- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00552461
Prospective Trial of Rituximab for Primary Pulmonary Alveolar Proteinosis (PAP)
September 26, 2023 updated by: Malur, Anagha, East Carolina University
Prospective Open-Label Trial of Rituximab for Primary Pulmonary Alveolar Proteinosis
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
10
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Irene Marshall, PA-C
- Phone Number: 252-744-5888
- Email: marshalli@ecu.edu
Study Locations
-
-
North Carolina
-
Greenville, North Carolina, United States, 27834
- East Carolina University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Diagnosis of primary PAP (new or chronic) with presence of anti-GM-CSF antibody
- Moderately symptomatic disease with PaO2 <70 on room air and on less than 6 L/min oxygen
- Able to give written informed consent and comply with the requirements of the study
- Adequate renal and liver function
- Negative serum pregnancy test (for women of child bearing age) and on acceptable birth control during and after study completion
Exclusion Criteria:
- Severe PAP and requires in-patient care and more urgent therapy with bilateral whole lung lavage
- Treatment with any investigational agent within 4 weeks of screening
- History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies
- History of HIV, recurrent significant infection or recurrent bacterial infections
- Known active bacterial, viral, fungal, mycobacterial, or other infection
- Ongoing use of high dose steroids (>10mg/day) or unstable steroid dose
- Significant cardiac or pulmonary disease or blood disorder
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
|
IV, 1000 mg, two weeks, 2 times
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Evaluate symptomatic, physiologic and radiographic effects of therapy
Time Frame: 6-months
|
6-months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Evaluate the overall tolerability of therapy and the requirement for therapeutic whole-lung lavage
Time Frame: 6-months
|
6-months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Mani S Kavuru, MD, East Carolina University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2007
Primary Completion (Actual)
July 1, 2009
Study Completion (Actual)
December 1, 2011
Study Registration Dates
First Submitted
October 31, 2007
First Submitted That Met QC Criteria
October 31, 2007
First Posted (Estimated)
November 2, 2007
Study Record Updates
Last Update Posted (Actual)
September 28, 2023
Last Update Submitted That Met QC Criteria
September 26, 2023
Last Verified
September 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- U2990s
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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-
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