Status:
ACTIVE_NOT_RECRUITING
Genetic Modifiers of Cystic Fibrosis (CF) Liver Disease
Lead Sponsor:
University of North Carolina, Chapel Hill
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Cystic Fibrosis Foundation
Conditions:
Cystic Fibrosis
Liver Disease
Eligibility:
All Genders
2+ years
Brief Summary
This study examines "modifier genes" that may play a role in the development of CF liver disease. Modifier genes are genes, other than the CF gene (CFTR), which may directly or indirectly have an affe...
Detailed Description
The clinical heterogeneity in cystic fibrosis (CF) is only partly explained by mutations in the CFTR gene. Most CF patients have evidence of liver dysfunction and focal biliary cirrhosis (fibrosis), a...
Eligibility Criteria
Inclusion
- Volunteers with CF, regardless of genotype and age, who have "severe" liver disease with portal hypertension (big spleen, i.e. "splenomegaly" and/or presence of enlarged vessels in the esophagus, i.e. esophageal varices) may be eligible to participate. This would include any person who has been evaluated for a liver transplant, or has already received a liver transplant.
Exclusion
- History of Alcohol Abuse
- History of Biliary Atresia
- History of Clinically Significant Hepatitis Infection
- History of Hepatic Vein Thrombosis
- History of Liver Cancer
- History of Portal Vein Thrombosis
- History of Clinically Significant use of total parenteral nutrition (TPN)
- History of Wilson's Disease
Key Trial Info
Start Date :
March 1 2004
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 1 2027
Estimated Enrollment :
154 Patients enrolled
Trial Details
Trial ID
NCT00804583
Start Date
March 1 2004
End Date
July 1 2027
Last Update
September 23 2025
Active Locations (1)
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1
The University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599