Phase I Study of Colchicine Therapy in Childhood Hepatic Cirrhosis - Full Text View

Phase I Study of Colchicine Therapy in Childhood Hepatic Cirrhosis

This study is ongoing, but not recruiting participants.

Sponsors and Collaborators:	National Center for Research Resources (NCRR) The Children's Hospital, Denver
Information provided by:	Office of Rare Diseases (ORD)
ClinicalTrials.gov Identifier:	NCT00004368

Purpose

OBJECTIVES:

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

Condition	Intervention	Phase
Cirrhosis Liver Cirrhosis	Drug: colchicine	Phase I

MedlinePlus related topics:

Cirrhosis

ChemIDplus related topics:

Colchicine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment

Further study details as provided by Office of Rare Diseases (ORD):

Estimated Enrollment:	15
Study Start Date:	May 1990

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

Ages Eligible for Study:	up to 17 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Advanced hepatic fibrosis or cirrhosis in children
Not pregnant

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004368

Sponsors and Collaborators

National Center for Research Resources (NCRR)

The Children's Hospital, Denver

Investigators


Study Chair:	Ronald J. Sokol	The Children's Hospital, Denver

More Information

Study ID Numbers:	199/11947, CHD-1089
First Received:	October 18, 1999
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00004368
Health Authority:	United States: Federal Government

Keywords provided by Office of Rare Diseases (ORD):

hepatic cirrhosis

gastrointestinal disorders

rare disease

Study placed in the following topic categories:

Liver Diseases

Digestive System Diseases

Fibrosis

Gastrointestinal Diseases

Rare Diseases

Colchicine

Liver Cirrhosis

Additional relevant MeSH terms:

Pathologic Processes

Molecular Mechanisms of Pharmacological Action

Antineoplastic Agents

Therapeutic Uses

Mitosis Modulators

Tubulin Modulators

Antimitotic Agents

Antirheumatic Agents

Gout Suppressants

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 10, 2008