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
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
1 other identifier
interventional
17
1 country
6
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started May 2015
Shorter than P25 for phase_2
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 26, 2015
CompletedFirst Posted
Study publicly available on registry
January 29, 2015
CompletedStudy Start
First participant enrolled
May 22, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 28, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
April 22, 2016
CompletedResults Posted
Study results publicly available
May 5, 2017
CompletedNovember 19, 2018
March 1, 2017
10 months
January 26, 2015
March 27, 2017
October 19, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)
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
Up to 4 weeks
Secondary Outcomes (3)
Percentage of Participants With SVR 4 Weeks After Discontinuation of Therapy (SVR4)
Posttreatment Week 4
Percentage of Participants With Virologic Failure
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
Days 1, 3, 5, 7, 14, 21, and 28
Study Arms (1)
LDV/SOF
EXPERIMENTALParticipants 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gilead Scienceslead
Study Sites (6)
Unknown Facility
San Francisco, California, United States
Unknown Facility
Chicago, Illinois, United States
Unknown Facility
New Orleans, Louisiana, United States
Unknown Facility
Detroit, Michigan, United States
Unknown Facility
New York, New York, United States
Unknown Facility
Dallas, Texas, United States
Related Publications (1)
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. doi: 10.1056/NEJMc1611829. No abstract available.
PMID: 27959735RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Trial Disclosures
- Organization
- Gilead Sciences
Study Officials
- STUDY DIRECTOR
Gilead Study Director
Gilead Sciences
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 26, 2015
First Posted
January 29, 2015
Study Start
May 22, 2015
Primary Completion
March 28, 2016
Study Completion
April 22, 2016
Last Updated
November 19, 2018
Results First Posted
May 5, 2017
Record last verified: 2017-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- 18 months after study completion
- Access Criteria
- A secured external environment with username, password, and RSA code.
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.