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Phase II Pilot Study of Cladribine (2-Chlorodeoxyadenosine; 2-CdA) for Early Stage Primary Sclerosing Cholangitis Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified health advice, visits or treatment with a real mD. We are not doctors. Always consult your doctor about Phase II Pilot Study of Cladribine (2-Chlorodeoxyadenosine; 2-CdA) for Early Stage Primary Sclerosing Cholangitis conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Phase II Pilot Study of Cladribine (2-Chlorodeoxyadenosine; 2-CdA) for Early Stage Primary Sclerosing Cholangitis Clinical research trials and Phase II Pilot Study of Cladribine (2-Chlorodeoxyadenosine; 2-CdA) for Early Stage Primary Sclerosing Cholangitis healthcare trials happen in many of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectivity of new drugs. The purpose of the studies / projects is to solve particular human medical questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to discover cures for all varieties of conditions, such as Phase II Pilot Study of Cladribine (2-Chlorodeoxyadenosine; 2-CdA) for Early Stage Primary Sclerosing Cholangitis. Phase II Pilot Study of Cladribine (2-Chlorodeoxyadenosine; 2-CdA) for Early Stage Primary Sclerosing Cholangitis Clinical Trials and other clinical trials allow volunteers to have health treatment alternatives before they are available to the masses. Some times the human subjects obtain treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a Phase II Pilot Study of Cladribine (2-Chlorodeoxyadenosine; 2-CdA) for Early Stage Primary Sclerosing Cholangitis clinical trial. Test subjects oftentimes receive the most effective healthcare possible for their Phase II Pilot Study of Cladribine (2-Chlorodeoxyadenosine; 2-CdA) for Early Stage Primary Sclerosing Cholangitis condition. Dangers are a reality, however, and may include extra or frequent physician visits, healthcare dangers (possibly life-jeopardising), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials patients.

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



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

For Condition: Cholangitis, Sclerosing
Status: Completed
Sponsor(s): National Center for Research Resources (NCRR) , Scripps Clinic
Synopsis: 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.
Details: PROTOCOL OUTLINE: Patients are treated with subcutaneous injections of cladribine (2-chlorodeoxyadenosine; 2-CdA) for 5 consecutive days every month for 3 months.
Eligibility:
Study Type:
  Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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
Total Enrollment: 5

Location and Contact Information:

Overall Study Official:
PaulPockros,  Study Chair,  Scripps Clinic


Additional Information:
Study ID Numbers:
  199/11707;  SCRF-94304
Study Start Date: December 1994
Record last reviewed: December 2001
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004762

Other Cholangitis, Sclerosing Studies:
1. Phase II Pilot Study of Cladribine (2-Chlorodeoxyadenosine; 2-CdA) for Early Stage Primary Sclerosing Cholangitis

2. Pilot Study of Budesonide for Patients with Primary Sclerosing Cholangitis

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

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