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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

Primary Purpose

Hepatitis C Virus Infection

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
SOF/VEL
Sponsored by
Gilead Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatitis C Virus Infection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Chiba University Hospital
  • Fukui-ken Saiseikai Hospital
  • Japanese Red Cross Fukuoka Hospital
  • Hiroshima University Hospital Institution Review Board
  • Iizuka Hospital
  • Nippon Medical School Hospital
  • Saitama Medical University Hospital
  • Juntendo University Shizuoka Hospital
  • Nara Medical University Hospital
  • Toranomon Hospital Kajigaya
  • Kumamoto Shinto General Hospital
  • Kurme University Hospital
  • Matsuyama Red Cross Hospital
  • Japanese Red Cross Musashino Hospital
  • Hyogo College of Medicine Hospital Institutional Review Board
  • National Hospital Organization Nagasaki Medical Center
  • Osaka Red Cross Hospital
  • Osaka City University Hospital
  • Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital
  • Osaka University Hospital
  • Kagawa Prefectural Central Hospital
  • Toranomon Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SOF/VEL

Arm Description

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

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
September 30, 2019
Last Updated
March 23, 2022
Sponsor
Gilead Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT04112303
Brief Title
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

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
October 16, 2019 (Actual)
Primary Completion Date
March 26, 2021 (Actual)
Study Completion Date
June 25, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gilead Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C Virus Infection

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
37 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SOF/VEL
Arm Type
Experimental
Arm Description
Participants received SOF/VEL (400/100 mg) orally once daily for up to 12 weeks.
Intervention Type
Drug
Intervention Name(s)
SOF/VEL
Other Intervention Name(s)
GS-7977/5816, Epclusa®
Intervention Description
Tablets administered orally once daily
Primary Outcome Measure Information:
Title
Percentage of Participants With Sustained Virologic Response (SVR) < Lower Limit of Quantification (LLOQ) 12 Weeks After Discontinuation of Treatment (SVR12)
Description
SVR12 was defined as hepatitis C virus ribonucleic acid (HCV RNA) < LLOQ (i.e., 15 IU/mL) at 12 weeks after stopping study treatment.
Time Frame
Posttreatment Week 12
Title
Percentage of Participants Who Experienced Any Treatment-Emergent Adverse Event (TEAE) Leading to Discontinuation of Study Drug
Description
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.
Time Frame
First dose date up to Week 12.1
Secondary Outcome Measure Information:
Title
Percentage of Participants With HCV RNA < LLOQ at 4 Weeks After Discontinuation of Treatment (SVR4)
Description
SVR4 was defined as HCV RNA < LLOQ (i.e.15 IU/mL) at 4 weeks after stopping study treatment.
Time Frame
Posttreatment Week 4
Title
Percentage of Participants With HCV RNA < LLOQ at 24 Weeks After Discontinuation of Treatment (SVR24)
Description
SVR24 was defined as HCV RNA < LLOQ (i.e.15 IU/mL) at 24 weeks after stopping study treatment.
Time Frame
Posttreatment Week 24
Title
Percentage of Participants With Virologic Failure
Description
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.
Time Frame
First dose date up to posttreatment Week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gilead Study Director
Organizational Affiliation
Gilead Sciences
Official's Role
Study Director
Facility Information:
Facility Name
Chiba University Hospital
City
Chiba
ZIP/Postal Code
260-8677
Country
Japan
Facility Name
Fukui-ken Saiseikai Hospital
City
Fukui
ZIP/Postal Code
918-8503
Country
Japan
Facility Name
Japanese Red Cross Fukuoka Hospital
City
Fukuoka-shi
ZIP/Postal Code
815-8555
Country
Japan
Facility Name
Hiroshima University Hospital Institution Review Board
City
Hiroshima-shi
ZIP/Postal Code
734-8551
Country
Japan
Facility Name
Iizuka Hospital
City
Iizuka
ZIP/Postal Code
820-8505
Country
Japan
Facility Name
Nippon Medical School Hospital
City
Inzai-shi
ZIP/Postal Code
2701694
Country
Japan
Facility Name
Saitama Medical University Hospital
City
Iruma
ZIP/Postal Code
350-0495
Country
Japan
Facility Name
Juntendo University Shizuoka Hospital
City
Izunokuni
ZIP/Postal Code
410-2295
Country
Japan
Facility Name
Nara Medical University Hospital
City
Kashihara-shi
ZIP/Postal Code
634-8522
Country
Japan
Facility Name
Toranomon Hospital Kajigaya
City
Kawasaki-shi
ZIP/Postal Code
213-8587
Country
Japan
Facility Name
Kumamoto Shinto General Hospital
City
Kumamoto
ZIP/Postal Code
862-8655
Country
Japan
Facility Name
Kurme University Hospital
City
Kurume-shi
ZIP/Postal Code
830-0011
Country
Japan
Facility Name
Matsuyama Red Cross Hospital
City
Matsuyama-shi
ZIP/Postal Code
7908524
Country
Japan
Facility Name
Japanese Red Cross Musashino Hospital
City
Musashino
ZIP/Postal Code
180-8610
Country
Japan
Facility Name
Hyogo College of Medicine Hospital Institutional Review Board
City
Nishinomiya
ZIP/Postal Code
663-8501
Country
Japan
Facility Name
National Hospital Organization Nagasaki Medical Center
City
Omura-shi
ZIP/Postal Code
856-8562
Country
Japan
Facility Name
Osaka Red Cross Hospital
City
Osaka
ZIP/Postal Code
543-8555
Country
Japan
Facility Name
Osaka City University Hospital
City
Osaka
ZIP/Postal Code
545-8586
Country
Japan
Facility Name
Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital
City
Sapporo-shi
ZIP/Postal Code
060-0033
Country
Japan
Facility Name
Osaka University Hospital
City
Suita-shi
ZIP/Postal Code
565-0871
Country
Japan
Facility Name
Kagawa Prefectural Central Hospital
City
Takamatsu-shi
ZIP/Postal Code
760-8557
Country
Japan
Facility Name
Toranomon Hospital
City
Tokyo
ZIP/Postal Code
105-8470
Country
Japan

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at https://www.gilead.com/science-and-medicine/research/clinical-trials-transparency-and-data-sharing-policy
IPD Sharing Time Frame
18 months after study completion
IPD Sharing Access Criteria
A secured external environment with username, password, and RSA code.
IPD Sharing URL
http://www.gilead.com/science-and-medicine/research/clinical-trials-transparency-and-data-sharing-policy
Citations:
PubMed Identifier
35802063
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.
Results Reference
derived

Learn more about this trial

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

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