Efficacy and Safety of Nintedanib in Japanese patients with early stage of idiopathic pulmonary fibrosis
Not Applicable
- Conditions
- Idiopathic pulmonary fibrosis (IPF)
- Registration Number
- JPRN-UMIN000038192
- Lead Sponsor
- Respiratory Medicine, Nagasaki University Graduate School of Biomedical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 215
Inclusion Criteria
Not provided
Exclusion Criteria
1)Patients who have initiated therapy with any antifibrotic agent for IPF. 2)Patients treated with corticosteroids (more than a prednisolone equivalent, 10 mg/day) or immunosuppressive agents. 3)Patients who are participating in any other interventional clinical trials. 4)Patients who are undergoing malignant tumor treatment. 5)Patients with a contraindication for nintedanib treatment.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in FVC at 156 week Occurrence of adverse events in each SOC/PT
- Secondary Outcome Measures
Name Time Method Secondary Endpoint(s) / Outcome: 1) Time to incidence of adverse events leading to nintedanib treatment discontinuation. 2) Time to incidence of adverse events leading to nintedanib dose reduction. 3) Incidence of adverse events leading to nintedanib treatment discontinuation. 4) Incidence of adverse events leading to nintedanib dose reduction.