Phase II Study of Methylprednisolone and Xylose Absorption in Children with Hypersensitivity Vasculitis Associated with Connective Tissue Disease

This study is currently recruiting patients.

Sponsored by

Children's Memorial Hospital, Chicago

Purpose

OBJECTIVES: I. Assess xylose absorption and blood levels of neopterin and von Willebrand factor antigen in children with active hypersensitivity vasculitis associated with connective tissue disease. II. Correlate the bioavailability and kinetic rate constant of absorption of oral methylprednisolone with that of xylose. III. Compare the bioavailability and kinetic rate constant of absorption of oral methylprednisolone during active and quiescent disease in the same child.

Study Type: Treatment

Official Title: Phase II Study of Methylprednisolone and Xylose Absorption in Children with Hypersensitivity Vasculitis Associated with Connective Tissue Disease

Further Study Details: PROTOCOL OUTLINE: Following a 12-hour fast, patients receive oral xylose and 2 hours later, oral methylprednisolone. The following day, patients receive intravenous methylprednisolone. Pharmacokinetic studies are performed each day. Patients are re-treated when disease becomes inactive (6-12 months later).  PROJECTED ACCRUAL: 24 patients will be entered over 2 years.  

Eligibility

Ages Eligible for Study:  4 Years    -   18 Years Criteria

PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Hypersensitivity vasculitis associated with connective tissue disease Proven by serology or skin, muscle, or kidney biopsy No severe renal involvement --Prior/Concurrent Therapy-- Not specified --Patient Characteristics-- Age: Over 4 Performance status: Not specified Hematopoietic: Hemoglobin at least 9 g/dL Hepatic: Not specified Renal: See Disease Characteristics Other: No other disease No critically ill or unstable children

Location and Contact Information

Illinois

Children's Memorial Hospital, Chicago, Chicago,   Illinois,   60614,   United States; Recruiting

Lauren M. Pachman       312-880-4360   

Study chairs or principal investigators

Lauren M. Pachman,  Study Chair

Children's Memorial Hospital, Chicago    

More Information

Study ID Numbers  199/11924;   NU-465

NLM Identifier  NCT00004357

Date study started September 1, 1997

Last Updated  April 1, 2000

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