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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Center for Research Resources (NCRR)
• Collaborator: Scripps Clinic
• Treatments: Cladribine

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