Autoantibody Reduction for Acute Exacerbations of Idiopathic Pulmonary Fibrosis

• Register: ClinicalTrials.gov
• Last refreshed on: 21 August 2023
• Main ID: NCT03286556
• Date of registration: 12/09/2017
• Prospective Registration: Yes
• Primary sponsor: University of Alabama at Birmingham
• Public title: Autoantibody Reduction for Acute Exacerbations of Idiopathic Pulmonary Fibrosis STRIVE-IPF
• Scientific title: Study of Therapeutic Plasma Exchange, Rituximab and Intravenous Immunoglobulin for Acute Exacerbations of Idiopathic Pulmonary Fibrosis (STRIVE-IPF)
• Date of first enrolment: September 4, 2018
• Target sample size: 51
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/ct2/show/NCT03286556
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

United States

Contacts

• Name: Steven R Duncan, MD

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Age between 40-85 years old.

2. A diagnosis of IPF that fulfills ATS/ERS Consensus Criteria.1

3. Worsening or new development of dyspnea or hypoxemia within the last 30 days.

4. Ground-glass abnormality and/or consolidation superimposed on a reticular or honeycomb
usual interstitial pneumonitis (UIP) pattern on locally read chest CT scan.

5. Ability and willingness to give informed consent (no surrogates) and adhere to study
requirements.

Exclusion Criteria:

1. Diagnoses of current infection per clinical or microbial assessments.

2. Diagnoses of an additional or alternative etiology for respiratory dysfunction based
upon clinical assessment, including congestive heart failure, sepsis, thromboembolism,
etc.

3. History or serologic evidence of hepatitis B or C infection.

4. 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.

5. 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.

6. Hemodynamic instability, defined as an inotrope or vasopressor requirement.

7. History of reaction to blood products or murine-derived products or prior rituximab
use.

8. 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.

9. Unwillingness to accept blood product transfusion.

10. Diagnosis of major comorbidities expected to interfere with study participation.

11. 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.

12. Current treatment with an angiotensin converting enzyme inhibitor that cannot be
discontinued and/or substituted (to obviate hemodynamic complications during TPE).

13. Concurrent participation in other experimental trials.

14. 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.

15. 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.

16. IgA deficiency (IgA level <7 mg/dL)- to preclude IVIG reactions.



Age minimum: 40 Years
Age maximum: 85 Years
Gender: All

Health Condition(s) or Problem(s) studied

Idiopathic Pulmonary Fibrosis, Acute Fatal Form

Intervention(s)

Drug: Autoantibody Reductive Therapy

Drug: Treatment as Usual (TAU)

Primary Outcome(s)

Survival [Time Frame: 6 months]

Secondary Outcome(s)

Walk distance [Time Frame: 6 months]

Adverse Events [Time Frame: Through study completion, an average of 1 year]

Oxygen requirements [Time Frame: 6 months]

Secondary ID(s)

F170530011

1U01HL133232-01A1

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

National Heart, Lung, and Blood Institute (NHLBI)

Brigham and Women's Hospital

Temple University

University of Pittsburgh