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Clinical Trials/NCT03565237
NCT03565237
Completed
Phase 4

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

Baxalta now part of Shire1 site in 1 country25 target enrollmentDecember 7, 2018
ConditionsHemophilia B

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.

Registry
clinicaltrials.gov
Start Date
December 7, 2018
End Date
August 11, 2021
Last Updated
3 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Baxalta now part of Shire
Responsible Party
Sponsor

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))

Study Sites (1)

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