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Completed

NCT Number: NCT02722837

Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed-Dose Combination in Participants With Chronic Hepatitis C Virus Infection

The primary objective of this study is to evaluate the efficacy, safety, and tolerability of treatment with sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) for 12 weeks in participants with chronic hepatitis C virus (HCV) infection.

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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

Krasnoyarsk Regional Center of AIDS Prevention, Krasnoyarsk, Russia

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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:

  • HCV RNA ≥ 10^4 IU/mL at screening
  • Chronic HCV infection (≥ 6 months) documented by prior medical history or liver biopsy

Key Exclusion Criteria:

  • Any other chronic liver disease
  • Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
  • Clinical hepatic decompensation
  • Prior exposure to SOF or other nucleotide analogue HCV NS5B inhibitor or any HCV NS5A inhibitor

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

Treatment and study plan

SOF/VEL

Drug

400/100 mg FDC tablet administered orally once daily

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

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) at 12 weeks after stopping study treatment.

  2. Percentage of Participants Who Permanently Discontinued Study Drug Due to an Adverse Event

    Time frame: Up to 12 weeks

Secondary outcomes

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

    Time frame: Posttreatment Week 24

    SVR24 was defined as HCV RNA < LLOQ at 24 weeks after stopping study treatment.

  3. Percentage of Participants With HCV RNA < LLOQ on Treatment at Week 1

    Time frame: Week 1

  4. Percentage of Participants With HCV RNA < LLOQ on Treatment at Week 2

    Time frame: Week 2

  5. Percentage of Participants With HCV RNA < LLOQ on Treatment at Week 4

    Time frame: Week 4

  6. Percentage of Participants With HCV RNA < LLOQ on Treatment at Week 8

    Time frame: Week 8

  7. Percentage of Participants With HCV RNA < LLOQ on Treatment at Week 12

    Time frame: Week 12

  8. Change From Baseline in HCV RNA at Week 1

    Time frame: Baseline (Day 1); Week 1

  9. Change From Baseline in HCV RNA at Week 2

    Time frame: Baseline (Day 1); Week 2

  10. Change From Baseline in HCV RNA at Week 4

    Time frame: Baseline (Day 1); Week 4

  11. Change From Baseline in HCV RNA at Week 8

    Time frame: Baseline (Day 1); Week 8

  12. Change From Baseline in HCV RNA at Week 12

    Time frame: Baseline (Day 1); Week 12

  13. Percentage of Participants With Virologic Failure

    Time frame: Up to Posttreatment Week 24

    Virologic failure was defined as:

    • 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), or
    • 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 3, Open-label Study to Investigate the Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed Dose Combination for 12 Weeks in Subjects With Chronic Hepatitis C Virus (HCV) Infection

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Mar 30, 2016
Registry last updated
Nov 16, 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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