Phase I Study of Colchicine Therapy in Childhood Hepatic Cirrhosis

• Sponsor: National Center for Research Resources (NCRR) (NIH)
• Overall Status: Unknown status
• CT.gov ID: NCT00004368
• Collaborator: Children's Hospital Colorado (Other)
• Enrollment: 15

Study Details

Study Description

Brief Summary

OBJECTIVES:

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

Condition or Disease	Intervention/Treatment	Phase
Cirrhosis; Liver Cirrhosis	Drug: colchicine	Phase 1

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 Design

• Study Type: Interventional
• Primary Purpose: Treatment
• Study Start Date: May 1, 1990

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

• Ages Eligible for Study: 0 Years to 17 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

• Advanced hepatic fibrosis or cirrhosis in children

• Not pregnant

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• National Center for Research Resources (NCRR)
• Children's Hospital Colorado

Investigators

• Study Chair: Ronald J. Sokol, Children's Hospital Colorado

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00004368
• Other Study ID Numbers: 199/11947; CHD-1089
• First Posted: Oct 19, 1999
• Last Update Posted: Jun 24, 2005
• Last Verified: Oct 1, 2003

• Keywords provided by , ,: hepatic cirrhosis; gastrointestinal disorders; rare disease
• Additional relevant MeSH terms: Liver Cirrhosis; Fibrosis; Colchicine

Study Results

No Results Posted as of Jun 24, 2005