NCT04614441Befejeződött
NICEFIT-ON: A Study Under Routine Clinical Practice in Taiwan to Observe the Long-term Outcome of People With Certain Types of Lung Disease (PF-ILD, SSc-ILD, IPF) Who Start Treatment With Nintedanib
Non-Interventional Collecting Evidences For ILD in Taiwan: Optimized Novel Therapy
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2025. aug. 19.
Rövid összefoglaló (regiszter, angolul)
To better understand the clinical characteristics of Idiopathic Pulmonary Fibrosis (IPF) / Systemic Sclerosis-associated-Interstitial Lung Disease (SSc-ILD)/ Progressive Fibrosing Interstitial Lung Disease (PF-ILD) patients treated with nintedanib and biomarkers associated with the disease course, a non-interventional, 3-year, prospective study will be conducted to collect the long-term real-world clinical data on IPF/SSc-ILD/PF-ILD patients newly administered with nintedanib in Taiwan
- Állapot (regiszter)
- Befejeződött
- Vizsgálattípus
- Megfigyeléses
- Résztvevők száma
- 214 (tényleges)
- Első benyújtás
- 2020. okt. 29.
- Kezdés
- 2021. jan. 21.
- Elsődleges befejezés
- 2025. máj. 14.
- Fő szponzor
- Boehringer Ingelheim
- Betegségek
- Idiopátiás tüdőfibrózis
- NCT-szám
- NCT04614441
Mit vállalsz
- Vizsgálat típusa: Megfigyeléses
- Bevont résztvevők: 214
- 2021. jan. 21. és az elsődleges befejezés (2025. máj. 14.) között
- 26 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.
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Korábbi kezelés
- Lung transplantation expected within the next 6 months.
- --Included in ongoing interventional trials
Kiket keres a vizsgálat
- This study plans to enroll approximately 500 patients with IPF/SSc-ILD/PF-ILD who newly initiate nintedanib per physicians' discretion within 6 months before participating in the study.
- IPF cohort:
- Diagnosed with IPF during the prior 6 months before study enrollment, based on the 2018 ATS/ERS/JRS/ALAT guideline
- Patient ≥ 40 years of age
- Newly initiating nintedanib within 6 months prior to participating in the study
- Providing written informed consent prior to participating in the study
- Having further follow-up possibility with participating physician during the planned study period
- Ability to read and write in local language
- SSc-ILD cohort:
- Diagnosed with SSc-ILD during the prior 6 months before study enrollment, based on 2013 ACR/EULAR
- Patient ≥ 20 years of age
- Newly initiating nintedanib OR not receiving nintedanib per physician's discretion (For patients who diagnosed with SSc-ILD but are not treated with nintedanib on physician's discretion, they will apply the same inclusion criteria, with baseline characteristics collected only) within 6 months prior to participating in the study
- Providing written informed consent prior to participating in the study
- Having further follow-up possibility with participating physician during the planned study period
- Ability to read and write in local language
- PF-ILD cohort:
- Diagnosed with PF-ILD (PF-ILD patients will be enrolled only after nintedanib acquires the label approval from TFDA) during the prior 6 months before study enrollment. The definition of PF-ILD diagnosis is as follows:
- --Patients who have ILD with a progressive phenotype, but are not diagnosed with IPF, per physician's judgment. The pathophysiology in these patients is characterized by self-sustaining fibrosis and a deterioration in lung function over time, with worsening respiratory symptoms, resistance to immune-modulatory therapies, and ultimately early mortality.
- Patient ≥ 20 years of age
- Newly initiating nintedanib OR not receiving nintedanib per physician's discretion (For patients who diagnosed with PF-ILD but are not treated with nintedanib on physician's discretion, they will apply the same inclusion criteria, with baseline characteristics collected only) within 6 months prior to participating in the study
- Providing written informed consent prior to participating in the study
- Having further follow-up possibility with participating physician during the planned study period
- Ability to read and write in local language
Életkor a regiszterben: 20 év – - · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (26)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| Chang-Hua Christian Hospital | Changhua | Tajvan | Ismeretlen állapot |
| Chang-Gung Memorial Hospital - Chiayi | Chiayi City | Tajvan | Ismeretlen állapot |
| National Taiwan University Hospital Hsin Chu Branch | Hsinchu | Tajvan | Ismeretlen állapot |
| Kaohsiung Chang Gung Memorial Hospital | Kaohsiung City | Tajvan | Ismeretlen állapot |
| E-DA Hospital | Kaohsiung City | Tajvan | Ismeretlen állapot |
| Kaohsiung Veterans General Hospital | Kaohsiung City | Tajvan | Ismeretlen állapot |
| Kaohsiung Medical University Chung-Ho Memorial Hospital | Kaohsiung City | Tajvan | Ismeretlen állapot |
| Taipei Tzu Chi General Hospital | New Taipei City | Tajvan | Ismeretlen állapot |
| Taipei Medical University Shuang Ho Hospital | New Taipei City | Tajvan | Ismeretlen állapot |
| Chung Shan Medical University Hospital | Taichung | Tajvan | Ismeretlen állapot |
| China Medical University Hospital | Taichung | Tajvan | Ismeretlen állapot |
| Taichung Veterans General Hospital | Taichung | Tajvan | Ismeretlen állapot |
| Asia University Hospital | Taichung | Tajvan | Ismeretlen állapot |
| Cheng Ching Hospital | Taichung | Tajvan | Ismeretlen állapot |
| MacKay Memorial Hospital | Taipei | Tajvan | Ismeretlen állapot |
| Cheng Hsin Rehabilitation Medical Center | Taipei | Tajvan | Ismeretlen állapot |
| Shin Kong Wu Ho Su Memorial Hospital | Taipei | Tajvan | Ismeretlen állapot |
| Tri-Service General Hospital | Taipei | Tajvan | Ismeretlen állapot |
| Taipei Medical University Hospital | Taipei | Tajvan | Ismeretlen állapot |
| National Taiwan University Hospital | Taipei | Tajvan | Ismeretlen állapot |
| Taipei Veterans General Hospital | Taipei | Tajvan | Ismeretlen állapot |
| Taitung MacKay Memorial Hospital | Taitung | Tajvan | Ismeretlen állapot |
| Chang Gung Memorial Hospital, Linkou | Taoyuan | Tajvan | Ismeretlen állapot |
| TaoYuan General Hospital | Taoyuan County | Tajvan | Ismeretlen állapot |
| National Yang-Ming University Hospital | Yilan | Tajvan | Ismeretlen állapot |
| National Taiwan University Hospital Yun-Lin Branch | Yunlin County | Tajvan | Ismeretlen állapot |
Ez az oldal tájékoztatás, nem orvosi tanács. Bármely vizsgálatról az orvosoddal beszélj.