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Phase II Pilot Study of Cladribine (2-Chlorodeoxyadenosine; 2-CdA) for Early Stage Primary Sclerosing Cholangitis

Primary Purpose

Cholangitis, Sclerosing

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
cladribine
Sponsored by
National Center for Research Resources (NCRR)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cholangitis, Sclerosing focused on measuring gastrointestinal disorders, primary sclerosing cholangitis, rare disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Stage I-III primary sclerosing cholangitis Radiologically and pathologically documented No concomitant liver disease, e.g.: Viral hepatitis Autoimmune hepatitis Primary biliary cirrhosis Cirrhosis Portal hypertension or associated complications Jaundice caused by dominant stricture --Prior/Concurrent Therapy-- No concurrent immunosuppressives --Patient Characteristics-- Hematopoietic: Absolute neutrophil count at least 2500/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 10 g/dL Other: No active infection No fistula abscess No active inflammatory bowel disease Quiescent disease allowed, including: Chronic ulcerative colitis Crohn's disease No other significant immunologic disorder No active malignancy No active alcohol or drug abuse No pregnant or nursing women Effective contraception required of fertile patients Endoscopic retrograde cholangiopancreatography within 36 months prior to registration Liver biopsy within 12 months prior to registration

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    February 24, 2000
    Last Updated
    June 23, 2005
    Sponsor
    National Center for Research Resources (NCRR)
    Collaborators
    Scripps Clinic
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00004762
    Brief Title
    Phase II Pilot Study of Cladribine (2-Chlorodeoxyadenosine; 2-CdA) for Early Stage Primary Sclerosing Cholangitis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2001
    Overall Recruitment Status
    Completed
    Study Start Date
    December 1994 (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
    Scripps Clinic

    4. Oversight

    5. Study Description

    Brief Summary
    OBJECTIVES: I. Evaluate the effects of cladribine (2-chlorodeoxyadenosine; 2-CdA) on biochemical, radiologic, and histologic parameters in patients with early stage primary sclerosing cholangitis.
    Detailed Description
    PROTOCOL OUTLINE: Patients are treated with subcutaneous injections of cladribine (2-chlorodeoxyadenosine; 2-CdA) for 5 consecutive days every month for 3 months.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cholangitis, Sclerosing
    Keywords
    gastrointestinal disorders, primary sclerosing cholangitis, rare disease

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Enrollment
    5 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    cladribine

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Stage I-III primary sclerosing cholangitis Radiologically and pathologically documented No concomitant liver disease, e.g.: Viral hepatitis Autoimmune hepatitis Primary biliary cirrhosis Cirrhosis Portal hypertension or associated complications Jaundice caused by dominant stricture --Prior/Concurrent Therapy-- No concurrent immunosuppressives --Patient Characteristics-- Hematopoietic: Absolute neutrophil count at least 2500/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 10 g/dL Other: No active infection No fistula abscess No active inflammatory bowel disease Quiescent disease allowed, including: Chronic ulcerative colitis Crohn's disease No other significant immunologic disorder No active malignancy No active alcohol or drug abuse No pregnant or nursing women Effective contraception required of fertile patients Endoscopic retrograde cholangiopancreatography within 36 months prior to registration Liver biopsy within 12 months prior to registration
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Paul J. Pockros
    Organizational Affiliation
    Scripps Clinic
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Learn more about this trial

    Phase II Pilot Study of Cladribine (2-Chlorodeoxyadenosine; 2-CdA) for Early Stage Primary Sclerosing Cholangitis

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