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

October 19, 2018 updated by: Gilead Sciences

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

17

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States
    • Illinois
      • Chicago, Illinois, United States
    • Louisiana
      • New Orleans, Louisiana, United States
    • Michigan
      • Detroit, Michigan, United States
    • New York
      • New York, New York, United States
    • Texas
      • Dallas, Texas, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Posttreatment Week 12
Percentage of Participants Who Prematurely Discontinued Study Drug Due to an Adverse Event
Time Frame: Up to 4 weeks
Up to 4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Posttreatment Week 4
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.
Up to Posttreatment Week 12
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
Days 1, 3, 5, 7, 14, 21, and 28

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gilead Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 22, 2015

Primary Completion (Actual)

March 28, 2016

Study Completion (Actual)

April 22, 2016

Study Registration Dates

First Submitted

January 26, 2015

First Submitted That Met QC Criteria

January 26, 2015

First Posted (Estimate)

January 29, 2015

Study Record Updates

Last Update Posted (Actual)

November 19, 2018

Last Update Submitted That Met QC Criteria

October 19, 2018

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GS-US-337-1428

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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.

IPD Sharing Time Frame

18 months after study completion

IPD Sharing Access Criteria

A secured external environment with username, password, and RSA code.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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