Post Marketing Surveillance of PIRESPA® TAB 200mg (Pirfenidone) for Evaluating the Safety and Efficacy
1 other identifier
observational
258
0 countries
N/A
Brief Summary
Post-marketing surveillance of Pirfenidone
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2014
Typical duration for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2017
CompletedFirst Submitted
Initial submission to the registry
August 24, 2018
CompletedFirst Posted
Study publicly available on registry
December 3, 2018
CompletedJuly 10, 2019
July 1, 2019
2.8 years
August 24, 2018
July 8, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Incidence of adverse event after this drug administration in general medical
48 weeks
Interventions
NA(observation study)
Eligibility Criteria
residents of Korea, in real-world practice
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
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.
PMID: 32297284DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 24, 2018
First Posted
December 3, 2018
Study Start
July 1, 2014
Primary Completion
April 1, 2017
Study Completion
April 1, 2017
Last Updated
July 10, 2019
Record last verified: 2019-07