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Completed

NCT Number: NCT02781571

Sofosbuvir/Velpatasvir Fixed Dose Combination in Participants With Chronic Hepatitis C Virus Infection Who Have Received a Liver Transplant

The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of sofosbuvir /velpatasvir (SOF/VEL) fixed-dose combination (FDC) in participants with chronic hepatitis C virus (HCV) who have received a liver transplant.

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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

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hospital Clínic de Barcelona, Barcelona, Spain

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Key Inclusion Criteria:

  • History of chronic HCV infection (≥ 6 months)
  • HCV genotype 1, 2, 3, 4, 5, 6, or indeterminate
  • Liver transplant ≥ 3 months prior to screening
  • Male and nonpregnant/ non-lactating female individuals without cirrhosis or with compensated cirrhosis

Key Exclusion Criteria:

  • History of clinically significant illness or any other medical disorder that may interfere with individual's treatment, assessment or compliance with the protocol,
  • Co-infection with HIV or hepatitis B virus
  • Known hypersensitivity to study medication,
  • Use of any prohibited concomitant medications as within with window before the Day 1 visit.
  • De novo or recurrent hepatocellular carcinoma posttransplant

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: Epclusa®, GS-7977/GS-5816

Primary outcomes

  1. Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Cessation of Therapy (SVR12)

    Time frame: Posttreatment Week 12

    SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ) at 12 weeks after stopping study treatment.

  2. Percentage of Participants Who Prematurely Discontinued Study Drug Due to Any Adverse Event

    Time frame: Up to 12 weeks

Secondary outcomes

  1. Percentage of Participants With Sustained Virologic Response 4 Weeks After Cessation 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 HCV RNA < LLOQ at Week 2

    Time frame: Week 2

  3. Percentage of Participants With HCV RNA < LLOQ at Week 4

    Time frame: Week 4

  4. Percentage of Participants With HCV RNA < LLOQ at Week 8

    Time frame: Week 8

  5. Percentage of Participants With HCV RNA < LLOQ at Week 12

    Time frame: Week 12

  6. HCV RNA at Week 2

    Time frame: Week 2

  7. HCV RNA at Week 4

    Time frame: Week 4

  8. HCV RNA at Week 8

    Time frame: Week 8

  9. HCV RNA at Week 12

    Time frame: Week 12

  10. Change From Baseline in HCV RNA at Week 2

    Time frame: Baseline; Week 2

  11. Change From Baseline in HCV RNA at Week 4

    Time frame: Baseline; Week 4

  12. Change From Baseline in HCV RNA at Week 8

    Time frame: Baseline; Week 8

  13. Change From Baseline in HCV RNA at Week 12

    Time frame: Baseline; Week 12

  14. Percentage of Participants With Virologic Failure

    Time frame: Up to Posttreatment Week 12

    Virologic failure was defined as

    On-treatment virologic failure:

    • Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ on 2 consecutive measurements 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 12 weeks of treatment)

    Virologic relapse:

    • HCV RNA ≥ LLOQ during the post-treatment period having achieved HCV RNA < LLOQ at end of treatment, confirmed with 2 consecutive values or last available post-treatment measurement

Sponsors and collaborators

Lead sponsor

Gilead Sciences

Industry

Registry information

Official study title

A Phase 2, Multicenter, Open-Label Study to Evaluate the Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed Dose Combination in Subjects With Chronic HCV Infection Who Have Received a Liver Transplant

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
May 24, 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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