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| Sponsor: | National Institute of Allergy and Infectious Diseases (NIAID) |
|---|---|
| Information provided by: | National Institutes of Health Clinical Center (CC) |
| ClinicalTrials.gov Identifier: | NCT00001155 |
Purpose
The purpose of this protocol is to continue to treat patients with Wegener's granulomatosis who have already entered the study, and to treat new patients. The investigators will attempt to correlate the clinical response with specific immunosuppressive effects of drug administration. The investigators are accumulating data on the optimal duration and side effects of therapy.
| Condition | Intervention | Phase |
|---|---|---|
|
Vasculitis Wegener's Granulomatosis |
Drug: cyclophosphamide |
Phase II |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Primary Purpose: Treatment |
| Official Title: | Treatment of Wegener's Granulomatosis With Cyclophosphamide |
| Estimated Enrollment: | 200 |
| Study Start Date: | February 1976 |
| Estimated Study Completion Date: | February 2002 |
The purpose of the protocol is to continue to treat patients with Wegener's granulomatosis who have already entered the study, and to treat new patients. The investigators will attempt to correlate the clinical response with specific immunosuppressive effects of drug administration. The investigators are accumulating data on the optimal duration and side effects of therapy.
Age Range: greater than 1 year
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Patients greater than 1 year of age with the clinical and pathological diagnosis of WG whose illness presents a risk of permanent disability or death. Examples of processes that impart risk of permanent disability or death include: peripheral and central nervous system disease, cardiac involvement, glomerulonephritis, and vascular comprise of gastrointestinal organs.
No women who are pregnant or intend to become pregnant.
No patients who have known malignancies.
Patients must be HIV negative.
Contacts and Locations More Information
| ClinicalTrials.gov Identifier: | NCT00001155 History of Changes |
| Other Study ID Numbers: | 760042, 76-I-0042 |
| Study First Received: | November 3, 1999 |
| Last Updated: | March 3, 2008 |
| Health Authority: | United States: Federal Government |
|
Vasculitis Prednisone Granuloma |
Wegener's Granulomatosis Cyclophosphamide Renal Biopsy |
|
Vasculitis Wegener Granulomatosis Vascular Diseases Cardiovascular Diseases Lung Diseases, Interstitial Lung Diseases Respiratory Tract Diseases Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis Systemic Vasculitis Cyclophosphamide Immunosuppressive Agents |
Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antirheumatic Agents Therapeutic Uses Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Myeloablative Agonists |
