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

This study has been completed.
Sponsor:
Collaborator:
Scripps Clinic
Information provided by:
Office of Rare Diseases (ORD)
ClinicalTrials.gov Identifier:
NCT00004762
First received: February 24, 2000
Last updated: June 23, 2005
Last verified: December 2001
  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 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Sponsors and Collaborators
Scripps Clinic
Investigators
Study Chair: Paul J. Pockros Scripps Clinic
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00004762     History of Changes
Other Study ID Numbers: 199/11707, SCRF-94304
Study First Received: February 24, 2000
Last Updated: June 23, 2005
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:
Cholangitis
Cholangitis, Sclerosing
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases
Cladribine
Antineoplastic Agents
Immunologic Factors
Immunosuppressive Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014