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Completed

NCT Number: NCT02487030

Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed Dose Combination, With or Without Ribavirin, in Egyptian Adults With Chronic Genotype 4 HCV Infection

The primary objective of this study was to evaluate the efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed dose combination (FDC) with or without ribavirin (RBV) in Egyptian adults with chronic genotype 4 hepatitis C virus (HCV) infection.

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Key information

Conditions

Hepatitis C Virus Infection Blood-Borne Infections Chronic Disease Communicable Diseases Digestive System Diseases Disease Attributes Flaviviridae Infections Hepatitis Hepatitis C Hepatitis C, Chronic Hepatitis, Chronic Hepatitis, Viral, Human Infections Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Al Mansurah, Egypt

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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:

  • Willing and able to provide written informed consent
  • Chronic HCV infection (≥ 6 months) documented by medical history or liver biopsy
  • HCV genotype 4 at screening
  • HCV treatment naive or prior participation in this study or study GS-US-334-0138 (Cohorts 1 and 2 only)
  • Cohort 3 only: HCV treatment-experienced (previously received therapy for HCV infection with an interferon (IFN)-containing regimen, with or without RBV and/or an HCV NS3/NS4A protease inhibitor (PI)
  • Body mass index (BMI) ≥ 18 kg/m^2
  • Screening laboratory values within defined thresholds
  • Use of effective protocol-approved contraception methods

Key Exclusion Criteria:

  • History of clinically-significant illness or any other major medical disorder that may interfere with treatment, assessment or compliance with the protocol
  • Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
  • Pregnant or nursing females or male with pregnant female partner
  • Clinically-relevant drug or alcohol abuse within 12 months of screening

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

RBV

Drug

Tablets administered orally in a divided daily dose based on weight (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)

Primary outcomes

  1. Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)

    Time frame: Posttreatment Week 12

    SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ) 12 weeks following the last dose of study drug.

  2. Percentage of Participants Who Discontinued LDV/SOF Drug Due to an Adverse Event (AE)

    Time frame: 12 weeks

Secondary outcomes

  1. Percentage of Participants With Sustained Virologic Response 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)

    Time frame: Posttreatment Weeks 4 and 24

    SVR4 and SVR24 were defined as HCV RNA < LLOQ 4 and 24 weeks after the last dose of study drug, respectively.

  2. Percentage of Participants With Overall Virologic Failure

    Time frame: Up to Posttreatment Week 24

    Virologic failure was defined as

    • On-treatment virologic failure
    • confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ, while on treatment (ie, breakthrough),
    • confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment (ie, rebound),
    • HCV RNA persistently ≥ LLOQ through 8 weeks of treatment (ie, nonresponse)
    • Relapse
    • HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at end of treatment, confirmed with 2 consecutive values or last available posttreatment measurement

Sponsors and collaborators

Lead sponsor

Gilead Sciences

Industry

Registry information

Official study title

A Phase 3, Randomized, Open-Label, Study to Evaluate the Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed Dose Combination, With or Without Ribavirin, in Egyptian Adults With Chronic Genotype 4 HCV Infection

Important dates

Study start
2015
Primary completion
2016
Study completion
2017
First posted
Jul 1, 2015
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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