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

Tracking Information

First Received Date ^ICMJE

October 18, 1999

Last Updated Date

June 23, 2005

Start Date ^ICMJE

May 1990

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00004368 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Phase I Study of Colchicine Therapy in Childhood Hepatic Cirrhosis

Official Title ^ICMJE

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.

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.

Study Phase

Phase I

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment

Condition ^ICMJE

Cirrhosis
Liver Cirrhosis

Intervention ^ICMJE

Drug: colchicine

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

Advanced hepatic fibrosis or cirrhosis in children
Not pregnant

Gender

Both

Ages

up to 17 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Administrative Information

NCT ID ^ICMJE

NCT00004368

Responsible Party

Study ID Numbers ^ICMJE

199/11947, CHD-1089

Study Sponsor ^ICMJE

National Center for Research Resources (NCRR)

Collaborators ^ICMJE

The Children's Hospital, Denver

Investigators ^ICMJE

Study Chair:

Ronald J. Sokol

The Children's Hospital, Denver

Information Provided By

Office of Rare Diseases (ORD)

Verification Date

October 2003

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP