Completed

Treatment of Wegener's Granulomatosis With Cyclophosphamide

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What is being tested

cyclophosphamide

Drug
Who is being recruted

Autoimmune Diseases+17

+ Cardiovascular Diseases

+ Hemic and Lymphatic Diseases

See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: February 1976
See protocol details

Summary

Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last updated: March 4, 2008
Sourced from a government-validated database.Claim as a partner

Study start date: February 1, 1976

Actual date on which the first participant was enrolled.

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

NCT00001155
Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last updated: March 4, 2008
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

200 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Autoimmune DiseasesCardiovascular DiseasesHemic and Lymphatic DiseasesImmune System DiseasesLung DiseasesLymphatic DiseasesLymphoproliferative DisordersPathologic ProcessesRespiratory Tract DiseasesSkin DiseasesPathological Conditions, Signs and SymptomsVascular DiseasesSkin and Connective Tissue DiseasesSkin Diseases, VascularLung Diseases, InterstitialSystemic VasculitisAnti-Neutrophil Cytoplasmic Antibody-Associated VasculitisGranulomaVasculitisGranulomatosis with Polyangiitis

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.

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

National Institute of Allergy and Infectious Diseases (NIAID)

Bethesda, United StatesOpen National Institute of Allergy and Infectious Diseases (NIAID) in Google Maps
CompletedOne Study Center