Pulmonary fibrosis (idiopathic) 

Combined PEX, Rituximab and Steroids in Acute IPF Exacerbations

Recruitment status:
Not recruiting
Primary Sponsor:
University of Pittsburgh
Recruitment countries:
United States
Health condition studied:
IPF
URL:
Link to the clinical trial website

About the trial

Interventions:
Drug: Combined Plasma Exchange (PEX), Rituximab, and Corticosteroids
Key inclusion and exclusion criteria:

  • Inclusion Criteria:

    - A diagnosis of idiopathic pulmonary fibrosis that fulfills American Thoracic Society
    Consensus Criteria.

    - Unexplained worsening or development of dyspnea or hypoxemia within 30 days leading
    to the current hospitalization.

    - Radiographic imaging showing ground-glass abnormality and/or consolidation
    superimposed on a background of reticular or honeycomb pattern consistent with UIP.

    - Intent on the part of the treating physician to use high dose steroid therapy as a
    therapeutic effort to treat a diagnosis of acute IPF exacerbation.

    Exclusion Criteria:

    - Diagnosis of documented infection based upon clinical evaluation and microbial
    testing.

    - Diagnosis of thromboembolic disease by clinical assessment.

    - Diagnosis of an additional etiology for ALI/ARDS based upon clinical assessment to
    include sepsis, aspiration, trauma, inhalational injury, acute pancreatitis, drug
    toxicity, blood product transfusion reaction, or stem cell transplantation.

    - Diagnosis of congestive heart failure that accounts for the hypoxemia.

    - Presence of active hepatitis B infection.

    - Coagulopathy defined as an INR > 1.8, PTT > 2 x control, and platelet count < 50K.

    - Hyperosmolar state or diabetic ketoacidosis to suggest uncontrolled diabetes mellitus
    or uncontrolled hypertension (systolic BP > 160 mm Hg and diastolic BP > 100 mm Hg)
    which would contraindicated the use of corticosteroids.

    - Hemodynamic instability defined as a vasopressor requirement which would
    contraindicate the use of plasmapheresis.

    - History of reaction to blood products, murine-derived products, or prior exposures to
    human-murine chimeric antibodies,

    - History of malignancy.

    - Inability or unwillingness to accept a blood transfusion.

    - Inability or unwillingness to complete post- treatment surveillance for 60 days.

    - Diagnosis of major comorbidities expected to interfere with subjects study
    participation for 60 days.
  • Age minimum:  18 Years
  • Age maximum:  80 Years
  • Gender:  Both
Primary outcomes:
Feasibility and safety of the regimen in patients with IPF exacerbations
Secondary outcomes:
Survival to 60 days or survival to transplantation
Target sample size:
10
Study type:
Interventional
Study design:
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Contacts:
  • Name:   Michael Donahoe, MD
  • Address: 
  • Phone: 
  • Email: 
  • Affiliation:  University of Pittsburgh

Technical details

Scientific title:
Open-Label, Feasibility Study of Combined Plasma Exchange (PEX), Rituximab, and Corticosteroids in Patients With Acute Idiopathic Pulmonary Fibrosis Exacerbations
Sources of monetary support:
Please refer to primary and secondary sponsors
Secondary sponsors:
Main ID:
NCT01266317
Secondary ID:
Register:
ClinicalTrials.gov
Date of registration:
22/12/2010
Date of first enrollment:
March 2011
Last refreshed:
3 February 2014

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