Health Condition 1: null- Severe Haemophilia A
Conditions
Interventions
Intervention1: on demand: rFVIIIFc
IV administration
Subject will follow either a prophylaxis or on-demand regimen, to be determined by the investigator. The starting dose in this study will be deter
Sponsors
Biogen Idec Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (PHI) in accordance with national and local subject privacy regulations. Parental or guardian consent is required for subjects who are less than 18 years of age or unable to give consent, or as applicable per local laws. 2. Subjects who have completed Study 997HA301.
Exclusion criteria
Exclusion criteria: 1. Confirmed positive high-titer inhibitor test (>=5.00 BU/mL) 2. Medical or other reasons that, in the opinion of the Investigator, make the subject unsuitable for enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| â?¢ Number of hospitalizations, excluding planned hospitalizations, elective surgery documented at Visit 1, and emergent surgery â?¢ Number of emergency room visits â?¢ Number of physician visits, excluding study visits â?¢ Number of hospitalization days â?¢ Number of days off work or school â?¢ Number of days off work for a parent/caregiver (demographic data for parents/caregivers will be collected at Visit 1) Timepoint: â?¢ Number of hospitalizations, excluding planned hospitalizations, elective surgery documented at Visit 1, and emergent surgery â?¢ Number of emergency room visits â?¢ Number of physician visits, excluding study visits â?¢ Number of hospitalization days â?¢ Number of days off work or school â?¢ Number of days off work for a parent/caregiver (demographic data for parents/caregivers will be collected at Visit 1) | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary objective of the study is to evaluate the efficacy of rFVIIIFc in the prevention and treatment of bleeding episodes in subjects with hemophilia A.Timepoint: The number of annualized bleeding episodes (spontaneous and traumatic) per subject The number of annualized spontaneous joint bleeding episodes per subject The total number of days of exposure per subject per year The mean dose of rFVIIIFc per kg per subject per year per treatment regimen Physicianâ??s global assessment of response to treatment using a 4-point scale Subjectâ??s assessment of response to treatment using a 4-point scale The incidence of AEs and serious adverse events (SAEs) | — |
Countries
Australia, Austria, Belgium, Chile, China, Germany, Hong Kong, India, New Zealand, Sweden, United Kingdom, United States of America
Contacts
Public ContactRitika Bajaj
Biogen
Outcome results
None listed