Phase IV Multi-Center, Prospective, Interventional, Post-Marketing Study in Hemophilia B Patients in India Receiving RIXUBIS as On-demand or Prophylaxis Under Standard Clinical Practice
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Hemophilia B
- Sponsor
- Baxalta now part of Shire
- Enrollment
- 25
- Locations
- 1
- Primary Endpoint
- Number of Participants With Serious Treatment-emergent Adverse Events (TEAEs) Related to RIXUBIS
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
The purpose of this study is to characterize the safety and describe the effectiveness of RIXUBIS in routine clinical practice.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Number of Participants With Serious Treatment-emergent Adverse Events (TEAEs) Related to RIXUBIS
Time Frame: From start of study drug administration up to End of treatment (EOT) (up to 6 months)
TEAE was defined as any event not presented prior to the initiation of the treatments or any event already present that worsens in either intensity or frequency following exposure to the treatments. A SAE was defined as any untoward medical occurrence that at any dose met one or more of the following criteria: outcome was fatal/resulted in death, life-threatening, required in-patient hospitalization or resulted in prolongation of an existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a medically important event that was not immediately life-threatening or resulted in death or required hospitalization but jeopardize the participant or required medical or surgical intervention to prevent any of the above outcomes. Relatedness to study drug was based on physician discretion. Number of participants with serious TEAEs related to RIXUBIS were reported.
Secondary Outcomes
- Annualized Bleeding Rate (ABR) With Prophylactic Use of RIXUBIS(From start of study drug administration up to EOT (up to 6 months))
- Number of Participants With TEAEs Related to RIXUBIS(From start of study drug administration up to EOT (up to 6 months))
- Number of Participants With Clinically Significant Laboratory Abnormalities(From start of study drug administration up to EOT (up to 6 months))
- Number of Participants Who Developed Binding Antibodies (Immunoglobulin G [IgG] and Immunoglobulin M [IgM]) to Factor IX (FIX)(From start of study drug administration up to EOT (up to 6 months))
- Number of Participants Who Developed Binding Antibodies to Chinese Hamster Ovary (CHO) Proteins and rFurin(From start of study drug administration up to EOT (up to 6 months))
- Rate of Success of RIXUBIS for Treatment of Bleeding Episodes(From screening up to EOT (up to 6 months))