Multicenter randomized double-blind comparison test followed by open-label continuous administration test of NPC-12T for Fibrodysplasia Ossificans Progressiva
- Conditions
- Fibrodysplasia Ossificans Progressiva
- Registration Number
- JPRN-UMIN000028429
- Lead Sponsor
- Kyoto University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 20
Not provided
1. Patients with acute or chronic infection 2. Patients with skin sore reaching dermis 3. Patients experiencing flare-up during last 90 days 4. Past usage of mTOR inhibitors or other molecular target drugs relating mTOR pathway 5. Usage of medicine or foods which are prohibited for concurrent use of Sirolimus 6. History of allergy to Sirolimus, Sirolimus derivatives or additive substance 7. Patients with HBV, with the history of HBV or with active type-C hepatitis. 8. Severe abnormality in blood or liver function 9. Uncontrollable abnormal lipid metabolism 10. Renal failure 11. Immunodeficiency including HIV or primary immunodeficiency 12. Patients who are not able to take tablet, or who have gastrointestinal disorders possibly leading to insufficient absorption of Sirolimus 13. Patients who had surgery during 8 weeks before the registry 14. Pregnant, probably pregnant, or breast-feeding women. Patients who do not agree birth control during clinical trial.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method