Decentrialz logo
  • HIPAA Compliant
  • ISO 27001 Certified
Find Trials
About UsContact
Become a Volunteer+1 877 705 1914

Status:

COMPLETED

Transplant-Related Accelerated Progression of Hepatitis C

Lead Sponsor:

National Institutes of Health Clinical Center (CC)

Conditions:

Hepatitis C

Cirrhosis

Eligibility:

All Genders

18+ years

Brief Summary

This study will explore why severe scarring of the liver (cirrhosis) develops so rapidly in hepatitis C-infected patients who have had a liver transplant and possibly in kidney transplant patients as ...

Detailed Description

Nearly all patients with hepatitis C virus (HCV) related end-stage liver disease who receive an orthotopic liver transplant (OLT) develop hepatitis C reinfection of the graft after transplantation. Mo...

Eligibility Criteria

Inclusion

  • INCLUSION CRITERIA
  • To fulfill criteria for study entry, the patient must:
  • be 18 years of age or older.
  • have detectable HCV RNA
  • require orthotopic liver transplantation for chronic hepatitis C induced cirrhosis or require renal transplantation for end-stage kidney disease
  • have a MELD score greater than 18 (for liver transplant patients) or have an otherwise high probability of receiving a liver or kidney transplant within six months of enrollment based on assessment by the clinical transplant team at each hospital.
  • be able/willing to travel to the collaborating center for blood sampling prior to liver or kidney transplantation, and at 2, 3, 4, 5, 6, 8, 12, 16, 24 weeks after transplantation and then bi-annually until the end of the study at 5 years
  • be willing to have study-related liver biopsies at 3 months, and then 1, 3 and 5 years after transplantation
  • provide informed consent.
  • EXCLUSION CRITERIA:
  • To fulfill criteria for study entry, the patient must NOT:
  • be HIV or Hepatitis B virus (HBsAg) positive
  • receive a liver graft from an anti-HCV antibody positive or HBV core positive donor
  • have other forms of liver disease including primary biliary cirrhosis, autoimmune hepatitis, hemochromatosis and Wilson's Disease
  • have hepatocellular carcinoma if any single lesion is 5 cm. or more or if there are 3 or more lesions exceeding 3 cm.
  • be on immunomodulatory medications such as corticosteroids within four weeks of collection of blood for pre-transplant baseline laboratory testing
  • have been diagnosed with any hereditary or acquired immunodeficiency state prior to liver or kidney transplantation

Exclusion

    Key Trial Info

    Start Date :

    June 22 2006

    Trial Type :

    OBSERVATIONAL

    End Date :

    January 22 2009

    Estimated Enrollment :

    100 Patients enrolled

    Trial Details

    Trial ID

    NCT00368225

    Start Date

    June 22 2006

    End Date

    January 22 2009

    Last Update

    July 2 2017

    Active Locations (3)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 1 (3 locations)

    1

    Georgetown University

    Washington D.C., District of Columbia, United States, 20007-2197

    2

    National Institutes of Health Clinical Center, 9000 Rockville Pike

    Bethesda, Maryland, United States, 20892

    3

    Inova Fairfax Hospital

    Falls Church, Virginia, United States, 22042