Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
National Institutes of Health Clinical Center (CC) |
---|---|
Information provided by: | National Institutes of Health Clinical Center (CC) |
ClinicalTrials.gov Identifier: | NCT00368225 |
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 well. The hepatitis C virus (HCV) can cause cirrhosis in about 20 percent of infected persons. Generally, it takes 20 years or more for cirrhosis to develop. After liver transplantation, however, patients may develop cirrhosis in as little as 5 years. Cirrhosis does not develop as rapidly in kidney transplant patients, but it may develop faster than in people who do not undergo transplantation. The study will look at the possible role of immune-suppressing medications given to liver and kidney transplant patients in increasing the severity of hepatitis C infection and in speeding the cirrhotic process.
Patients 18 years of age and older with chronic HCV infection who require a liver transplant for end-stage liver disease or a kidney transplant for kidney failure may be eligible for this study. Liver transplant patients are recruited from the Inova Fairfax Liver Transplant Center in Fairfax, Virginia, and from the Georgetown University Medical Center Liver Transplant Institute in Washington, D.C. Kidney transplant patients are recruited from the Transplantation Branch of the National Institute of Diabetes and Digestive and Kidney Diseases.
Participants undergo the following procedures:
Condition |
---|
Hepatitis C Cirrhosis |
Study Type: | Observational |
Study Design: | Prospective |
Official Title: | Transplant-Related Accelerated Progression of Hepatitis C (TRAP-C) |
Estimated Enrollment: | 100 |
Study Start Date: | June 2006 |
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. Most of these patients will progress to chronic hepatitis and 20-30% will experience a rapid progression to cirrhosis. It is unclear why it generally takes 20 or more years for progression to cirrhosis after the initial HCV infection, but as little as five years after OLT. Additionally, it is paradoxical that hepatitis C, which is thought to be immune-mediated, should advance more rapidly in patients who are immune suppressed. Rapid fibrosis progression post-transplantation is likely related to complex interactions between viral factors, host immune responses and induction and maintenance of immunosuppression for the prevention of graft rejection.
This study has been designed as an observational, hypothesis-generating pilot study of patients with chronic hepatitis C requiring organ transplantation and concomitant immunosuppression. Patients who require a liver-transplant for chronic hepatitis C-related end-stage liver disease and patients with hepatitis C who require a kidney transplant for renal failure will be enrolled and followed for up to five years. Virologic, immunologic and intrahepatic parameters will be correlated with the level of immunosuppression, degree of fibrosis, progression to cirrhosis and liver-related deaths in study subjects. The objectives of this study are to: 1) determine the proportion of patients with hepatitis C that progress to bridging fibrosis or cirrhosis at three and five years after liver or kidney transplantation (rapid-progressors); 2) compare virologic, host-immune and intrahepatic factors in rapid-progressors to non-progressors and slow progressors; 3) characterize the relationship between general and HCV-specific immune responses and the extent of liver fibrosis; and 4) develop a predictive model that discriminates between rapid-progressors and non- or slow-progressors.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
To fulfill criteria for study entry, the patient must:
EXCLUSION CRITERIA:
To fulfill criteria for study entry, the patient must NOT:
Contact: Patient Recruitment and Public Liaison Office | (800) 411-1222 | prpl@mail.cc.nih.gov |
Contact: TTY | 1-866-411-1010 |
United States, District of Columbia | |
Georgetown University | Recruiting |
Washington, District of Columbia, United States, 20007-2197 | |
United States, Maryland | |
National Institutes of Health Clinical Center, 9000 Rockville Pike | Recruiting |
Bethesda, Maryland, United States, 20892 | |
United States, Virginia | |
Inova Fairfax Hospital | Recruiting |
Falls Church, Virginia, United States, 22042 |
Study ID Numbers: | 060193, 06-CC-0193 |
Study First Received: | August 23, 2006 |
Last Updated: | July 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00368225 |
Health Authority: | United States: Federal Government |
Viral Hepatitis Hepatitis C HCV Liver Transplant Renal Transplant |
Hepatitis C HCV Liver Transplant Kidney Transplant |
Virus Diseases Hepatitis Liver Diseases Digestive System Diseases Fibrosis |
Disease Progression Hepatitis, Viral, Human Liver Cirrhosis Hepatitis C |
RNA Virus Infections Pathologic Processes Flaviviridae Infections |