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| Descriptive Information Fields | |
| Brief Title † | Treatment of Wegener's Granulomatosis With Cyclophosphamide |
| Official Title † | Treatment of Wegener's Granulomatosis With Cyclophosphamide |
| Brief Summary | 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. |
| Detailed Description | 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 |
| Study Phase | Phase II |
| Study Type † | Interventional |
| Study Design † | Treatment, Safety/Efficacy Study |
| Primary Outcome Measure † | |
| Secondary Outcome Measure † | |
| Condition † | Vasculitis Wegener's Granulomatosis |
| Intervention † | Drug: cyclophosphamide |
| MEDLINE PMIDs | 8602705, 1739240 |
| Links | |
| Recruitment Information Fields | |
| Recruitment Status † | Completed |
| Enrollment † | 200 |
| Start Date † | February 1976 |
| Completion Date | February 2002 |
| Eligibility Criteria † | 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. |
| Gender | Both |
| Ages | |
| Accepts Healthy Volunteers | No |
| Contacts †† | |
| Location Countries † | United States |
| Administrative Information Fields | |
| NCT ID † | NCT00001155 |
| Organization ID | 760042 |
| Secondary IDs †† | 76-I-0042 |
| Study Sponsor † | National Institute of Allergy and Infectious Diseases (NIAID) |
| Collaborators †† | |
| Investigators † | |
| Information Provided By | National Institutes of Health Clinical Center (CC) |
| Verification Date | February 2002 |
| First Received Date † | November 3, 1999 |
| Last Updated Date | March 3, 2008 |