search
Back to results

Phase I Study of Colchicine Therapy in Childhood Hepatic Cirrhosis

Primary Purpose

Cirrhosis, Liver Cirrhosis

Status
Unknown status
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
colchicine
Sponsored by
National Center for Research Resources (NCRR)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cirrhosis focused on measuring hepatic cirrhosis, gastrointestinal disorders, rare disease

Eligibility Criteria

0 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Advanced hepatic fibrosis or cirrhosis in children Not pregnant

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    October 18, 1999
    Last Updated
    June 23, 2005
    Sponsor
    National Center for Research Resources (NCRR)
    Collaborators
    Children's Hospital Colorado
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT00004368
    Brief Title
    Phase I Study of Colchicine Therapy in Childhood Hepatic Cirrhosis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2003
    Overall Recruitment Status
    Unknown status
    Study Start Date
    May 1990 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    National Center for Research Resources (NCRR)
    Collaborators
    Children's Hospital Colorado

    4. Oversight

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cirrhosis, Liver Cirrhosis
    Keywords
    hepatic cirrhosis, gastrointestinal disorders, rare disease

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Enrollment
    15 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    colchicine

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    0 Years
    Maximum Age & Unit of Time
    17 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Advanced hepatic fibrosis or cirrhosis in children Not pregnant
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ronald J. Sokol
    Organizational Affiliation
    Children's Hospital Colorado
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Learn more about this trial

    Phase I Study of Colchicine Therapy in Childhood Hepatic Cirrhosis

    We'll reach out to this number within 24 hrs