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

NCT04112303 | Completed Phase 3 Results FDA Drug

• 2 other identifiers: GS-US-342-5531JapicCTI-194989
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 22

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.

Conditions

Hepatitis C Virus Infection

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (3)

• Percentage of Participants With HCV RNA < LLOQ at 4 Weeks After Discontinuation of Treatment (SVR4)

  Posttreatment Week 4

• Percentage of Participants With HCV RNA < LLOQ at 24 Weeks After Discontinuation of Treatment (SVR24)

  Posttreatment Week 24

• Percentage of Participants With Virologic Failure

  First dose date up to posttreatment Week 24

Study Arms (1)

SOF/VEL

EXPERIMENTAL

Participants received SOF/VEL (400/100 mg) orally once daily for up to 12 weeks.

Drug: SOF/VEL

Interventions

SOF/VEL DRUG

Tablets administered orally once daily

Also known as: GS-7977/5816, Epclusa®

SOF/VEL

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

• Gilead Sciences: lead

Study Sites (22)

Chiba University Hospital

Chiba, 260-8677, Japan

Location

Fukui-ken Saiseikai Hospital

Fukui, 918-8503, Japan

Location

Japanese Red Cross Fukuoka Hospital

Fukuoka, 815-8555, Japan

Location

Hiroshima University Hospital Institution Review Board

Hiroshima, 734-8551, Japan

Location

Iizuka Hospital

Iizuka, 820-8505, Japan

Location

Nippon Medical School Hospital

Inzai-shi, 2701694, Japan

Location

Saitama Medical University Hospital

Iruma, 350-0495, Japan

Location

Juntendo University Shizuoka Hospital

Izunokuni, 410-2295, Japan

Location

Nara Medical University Hospital

Kashihara-shi, 634-8522, Japan

Location

Toranomon Hospital Kajigaya

Kawasaki-shi, 213-8587, Japan

Location

Kumamoto Shinto General Hospital

Kumamoto, 862-8655, Japan

Location

Kurme University Hospital

Kurume-shi, 830-0011, Japan

Location

Matsuyama Red Cross Hospital

Matsuyama, 7908524, Japan

Location

Japanese Red Cross Musashino Hospital

Musashino, 180-8610, Japan

Location

Hyogo College of Medicine Hospital Institutional Review Board

Nishinomiya, 663-8501, Japan

Location

National Hospital Organization Nagasaki Medical Center

Omura-shi, 856-8562, Japan

Location

Osaka Red Cross Hospital

Osaka, 543-8555, Japan

Location

Osaka City University Hospital

Osaka, 545-8586, Japan

Location

Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital

Sapporo, 060-0033, Japan

Location

Osaka University Hospital

Suita-shi, 565-0871, Japan

Location

Kagawa Prefectural Central Hospital

Takamatsu, 760-8557, Japan

Location

Toranomon Hospital

Tokyo, 105-8470, Japan

Location

Related Publications (1)

• 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.

  PMID: 35802063 DERIVED

MeSH Terms

Conditions

Hepatitis C

Interventions

sofosbuvir-velpatasvir drug combination

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Results Point of Contact

• Title: Gilead Clinical Study Information Center
• Organization: Gilead Sciences

GileadClinicalTrials@gilead.com

1-833-445-3230 (GILEAD-0)

Study Officials

• Gilead Study Director

  Gilead Sciences

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2019
• First Posted: October 2, 2019
• Study Start: October 16, 2019
• Primary Completion: March 26, 2021
• Study Completion: June 25, 2021
• Last Updated: April 20, 2022
• Results First Posted: April 20, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: 18 months after study completion
• Access Criteria: A secured external environment with username, password, and RSA code.

Locations

JP (22)