Post Marketing Surveillance of PIRESPA® TAB 200mg (Pirfenidone) for Evaluating the Safety and Efficacy

Launched by ILDONG PHARMACEUTICAL CO LTD · Nov 29, 2018

Keywords

ClinConnect Summary

Pirfenidone (Pirespa®) is an anti fibrotic drug, which was approved in 2012 in the Republic of Korea for the treatment of patients with idiopathic pulmonary fibrosis (IPF). A post-marketing survey was conducted following the approval to obtain data on the safety and efficacy of pirfenidone for IPF treatment in real-world practice.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Among patients diagnosed as idiopathic pulmonary fibrosis, only those who have used the testing drug under the general medical conditions for a certain investigation period after the beginning of the investigation and also signed a the "Personal Information Utilization Agreement" form. However, for those who have already received the drug before the beginning of the investigation, only the subjects whose medical record can be used are included.
• Exclusion Criteria:
• • 1. Subjects who is hypersensitive to the active ingredient or additives of this drug
• • 2. Subjects who have severe hepatopathy
• • 3. Subjects who have severe renal disorder (creatinine clearance\<30mL/min) or a terminal renal disease treated by dialysis
• • 4. Subjects who received a combined treatment of fluvoxamine
• • 5. Subjects who have genetic problems, such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption