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OpenTrials
Completed

NCT Number: NCT02822794

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

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.

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Key information

Conditions

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

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Ehime, Japan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SOF/VEL

Drug

400/100 mg tablet administered orally once daily

Other names: GS-7977/GS-5816, Epclusa®

RBV

Drug

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 names: REBETOL®

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Gilead Sciences

Industry

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jul 4, 2016
Registry last updated
Nov 14, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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