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Sponsors and Collaborators: |
East Carolina University Genentech |
Information provided by: | East Carolina University |
ClinicalTrials.gov Identifier: | NCT00552461 |
The purpose of this study is to determine whether the use of rituximab is effective in treating pulmonary alveolar proteinosis by leading to an improvement in lung function and disease status.
Condition | Intervention | Phase |
Pulmonary Alveolar Proteinosis Primary Disease |
Drug: rituximab |
Phase II |
ChemIDplus related topics: | Rituximab Sargramostim Granulocyte-macrophage colony-stimulating factor |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
Official Title: | Prospective Open-Label Trial of Rituximab for Primary Pulmonary Alveolar Proteinosis |
Estimated Enrollment: | 10 |
Study Start Date: | January 2007 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
1: Experimental |
Drug: rituximab
IV, 1000 mg, two weeks, 2 times
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The goal of this study is to conduct a prospective, open-label 6-month trial of rituximab in patients who present with symptomatic primary or idiopathic PAP. A total of 10 subjects with primary PAP will be enrolled over 12 months at East Carolina University. Patients over age 18 with a clinical diagnosis of moderate symptomatic idiopathic PAP, established by appropriate clinical history, radiographic and physiologic findings, presence of circulating anti-GM-CSF antibody, and confirmatory findings on bronchoscopy with bronchoalveolar lavage and/or open-lung biopsy will be recruited. Patients with newly diagnosed PAP or established disease may be considered for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Irene Marshall, PA-C | 252-744-5888 | marshalli@ecu.edu |
United States, North Carolina | |||||
East Carolina University | Recruiting | ||||
Greenville, North Carolina, United States, 27834 | |||||
Contact: Mani S Kavuru, MD 252-744-4653 kavurum@ecu.edu | |||||
Contact: Irene Marshall, PA-C 252-744-5888 marshalli@ecu.edu | |||||
Principal Investigator: Mani S Kavuru, MD |
East Carolina University |
Genentech |
Principal Investigator: | Mani S Kavuru, MD | East Carolina University |
East Carolina University Division of Pulmonary 
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Responsible Party: | East Carolina University ( Mani S. Kavuru, MD, Prinicipal Investigator, Professor and Division Chief Pulmonary & CCM ) |
Study ID Numbers: | U2990s |
First Received: | October 31, 2007 |
Last Updated: | May 6, 2008 |
ClinicalTrials.gov Identifier: | NCT00552461 |
Health Authority: | United States: Institutional Review Board |
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