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Phase I Study of Colchicine Therapy in Childhood Hepatic Cirrhosis

Status
UNKNOWN
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00004368
Enrollment
15
Registered
1999-10-19
Start date
1990-05-31
Completion date
Unknown
Last updated
2005-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cirrhosis, Liver Cirrhosis

Keywords

hepatic cirrhosis, gastrointestinal disorders, rare disease

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.

Interventions

DRUGcolchicine

Sponsors

Children's Hospital Colorado
CollaboratorOTHER
National Center for Research Resources (NCRR)
Lead SponsorNIH

Study design

Primary purpose
TREATMENT

Eligibility

Sex/Gender
ALL
Age
0 Years to 17 Years
Healthy volunteers
No

Inclusion criteria

* Advanced hepatic fibrosis or cirrhosis in children * Not pregnant

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026