Back to resultsTreatment of Wegener's Granulomatosis With Cyclophosphamide
Primary Purpose
Vasculitis, Wegener's Granulomatosis
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
cyclophosphamide
Sponsored by
About this trial
This is an interventional treatment trial for Vasculitis focused on measuring Vasculitis, Prednisone, Granuloma, Wegener's Granulomatosis, Cyclophosphamide, Renal Biopsy
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.
Sites / Locations
- National Institute of Allergy and Infectious Diseases (NIAID)
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00001155
First Posted
November 3, 1999
Last Updated
March 3, 2008
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
1. Study Identification
Unique Protocol Identification Number
NCT00001155
Brief Title
Treatment of Wegener's Granulomatosis With Cyclophosphamide
Official Title
Treatment of Wegener's Granulomatosis With Cyclophosphamide
Study Type
Interventional
2. Study Status
Record Verification Date
February 2002
Overall Recruitment Status
Completed
Study Start Date
February 1976 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2002 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
4. Oversight
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vasculitis, Wegener's Granulomatosis
Keywords
Vasculitis, Prednisone, Granuloma, Wegener's Granulomatosis, Cyclophosphamide, Renal Biopsy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Enrollment
200 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
cyclophosphamide
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
National Institute of Allergy and Infectious Diseases (NIAID)
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
8602705
Citation
Talar-Williams C, Hijazi YM, Walther MM, Linehan WM, Hallahan CW, Lubensky I, Kerr GS, Hoffman GS, Fauci AS, Sneller MC. Cyclophosphamide-induced cystitis and bladder cancer in patients with Wegener granulomatosis. Ann Intern Med. 1996 Mar 1;124(5):477-84. doi: 10.7326/0003-4819-124-5-199603010-00003.
Results Reference
background
PubMed Identifier
1739240
Citation
Hoffman GS, Kerr GS, Leavitt RY, Hallahan CW, Lebovics RS, Travis WD, Rottem M, Fauci AS. Wegener granulomatosis: an analysis of 158 patients. Ann Intern Med. 1992 Mar 15;116(6):488-98. doi: 10.7326/0003-4819-116-6-488.
Results Reference
background
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Treatment of Wegener's Granulomatosis With Cyclophosphamide
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