Status:
COMPLETED
Autoantibody Reduction for Acute Exacerbations of Idiopathic Pulmonary Fibrosis
Lead Sponsor:
University of Alabama at Birmingham
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Brigham and Women's Hospital
Conditions:
Idiopathic Pulmonary Fibrosis, Acute Fatal Form
Eligibility:
All Genders
40-85 years
Phase:
PHASE2
Brief Summary
Acute exacerbations (AE) are a dreaded manifestation of idiopathic pulmonary fibrosis (IPF) that presents with rapidly worsening respiratory function over days to weeks. AE account for about 1/2 the d...
Detailed Description
The primary goal of clinical trial is to determine effects of combined therapeutic plasma exchange (TPE), rituximab, and intravenous immunoglobulin (IVIG) in comparison to effects of treatment as usua...
Eligibility Criteria
Inclusion
- Age between 40-85 years old.
- A diagnosis of IPF that fulfills ATS/ERS Consensus Criteria.1
- Worsening or new development of dyspnea or hypoxemia within the last 30 days.
- Ground-glass abnormality and/or consolidation superimposed on a reticular or honeycomb usual interstitial pneumonitis (UIP) pattern on locally read chest CT scan.
- Ability and willingness to give informed consent (no surrogates) and adhere to study requirements.
Exclusion
- Diagnoses of current infection per clinical or microbial assessments.
- Diagnoses of an additional or alternative etiology for respiratory dysfunction based upon clinical assessment, including congestive heart failure, sepsis, thromboembolism, etc.
- History or serologic evidence of hepatitis B or C infection.
- Coagulopathy, defined as a International Normalized Ratio (INR) \>1.6, partial thromboplastin time (PTT) \> 2x control, fibrinogen \<100 mg/dL, or platelet count \<50 thousand (K) unless these abnormalities can be reversed safely.
- Hyperosmolar state or diabetic ketoacidosis to suggest uncontrolled diabetes, or uncontrolled hypertension (systolic BP \>160 mm Hg and diastolic BP \>100 mm Hg) that would contraindicate use of corticosteroids.
- Hemodynamic instability, defined as an inotrope or vasopressor requirement.
- History of reaction to blood products or murine-derived products or prior rituximab use.
- History of malignancy, excluding basal or squamous cell skin cancer and low-risk prostate cancer, the latter defined as stage T1 or T2a, with prostate specific antigen (PSA) less than 10 ng/dl. The experimental treatments are not known to promote cancer progression, and these criteria are within current guidelines.
- Unwillingness to accept blood product transfusion.
- Diagnosis of major comorbidities expected to interfere with study participation.
- Treatment for \>14 days within the preceding month with \>20 mg. prednisone (or equivalent) or any treatment during the last month with a cellular immuno-suppressant (e.g., cyclophosphamide, methotrexate, calcineurin inhibitors, mycophenolate, azathioprine, etc.). An exception will be made if the patient has a bronchoalveolar lavage (BAL) negative for pathogens.
- Current treatment with an angiotensin converting enzyme inhibitor that cannot be discontinued and/or substituted (to obviate hemodynamic complications during TPE).
- Concurrent participation in other experimental trials.
- Fertile females who do not agree to contraception or abstinence, or have a positive pregnancy test (urine or blood). IPF is a disease of older adults, and male predominant, so this will not be a frequent consideration.
- Presence of positive (abnormal) classical autoimmune tests: anti-nuclear antibody (ANA), rheumatoid factor (RF), Anti- Sjögren's-syndrome-related antigen (SSA) , and Anti-Cyclic Citrullinated Peptide (CCP). This criterion will eliminate patients with confounding classical autoimmune syndromes. Many IPF patients will have already had these tests, which are standard of practice (SOP) at many IPF centers, and these prior results will suffice if the tests were performed within the last year. Otherwise, these tests need to be performed prior to enrollment and they can usually be procured in 1-2 days. Based on experience, we anticipate \~10% of patients who fulfill all other IPF criteria will nonetheless be positive for one of these classical autoantibody tests.
- IgA deficiency (IgA level \<7 mg/dL)- to preclude IVIG reactions.
Key Trial Info
Start Date :
September 4 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2024
Estimated Enrollment :
51 Patients enrolled
Trial Details
Trial ID
NCT03286556
Start Date
September 4 2018
End Date
August 1 2024
Last Update
August 28 2024
Active Locations (7)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
2
Dan Dilling
Chicago, Illinois, United States, 60611
3
Thomas Jefferson University Medical Center
Philadelphia, Pennsylvania, United States, 19107
4
Temple University Hospital
Philadelphia, Pennsylvania, United States, 19140