Cladribine Treatment for Early Stage Primary Sclerosing Cholangitis
cladribine
Bile Duct Diseases+7
+ Biliary Tract Diseases
+ Cholangitis
Treatment Study
Summary
Study start date: December 1, 1994
Actual date on which the first participant was enrolled.PROTOCOL OUTLINE: Patients are treated with subcutaneous injections of cladribine (2-chlorodeoxyadenosine; 2-CdA) for 5 consecutive days every month for 3 months.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.5 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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