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

Completed

• Conditions: Idiopathic Pulmonary Fibrosis

• Registration Number: NCT03761082
• Lead Sponsor: IlDong Pharmaceutical Co Ltd

Brief Summary

Post-marketing surveillance of Pirfenidone

Detailed Description

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.

Study Timeline

• Study Start: 2014-07
• Primary Completion: 2017-04
• Study Completion: 2017-04
• Study First Submitted: 2018-08-24
• Study First Submitted QC: 2018-11-29
• Study First Posted: 2018-12-03
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-08
• Last Update Posted: 2019-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 258

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The change from baseline to week 48 in the percentage of the predicted FVC	up to 48 weeks	In case of administering this drug for more than 12 weeks after registration in the investigation, response evaluation is conducted every 12 weeks (12,24,36,48 weeks) and records are investigated before administration of this drug and after 12, 24,36,48 weeks of administration.

Secondary Outcome Measures

Name	Time	Method
Incidence of adverse event after this drug administration in general medical	48 weeks	Any adverse events occurred after this drug dosing will be recorded. Description of adverse event(s) including type of adverse event(s), onset/end date, severity, action taken, causal relationship to the drug and investigator's view on the adverse event(s) will be captured, whether it is related to the drug or not and until follow up visit more than 1 time during the surveillance period.; Lab abnormalities and changes in vital signs are considered to be adverse events only if they result in discontinuation from the study, necessitate therapeutic medical intervention, and/or if the investigator considers them to be adverse events.