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

Cholangitis, Sclerosing Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00004762
• Other study ID #: 199/11707
• Secondary ID: SCRF-94304
• Status: Completed
• Phase: Phase 2
• First received: February 24, 2000
• Last updated: June 23, 2005
• Start date: December 1994

Study information

• Verified date: December 2001
• Source: Office of Rare Diseases (ORD)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Description:

PROTOCOL OUTLINE:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cholangitis
• Cholangitis, Sclerosing

Intervention

Drug:
• cladribine

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
National Center for Research Resources (NCRR)	Scripps Clinic