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

Tracking Information

First Received Date ^ICMJE

February 24, 2000

Last Updated Date

June 23, 2005

Start Date ^ICMJE

December 1994

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00004762 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Brief 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.

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.

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment

Condition ^ICMJE

Cholangitis, Sclerosing

Intervention ^ICMJE

Drug: cladribine

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Administrative Information

NCT ID ^ICMJE

NCT00004762

Responsible Party

Study ID Numbers ^ICMJE

199/11707, SCRF-94304

Study Sponsor ^ICMJE

National Center for Research Resources (NCRR)

Collaborators ^ICMJE

Scripps Clinic

Investigators ^ICMJE

Study Chair:

Paul J. Pockros

Scripps Clinic

Information Provided By

Office of Rare Diseases (ORD)

Verification Date

December 2001

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP