Pirfenidone for Progressive Fibrotic Sarcoidosis

• Status: Unknown status
• Trial end date: 2020-03-30
• Target enrollment: 0
• Participant gender: All

Summary

Study comparing pirfenidone versus placebo for patients with advanced fibrotic sarcoidosis

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Cincinnati
• Collaborator: Royal Brompton & Harefield NHS Foundation Trust
• Treatments: Pirfenidone

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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