RECRUITING

Study of Hepatitis Eradication Receiving Protease Inhibitor Administration

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is a prospective, non-blinded cohort study that will assess the safety, tolerability, and antiviral efficacy of glecaprevir/pibrentasivir therapy given post-discharge to HCV-negative recipients of HCV infected donors. Patients who meet entry criteria will be enrolled while on the transplant waitlist. At the time of transplant, some donors will be HCV positive / NAT positive and some will not be infected. Enrolled patients who receive an HCV negative donor will serve as contemporaneous controls. All study subjects who receive an HCV positive organ will be confirmed to have acquired HCV infection and genotype will be assessed prior to treatment with therapy.

Official Title

The Study of Hepatitis Eradication Receiving Protease Inhibitor Administration

Quick Facts

Study Start:2019-03-20
Study Completion:2024-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03886077

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Subjects must meet all of the inclusion criteria specified below in order to be eligible for participation in this study
  2. 1. Willing and capable of providing written informed consent
  3. 2. Age ≥18 years
  4. 3. On UNOS list as a candidate for heart transplant
  1. * Subjects who meet any of the following exclusion criteria cannot be enrolled in this study.
  2. 1. Individuals under 18 years of age
  3. 2. History of advanced liver disease, including active hepatitis B or C, detectable hepatitis B surface Ag, hepatitis B DNA, HCV RNA, or cirrhosis
  4. 3. Pregnant individuals
  5. 4. HIV antibody positive

Contacts and Locations

Study Contact

David Baran, MD
CONTACT
7573882831
dabaran@sentara.com
Gerry Cruz
CONTACT
7573882229
gacruz@sentara.com

Principal Investigator

David Baran, MD
PRINCIPAL_INVESTIGATOR
Sentara Norfolk General Hospital

Study Locations (Sites)

Sentara Norfolk General Hospital
Norfolk, Virginia, 23507
United States

Collaborators and Investigators

Sponsor: Sentara Norfolk General Hospital

  • David Baran, MD, PRINCIPAL_INVESTIGATOR, Sentara Norfolk General Hospital

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 Registration Dates

Study Start Date2019-03-20
Study Completion Date2024-12-31

Study Record Updates

Study Start Date2019-03-20
Study Completion Date2024-12-31

Terms related to this study

Additional Relevant MeSH Terms

  • Coronary Artery Disease
  • Morality