Phase I Study of Colchicine Therapy in Childhood Hepatic Cirrhosis

The recruitment status of this study is unknown because the information has not been verified recently.

Verified October 2003 by Office of Rare Diseases (ORD). Recruitment status was Active, not recruiting

First Received on October 18, 1999. Last Updated on June 23, 2005 History of Changes

Sponsor:	National Center for Research Resources (NCRR)
Collaborator:	Children's Hospital Colorad
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

Study Type:	Interventional
Study Design:	Primary Purpose: Treatment

Resource links provided by NLM:

Genetics Home Reference related topics: North American Indian childhood cirrhosis

MedlinePlus related topics: Cirrhosis

Drug Information available for: Colchicine

U.S. FDA Resources

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)

Children's Hospital Colorad

Investigators

Study Chair:

Ronald J. Sokol

Children's Hospital Colorad

More Information

No publications provided

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

Keywords provided by Office of Rare Diseases (ORD):

hepatic cirrhosis
gastrointestinal disorders
rare disease

Additional relevant MeSH terms:

Liver Cirrhosis
Fibrosis
Liver Diseases
Digestive System Diseases
Pathologic Processes
Colchicine
Tubulin Modulators
Antimitotic Agents

Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Gout Suppressants
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents

ClinicalTrials.gov processed this record on February 12, 2012