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Prevention of Transmission of Hepatitis C Virus (HCV) From HCV-Viremic Organ Donor

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04596475
Recruitment Status : Not yet recruiting
First Posted : October 22, 2020
Last Update Posted : October 22, 2020
Sponsor:
Information provided by (Responsible Party):
Saima Aslam, University of California, San Diego

Brief Summary:
This trial will be done in participants who undergo transplantation of heart, kidney or lung at University of California, San Diego (UCSD) and receive a hepatitis C infected donor organ. In this trial, the plan is to start hepatitis C treatment just before transplant surgery and treat for a short one-week course to see if hepatitis C infection can be prevented in the transplant recipient. The plan is to perform this trial in 10 participants and if successful, the next step is to try to make it standard of care as prevention of infection is better than treating hepatitis C after discharge from transplant surgery (which is usually a 12 week standard treatment).

Condition or disease Intervention/treatment Phase
Hepatitis C Hepatitis C Virus Infection, Response to Therapy of Drug: glecaprevir/pibrentasvir (GLE/PIB) Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Prevention of Transmission of Hepatitis C Virus (HCV) From HCV-Viremic Organ Donor to HCVNegative Organ Transplant Recipient - Pilot Trial
Estimated Study Start Date : October 2020
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : March 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Treatment Arm Drug: glecaprevir/pibrentasvir (GLE/PIB)
The study intervention consists of a single daily dose of GLE/PIB 100/40 mg (one dose consists of 3 tablets) administered orally; or crushed and administered via a feeding tube if participant is unable to swallow by mouth, for example in the immediate post-operative period. First dose will be administered in the pre-operative period within 4 hours of surgery followed by once daily doses for 7 days total.




Primary Outcome Measures :
  1. Percentage of participants with Sustained Virological Response [ Time Frame: 91 days ]
    The primary outcome is the percentage of patients sustained virological response (SVR) at day 91 after completion of a 7-day course of GLE/PIB.


Secondary Outcome Measures :
  1. Percentage of participants with treatment-related Serious Adverse Events [ Time Frame: 91 days ]
    Safety and tolerability of the 7-day GLR/PIB course. Safety and tolerability will be assessed by documenting Serious Adverse Events (based on NIH criteria) for the duration of the study. Safety assessments will occur through review of the medical record of the patient, review of laboratory parameters and open-ended questions at the in-person assessments.



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

Inclusion Criteria:

  • adults aged 18 years or greater
  • participants actively listed for heart, lung and/or kidney transplant
  • participants have already consented to receive HCV-viremic organs as part of the institution's clinical practice protocol (involves education and informed consent), and are able to sign informed consent for this research study.

Exclusion Criteria:

  • participants who have a prior history of HCV infection regardless of treatment status, pre-existing human immunodeficiency virus (HIV) or hepatitis B virus (HBV) infection
  • participants who are not able to sign informed consent for this research study
  • participants who have not agreed to accept HCV+ organs as part of the UCSD clinical practice protocol
  • participants who are listed for a liver transplant (either as a single organ or combined organ transplant).

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): NCT04596475


Contacts
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Contact: Saima Aslam, MD (858) 657-7000 saslam@health.ucsd.edu
Contact: Claudia Ramirez-Sanchez, MD ccramirezsanchez@health.ucsd.edu

Locations
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United States, California
University of California San Diego
San Diego, California, United States, 92037
Contact: Saima Aslam, MD       saslam@health.ucsd.edu   
Contact: Claudia Ramirez-Sanchez, MD       ccramirezsanchez@health.ucsd.edu   
Principal Investigator: Saima Aslam, MD         
Sub-Investigator: Victor Pretorius, MBBS         
Sub-Investigator: Kristin Mekeel, MD         
Sub-Investigator: Eugene Golts, MD         
Sub-Investigator: Eric Adler, MD         
Sub-Investigator: Claudia Ramirez-Sanchez, MD         
Sponsors and Collaborators
University of California, San Diego
Publications:

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Responsible Party: Saima Aslam, Associate Professor, University of California, San Diego
ClinicalTrials.gov Identifier: NCT04596475    
Other Study ID Numbers: Project #200895
First Posted: October 22, 2020    Key Record Dates
Last Update Posted: October 22, 2020
Last Verified: October 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis C
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections