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

Post-marketing surveillance of Pirfenidone

Study Overview

• Status: Completed
• Conditions: Idiopathic Pulmonary Fibrosis
• Intervention / Treatment: Other: NA(observation study)

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 Type: Observational
• Enrollment (Actual): 258

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

residents of Korea, in real-world practice

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The change from baseline to week 48 in the percentage of the predicted FVC	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.	up to 48 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of adverse event after this drug administration in general medical	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.	48 weeks

Collaborators and Investigators

• Sponsor: IlDong Pharmaceutical Co Ltd

Publications and helpful links

General Publications

• Chung MP, Park MS, Oh IJ, Lee HB, Kim YW, Park JS, Uh ST, Kim YS, Jegal Y, Song JW. Safety and Efficacy of Pirfenidone in Advanced Idiopathic Pulmonary Fibrosis: A Nationwide Post-Marketing Surveillance Study in Korean Patients. Adv Ther. 2020 May;37(5):2303-2316. doi: 10.1007/s12325-020-01328-8. Epub 2020 Apr 15.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2014
• Primary Completion (Actual): April 1, 2017
• Study Completion (Actual): April 1, 2017

Study Registration Dates

• First Submitted: August 24, 2018
• First Submitted That Met QC Criteria: November 29, 2018
• First Posted (Actual): December 3, 2018

Study Record Updates

• Last Update Posted (Actual): July 10, 2019
• Last Update Submitted That Met QC Criteria: July 8, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis
• Other Study ID Numbers: ID-PIR-401

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: not yet discussed on the issue

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No