NCT00552461

Prospective Trial of Rituximab for Primary Pulmonary Alveolar Proteinosis

Prospective Open-Label Trial of Rituximab for Primary Pulmonary Alveolar Proteinosis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: East Carolina University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Pulmonary Alveolar Proteinosis
• Primary Disease

Interventions

Type	Name	Description
DRUG	rituximab	IV, 1000 mg, two weeks, 2 times

Timeline

• Start date: 2007-01-01
• Primary completion: 2009-07-01
• Completion: 2011-12-01
• First posted: 2007-11-02
• Last updated: 2023-09-28

Locations

1 site across 1 country: United States