intedanib treatment for the patients with systemic scleroderma-associated interstitial lung disease-a prospective observational study
Not Applicable
Recruiting
- Conditions
- Systemic scleroderma-associated interstitial lung disease
- Registration Number
- JPRN-UMIN000039605
- Lead Sponsor
- Department of Respiratory Medicine, Juntendo University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 100
Inclusion Criteria
Not provided
Exclusion Criteria
(1) Difficulty obtaining patients' consent (2) Severe heart disease (3) AST >=2*ULN, ALT >=2*ULN, or T-bil >=2*ULN (4) Pregnancy (5) Complication with other CTD, RA, SLE,PM/DM, MCTD, SjS, Behcet's disease, and vasculitis (6) Coexistence with pulmonary arterial hypertension, bronchial asthma, Malignant tumor, sarcoidosis, bronchiectasis, respiratory infection (7) A patient who already receive nintedanib or other anti-fibrotic agents (8) A patient with risk of fatal bleeding (9) Past history of thrombosis less than 3 months (10) A patient who started clinical trials less than 3 months (11) A patient improper to this clinical trial according to the decision of a principal investigator
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method