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
- Registration Number
- NCT04112303
- Lead Sponsor
- Gilead Sciences
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 37
- 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.
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description SOF/VEL SOF/VEL Participants received SOF/VEL (400/100 mg) orally once daily for up to 12 weeks.
- Primary Outcome Measures
Name Time Method Percentage of Participants Who Experienced Any Treatment-Emergent Adverse Event (TEAE) Leading to Discontinuation of Study Drug First dose date up to Week 12.1 TEAEs were defined as any AEs with an onset date on or after the study drug start and no later than 30 days after permanent discontinuation of study drug and/or any AEs leading to premature discontinuation of the study drug.
Percentage of Participants With Sustained Virologic Response (SVR) < Lower Limit of Quantification (LLOQ) 12 Weeks After Discontinuation of Treatment (SVR12) Posttreatment Week 12 SVR12 was defined as hepatitis C virus ribonucleic acid (HCV RNA) \< LLOQ (i.e., 15 IU/mL) at 12 weeks after stopping study treatment.
- Secondary Outcome Measures
Name Time Method Percentage of Participants With HCV RNA < LLOQ at 4 Weeks After Discontinuation of Treatment (SVR4) Posttreatment Week 4 SVR4 was defined as HCV RNA \< LLOQ (i.e.15 IU/mL) at 4 weeks after stopping study treatment.
Percentage of Participants With HCV RNA < LLOQ at 24 Weeks After Discontinuation of Treatment (SVR24) Posttreatment Week 24 SVR24 was defined as HCV RNA \< LLOQ (i.e.15 IU/mL) at 24 weeks after stopping study treatment.
Percentage of Participants With Virologic Failure First dose date up to posttreatment Week 24 Virologic failure was defined as:
* On-treatment virologic failure:
* Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA \< LLOQ while on treatment), or
* Rebound (confirmed \> 1 log10 IL/mL increase in HCV RNA from nadir while on treatment), or
* Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)
* Virologic relapse:
* Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA \< LLOQ at end of treatment.
Trial Locations
- Locations (22)
Fukui-ken Saiseikai Hospital
🇯🇵Fukui, Japan
Chiba University Hospital
🇯🇵Chiba, Japan
Iizuka Hospital
🇯🇵Iizuka, Japan
Japanese Red Cross Fukuoka Hospital
🇯🇵Fukuoka-shi, Japan
Toranomon Hospital Kajigaya
🇯🇵Kawasaki-shi, Japan
Toranomon Hospital
🇯🇵Tokyo, Japan
Hiroshima University Hospital Institution Review Board
🇯🇵Hiroshima-shi, Japan
Saitama Medical University Hospital
🇯🇵Iruma, Japan
Nippon Medical School Hospital
🇯🇵Inzai-shi, Japan
Juntendo University Shizuoka Hospital
🇯🇵Izunokuni, Japan
Kurme University Hospital
🇯🇵Kurume-shi, Japan
Japanese Red Cross Musashino Hospital
🇯🇵Musashino, Japan
Hyogo College of Medicine Hospital Institutional Review Board
🇯🇵Nishinomiya, Japan
National Hospital Organization Nagasaki Medical Center
🇯🇵Omura-shi, Japan
Osaka City University Hospital
🇯🇵Osaka, Japan
Osaka Red Cross Hospital
🇯🇵Osaka, Japan
Kagawa Prefectural Central Hospital
🇯🇵Takamatsu-shi, Japan
Osaka University Hospital
🇯🇵Suita-shi, Japan
Nara Medical University Hospital
🇯🇵Kashihara-shi, Japan
Kumamoto Shinto General Hospital
🇯🇵Kumamoto, Japan
Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital
🇯🇵Sapporo-shi, Japan
Matsuyama Red Cross Hospital
🇯🇵Matsuyama-shi, Japan