Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 9 of 115 for:    "Viral Infectious Disease" | "Ledipasvir"

Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed Dose Combination Administered in Patients Infected With Chronic Genotype 1 or 4 HCV for Use in the Peri-Operative Liver Transplantation Setting

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02350569
Recruitment Status : Completed
First Posted : January 29, 2015
Results First Posted : May 5, 2017
Last Update Posted : November 19, 2018
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Tracking Information
First Submitted Date  ICMJE January 26, 2015
First Posted Date  ICMJE January 29, 2015
Results First Submitted Date  ICMJE March 27, 2017
Results First Posted Date  ICMJE May 5, 2017
Last Update Posted Date November 19, 2018
Actual Study Start Date  ICMJE May 22, 2015
Actual Primary Completion Date March 28, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 27, 2017)
  • 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.
  • Percentage of Participants Who Prematurely Discontinued Study Drug Due to an Adverse Event [ Time Frame: Up to 4 weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: January 26, 2015)
  • Percentage 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 events leading to premature discontinuation of study drug [ Time Frame: Up to 4 weeks ]
Change History Complete list of historical versions of study NCT02350569 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 27, 2017)
  • 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.
  • Percentage of Participants With Virologic Failure [ Time Frame: Up to Posttreatment Week 12 ]
    Virologic failure was defined as:
    • End of treatment virologic failure:
      • Completed 28 days LDV/SOF treatment and had HCV RNA ≥ LLOQ at last measurement on treatment
    • Virologic relapse:
      • Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment HCV RNA measurement.
  • Percentage of Participants With HCV RNA < LLOQ While on Treatment at Days 1, 3, 5, 7, 14, 21, and 28 [ Time Frame: Days 1, 3, 5, 7, 14, 21, and 28 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: January 26, 2015)
  • 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 are defined as HCV RNA < the LLOQ 4 and 24 weeks following the last dose of study drug, respectively.
  • Percentage of participants with HCV RNA < LLOQ by visit while on treatment [ Time Frame: Up to 4 weeks ]
  • Percentage of Participants With Virologic Failure [ Time Frame: Up to Posttreatment Week 24 ]
    Virologic failure is defined as
    • On-treatment virologic failure
      • HCV RNA ≥ LLOQ at the last observed HCV RNA collected on-treatment (ie, end of treatment measurement)
    • 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 Administered in Patients Infected With Chronic Genotype 1 or 4 HCV for Use in the Peri-Operative Liver Transplantation Setting
Official Title  ICMJE A Phase 2, Multicenter, Open-Label Study to Investigate the Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed Dose Combination Administered in Patients Infected With Chronic HCV for Use in the Peri-Operative Liver Transplantation Setting
Brief Summary The primary objective of this study is to evaluate the antiviral efficacy of treatment with ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) therapy at the time of liver transplantation and through 4 weeks posttransplant in adults with genotype 1 or 4 hepatitis C virus (HCV) infection who are undergoing primary liver transplantation.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group 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
Other Names:
  • Harvoni®
  • GS-5885/GS-7977
Study Arms  ICMJE Experimental: LDV/SOF
Participants with genotype 1 or 4 HCV who are undergoing liver transplant will receive one dose of LDV/SOF prior to the transplant and then will receive LDV/SOF once daily for 4 weeks following the transplant.
Intervention: Drug: LDV/SOF
Publications * Levitsky J, Verna EC, O'Leary JG, Bzowej NH, Moonka DK, Hyland RH, Arterburn S, Dvory-Sobol H, Brainard DM, McHutchison JG, Terrault NA. Perioperative Ledipasvir-Sofosbuvir for HCV in Liver-Transplant Recipients. N Engl J Med. 2016 Nov 24;375(21):2106-2108.

*   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: March 27, 2017)
17
Original Estimated Enrollment  ICMJE
 (submitted: January 26, 2015)
25
Actual Study Completion Date  ICMJE April 22, 2016
Actual Primary Completion Date March 28, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Key Inclusion Criteria:

  • Willing and able to provide written informed consent or for those individuals where hepatic encephalopathy affects their ability to provide initial or ongoing consent, has an appropriate and legally-authorized representative (LAR) willing and able to provide consent on behalf of the individual.
  • HCV RNA infection with quantifiable virus at screening
  • Must have chronic genotype 1 or 4 HCV infection for ≥ 6 months by medical history or liver biopsy
  • Currently on the liver transplantation wait list
  • Screening electrocardiogram (ECG) without clinically significant abnormalities.
  • A negative serum pregnancy test result is required for females

Key Exclusion Criteria:

  • Any previous solid organ transplant
  • Any serious or active medical or psychiatric illness which, in the opinion of the investigator, would interfere with participant's treatment, assessment, or compliance
  • HIV infection or a positive hepatitis B virus surface antigen result
  • History of malignancy (with exception of hepatocellular carcinoma within Milan criteria, certain resolved skin cancers or other early cancer for which surgical resection is considered to be completely curative)
  • Treatment with any approved or experimental medication with known anti-HCV activity within 1 month prior to screening date
  • Prior exposure to an HCV non-structural protein (NS)5A inhibitor
  • Patients on hemodialysis prior to or at the time of transplantation will be excluded
  • Creatinine clearance (CLcr) < 40 mL/min at screening or < 40 mL/min on day of transplant
  • Participation in a clinical study with an investigational drug or biologic within 28 days prior to screening visit
  • Receipt or planned receipt of an organ from an HCV positive donor

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 United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02350569
Other Study ID Numbers  ICMJE GS-US-337-1428
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
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 March 2017

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