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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

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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

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.

Condition or disease Intervention/treatment Phase
Hepatitis C Virus Infection Drug: LDV/SOF Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : May 22, 2015
Actual Primary Completion Date : March 28, 2016
Actual Study Completion Date : April 22, 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Sofosbuvir

Arm Intervention/treatment
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.
Drug: LDV/SOF
90/400 mg FDC tablet administered orally
Other Names:
  • Harvoni®
  • GS-5885/GS-7977




Primary Outcome Measures :
  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 Prematurely Discontinued Study Drug Due to an Adverse Event [ Time Frame: Up to 4 weeks ]

Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02350569


Locations
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United States, California
San Francisco, California, United States
United States, Illinois
Chicago, Illinois, United States
United States, Louisiana
New Orleans, Louisiana, United States
United States, Michigan
Detroit, Michigan, United States
United States, New York
New York, New York, United States
United States, Texas
Dallas, Texas, United States
Sponsors and Collaborators
Gilead Sciences
Investigators
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Study Director: Gilead Study Director Gilead Sciences

Publications of Results:
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Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT02350569     History of Changes
Other Study ID Numbers: GS-US-337-1428
First Posted: January 29, 2015    Key Record Dates
Results First Posted: May 5, 2017
Last Update Posted: November 19, 2018
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
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
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

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Gilead Sciences:
liver transplant
hepatitis C
Gilead
Communicable Diseases
Infection
Liver Diseases
RNA Virus Infections
Additional relevant MeSH terms:
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Virus Diseases
RNA Virus Infections
Ledipasvir
Ledipasvir, sofosbuvir drug combination
Infection
Hepatitis C
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Flaviviridae Infections
Sofosbuvir
Antiviral Agents
Anti-Infective Agents