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

National Center for Research Resources (NCRR)

Status and phase: Completed; Phase 2

Conditions: Cholangitis, Sclerosing

Treatments: Drug: cladribine

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00004762

199/11707

SCRF-94304

Details and patient eligibility

About

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.

Full description

PROTOCOL OUTLINE:

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

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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