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

This study has been completed.

First Received: February 24, 2000 Last Updated: June 23, 2005 History of Changes

Sponsor:	National Center for Research Resources (NCRR)
Collaborator:	Scripps Clinic
Information provided by:	Office of Rare Diseases (ORD)
ClinicalTrials.gov Identifier:	NCT00004762

Purpose

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.

Condition	Intervention	Phase
Cholangitis, Sclerosing	Drug: cladribine	Phase II

Study Type:	Interventional
Study Design:	Treatment

Resource links provided by NLM:

Drug Information available for: Cladribine

U.S. FDA Resources

Further study details as provided by Office of Rare Diseases (ORD):

Estimated Enrollment:	5
Study Start Date:	December 1994

Detailed Description:

PROTOCOL OUTLINE:

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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004762

Sponsors and Collaborators

National Center for Research Resources (NCRR)

Scripps Clinic

Investigators

Study Chair:

Paul J. Pockros

Scripps Clinic

More Information

No publications provided

Study ID Numbers:	199/11707, SCRF-94304
Study First Received:	February 24, 2000
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00004762 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by Office of Rare Diseases (ORD):

gastrointestinal disorders
primary sclerosing cholangitis
rare disease

Additional relevant MeSH terms:

Cladribine
Cholangitis
Digestive System Diseases
Immunologic Factors
Cholangitis, Sclerosing
Antineoplastic Agents

Bile Duct Diseases
Therapeutic Uses
Biliary Tract Diseases
Physiological Effects of Drugs
Immunosuppressive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 27, 2009