Status:
UNKNOWN
Pirfenidone for Progressive Fibrotic Sarcoidosis
Lead Sponsor:
University of Cincinnati
Collaborating Sponsors:
Royal Brompton & Harefield NHS Foundation Trust
Conditions:
Sarcoidosis, Pulmonary
Eligibility:
All Genders
18-90 years
Phase:
PHASE4
Brief Summary
Study comparing pirfenidone versus placebo for patients with advanced fibrotic sarcoidosis
Detailed Description
Patients who meet the inclusion and exclusion criteria will be randomized to be treated with either placebo or pirfenidone at the current approved dosage for idiopathic pulmonary fibrosis at a 2:1 pir...
Eligibility Criteria
Inclusion
- Diagnosis of sarcoidosis
- Pulmonary function testing with a Composite Physiologic Index (CPI) score of greater than 40
- Patient must have evidence of \>20% fibrosis on high resolution cat scan
- Patients must be on a stable prednisone therapy for sarcoidosis for at least two months and no change in other immunosuppressives in the two months prior to entry into study
- Age greater than 18 and less than 90.
- Able to provide written informed consent for participation in the study
Exclusion
- Patients receiving therapy for precapillary pulmonary hypertension.
- Patients with liver disease Childs class 3 or 4
- Patients with a left ventricular ejection fraction of less than 40%
- Patients receiving more than 20 mg prednisone daily or its equivalent
- Patients with massive hemoptysis within prior three months. Patients with mycetomas are eligible as long as no massive hemoptysis in prior three months.
- Patients with clinically important co-existing disease which in the opinion of the investigator is likely to affect patient's chance for survival during the course of the study
- Patient who is pregnant, lactating, intending to become pregnant during the study, or child bearing capacity who is not willing to use appropriate birth control methods approved by investigator
Key Trial Info
Start Date :
September 27 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 30 2020
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT03260556
Start Date
September 27 2017
End Date
March 30 2020
Last Update
September 28 2017
Active Locations (1)
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1
University of Cincinnati
Cincinnati, Ohio, United States, 45267