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OpenTrials
Completed

NCT Number: NCT03761082

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

Post-marketing surveillance of Pirfenidone

Completed

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Key information

Conditions

Idiopathic Pulmonary Fibrosis Lung Diseases Lung Diseases, Interstitial Pulmonary Fibrosis Respiratory Tract Diseases

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • Subjects who is hypersensitive to the active ingredient or additives of this drug
  • Subjects who have severe hepatopathy
  • Subjects who have severe renal disorder (creatinine clearance<30mL/min) or a terminal renal disease treated by dialysis
  • Subjects who received a combined treatment of fluvoxamine
  • Subjects who have genetic problems, such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption

Treatment and study plan

NA(observation study)

Other

NA(observation study)

Primary outcomes

  1. The change from baseline to week 48 in the percentage of the predicted FVC

    Time frame: 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 outcomes

  1. Incidence of adverse event after this drug administration in general medical

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

IlDong Pharmaceutical Co Ltd

Industry

Registry information

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Dec 3, 2018
Registry last updated
Jul 10, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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