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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 18 January 2016
Main ID:  NCT01524068
Date of registration: 27/01/2012
Prospective Registration: Yes
Primary sponsor: University of Pittsburgh
Public title: A MultiCenter Study of Combined PEX, Rituximab, and Steroids in Acute Idiopathic Pulmonary Fibrosis Exacerbations
Scientific title: A Multicenter, Open-Label, Phase II Study of Combined Plasma Exchange (PEX), Rituximab, and Corticosteroids in Patients With Acute Idiopathic Pulmonary Fibrosis Exacerbations
Date of first enrolment: September 2012
Target sample size: 0
Recruitment status: Withdrawn
URL:  https://clinicaltrials.gov/show/NCT01524068
Study type:  Interventional
Study design:  Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment  
Phase:  Phase 2
Countries of recruitment
United States
Contacts
Name:     Steven Duncan, MD
Address: 
Telephone:
Email:
Affiliation:  University of Pittsburgh
Key inclusion & exclusion criteria

INCLUSION CRITERIA:

1. A diagnosis of idiopathic pulmonary fibrosis that fulfills American Thoracic Society
Consensus Criteria.1

2. Unexplained worsening or development of dyspnea or hypoxemia within the preceding 30
days.

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

EXCLUSION CRITERIA

1. Diagnosis of documented infection, thromboembolic disease, an additional etiology for
acute lung injury/adult respiratory distress syndrome, congestive heart failure.

2. Presence of active hepatitis B infection.

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

4. Hyperosmolar state or diabetic ketoacidosis to suggest uncontrolled diabetes mellitus
or uncontrolled hypertension.

5. Hemodynamic instability.

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

7. History of malignancy.

8. Unwillingness to accept a blood transfusion.

9. Unwillingness to agree to full supportive medical care (e.g., intubation) for up to 2
weeks after enrollment.

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

11. Diagnosis of major comorbidities expected to interfere with subjects study
participation for 28 days.

12. 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.).

13. 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).



Age minimum: 18 Years
Age maximum: 90 Years
Gender: Both
Health Condition(s) or Problem(s) studied
Idiopathic Pulmonary Fibrosis
Intervention(s)
Drug: Standard Steroid Treatment
Drug: The Standard Steroid Treatment, Plasma Exchange and rituximab
Primary Outcome(s)
Reduction of autoantibody titers [Time Frame: Baseline to Day 28]
Secondary Outcome(s)
Adverse event (AE) rates [Time Frame: Baseline to Day 60]
B-cell counts [Time Frame: Baseline to Day 60]
IgG concentrations [Time Frame: Baseline to Day 60]
Secondary ID(s)
PRO12010444
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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