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CompletedNCT00001155Updated Mar 4, 2008

Treatment of Wegener's Granulomatosis With Cyclophosphamide

A Phase 2 interventional study of cyclophosphamide in Vasculitis and Wegener's Granulomatosis, sponsored by National Institute of Allergy and Infectious Diseases (NIAID). Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2008-03-04.

Sponsored by National Institute of Allergy and Infectious Diseases (NIAID) · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
200
Sex
All
01

Study 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.

Read the 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

02

Conditions studied

  • Vasculitis
  • Wegener's Granulomatosis

Keywords

  • Vasculitis
  • Prednisone
  • Granuloma
  • Wegener's Granulomatosis
  • Cyclophosphamide
  • Renal Biopsy
03

In context

Granulomatosis with Polyangiitis

104 studies on the registry are indexed under Granulomatosis with Polyangiitis; 19 are open to participants now.

This study's enrollment of 200 is above the median of 70 across 67 interventional studies indexed under Granulomatosis with Polyangiitis.

Browse Granulomatosis with Polyangiitis studies →

Lead sponsor

National Institute of Allergy and Infectious Diseases (NIAID) is the lead sponsor of 2,401 studies on the registry; 179 are open to participants now.

Of its 396 completed or terminated interventional studies of FDA-regulated products, 294 (74%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
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.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Enrollment
200 participants

Interventions

  • Drugcyclophosphamide
06

Study locations

1 site
  • National Institute of Allergy and Infectious Diseases (NIAID)
    Bethesda, Maryland 20892, United States
07

References and documents

Publications

  • 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. PubMed 8602705 ↗
  • 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. PubMed 1739240 ↗
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 4, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00001155
Lead sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
First posted
Nov 4, 1999
Start date
Feb 1976
Completion
Feb 2002
Last update
Mar 4, 2008
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2002. You cannot join it, but the record below documents what was studied.

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