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NCT00004368 Clinical Trial

Phase I Study of Colchicine Therapy in Childhood Hepatic Cirrhosis

Liver Cirrhosis Clinical Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT00004368
Other study ID # 199/11947
Secondary ID CHD-1089
Status Active, not recruiting
Phase Phase 1
First received October 18, 1999
Last updated June 23, 2005
Start date May 1990

Study information
Verified date October 2003
Source Office of Rare Diseases (ORD)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

OBJECTIVES:

I. Investigate the efficacy and safety of colchicine therapy in improving hepatic function and reducing hepatic fibrosis (scarring) in children with hepatic cirrhosis.

Description:

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 15
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group N/A to 17 Years
Eligibility - Advanced hepatic fibrosis or cirrhosis in children

- Not pregnant

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• colchicine

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
National Center for Research Resources (NCRR) Children's Hospital Colorado
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