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Completed

NCT Number: NCT02738333

Ledipasvir/Sofosbuvir Fixed-Dose Combination for 12 Weeks in Participants With Chronic Genotype 2 HCV Infection

The primary objectives of this study are to evaluate the antiviral efficacy of therapy with ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) and to evaluate the safety and tolerability of LDV/SOF FDC and sofosbuvir (SOF) + ribavirin (RBV) in participants with chronic genotype 2 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

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Bunkyō City, 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 genotype 2 HCV-infected males and non-pregnant/non-lactating females
  • Aged 20 years or older
  • Treatment naive or treatment experienced
  • At least 20 subjects will have Child-Pugh-A compensated cirrhosis. In Cohort 2, participants must be ineligible or intolerant of RBV.

Key Exclusion Criteria:

  • Previous exposure to an NS5A or NS5B inhibitor
  • Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
  • Pregnant or nursing female or male with pregnant female partner

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

Treatment and study plan

LDV/SOF

Drug

90/400 mg FDC tablet administered orally once daily

Other names: Harvoni®, GS-5885/GS-7977

SOF

Drug

400 mg tablet administered orally once daily

Other names: Sovaldi®, GS-7977, PSI-7977

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 12 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. Change From Baseline in HCV RNA at Week 1

    Time frame: Baseline; Week 1

  13. Change From Baseline in HCV RNA at Week 2

    Time frame: Baseline; Week 2

  14. Change From Baseline in HCV RNA at Week 3

    Time frame: Baseline; Week 3

  15. Change From Baseline in HCV RNA at Week 4

    Time frame: Baseline; Week 4

  16. Change From Baseline in HCV RNA at Week 5

    Time frame: Baseline; Week 5

  17. Change From Baseline in HCV RNA at Week 6

    Time frame: Baseline; Week 6

  18. Change From Baseline in HCV RNA at Week 8

    Time frame: Baseline; Week 8

  19. Change From Baseline in HCV RNA at Week 10

    Time frame: Baseline; Week 10

  20. Change From Baseline in HCV RNA at Week 12

    Time frame: Baseline; Week 12

  21. 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 3b, Multicenter, Randomized, Open-Label Study to Investigate the Efficacy and Safety of Ledipasvir/Sofosbuvir Fixed-Dose Combination for 12 Weeks in Subjects With Chronic Genotype 2 HCV Infection

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Apr 14, 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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