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Treatment of Wegener's Granulomatosis With Cyclophosphamide

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ClinicalTrials.gov Identifier: NCT00001155
Recruitment Status : Completed
First Posted : November 4, 1999
Last Update Posted : March 4, 2008
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)

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.

Condition or disease Intervention/treatment Phase
Vasculitis Wegener's Granulomatosis Drug: cyclophosphamide Phase 2

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 Type : Interventional  (Clinical Trial)
Enrollment : 200 participants
Primary Purpose: Treatment
Official Title: Treatment of Wegener's Granulomatosis With Cyclophosphamide
Study Start Date : February 1976
Study Completion Date : February 2002






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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00001155


Locations
United States, Maryland
National Institute of Allergy and Infectious Diseases (NIAID)
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)

Publications:
ClinicalTrials.gov Identifier: NCT00001155     History of Changes
Other Study ID Numbers: 760042
76-I-0042
First Posted: November 4, 1999    Key Record Dates
Last Update Posted: March 4, 2008
Last Verified: February 2002

Keywords provided by National Institutes of Health Clinical Center (CC):
Vasculitis
Prednisone
Granuloma
Wegener's Granulomatosis
Cyclophosphamide
Renal Biopsy

Additional relevant MeSH terms:
Vasculitis
Granulomatosis with Polyangiitis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases, Interstitial
Lung Diseases
Respiratory Tract Diseases
Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
Systemic Vasculitis
Autoimmune Diseases
Immune System Diseases
Cyclophosphamide
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists