Clinical trial NCT02996682: Efficacy and Safety of Sofosbuvir/Velpatasvir ± Ribavirin for 12 Weeks in Adults With Chronic HCV Infection and Decompensated Cirrhosis
Official title: A Multicenter, Randomized, Phase 3, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir/Velpatasvir ± Ribavirin for 12 Weeks in Subjects With Chronic HCV Infection and Decompensated Cirrhosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hepatitis C Virus Infection
Keywords: Communicable Diseases
Hepatitis
Hepatitis C
Virus Diseases
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Velpatasvir
RNA Virus Infections
Ribavirin
Sofosbuvir
Antiviral Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents
Decompensated Cirrhosis
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2016-12-19
Enrollment: 102
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, safety, and tolerability of sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) with or without ribavirin (RBV) for 12 weeks in adults with chronic hepatitis C virus (HCV) infection and decompensated cirrhosis.


Eligibility criteria: Key Inclusion Criteria:

* Chronic HCV-infected males and non-pregnant/non-lactating females
* Treatment naive or treatment experienced individuals
* Child-Pugh-Turcotte Score 7-12 at screening

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 Discontinued Treatment (SOF/VEL or RBV) Early 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 Who Had HCV RNA < LLOQ by Visit While on Treatment
timeFrame: Up to 12 weeks
measure: Change From Baseline in HCV RNA
timeFrame: Baseline and up to 12 weeks
measure: Percentage of Participants With a Decrease, No Change, or Increase in Model for End Stage Liver Disease (MELD) Score
timeFrame: Baseline to Posttreatment Week 24
measure: Percentage of Participants With Improved and Worsened Child-Pugh-Turcotte (CPT) Class
timeFrame: Baseline to Posttreatment Week 24
measure: Percentage of Participants With Virologic Failure
timeFrame: Up to Posttreatment Week 24
Other outcomes:
Locations:
city: Shimonoseki
country: Japan
state: Yamaguchi
city: Bunkyo
country: Japan
city: Chiba
country: Japan
city: Chuo
country: Japan
city: Ehime
country: Japan
city: Fukui
country: Japan
city: Fukuyama-shi
country: Japan
city: Hiroshima
country: Japan
city: Ibaraki
country: Japan
city: Ichikawa
country: Japan
city: Iizuka City
country: Japan
city: Iruma
country: Japan
city: Izunokuni
country: Japan
city: Kashibara
country: Japan
city: Kofu
country: Japan
city: Kumamoto-shi
country: Japan
city: Kurume
country: Japan
city: Kyoto
country: Japan
city: Miyazaki-shi
country: Japan
city: Morioka
country: Japan
city: Musashino
country: Japan
city: Nagoya
country: Japan
city: Nishinomiya
country: Japan
city: Okayama
country: Japan
city: Omura
country: Japan
city: Osaka
country: Japan
city: Sapporo
country: Japan
city: Sendai
country: Japan
city: Shimotsuga-gun
country: Japan
city: Suita
country: Japan
city: Takamatsu
country: Japan
city: Ube
country: Japan
city: Yamagata
country: Japan
Study officials:
affiliation: Gilead Sciences
name: Gilead Study Director
role: STUDY_DIRECTOR
References:
citation: Takehara T, Kurosaki M, Tanaka Y, Tatsumi T, Ikeda F, Takikawa Y, et al. Sofosbuvir/Velpatasvir with or without Ribavirin for 12 Weeks in HCV-Infected Japanese Subjects with Decompensated Cirrhosis [Presentation]. 54th Annual Meeting of Japan Society of Hepatology; 2018 June 15; Osaka, Japan.