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Sponsors and Collaborators: |
National Center for Research Resources (NCRR) The Children's Hospital, Denver |
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Information provided by: | Office of Rare Diseases (ORD) |
ClinicalTrials.gov Identifier: | NCT00004368 |
OBJECTIVES:
I. Investigate the efficacy and safety of colchicine therapy in improving hepatic function and reducing hepatic fibrosis (scarring) in children with hepatic cirrhosis.
Condition | Intervention | Phase |
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Cirrhosis Liver Cirrhosis |
Drug: colchicine |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Estimated Enrollment: | 15 |
Study Start Date: | May 1990 |
PROTOCOL OUTLINE: Patients receive colchicine orally twice daily for 24 months. After the first month, the dose of colchicine will increase and remain at that dose for the duration of study. Patients are evaluated every 6 months during study.
Ages Eligible for Study: | up to 17 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
- Advanced hepatic fibrosis or cirrhosis in children - Not pregnant
Study ID Numbers: | 199/11947, CHD-1089 |
Study First Received: | October 18, 1999 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00004368 History of Changes |
Health Authority: | United States: Federal Government |
hepatic cirrhosis gastrointestinal disorders rare disease |
Liver Diseases Digestive System Diseases Fibrosis Gastrointestinal Diseases Tubulin Modulators |
Rare Diseases Colchicine Antimitotic Agents Liver Cirrhosis Antirheumatic Agents |
Liver Diseases Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Fibrosis Mitosis Modulators Liver Cirrhosis Antimitotic Agents Gout Suppressants |
Pharmacologic Actions Digestive System Diseases Pathologic Processes Therapeutic Uses Tubulin Modulators Colchicine Antirheumatic Agents |