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

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


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:


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


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


--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--


  • Absolute neutrophil count at least 2500/mm3
  • Platelet count at least 100,000/mm3
  • Hemoglobin at least 10 g/dL


  • 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
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Please refer to this study by its identifier: NCT00004762

Sponsors and Collaborators
National Center for Research Resources (NCRR)
Scripps Clinic
Study Chair: Paul J. Pockros Scripps Clinic
  More Information Identifier: NCT00004762     History of Changes
Other Study ID Numbers: 199/11707
Study First Received: February 24, 2000
Last Updated: June 23, 2005

Keywords provided by Office of Rare Diseases (ORD):
gastrointestinal disorders
primary sclerosing cholangitis
rare disease

Additional relevant MeSH terms:
Cholangitis, Sclerosing
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs processed this record on August 18, 2017