Clinical trial NCT04112303: Study to Investigate the Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed-Dose Combination for 12 Weeks in Adults With Chronic HCV Infection and Compensated Cirrhosis
Official title: A Phase 3 Multicenter, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed-Dose Combination for 12 Weeks in Subjects With Chronic HCV Infection and Compensated Cirrhosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hepatitis C Virus Infection
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2019-10-02
Enrollment: 37
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 evaluate the antiviral efficacy, safety, and tolerability of therapy with sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) in adults with chronic hepatitis C virus (HCV) infection and compensated cirrhosis.


Eligibility criteria: Key Inclusion Criteria:

* Chronic HCV-infected males and non-pregnant/non-lactating females
* Treatment-naïve or treatment-experienced individuals
* Compensated cirrhosis at Screening

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

Primary outcomes:
measure: Percentage of Participants With Sustained Virologic Response (SVR) < Lower Limit of Quantification (LLOQ) 12 Weeks After Discontinuation of Treatment (SVR12)
timeFrame: Posttreatment Week 12
measure: Percentage of Participants Who Experienced Any Treatment-Emergent Adverse Event (TEAE) Leading to Discontinuation of Study Drug
timeFrame: First dose date up to Week 12.1
Secondary outcomes:
measure: Percentage of Participants With HCV RNA < LLOQ at 4 Weeks After Discontinuation of Treatment (SVR4)
timeFrame: Posttreatment Week 4
measure: Percentage of Participants With HCV RNA < LLOQ at 24 Weeks After Discontinuation of Treatment (SVR24)
timeFrame: Posttreatment Week 24
measure: Percentage of Participants With Virologic Failure
timeFrame: First dose date up to posttreatment Week 24
Other outcomes:
Locations:
city: Chiba
country: Japan
facility: Chiba University Hospital
city: Fukui
country: Japan
facility: Fukui-ken Saiseikai Hospital
city: Fukuoka-shi
country: Japan
facility: Japanese Red Cross Fukuoka Hospital
city: Hiroshima-shi
country: Japan
facility: Hiroshima University Hospital Institution Review Board
city: Iizuka
country: Japan
facility: Iizuka Hospital
city: Inzai-shi
country: Japan
facility: Nippon Medical School Hospital
city: Iruma
country: Japan
facility: Saitama Medical University Hospital
city: Izunokuni
country: Japan
facility: Juntendo University Shizuoka Hospital
city: Kashihara-shi
country: Japan
facility: Nara Medical University Hospital
city: Kawasaki-shi
country: Japan
facility: Toranomon Hospital Kajigaya
city: Kumamoto
country: Japan
facility: Kumamoto Shinto General Hospital
city: Kurume-shi
country: Japan
facility: Kurme University Hospital
city: Matsuyama-shi
country: Japan
facility: Matsuyama Red Cross Hospital
city: Musashino
country: Japan
facility: Japanese Red Cross Musashino Hospital
city: Nishinomiya
country: Japan
facility: Hyogo College of Medicine Hospital Institutional Review Board
city: Omura-shi
country: Japan
facility: National Hospital Organization Nagasaki Medical Center
city: Osaka
country: Japan
facility: Osaka Red Cross Hospital
city: Osaka
country: Japan
facility: Osaka City University Hospital
city: Sapporo-shi
country: Japan
facility: Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital
city: Suita-shi
country: Japan
facility: Osaka University Hospital
city: Takamatsu-shi
country: Japan
facility: Kagawa Prefectural Central Hospital
city: Tokyo
country: Japan
facility: Toranomon Hospital
Study officials:
affiliation: Gilead Sciences
name: Gilead Study Director
role: STUDY_DIRECTOR
References:
citation: Takehara T, Izumi N, Mochida S, Genda T, Fujiyama S, Notsumata K, Tamori A, Suzuki F, Suri V, Mercier RC, Matsuda T, Matsuda K, Kato N, Chayama K, Kumada H. Sofosbuvir-velpatasvir in adults with hepatitis C virus infection and compensated cirrhosis in Japan. Hepatol Res. 2022 Oct;52(10):833-840. doi: 10.1111/hepr.13810. Epub 2022 Aug 8.