NCT00004762

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for phase_2

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 1994

Completed
5.2 years until next milestone

First Submitted

Initial submission to the registry

February 24, 2000

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 25, 2000

Completed
Last Updated

June 24, 2005

Status Verified

December 1, 2001

First QC Date

February 24, 2000

Last Update Submit

June 23, 2005

Conditions

Cholangitis, Sclerosing

Keywords

gastrointestinal disordersprimary sclerosing cholangitisrare disease

Interventions

cladribineDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

MeSH Terms

Conditions

Cholangitis, SclerosingGastrointestinal DiseasesRare Diseases

Interventions

Cladribine

Condition Hierarchy (Ancestors)

CholangitisBile Duct DiseasesBiliary Tract DiseasesDigestive System DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

2-ChloroadenosineAdenosinePurine NucleosidesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsDeoxyadenosinesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesRibonucleosides

Study Officials

  • Paul J. Pockros

    Scripps Clinic

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

February 24, 2000

First Posted

February 25, 2000

Study Start

December 1, 1994

Last Updated

June 24, 2005

Record last verified: 2001-12