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Treatment of Wegener's Granulomatosis With Cyclophosphamide

This study has been completed.
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00001155
First received: November 3, 1999
Last updated: March 3, 2008
Last verified: February 2002
  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 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Primary Purpose: Treatment
Official Title: Treatment of Wegener's Granulomatosis With Cyclophosphamide

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
ClinicalTrials.gov Identifier: NCT00001155     History of Changes
Other Study ID Numbers: 760042, 76-I-0042
Study First Received: November 3, 1999
Last Updated: March 3, 2008
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

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

ClinicalTrials.gov processed this record on November 24, 2014