multicenter lymphangioleiomyomatosis sirolimus trial for safety
- Conditions
- lymphangioleiomyomatosis
- Registration Number
- JPRN-jRCT2091220096
- Lead Sponsor
- Koh Nakata, MD, PhD
- Brief Summary
Sirloins two year medication inhibits the deterioration of lung function in patients with mild LAM as well as moderate to severe LAM which was confirmed by MILES trial previously. O those improved, the improvement of lung function was remarkable in patients with history of chylothorax.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 65
a. written informed consent
b. diagnosis of LAM by chest HRCT
etc.
a. history of myocardial infarction, angina or stroke
b. pregnant, breastfeeding or plans to become pregnant
c. unable or unwilling to use adequate contraception
d. significant hematologic or hepatic abnormality
e. intercurrent infection or HBV career
f. any surgery within 8 weeks of initiation of study drug
g. uncontrolled hyperlipidemia
h. previous lung transplant or currently on lung transplant list
etc.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method