Clinical trial NCT02822794: Sofosbuvir/Velpatasvir Fixed-Dose Combination and Ribavirin for 12 or 24 Weeks in Participants With Chronic Genotype 1 or 2 Hepatitis C Virus Infection Who Have Previously Failed a Direct-Acting Antiviral-Containing Regimen
Official title: A Phase 3, Multicenter, Randomized, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed-Dose Combination and Ribavirin for 12 or 24 Weeks in Subjects With Chronic Genotype 1 or 2 HCV Infection Who Have Previously Failed a Direct-Acting Antiviral-Containing Regimen
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hepatitis C Virus Infection
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2016-07-04
Enrollment: 117
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to evaluate the antiviral efficacy, safety, and tolerability of therapy with sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) and ribavirin (RBV) in participants with chronic genotype 1 or 2 hepatitis C virus (HCV) infection who have previously failed a direct-acting antiviral (DAA)-containing regimen.


Eligibility criteria: Key Inclusion Criteria:

* Genotype 1 or 2 HCV infection
* Chronic HCV infection (≥ 6 months prior to screening) documented by prior medical history or liver biopsy
* Previously treated with a DAA-containing regimen of at least 4 week duration

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 24 weeks
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 SVR at 24 Weeks After Discontinuation of Therapy (SVR24)
timeFrame: Posttreatment Week 24
measure: Percentage of Participants With HCV RNA < LLOQ at Week 1
timeFrame: Week 1
measure: Percentage of Participants With HCV RNA < LLOQ at Week 2
timeFrame: Week 2
measure: Percentage of Participants With HCV RNA < LLOQ at Week 3
timeFrame: Week 3
measure: Percentage of Participants With HCV RNA < LLOQ at Week 4
timeFrame: Week 4
measure: Percentage of Participants With HCV RNA < LLOQ at Week 5
timeFrame: Week 5
measure: Percentage of Participants With HCV RNA < LLOQ at Week 6
timeFrame: Week 6
measure: Percentage of Participants With HCV RNA < LLOQ at Week 8
timeFrame: Week 8
measure: Percentage of Participants With HCV RNA < LLOQ at Week 10
timeFrame: Week 10
measure: Percentage of Participants With HCV RNA < LLOQ at Week 12
timeFrame: Week 12
measure: Percentage of Participants With HCV RNA < LLOQ at Week 16
timeFrame: Week 16
measure: Percentage of Participants With HCV RNA < LLOQ at Week 20
timeFrame: Week 20
measure: Percentage of Participants With HCV RNA < LLOQ at Week 24
timeFrame: Week 24
measure: Change From Baseline in HCV RNA at Week 1
timeFrame: Baseline; Week 1
measure: Change From Baseline in HCV RNA at Week 2
timeFrame: Baseline; Week 2
measure: Change From Baseline in HCV RNA at Week 3
timeFrame: Baseline; Week 3
measure: Change From Baseline in HCV RNA at Week 4
timeFrame: Baseline; Week 4
measure: Change From Baseline in HCV RNA at Week 5
timeFrame: Baseline; Week 5
measure: Change From Baseline in HCV RNA at Week 6
timeFrame: Baseline; Week 6
measure: Change From Baseline in HCV RNA at Week 8
timeFrame: Baseline; Week 8
measure: Change From Baseline in HCV RNA at Week 10
timeFrame: Baseline; Week 10
measure: Change From Baseline in HCV RNA at Week 12
timeFrame: Baseline; Week 12
measure: Change From Baseline in HCV RNA at Week 16
timeFrame: Baseline; Week 16
measure: Change From Baseline in HCV RNA at Week 20
timeFrame: Baseline; Week 20
measure: Change From Baseline in HCV RNA at Week 24
timeFrame: Baseline; Week 24
measure: Percentage of Participants With Overall Virologic Failure
timeFrame: Up to Posttreatment Week 24
Other outcomes:
Locations:
city: Ehime
country: Japan
city: Hiroshima
country: Japan
city: Ichikawa-shi
country: Japan
city: Iruma-gun
country: Japan
city: Kashihara
country: Japan
city: Kurume-shi
country: Japan
city: Kyoto
country: Japan
city: Maebashi
country: Japan
city: Musashino-shi
country: Japan
city: Nagoya
country: Japan
city: Nishinomiya
country: Japan
city: Ogaki City
country: Japan
city: Okayama
country: Japan
city: Omura
country: Japan
city: Sapporo
country: Japan
city: Suita
country: Japan
city: Takamatsu-shi
country: Japan
city: Yamagata
country: Japan
Study officials:
affiliation: Gilead Sciences
name: Gilead Study Director
role: STUDY_DIRECTOR
References: