Phase I Study of Colchicine Therapy in Childhood Hepatic Cirrhosis

This study is ongoing, but not recruiting participants.

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

Sponsor:	National Center for Research Resources (NCRR)
Collaborator:	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

Study Type:	Interventional
Study Design:	Treatment

Resource links provided by NLM:

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)

The Children's Hospital, Denver

Investigators

Study Chair:

Ronald J. Sokol

The Children's Hospital, Denver

More Information

No publications provided

Study ID Numbers:	199/11947, CHD-1089
Study First Received:	October 18, 1999
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00004368 History of Changes
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 Diseases
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Fibrosis
Mitosis Modulators
Liver Cirrhosis
Antimitotic Agents
Gout Suppressants

Pharmacologic Actions
Digestive System Diseases
Pathologic Processes
Therapeutic Uses
Tubulin Modulators
Colchicine
Antirheumatic Agents

ClinicalTrials.gov processed this record on November 05, 2009