Clinical trial NCT02738333: Ledipasvir/Sofosbuvir Fixed-Dose Combination for 12 Weeks in Participants With Chronic Genotype 2 HCV Infection
Official title: A Phase 3b, Multicenter, Randomized, Open-Label Study to Investigate the Efficacy and Safety of Ledipasvir/Sofosbuvir Fixed-Dose Combination for 12 Weeks in Subjects With Chronic Genotype 2 HCV Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hepatitis C Virus Infection
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2016-04-14
Enrollment: 239
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 objectives of this study are to evaluate the antiviral efficacy of therapy with ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) and to evaluate the safety and tolerability of LDV/SOF FDC and sofosbuvir (SOF) + ribavirin (RBV) in participants with chronic genotype 2 hepatitis C virus (HCV) infection.


Eligibility criteria: Key Inclusion Criteria:

* Chronic genotype 2 HCV-infected males and non-pregnant/non-lactating females
* Aged 20 years or older
* Treatment naive or treatment experienced
* At least 20 subjects will have Child-Pugh-A compensated cirrhosis. In Cohort 2, participants must be ineligible or intolerant of RBV.

Key Exclusion Criteria:

* Previous exposure to an NS5A or NS5B inhibitor
* Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
* Pregnant or nursing female or male with pregnant female partner

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 12 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: 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: Percentage of Participants With Overall Virologic Failure
timeFrame: Up to Posttreatment Week 24
Other outcomes:
Locations:
city: Bunkyo
country: Japan
city: Chiba
country: Japan
city: Chuo City
country: Japan
city: Ehime
country: Japan
city: Fukuoka
country: Japan
city: Fukuyama
country: Japan
city: Gifu
country: Japan
city: Ibaragi
country: Japan
city: Ikeda
country: Japan
city: Iruma-gun
country: Japan
city: Itabashi
country: Japan
city: Izunokuni
country: Japan
city: Kagoshima
country: Japan
city: Kashihara
country: Japan
city: Kitakyushu
country: Japan
city: Kumamoto
country: Japan
city: Kyoto
country: Japan
city: Maebashi
country: Japan
city: Matsumoto
country: Japan
city: Morioka
country: Japan
city: Musashino
country: Japan
city: Nagasaki
country: Japan
city: Nagoya
country: Japan
city: Nishinomiya
country: Japan
city: Ogaki City
country: Japan
city: Okayama
country: Japan
city: Omura
country: Japan
city: Osaka
country: Japan
city: Sagamihara
country: Japan
city: Saga
country: Japan
city: Sapporo
country: Japan
city: Sendai
country: Japan
city: Suita
country: Japan
city: Takamatsu
country: Japan
city: Ube
country: Japan
city: Yamagata
country: Japan
city: Yufu
country: Japan
Study officials:
affiliation: Gilead Sciences
name: Gilead Study Director
role: STUDY_DIRECTOR
References: