Congenital haemophilia with inhibitors
Conditions
Sponsors
KM Biologics Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Patients who are expected to complete the observation at week 24 of the preceding KD2-305 phase II/III study (2) Patients who are considered eligible for the study by the investigator (3) Patients who or whose legally acceptable representatives have provided written informed consent in hope of continuous administration
Exclusion criteria
Exclusion criteria: (1) Patients undergoing immune tolerance induction (ITI) treatment (2) Patients with diseases that develop abnormality in the coagulation/fibrinolytic system other than the target disease of the study or suspected of such (3) Patients with hypercoagulability or such possibilities (4) Patients with a history of disseminated intravascular coagulation (DIC) or thromboembolism (5) Patients with a history of shock or hypersensitivity to protein preparations such as blood derivatives (6) Patients who have undergone surgical procedure and have not fully recovered when participating in the study or patients who are scheduled to undergo surgery during the study (7) Patients with acquired immunodeficiency syndrome (AIDS) defining illness (8) Patients with severe liver disorder or renal disorder (9) Patients with current serious medical conditions such as malignant tumor or leukaemia who will or are highly likely to undergo chemotherapy or radiotherapy during the study (10) Patients with hemolytic or blood loss anaemia (11) Patients who are scheduled to participate in any other clinical studies during the study (12) Patients who have received HEMLIBRA (R) Subcutaneous Injection within 4 months prior to the eligibility confirmation for the study (13) Patients who are considered ineligible for the study by the investigator or subinvestigator for any other reason
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety Number of cases, number of patients, and incidence rate of adverse events | — |
Secondary
| Measure | Time frame |
|---|---|
| efficacy 1) Annual bleeding rate 2) Annual bleeding rate by bleeding site 3) Time for treatment | — |
Countries
Japan
Contacts
Public ContactMasatoshi Yamashita
KM Biologics Co., Ltd.
Outcome results
None listed