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Phase I Study of Colchicine Therapy in Childhood Hepatic Cirrhosis

Information source: Office of Rare Diseases (ORD)
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Cirrhosis; Liver Cirrhosis

Intervention: colchicine (Drug)

Phase: Phase 1

Status: Active, not recruiting

Sponsored by: National Center for Research Resources (NCRR)

Official(s) and/or principal investigator(s):
Ronald J. Sokol, Study Chair, Affiliation: Children's Hospital Colorado

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.

Clinical Details

Study design: Primary Purpose: Treatment

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.

Eligibility

Minimum age: N/A. Maximum age: 17 Years. Gender(s): Both.

Criteria:

- Advanced hepatic fibrosis or cirrhosis in children

- Not pregnant

Locations and Contacts

Additional Information

Starting date: May 1990
Last updated: June 23, 2005

Page last updated: August 20, 2015

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