Unique ID issued by UMIN | UMIN000039027 |
---|---|
Receipt number | R000044502 |
Scientific Title | Real world multicenter prospective study of combination therapy of anti-fibrotic agents in idiopathic pulmonary fibrosis(J-AVENGERS) |
Date of disclosure of the study information | 2019/12/27 |
Last modified on | 2019/12/27 23:17:25 |
Real world multicenter prospective study of combination therapy of anti-fibrotic agents in idiopathic pulmonary fibrosis(J-AVENGERS)
J-AVENGERS
Real world multicenter prospective study of combination therapy of anti-fibrotic agents in idiopathic pulmonary fibrosis(J-AVENGERS)
J-AVENGERS
Japan |
idiopathic pulmonary fibrosis
Pneumology |
Others
NO
To examine the efficacy of combination therapy of anti-fibrotic agents for IPF
Efficacy
Proportion of patients whose annual decline of FVC was more than 10%
1. Comparison of decline of FVC before and after initiation of combination therapy
2. Proportion of incidence of acute exacerbation of IPF
3. Time to the acute exacerbation of IPF
4. Survival rate at 48 weeks
5. Proportion of incidence of adverse events
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
48 weeks of observational period, administration of nintedanib, 100mg or 150mg twice a day and pirfenidone, 200mg, 400mg, or 600mg 3 times a day
40 | years-old | <= |
Not applicable |
Male and Female
1)IPF diagnosed on IPF diagnosis guidelines published by American Thoracic Society, European Respiratory Society, Japanese Respiratory Society, and Latin American Thoracic Association 2018
2)Patients who continue nintedanib
3)Patients whose FVC declined before initiation of combination therapy of anti-fibrotic agents
4)Patients with FVC > = 50%
5)Patients with DLCO > = 30%
6)Patients > = 40 year-old
7)Patients able to give informed consent
1)Patients with FEV1/FVC < 0.7
2)Patients who have treated with combination therapy of anti-fibrotic agents
3)Patients who require fibrinolysis, full-dose therapeutic anticoagulation, or high dose antiplatelet therapy
4)Patients who had acute exacerbation of IPF within 6 months
5)Patients who have uncontrolled complications (unstable angina, acute myocardial infarction, severe bronchial asthma, heart failure, bleeding tendency)
6)Patients who cannot perform pulmonary function test
7)Patients who are pregnant
8)Other patients who are judged to be inappropriate as a target by the doctor's judgment
35
1st name | Minoru |
Middle name | |
Last name | Inomata |
Japanese Red Cross Medical Canter
Department of Respiratory Medicine
1508935
4-1-22 Hiroo Shibuya-ku Tokyo
0334001311
inomata_minoru@med.jrc.or.jp
1st name | Minoru |
Middle name | |
Last name | Inomata |
Japanese Red Cross Medical Canter
Department of Respiratory Medicine
1508935
4-1-22 Hiroo Shibuya-ku Tokyo
0334001311
inomata_minoru@med.jrc.or.jp
Japanese Red Cross Medical Canter
Japanese Red Cross Medical Canter
Self funding
Japanese Red Cross Medical Canter
4-1-22 Hiroo Shibuya-ku Tokyo
0334001311
inomata_minoru@med.jrc.or.jp
NO
2019 | Year | 12 | Month | 27 | Day |
Unpublished
Open public recruiting
2019 | Year | 12 | Month | 25 | Day |
2019 | Year | 12 | Month | 25 | Day |
2019 | Year | 12 | Month | 26 | Day |
2024 | Year | 12 | Month | 31 | Day |
2019 | Year | 12 | Month | 27 | Day |
2019 | Year | 12 | Month | 27 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044502