Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:40 AM
Ignite Modification Date:
2025-12-25 @ 4:40 AM
NCT ID:
NCT03702218
Eligibility Criteria:
Inclusion Criteria:
* RECIPIENT INCLUSION CRITERIA
* Patients undergoing solid organ transplantation, including liver, kidney, and simultaneous liver-kidney who are not chronically infected with HCV
* No evident contraindication for organ transplantation
* HCV RNA negative (can be isolated HCV antibody positive provided the patient will have no history of previously treated HCV)
* Age 18-75 years at the time of transplantation
* Signed Informed Consent Form
* No identified living organ donor
* Able to travel to the University of Maryland for routine post-transplant and HCV follow-up visits
* Men and women must agree to use at least one barrier method to prevent any secretion exchange
* No active illicit drug use
DONOR INCLUSION CRITERIA
• Qualitative HCV nucleic acid test (NAT) positive and/or Hepatitis C antibody positive HCV donors offered to the University of Maryland.
Exclusion Criteria:
RECIPIENT EXCLUSION CRITERIA
* History of prior solid organ transplantation
* HIV infection
* HBV surface antigen or DNA positive. Organs from HCV positive donors who are also Hepatitis B core antibody positive (hepatitis B surface antigen negative) can be used. These patients will however need to undergo prophylaxis for HBV according to their respective organ specific criteria and during treatment for hepatitis C due to the increased risk of reactivation of hepatitis B with DAA therapy
* Waitlisted for a multi-organ transplant (with the exception of simultaneous liver-kidney transplant)
* HCV RNA positive (can be isolated HCV antibody positive provided the patient will have no history of previously treated HCV)
* Prior direct-acting antiviral (DAA) treatment for HCV. Patients previously treated with interferon-based regimens may be included.
DONOR EXCLUSION CRITERIA
* Every donor that is considered unsuitable by the transplant surgeon for any reason.
* Hepatocellular carcinoma
* HIV infection
* Use of HCV positive livers to be determined according to current existing criteria
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT03702218
Study Brief:
Protocol Section:
NCT03702218