Pirfenidone for Progressive Fibrotic Sarcoidosis
Status unconfirmed · Phase 4 · Has a placebo group
Conditions studied: Sarcoidosis, Pulmonary
In brief
Study comparing pirfenidone versus placebo for patients with advanced fibrotic sarcoidosis
Key facts
- Study ID
- NCT03260556
- Run by
- University of Cincinnati
- People needed
- 60
- Starts
- 2017-09-27
- Expected to finish
- 2020-03-30
- Last updated by the study team
- 2017-09-28
Who can join
Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- University of Cincinnati — Cincinnati, Ohio, United States (enrolling)
Full record on ClinicalTrials.gov
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