NCT00552461

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jan 2007

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

October 31, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 2, 2007

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
2.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

September 28, 2023

Status Verified

September 1, 2023

Enrollment Period

2.5 years

First QC Date

October 31, 2007

Last Update Submit

September 26, 2023

Conditions

Pulmonary Alveolar ProteinosisPrimary Disease

Keywords

Pulmonary alveolar proteinosisPrimary Pulmonary alveolar proteinosisRituximabIdiopathicSymptomaticGM-CSF Antibody

Outcome Measures

Primary Outcomes (1)

  • Evaluate symptomatic, physiologic and radiographic effects of therapy

    6-months

Secondary Outcomes (1)

  • Evaluate the overall tolerability of therapy and the requirement for therapeutic whole-lung lavage

    6-months

Study Arms (1)

1

EXPERIMENTAL
Drug: rituximab

Interventions

rituximabDRUG

IV, 1000 mg, two weeks, 2 times

Also known as: Rituxan, MabThera
1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

East Carolina University

Greenville, North Carolina, 27834, United States

Location

Related Publications (1)

  • Kavuru MS, Malur A, Marshall I, Barna BP, Meziane M, Huizar I, Dalrymple H, Karnekar R, Thomassen MJ. An open-label trial of rituximab therapy in pulmonary alveolar proteinosis. Eur Respir J. 2011 Dec;38(6):1361-7. doi: 10.1183/09031936.00197710. Epub 2011 Apr 8.

    PMID: 21478218DERIVED

Related Links

MeSH Terms

Conditions

Pulmonary Alveolar Proteinosis

Interventions

Rituximab

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-DerivedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Mani S Kavuru, MD

    East Carolina University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Director, Division of Pulmonary, Critical Care and Sleep Medicine

Study Record Dates

First Submitted

October 31, 2007

First Posted

November 2, 2007

Study Start

January 1, 2007

Primary Completion

July 1, 2009

Study Completion

December 1, 2011

Last Updated

September 28, 2023

Record last verified: 2023-09

Locations

US(1)