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:
2025-12-24 @ 4:09 PM
Ignite Modification Date:
2025-12-24 @ 4:09 PM
NCT ID:
NCT00656266
Eligibility Criteria:
Inclusion Criteria:
* End-stage liver disease or acute fulminant hepatic failure recalcitrant to conventional medical or surgical therapy.
* Listed as candidate for pediatric liver transplantation listed with United Network for Organ Sharing (UNOS).
* Patients must be 18 years of age or younger.
Exclusion Criteria:
* History of autoimmune disease or primary sclerosing cholangitis.
* History of end-stage renal disease, dialysis treatment or acute renal failure (not including hepatorenal syndrome).
* Patients with pretransplant renal insufficiency as determined by a glomerular filtration rate (GFR) of \<80 mL/min/1.73m2 (see below).
* Patients with renal agenesis or hypoplasia, polycystic kidney disease, or hydroureter seen on pretransplant renal ultrasound.
* Patients with malignancy or previous malignancy.
* Patients with active bacterial, viral, or fungal infections.
* Patients with a pretransplant diagnosis of diabetes mellitus.
* Patients with history of previous transplant or multi-organ recipients.
* Patients with serological evidence of HIV, HBSAg or HCV.
* Patients with hereditary syndrome that causes genetic deficiency of hypoxanthine-guanine phosphoribosyl-transferase (HGPRT) such as Lesch-Nyhan or Kelley-Seegmiller syndrome.
* Patients with history of phenylketonuria.
* Females that are pregnant or breastfeeding.
* Sexually active females who are not: a) post-menopausal, or b) surgically sterile, and c) using an acceptable method of contraception (oral contraceptive, implanted devices, injection, and barrier devices are acceptable; condoms used alone are not acceptable).
* Patients with alcohol abuse, substance abuse or smoking within the previous 6 months.
* Patients or caretakers of patients with psychogenic factors that preclude therapeutic compliance.
* Inability to reach participating hospital within 2 hours of notification.
* Any conditions or any circumstance that makes it unsafe to undergo a liver transplant.
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
16 Years
Study:
NCT00656266
Study Brief:
Protocol Section:
NCT00656266