Status:
WITHDRAWN
A MultiCenter Study of Combined PEX, Rituximab, and Steroids in Acute Idiopathic Pulmonary Fibrosis Exacerbations
Lead Sponsor:
University of Pittsburgh
Conditions:
Idiopathic Pulmonary Fibrosis
Eligibility:
All Genders
18-90 years
Phase:
PHASE2
Brief Summary
This is a randomized, multi-center, open-label Phase II clinical trial to determine the efficacy of combined plasma exchange (PEX), rituximab, and conventional corticosteroid administration, in compar...
Detailed Description
This is a randomized, multi-center, open-label Phase II clinical trial to determine the efficacy of combined plasma exchange (PEX), rituximab, and conventional corticosteroid administration, in compar...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- A diagnosis of idiopathic pulmonary fibrosis that fulfills American Thoracic Society Consensus Criteria.1
- Unexplained worsening or development of dyspnea or hypoxemia within the preceding 30 days.
- Radiographic imaging showing ground-glass abnormality and/or consolidation superimposed on a reticular or honeycomb pattern consistent with UIP.
- EXCLUSION CRITERIA
- Diagnosis of documented infection, thromboembolic disease, an additional etiology for acute lung injury/adult respiratory distress syndrome, congestive heart failure.
- 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.
- Hemodynamic instability.
- History of reaction to blood products, murine-derived products, or prior exposures to human-murine chimeric antibodies,
- History of malignancy.
- Unwillingness to accept a blood transfusion.
- Unwillingness to agree to full supportive medical care (e.g., intubation) for up to 2 weeks after enrollment.
- Inability or unwillingness to complete post-treatment surveillance for 60 days.
- Diagnosis of major comorbidities expected to interfere with subjects study participation for 28 days.
- Treatment for \>5 days within the preceding month with \>20 mg prednisone (or equivalent dose corticosteroid) or any treatment during the preceding month with a potent cellular immunosuppressant (e.g., cyclophosphamide, methotrexate, mycophenolate, azathiaprine, calcineurin inhibitors, etc.) unless the patient has a BAL negative for opportunistic pathogens (e.g, Pneumocystis, viruses, intracellular organisms, mycobacteria, etc.).
- Current treatment with an angiotensin converting enzyme inhibitor that cannot be discontinued and/or substituted with another antihypertensive agent (to minimize potential hemodynamic complications during PEX).
Exclusion
Key Trial Info
Start Date :
September 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2016
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01524068
Start Date
September 1 2012
End Date
June 1 2016
Last Update
January 5 2016
Active Locations (5)
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1
Geisinger Medical Center
Danville, Pennsylvania, United States, 17822
2
Temple University Medical Center
Philladelphia, Pennsylvania, United States, 19140
3
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
4
University of Texas Medical Branch - Galveston
Galveston, Texas, United States, 77555