Idiopathic Pulmonary FibrosisNCT03761082
Post Marketing Surveillance of PIRESPA® TAB 200mg (Pirfenidone) for Evaluating the Safety and Efficacy
An observational study of Idiopathic Pulmonary Fibrosis, run by IlDong Pharmaceutical Co Ltd.
Trial summary
Post-marketing surveillance of Pirfenidone Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis
- What is being tested?
- NA(observation study)
- How many people
- 258 participants
- Where
- No sites listed yet
- Study dates
- Jul 2014to Apr 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: residents of Korea, in real-world practice
Who may be able to join
- 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.
Who cannot join
- 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
About this study
Post-marketing surveillance of Pirfenidone
Read the 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.
- Conditions
- Idiopathic Pulmonary Fibrosis
- Being tested
- NA(observation study)
- Medical subject headings
- Idiopathic Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NA(observation study)Other
NA(observation study)
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 48 weeks
Secondary outcomes (1)
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.
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2018
- Study startJul 2014
- Primary completionApr 2017
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Idiopathic Pulmonary FibrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 258 participants (actual)
Sponsor and investigators
- Lead sponsor
- IlDong Pharmaceutical Co Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03761082
- Sponsor's protocol ID
- ID-PIR-401
- Status last verified
- Jul 2019
- First submitted
- 24 Aug 2018
- Last updated
- 10 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: not yet discussed on the issue
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.
PubMed 32297284
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post Marketing Surveillance of PIRESPA® TAB 200mg (Pirfenidone) for Evaluating the Safety and Efficacy
- ClinicalTrials.gov ID
- NCT03761082
- Acronym / sponsor ID
- ID-PIR-401
- Conditions
- Idiopathic Pulmonary Fibrosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 258 participants (actual)
- Lead sponsor
- IlDong Pharmaceutical Co LtdIndustry (pharma, biotech, devices)
- Study start
- Jul 2014 (actual)
- Primary completion
- Apr 2017 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 3 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- residents of Korea, in real-world practice
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NA(observation study)NA(observation study) | Other | – |
Primary outcome
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.
1 secondary outcome
Incidence of adverse event after this drug administration in general medical
Time frame: 48 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2019.
- Derived from this study: PubMed 32297284Chung 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.
- Individual participant dataSharing planned: Undecided. not yet discussed on the issue
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Idiopathic Pulmonary Fibrosis, run by IlDong Pharmaceutical Co Ltd.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change from baseline to week 48 in the percentage of the predicted FVC (time frame: up to 48 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03761082, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2019.