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Completed

NCT Number: NCT02010255

Ledipasvir/Sofosbuvir Fixed-Dose Combination Plus Ribavirin in Participants With Chronic HCV With Advanced Liver Disease or Post-Liver Transplant

This study will evaluate ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) plus ribavirin (RBV) in participants with advanced liver disease or posttransplant and chronic genotype 1 or 4 hepatitis C virus (HCV) infection.

* Cohort A: decompensated cirrhosis (advanced liver disease), no prior liver transplant; * Cohort B: post-liver transplant, with or without cirrhosis; * Group assignment within cohorts is based on severity of liver impairment at screening (Child-Pugh-Turcotte (CPT) score for participants with cirrhosis; fibrosis; or presence of disease for fibrosing cholestatic hepatitis (FCH) groups) * Randomization is 1:1 within groups to 12 or 24 weeks of LDV/SOF+RBV treatment.

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Key information

Conditions

Chronic HCV Infection

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Royal Prince Alfred Hospital, University of Sydney, Camperdown, New South Wales, Australia

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Able to provide written informed consent
  • Chronic genotype 1 and/or 4 HCV infection
  • Normal ECG
  • Negative serum pregnancy test for female subjects
  • Male subjects and female subjects of childbearing potential must agree to use contraception
  • Able to comply with the dosing instructions for study drug and able to complete the study schedule of assessments, including all required post treatment visits

Exclusion criteria

  • Serious or active medical or psychiatric illness
  • HIV or hepatitis B viral (HBV) infection
  • Stomach disorder that could interfere with the absorption of the study drug
  • Treated with an anti-HCV medication in the last 30 days
  • Any prior exposure to an HCV nonstructural protein (NS)5a-specific inhibitor
  • Use of human granulocyte-macrophage colony-stimulating factor (GM-CSF), epoetin alfa or other therapeutic hematopoietic agents within 2 weeks of screening
  • History of clinically significant medical condition associated with other chronic liver disease
  • Active spontaneous bacterial peritonitis at screening
  • Females who are breastfeeding
  • Infection requiring systemic antibiotics
  • Participated in a clinical study with an investigational drug or biologic within the last 30 days
  • Active or history (last 6 months) of drug or alcohol abuse
  • History of organ transplant other than liver, kidney, or corneal.

Treatment and study plan

LDV/SOF

Drug

LDV/SOF FDC tablet administered orally once daily

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

RBV

Drug

RBV tablets administered orally in a divided daily dose

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 Discontinued Study Drug Due to an Adverse Event

    Time frame: Up to 24 weeks

Secondary outcomes

  1. Percentage of Participants With SVR 2 Weeks After Discontinuation of Therapy (SVR2)

    Time frame: Posttreatment Week 2

    SVR2 was defined as HCV RNA < LLOQ at 2 weeks after stopping study treatment.

  2. Percentage of Participants With SVR 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.

  3. Percentage of Participants With SVR 8 Weeks After Discontinuation of Therapy (SVR8)

    Time frame: Posttreatment Week 8

    SVR8 was defined as HCV RNA < LLOQ at 8 weeks after stopping study treatment.

  4. Percentage of Participants With SVR 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.

  5. Percentage of Participants With 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 on 2 consecutive measurements while on treatment), or
    • Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment)
    • Virologic relapse:
    • Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit.

  6. Percentage of Participants With Posttransplant Virologic Response (pTVR) at Posttransplant Week 12

    Time frame: Posttreatment Week 12

    pTVR was defined as HCV RNA < LLOQ at Week 12 after transplant.

  7. Percentage of Participants With HCV RNA < LLOQ at Week 1

    Time frame: Week 1

  8. Percentage of Participants With HCV RNA < LLOQ at Week 2

    Time frame: Week 2

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

    Time frame: Week 4

  10. Percentage of Participants With HCV RNA < LLOQ at Week 6

    Time frame: Week 6

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

    Time frame: Week 8

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

    Time frame: Week 12

  13. Percentage of Participants With HCV RNA < LLOQ at Week 16

    Time frame: Week 16

  14. Percentage of Participants With HCV RNA < LLOQ at Week 20

    Time frame: Week 20

  15. Percentage of Participants With HCV RNA < LLOQ at Week 24

    Time frame: Week 24

  16. HCV RNA Levels and Change From Baseline at Week 1

    Time frame: Baseline; Week 1

  17. HCV RNA Levels and Change From Baseline at Week 2

    Time frame: Baseline; Week 2

  18. HCV RNA Levels and Change From Baseline at Week 4

    Time frame: Baseline; Week 4

  19. HCV RNA Levels and Change From Baseline at Week 6

    Time frame: Baseline; Week 6

  20. HCV RNA Levels and Change From Baseline at Week 8

    Time frame: Baseline; Week 8

  21. HCV RNA Levels and Change From Baseline at Week 12

    Time frame: Baseline; Week 12

  22. Percentage of Participants With a Decrease, No Change, or Increase Between Baseline and Posttreatment Week 4 in MELD Score

    Time frame: Baseline to Posttreatment Week 4

    Model for End-Stage Liver Disease (MELD) scores are used to assess prognosis and suitability for liver transplantation. Scores can range from 6 to 40; higher scores/increased scores indicate greater severity of disease.

  23. Percentage of Participants With a Decrease, No Change, or Increase Between Baseline and Posttreatment Week 4 in CPT Score

    Time frame: Baseline to Posttreatment Week 4

    CPT scores grade the severity of cirrhosis and are used to determine the need for liver transplantation. Scores can range from 5 to 15 (maximum score for entry into the study was 12); higher scores/increased scores indicate greater severity of disease. Groups are arranged by cohort, then by duration of treatment, then by CPT class at baseline.

Sponsors and collaborators

Lead sponsor

Gilead Sciences

Industry

Registry information

Official study title

A Phase 2, Multicenter, Open-Label Study to Investigate the Safety and Efficacy of Sofosbuvir/Ledipasvir Fixed-Dose Combination + Ribavirin Administered in Subjects Infected With Chronic HCV Who Have Advanced Liver Disease or Are Post-Liver Transplant

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Dec 12, 2013
Registry last updated
Nov 19, 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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