Status:
COMPLETED
Post Marketing Surveillance of PIRESPA® TAB 200mg (Pirfenidone) for Evaluating the Safety and Efficacy
Lead Sponsor:
IlDong Pharmaceutical Co Ltd
Conditions:
Idiopathic Pulmonary Fibrosis
Eligibility:
All Genders
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 1 2017
Estimated Enrollment :
258 Patients enrolled
Trial Details
Trial ID
NCT03761082
Start Date
July 1 2014
End Date
April 1 2017
Last Update
July 10 2019
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