Hemophilia A
Conditions
Sponsors
Chugai Pharmaceutical Co., Ltd.
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: [Healthy volunteer] - Japanese or Caucasian - Age 20 - 44 years, inclusive [Patient] - Japanese severe congenital hemophilia A - Age 12 - 59 years, inclusive - Recorded bleeding episodes (bleeding period, bleeding site) and the therapeutic history with blood coagulation factor products for six months prior to entry - Meet any of the criteria below at the time of entry (1) For patient with inhibitors, exhibited bleeding more frequently than once a month for six months prior to entry (2) For patient without inhibitors, administered factor VIII products more than 150 times prior to entry, and underwent prophylaxis for six months prior to entry
Exclusion criteria
Exclusion criteria: [Healthy volunteer] - Have thromboembolic disease, such as deep vein thrombosis, or its previous history [Patient] - With bleeding disease except congenital hemophilia A - Have thromboembolic disease, such as deep vein thrombosis, or its previous history - Plan to undergo the immune tolerance induction therapy during the clinical study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tolerability, Safety, Pharmacokinetics, Pharmacodynamics Observation, Laboratory tests | — |
Outcome results
None listed