California
city: San Marcos
country: United States
state: California
city: Aurora
country: United States
state: Colorado
city: Gainesville
country: United States
state: Florida
city: Jacksonville
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Orlando
country: United States
state: Florida
city: Wellington
country: United States
state: Florida
city: Baltimore
country: United States
state: Maryland
city: Boston
country: United States
state: Massachusetts
city: Hillsborough
country: United States
state: New Jersey
city: Manhasset
country: United States
state: New York
city: Durham
country: United States
state: North Carolina
city: Fayetteville
country: United States
state: North Carolina
city: Philadelphia
country: United States
state: Pennsylvania
city: Pittsburgh
country: United States
state: Pennsylvania
city: Germantown
country: United States
state: Tennessee
city: Nashville
country: United States
state: Tennessee
city: Dallas
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Falls Church
country: United States
state: Virginia
city: Norfolk
country: United States
state: Virginia
city: Richmond
country: United States
state: Virginia
city: Darlinghurst
country: Australia
state: New South Wales
city: Fitzroy
country: Australia
state: Victoria
city: Melbourne
country: Australia
state: Victoria
city: Murdoch
country: Australia
state: Western Australia
city: Auckland
country: New Zealand
city: Christchurch
country: New Zealand
city: San Juan
country: Puerto Rico
Study officials:
affiliation: Gilead Sciences
name: Gilead Study Director
role: STUDY_DIRECTOR
References:
citation: Gane EJ, Shiffman ML, Etzkorn K, Morelli G, Stedman C, Davis MN, et al. Sofosbuvir/Velpatasvir in Combination With Ribavirin for 24 Weeks is Effective Retreatment for Patients Who Failed Prior NS5A Containing DAA Regimens: Results of the GS-US-342-1553 Study [Abstract PS024]. J Hepatology 2016;64:S147-S8.