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Sofosbuvir/Velpatasvir Fixed-Dose Combination and Ribavirin for 12 or 24 Weeks in Participants With Chronic Genotype 1 or 2 Hepatitis C Virus Infection Who Have Previously Failed a Direct-Acting Antiviral-Containing Regimen

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ClinicalTrials.gov Identifier: NCT02822794
Recruitment Status : Completed
First Posted : July 4, 2016
Results First Posted : July 3, 2018
Last Update Posted : November 14, 2018
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Brief Summary:
The primary objective of this study is to evaluate the antiviral efficacy, safety, and tolerability of therapy with sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) and ribavirin (RBV) in participants with chronic genotype 1 or 2 hepatitis C virus (HCV) infection who have previously failed a direct-acting antiviral (DAA)-containing regimen.

Condition or disease Intervention/treatment Phase
Hepatitis C Virus Infection Drug: SOF/VEL Drug: RBV Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 117 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 3, Multicenter, Randomized, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed-Dose Combination and Ribavirin for 12 or 24 Weeks in Subjects With Chronic Genotype 1 or 2 HCV Infection Who Have Previously Failed a Direct-Acting Antiviral-Containing Regimen
Actual Study Start Date : July 25, 2016
Actual Primary Completion Date : June 2, 2017
Actual Study Completion Date : August 25, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: SOF/VEL FDC + RBV 12 weeks
SOF/VEL FDC + RBV for 12 weeks in participants with genotype 1 or 2 HCV infection
Drug: SOF/VEL
400/100 mg tablet administered orally once daily
Other Names:
  • GS-7977/GS-5816
  • Epclusa®

Drug: RBV
Capsules administered orally in a divided daily dose according to package insert weight-based dosing recommendations (≤ 60 kg = 600 mg, > 60 kg to ≤ 80 kg = 800 mg, and ≥ 80 kg = 1000 mg)
Other Name: REBETOL®

Experimental: SOF/VEL FDC + RBV 24 weeks
SOF/VEL FDC + RBV for 24 weeks in participants with genotype 1 or 2 HCV infection
Drug: SOF/VEL
400/100 mg tablet administered orally once daily
Other Names:
  • GS-7977/GS-5816
  • Epclusa®

Drug: RBV
Capsules administered orally in a divided daily dose according to package insert weight-based dosing recommendations (≤ 60 kg = 600 mg, > 60 kg to ≤ 80 kg = 800 mg, and ≥ 80 kg = 1000 mg)
Other Name: REBETOL®




Primary Outcome Measures :
  1. Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) [ Time Frame: Posttreatment Week 12 ]
    SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.

  2. Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event [ Time Frame: Up to 24 weeks ]

Secondary Outcome Measures :
  1. Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4) [ Time Frame: Posttreatment Week 4 ]
    SVR4 was defined as HCV RNA < LLOQ at 4 weeks after stopping study treatment.

  2. Percentage of Participants With SVR at 24 Weeks After Discontinuation of Therapy (SVR24) [ Time Frame: Posttreatment Week 24 ]
    SVR 24 was defined as HCV RNA < LLOQ at 24 weeks after stopping study treatment.

  3. Percentage of Participants With HCV RNA < LLOQ at Week 1 [ Time Frame: Week 1 ]
  4. Percentage of Participants With HCV RNA < LLOQ at Week 2 [ Time Frame: Week 2 ]
  5. Percentage of Participants With HCV RNA < LLOQ at Week 3 [ Time Frame: Week 3 ]
  6. Percentage of Participants With HCV RNA < LLOQ at Week 4 [ Time Frame: Week 4 ]
  7. Percentage of Participants With HCV RNA < LLOQ at Week 5 [ Time Frame: Week 5 ]
  8. Percentage of Participants With HCV RNA < LLOQ at Week 6 [ Time Frame: Week 6 ]
  9. Percentage of Participants With HCV RNA < LLOQ at Week 8 [ Time Frame: Week 8 ]
  10. Percentage of Participants With HCV RNA < LLOQ at Week 10 [ Time Frame: Week 10 ]
  11. Percentage of Participants With HCV RNA < LLOQ at Week 12 [ Time Frame: Week 12 ]
  12. Percentage of Participants With HCV RNA < LLOQ at Week 16 [ Time Frame: Week 16 ]
  13. Percentage of Participants With HCV RNA < LLOQ at Week 20 [ Time Frame: Week 20 ]
  14. Percentage of Participants With HCV RNA < LLOQ at Week 24 [ Time Frame: Week 24 ]
  15. Change From Baseline in HCV RNA at Week 1 [ Time Frame: Baseline; Week 1 ]
  16. Change From Baseline in HCV RNA at Week 2 [ Time Frame: Baseline; Week 2 ]
  17. Change From Baseline in HCV RNA at Week 3 [ Time Frame: Baseline; Week 3 ]
  18. Change From Baseline in HCV RNA at Week 4 [ Time Frame: Baseline; Week 4 ]
  19. Change From Baseline in HCV RNA at Week 5 [ Time Frame: Baseline; Week 5 ]
  20. Change From Baseline in HCV RNA at Week 6 [ Time Frame: Baseline; Week 6 ]
  21. Change From Baseline in HCV RNA at Week 8 [ Time Frame: Baseline; Week 8 ]
  22. Change From Baseline in HCV RNA at Week 10 [ Time Frame: Baseline; Week 10 ]
  23. Change From Baseline in HCV RNA at Week 12 [ Time Frame: Baseline; Week 12 ]
  24. Change From Baseline in HCV RNA at Week 16 [ Time Frame: Baseline; Week 16 ]
  25. Change From Baseline in HCV RNA at Week 20 [ Time Frame: Baseline; Week 20 ]
  26. Change From Baseline in HCV RNA at Week 24 [ Time Frame: Baseline; Week 24 ]
  27. Percentage of Participants With Overall Virologic Failure [ Time Frame: 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 IU/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 last on-treatment visit.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • Genotype 1 or 2 HCV infection
  • Chronic HCV infection (≥ 6 months prior to screening) documented by prior medical history or liver biopsy
  • Previously treated with a DAA-containing regimen of at least 4 week duration

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02822794


Locations
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Japan
Ehime, Japan
Hiroshima, Japan
Ichikawa-shi, Japan
Iruma-gun, Japan
Kashihara, Japan
Kurume-shi, Japan
Kyoto, Japan
Maebashi, Japan
Musashino-shi, Japan
Nagoya, Japan
Nishinomiya, Japan
Ogaki City, Japan
Okayama, Japan
Omura, Japan
Sapporo, Japan
Suita, Japan
Takamatsu-shi, Japan
Yamagata, Japan
Sponsors and Collaborators
Gilead Sciences
Investigators
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Study Director: Gilead Study Director Gilead Sciences
  Study Documents (Full-Text)

Documents provided by Gilead Sciences:
Statistical Analysis Plan  [PDF] June 13, 2017
Study Protocol  [PDF] June 13, 2016


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Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT02822794     History of Changes
Other Study ID Numbers: GS-US-342-3921
First Posted: July 4, 2016    Key Record Dates
Results First Posted: July 3, 2018
Last Update Posted: November 14, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at http://www.gilead.com/research/disclosure-and-transparency.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: 18 months after study completion
Access Criteria: A secured external environment with username, password, and RSA code.
URL: http://www.gilead.com/research/disclosure-and-transparency

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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
Additional relevant MeSH terms:
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Hepatitis C
Infection
Communicable Diseases
Hepatitis A
Hepatitis
Virus Diseases
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Ribavirin
Antiviral Agents
Sofosbuvir
Velpatasvir
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents