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

Hepatitis C Virus Infection Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04112303
• Other study ID #: GS-US-342-5531
• Secondary ID: JapicCTI-194989
• Status: Completed
• Phase: Phase 3
• Start date: October 16, 2019
• Est. completion date: June 25, 2021

Study information

• Verified date: March 2022
• Source: Gilead Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: June 25, 2021
• Est. primary completion date: March 26, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Communicable Diseases
• Hepatitis C
• Hepatitis C Virus Infection
• Infections

Intervention

Drug:
• SOF/VEL
Tablets administered orally once daily

Locations

Country	Name	City	State
Japan	Chiba University Hospital	Chiba
Japan	Fukui-ken Saiseikai Hospital	Fukui
Japan	Japanese Red Cross Fukuoka Hospital	Fukuoka-shi
Japan	Hiroshima University Hospital Institution Review Board	Hiroshima-shi
Japan	Iizuka Hospital	Iizuka
Japan	Nippon Medical School Hospital	Inzai-shi
Japan	Saitama Medical University Hospital	Iruma
Japan	Juntendo University Shizuoka Hospital	Izunokuni
Japan	Nara Medical University Hospital	Kashihara-shi
Japan	Toranomon Hospital Kajigaya	Kawasaki-shi
Japan	Kumamoto Shinto General Hospital	Kumamoto
Japan	Kurme University Hospital	Kurume-shi
Japan	Matsuyama Red Cross Hospital	Matsuyama-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	Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital	Sapporo-shi
Japan	Osaka University Hospital	Suita-shi
Japan	Kagawa Prefectural Central Hospital	Takamatsu-shi
Japan	Toranomon Hospital	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Gilead Sciences

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Sustained Virologic Response (SVR) < Lower Limit of Quantification (LLOQ) 12 Weeks After Discontinuation of Treatment (SVR12)	SVR12 was defined as hepatitis C virus ribonucleic acid (HCV RNA) < LLOQ (i.e., 15 IU/mL) at 12 weeks after stopping study treatment.	Posttreatment Week 12
Primary	Percentage of Participants Who Experienced Any Treatment-Emergent Adverse Event (TEAE) Leading to Discontinuation of Study Drug	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.	First dose date up to Week 12.1
Secondary	Percentage of Participants With HCV RNA < LLOQ at 4 Weeks After Discontinuation of Treatment (SVR4)	SVR4 was defined as HCV RNA < LLOQ (i.e.15 IU/mL) at 4 weeks after stopping study treatment.	Posttreatment Week 4
Secondary	Percentage of Participants With HCV RNA < LLOQ at 24 Weeks After Discontinuation of Treatment (SVR24)	SVR24 was defined as HCV RNA < LLOQ (i.e.15 IU/mL) at 24 weeks after stopping study treatment.	Posttreatment Week 24
Secondary	Percentage of Participants With Virologic Failure	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.	First dose date up to posttreatment Week 24