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Phase I Study of Colchicine Therapy in Childhood Hepatic Cirrhosis



Phase I Study of Colchicine Therapy in Childhood Hepatic Cirrhosis

For Condition: Cirrhosis,Liver Cirrhosis
Status: No longer recruiting
Sponsor(s): National Center for Research Resources (NCRR) , Children's Hospital Denver
Synopsis: OBJECTIVES: I. Investigate the efficacy and safety of colchicine therapy in improving hepatic function and reducing hepatic fibrosis (scarring) in children with hepatic cirrhosis.
Details: 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.
Eligibility:
Study Type:
  Interventional, Treatment
Minimum Age/Maximum Age: /17 Years
Genders: Both
Protocol Entry Criteria: - Advanced hepatic fibrosis or cirrhosis in children - Not pregnant
Total Enrollment: 15

Location and Contact Information:

Overall Study Official:
RonaldSokol,  Study Chair,  Children's Hospital Denver


Additional Information:
Study ID Numbers:
  199/11947;  CHD-1089
Study Start Date: May 1990
Record last reviewed: October 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004368

Other Cirrhosis Studies:
1. Gabapentin to treat itch in patients with liver disease

2. Peg-Intron for Prevention of Disease Progression in Chronic Hepatitis C Patients with Cirrhosis who failed with a Interferon plus Ribavirin Therapy

3. Role of nitric oxide in cirrhosis: relationship with systemic hemodynamics, renal function, vasoactive systems and endotoxemia

4. Phase II Study of Lactulose and Circadian Rhythms in Patients with Cirrhosis

5. Prevention of Recurrent Hepatitis B after Liver Transplantation

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