XT007_Hemophilia-A_NXT001JG (NXTAGE)
- Conditions
- Hemophilia A
- Registration Number
- JPRN-jRCT2080224835
- Lead Sponsor
- Chugai Pharmaceutical Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- recruiting
- Sex
- Male
- Target Recruitment
- 106
[Healthy volunteer]
- Japanese
- Age 20 - 44 years, inclusive
[Patient]
- Severe congenital hemophilia A
- Age 12 - 59 years, inclusive
- Documented bleeding episodes (bleeding period, bleeding site) and the therapeutic history with blood coagulation factor products for 24 weeks prior to enrollment
[Healthy volunteer]
- Previous or concomitant thromboembolic (TE) disease such as deep vein thrombosis (DVT), or signs of TE disease or thrombotic microangiopathy (TMA)
[Patient]
- Bleeding disorder other than congenital hemophilia A
- Previous or concomitant thromboembolic (TE) disease such as deep vein thrombosis (DVT), or signs of TE disease or thrombotic microangiopathy (TMA)
- Planned immune tolerance induction (ITI) therapy during the study period
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method safety<br>efficacy<br>pharmacokinetics<br>pharmacodynamics<br>Safety, efficacy, phamacodynamics, pharmacokinetics
- Secondary Outcome Measures
Name Time Method other<br>Immunogenecity