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Completed

NCT Number: NCT04112303

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

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.

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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 3

Primary location

Chiba University Hospital, Chiba, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

SOF/VEL

Drug

Tablets administered orally once daily

Other names: GS-7977/5816, Epclusa®

Primary outcomes

  1. Percentage of Participants With Sustained Virologic Response (SVR) < Lower Limit of Quantification (LLOQ) 12 Weeks After Discontinuation of Treatment (SVR12)

    Time frame: Posttreatment Week 12

    SVR12 was defined as hepatitis C virus ribonucleic acid (HCV RNA) < LLOQ (i.e., 15 IU/mL) at 12 weeks after stopping study treatment.

  2. Percentage of Participants Who Experienced Any Treatment-Emergent Adverse Event (TEAE) Leading to Discontinuation of Study Drug

    Time frame: First dose date up to Week 12.1

    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 outcomes

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

    Time frame: Posttreatment Week 4

    SVR4 was defined as HCV RNA < LLOQ (i.e.15 IU/mL) at 4 weeks after stopping study treatment.

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

    Time frame: Posttreatment Week 24

    SVR24 was defined as HCV RNA < LLOQ (i.e.15 IU/mL) at 24 weeks after stopping study treatment.

  3. Percentage of Participants With Virologic Failure

    Time frame: First dose date 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 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.

Sponsors and collaborators

Lead sponsor

Gilead Sciences

Industry

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Oct 2, 2019
Registry last updated
Apr 20, 2022

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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