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

National Center for Research Resources (NCRR)5 enrolled

Overview

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.

PROTOCOL OUTLINE: Patients are treated with subcutaneous injections of cladribine (2-chlorodeoxyadenosine; 2-CdA) for 5 consecutive days every month for 3 months.

Study Type

INTERVENTIONAL

Purpose

TREATMENT

Enrollment

Conditions

Cholangitis, Sclerosing

Interventions

cladribineDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Data from ClinicalTrials.gov

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