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Trial record 11 of 115 for:    "Viral Infectious Disease" | "Ledipasvir"

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

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ClinicalTrials.gov Identifier: NCT02487030
Recruitment Status : Completed
First Posted : July 1, 2015
Results First Posted : December 14, 2017
Last Update Posted : November 16, 2018
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Tracking Information
First Submitted Date  ICMJE June 27, 2015
First Posted Date  ICMJE July 1, 2015
Results First Submitted Date  ICMJE November 9, 2017
Results First Posted Date  ICMJE December 14, 2017
Last Update Posted Date November 16, 2018
Actual Study Start Date  ICMJE September 7, 2015
Actual Primary Completion Date November 11, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 9, 2017)
  • 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.
  • Percentage of Participants Who Discontinued LDV/SOF Drug Due to an Adverse Event (AE) [ Time Frame: 12 weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: June 27, 2015)
  • Proportion of participants with sustained virologic response 12 weeks after discontinuation of therapy (SVR12) [ Time Frame: Posttreatment Week 12 ]
    SVR12 is defined as HCV RNA < the lower limit of quantitation (LLOQ) 12 weeks following the last dose of study drug.
  • Incidence of any adverse event leading to permanent discontinuation of study drug [ Time Frame: Up to 12 weeks ]
Change History Complete list of historical versions of study NCT02487030 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 9, 2017)
  • 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.
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: June 27, 2015)
  • Proportion 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 are defined as HCV RNA < LLOQ 4 and 24 weeks after the last dose of study drug, respectively.
  • Proportion of participants with virologic failure [ Time Frame: Up to Posttreatment Week 24 ]
    Virologic failure is 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed Dose Combination, With or Without Ribavirin, in Egyptian Adults With Chronic Genotype 4 HCV Infection
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Hepatitis C Virus Infection
Intervention  ICMJE
  • Drug: LDV/SOF
    90/400 mg FDC tablet administered orally once daily
    Other Names:
    • Harvoni®
    • GS-5885/GS-7977
  • Drug: RBV
    Tablets administered orally in a divided daily dose based on weight (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)
Study Arms  ICMJE
  • Experimental: LDV/SOF 8 wk TN (Cohort 1, Group 1)
    LDV/SOF for 8 weeks (treatment-naive (TN))
    Intervention: Drug: LDV/SOF
  • Experimental: LDV/SOF+RBV 8 wk TN (Cohort 1, Group 2)
    LDV/SOF+RBV for 8 weeks (treatment-naive)
    Interventions:
    • Drug: LDV/SOF
    • Drug: RBV
  • Experimental: LDV/SOF 12 wk TN (Cohort 1, Group 3)
    LDV/SOF for 12 weeks (treatment-naive)
    Intervention: Drug: LDV/SOF
  • Experimental: LDV/SOF+RBV 12 wk TN (Cohort 1, Group 4)
    LDV/SOF+RBV for 12 weeks (treatment-naive)
    Interventions:
    • Drug: LDV/SOF
    • Drug: RBV
  • Experimental: LDV/SOF+RBV 12 wk TE (Cohort 2)
    Treatment-experienced (TE) participants who completed treatment in Gilead sponsored study GS-US-334-0138 or in Cohort 1 of this study and did not achieve SVR12 will receive LDV/SOF+RBV for 12 weeks.
    Interventions:
    • Drug: LDV/SOF
    • Drug: RBV
  • Experimental: LDV/SOF 12 wk TE (Cohort 3, Group 1)
    LDV/SOF for 12 weeks (treatment-experienced)
    Intervention: Drug: LDV/SOF
  • Experimental: LDV/SOF+RBV 12 wk TE (Cohort 3, Group 2)
    LDV/SOF+RBV for 12 weeks (treatment-experienced)
    Interventions:
    • Drug: LDV/SOF
    • Drug: RBV
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 17, 2016)
255
Original Estimated Enrollment  ICMJE
 (submitted: June 27, 2015)
200
Actual Study Completion Date  ICMJE February 4, 2017
Actual Primary Completion Date November 11, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02487030
Other Study ID Numbers  ICMJE GS-US-337-1643
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at http://www.gilead.com/research/disclosure-and-transparency.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Time Frame: 18 months after study completion
Access Criteria: A secured external environment with username, password, and RSA code.
URL: http://www.gilead.com/research/disclosure-and-transparency
Responsible Party Gilead Sciences
Study Sponsor  ICMJE Gilead Sciences
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Gilead Study Director Gilead Sciences
PRS Account Gilead Sciences
Verification Date November 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP