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OpenTrials
Completed

NCT Number: NCT00004762

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

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.

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Key information

Conditions

Cholangitis, Sclerosing Bile Duct Diseases Biliary Tract Diseases Cholangitis Digestive System Diseases Disease Attributes Gastrointestinal Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Rare Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

About this study

PROTOCOL OUTLINE:

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

cladribine

Drug

Sponsors and collaborators

Lead sponsor

National Center for Research Resources (NCRR)

Nih

Collaborators

  • Scripps Clinic

Registry information

Important dates

Study start
1994
First posted
Feb 25, 2000
Registry last updated
Jun 24, 2005

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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