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

Roche

Status: Completed

Conditions: Idiopathic Pulmonary Fibrosis

Treatments: Drug: Pirfenidone

Study type: Observational

Funder types: Industry

Identifiers

NCT02622477

ML30016

Details and patient eligibility

About

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 Esbriet® (Pirfenidone).

Enrollment: 12 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

12 participants in 1 patient group

Participants with idiopathic pulmonary fibrosis

Description:

Participants with idiopathic pulmonary fibrosis receiving Pirfenidone will be observed for treatment responses.

Treatment:

Drug: Pirfenidone