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Treatment of Wegener's Granulomatosis With Cyclophosphamide

This study has been completed.

Sponsored by: 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

MedlinePlus related topics:   Vasculitis    Wegener's Granulomatosis   

ChemIDplus related topics:   Cyclophosphamide    Prednisone   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Safety/Efficacy Study
Official Title:   Treatment of Wegener's Granulomatosis With Cyclophosphamide

Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment:   200
Study Start Date:   February 1976
Estimated Study Completion Date:   February 2002

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

  Eligibility
Genders Eligible for Study:   Both
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.

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00001155

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

Sponsors and Collaborators
  More Information

Publications:

Study ID Numbers:   760042, 76-I-0042
First Received:   November 3, 1999
Last Updated:   March 3, 2008
ClinicalTrials.gov Identifier:   NCT00001155
Health Authority:   United States: Federal Government

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

Study placed in the following topic categories:
Prednisone
Lung Diseases, Interstitial
Vasculitis
Urologic Diseases
Respiratory Tract Diseases
Wegener Granulomatosis
Lung Diseases
Wegener's granulomatosis
Vascular Diseases
Cyclophosphamide
Kidney Diseases
Granuloma

Additional relevant MeSH terms:
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Therapeutic Uses
Physiological Effects of Drugs
Myeloablative Agonists
Cardiovascular Diseases
Antineoplastic Agents, Alkylating
Antirheumatic Agents
Alkylating Agents
Immunosuppressive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 05, 2008




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