Phase 2
N=9
Combined PEX, Rituximab and Steroids in Acute Idiopathic Pulmonary Fibrosis Exacerbations
IPF
Bottom Line
View on ClinicalTrials.gov: NCT01266317 ↗Enrolled (actual)
9
Serious AEs
10.0%
Results posted
Jan 2018
Primary outcome: Primary: Number of Participants With Respiratory and/or Hemodynamic Deteriorations — 1; 3 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Combined Plasma Exchange (PEX), Rituximab, and Corticosteroids (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Michael Donahoe
- Primary completion
- Jul 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Respiratory and/or Hemodynamic Deteriorations |
1; 3 | — |
| SECONDARY Number of Participants Survived to 60 Days or to Transplantation |
3 | — |
Summary
This is an open-label Phase I/II trial to assess the feasibility and safety of combined plasma exchange (PEX), rituximab, and conventional corticosteroid administration on the outcome of hospitalized patients with acute IPF exacerbations. The specific aims of this study are:
1. To assess the feasibility and safety of combined PEX, rituximab, and conventional corticosteroid administrations for the treatment of hospitalized patients with acute IPF exacerbations by monitoring indices of respiratory (PaO2) and cardiovascular function during the treatment interval.
2. To assess the efficacy of combined PEX, rituximab, and conventional corticosteroid administrations for the treatment of hospitalized patients with acute IPF exacerbations on patient survival in comparison to historical controls. Patient survival for this investigation will be defined using the composite outcome of 60 day survival and/or survival to lung transplantation.
Subjects between 18 and 80 years of age who have a confirmed diagnosis of IPF, and meet all the study requirements will be enrolled in this study. A total of 10 subjects of both genders and all ethnic backgrounds with acute IPF exacerbations hospitalized at University of Pittsburgh Medical Center will be enrolled in this study.
Eligibility 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 usual interstitial pneumonia.
- 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 Acute Lung Injury/Acute Respiratory Distress Syndrome 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 International Normalized Ratio > 1.8, Partial Thromboplastin Time > 2 x control, and platelet count 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.
Data sourced from ClinicalTrials.gov (NCT01266317). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.