Phase I Study of Colchicine Therapy in Childhood Hepatic Cirrhosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

1990-05-31

Brief Summary

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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

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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.

Conditions

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Cirrhosis Liver Cirrhosis

Study Design

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Primary Study Purpose

TREATMENT

Interventions

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colchicine

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Advanced hepatic fibrosis or cirrhosis in children
* Not pregnant

Minimum Eligible Age

0 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Ronald J. Sokol

Role: STUDY_CHAIR

Children's Hospital Colorado

Other Identifiers

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CHD-1089

Identifier Type: -

Identifier Source: secondary_id

199/11947