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OpenTrials
Completed

NCT Number: NCT02081079

Efficacy and Safety of Ledipasvir/Sofosbuvir Fixed-Dose Combination in Treatment-Naive and Treatment-Experienced Subjects With Chronic Genotype 4 or 5 HCV Infection

This study is to evaluate the efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) in participants with chronic genotype 4 or 5 hepatitis C virus (HCV) infection as measured by the proportion of subjects with sustained virologic response (SVR12), defined as HCV RNA < lower limit of quantification (LLOQ) 12 weeks after discontinuation of therapy.

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Key information

Conditions

Chronic Genotype 4 HCV Chronic Genotype 5 HCV

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Clermont-Ferrand, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • HCV RNA ≥ 10^4 IU/mL at screening
  • Chronic genotype 4 or 5 HCV Infection
  • Individuals may be treatment naive or treatment experienced
  • Presence or absence of cirrhosis, a liver biopsy may be required
  • Healthy according to medical history and physical examination with the exception of HCV diagnosis
  • Agree to use two forms of highly effective contraception for the duration of the study

Exclusion criteria

  • History or current evidence of any condition, therapy, laboratory abnormality or other circumstance that might confound the results of the study, or interfere with the individual's participation for the full duration of the study or not be in the best interest of the individual in the opinion of the investigator
  • Prior exposure to approved or experimental HCV specific direct acting antiviral(s) (DAA) other than NS3/4A protease inhibitors
  • History of any other clinically significant chronic liver disease
  • Evidence of or history of decompensated liver disease
  • HIV or chronic hepatitis B (HBV) infection
  • Hepatocellular carcinoma (HCC) or other malignancy (with exception of certain resolved skin cancers)
  • Chronic use of immunosuppressive agents or immunomodulatory agents

Treatment and study plan

LDV/SOF

Drug

LDV/SOF (90/400 mg) FDC tablet administered orally once daily

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

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 LDV/SOF Due to an Adverse Event

    Time frame: Up to 12 weeks

Secondary outcomes

  1. Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)

    Time frame: Posttreatment Weeks 4 and 24

    SVR4 and SVR 24 were defined as HCV RNA < LLOQ at 4 and 24 weeks after stopping study treatment, respectively.

  2. Percentage of Patients With Virologic Failure

    Time frame: Up to posttreatment Week 24

    Virologic failure was defined as either:

    • 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); or
    • Relapse:
    • HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while receiving treatment

  3. Change From Baseline in HCV RNA at Weeks 2, 4, 8, and 12

    Time frame: Baseline; Weeks 2, 4, 8, and 12

Sponsors and collaborators

Lead sponsor

Gilead Sciences

Industry

Registry information

Official study title

A Phase 2, Multicenter, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir/Ledipasvir Fixed-Dose Combination in Treatment-Naive and Treatment-Experienced Subjects With Chronic Genotype 4 or 5 HCV Infection

Important dates

Study start
2014
Primary completion
2014
Study completion
2015
First posted
Mar 7, 2014
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.