None listed
Conditions
Interventions
None listed
Sponsors
Yungjin Pharm
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients who were diagnosed with idiopathic pulmonary fibrosis, administered Fybro for the first time. 2. Signed informed consent form to participate the study.
Exclusion criteria
Exclusion criteria: 1. Those who are contraindicated for administration of this drug according to approval drug information by MFDS 1) Patients who are hypersensitive to the main ingredient or additives of this drug 2) Patients with severe hepatic impairment or end-stage epilepsy 3) Patients with severe renal impairment or end-stage renal disease requiring dialysis 4) Patients receiving concomitant fluvoxamine 5) Patients with genetic problems such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption 2. A person who uses it for purposes other than approval indication 3. Patients who are participating in other clinical trials
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1) Serious Adverse Event(SAE), Adverse Drug Reaction(ADR) 2) AE, ADR which are not listed in the precaution of this drug information 3) Serious unexpected adverse event/adverse drug 4) Known ADR 5) Mild ADR 6) Other safety information 7) Adverse events known as significant identified or potential risks in the risk management plan(RMP);1) Comparing FVC values at baseline and 6 months 2) Comparing DLco values at baseline and 6 months 3) Comparing SpO2 under 6MWT at baseline and 6 months 4) Overall improvement rate 5) Comparison according to IPF stage in sub group | — |
Countries
Korea, Republic of
Contacts
Public ContactJin Woo Song
Asan Medical Center
Outcome results
None listed