Overview

Clinical Progression of Mild to Moderate Idiopathic Pulmonary Fibrosis (IPF) Under a Therapy With EsbrietĀ® (Pirfenidone)

Status:
Completed
Trial end date:
2016-12-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of the study was to assess the clinical outcome of patients with a mild to moderate IPF after a one-year therapy with EsbrietĀ® (Pirfenidone).
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Hoffmann-La Roche
Collaborator:
InterMune Deutschland GmbH
Treatments:
Pirfenidone
Criteria
Inclusion Criteria:

Adult patients with confident diagnosis of mild to moderate IPF, who had previously not yet
been treated with Pirfenidone

Exclusion Criteria:

Hypersensitivity to the active substance or one of the other excipients of Pirfenidone
Concomitant use of Fluvoxamin Severe hepatic impairment or end stage liver disease Severe
renal impairment (Creatinine-Clearance <30 ml/min) or end stage renal disease requiring
dialysis Simultaneous participation in interventional studies Previously treated with
Pirfenidone for longer than 30 days