Phase I Study of Colchicine Therapy in Childhood Hepatic Cirrhosis

Phase 1

• Conditions: Cirrhosis; Liver Cirrhosis

• Registration Number: NCT00004368
• Lead Sponsor: National Center for Research Resources (NCRR)

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 1990-05
• Study First Submitted: 1999-10-18
• Study First Submitted QC: 1999-10-18
• Study First Posted: 1999-10-19
• Status Verified: 2003-10
• Last Update Submitted: 2005-06-23
• Last Update Posted: 2005-06-24

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified