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Phase I Study of Colchicine Therapy in Childhood Hepatic Cirrhosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00004368
Recruitment Status : Unknown
Verified October 2003 by Office of Rare Diseases (ORD).
Recruitment status was:  Active, not recruiting
First Posted : October 19, 1999
Last Update Posted : June 24, 2005
Sponsor:
Collaborator:
Children's Hospital Colorado
Information provided by:
Office of Rare Diseases (ORD)

Brief 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.


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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 15 participants
Primary Purpose: Treatment
Study Start Date : May 1990

Resource links provided by the National Library of Medicine

Drug Information available for: Colchicine





Information from the National Library of Medicine

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Ages Eligible for Study:   up to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
  • Advanced hepatic fibrosis or cirrhosis in children
  • Not pregnant

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004368


Sponsors and Collaborators
National Center for Research Resources (NCRR)
Children's Hospital Colorado
Investigators
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Study Chair: Ronald J. Sokol Children's Hospital Colorado
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ClinicalTrials.gov Identifier: NCT00004368    
Other Study ID Numbers: 199/11947
CHD-1089
First Posted: October 19, 1999    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: October 2003
Keywords provided by Office of Rare Diseases (ORD):
hepatic cirrhosis
gastrointestinal disorders
rare disease
Additional relevant MeSH terms:
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Liver Cirrhosis
Fibrosis
Pathologic Processes
Liver Diseases
Digestive System Diseases
Colchicine
Gout Suppressants
Antirheumatic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents