Brief Title
RIXUBIS PMS India (RIXUBIS PMS)
Official Title
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
Brief Summary
The purpose of this study is to characterize the safety and describe the effectiveness of
RIXUBIS in routine clinical practice.
Study Phase
Phase 4
Study Type
Interventional
Primary Outcome
Number of Participants With Serious Treatment-emergent Adverse Events (TEAEs) Related to RIXUBIS
Secondary Outcome
Number of Participants With TEAEs Related to RIXUBIS
Condition
Hemophilia B
Intervention
RIXUBIS: On-Demand
Study Arms / Comparison Groups
All Study Participants
Description: Study participants with Hemophilia B in India receiving Rixubis
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Biological
Estimated Enrollment
25
Start Date
December 7, 2018
Completion Date
August 11, 2021
Primary Completion Date
August 11, 2021
Eligibility Criteria
Inclusion Criteria
1. The participant or legally authorized representative (in case of study participants
<18 years of age) gave written informed consent to participate in the study.
2. Participant has hemophilia B.
3. Participant is defined as previously-treated patient (PTP):
- Participant aged ≥ 6 years that has been previously treated with plasma-derived
and/or recombinant factor IX (FIX) concentrate(s) for a minimum of 150 exposure
days (EDs).
- Participant aged < 6 years that has been previously treated with plasma-derived
and/or recombinant FIX concentrate(s) for a minimum of 50 EDs.
4. Participant has no evidence of a history of FIX inhibitors.
5. Participant is human immunodeficiency virus negative (HIV-); or HIV+ with stable
disease and CD4+ count ≥ 200 cells/mm^3, as confirmed by central laboratory at
screening.
6. Participant is hepatitis C virus negative (HCV-) by antibody or PCR testing (if
positive, antibody titer will be confirmed by polymerase chain reaction (PCR)), as
confirmed by central laboratory at screening; or HCV+ with chronic stable hepatitis.
7. The participant is willing and able to comply with the requirements of the protocol.
Exclusion Criteria
1. Participant has known hypersensitivity or presence of any contraindication to RIXUBIS
or its excipients including hamster protein.
2. Participant has evidence of an ongoing or recent thrombotic disease, fibrinolysis or
disseminated intravascular coagulation (DIC).
3. Participant has a history of FIX inhibitors with a titer ≥ 0.6 Bethesda Units (BU) (as
determined by the Nijmegen modification of the Bethesda assay or the assay, employed
in the respective local laboratory) at any time prior to screening.
4. Participant has a detectable FIX inhibitor at screening, with a titer ≥ 0.6 BU as
determined by the Nijmegen modification of the Bethesda assay in the central
laboratory.
5. Participant has severe chronic liver disease as evidenced by, but not limited to, any
of the following: International Normalized Ratio (INR) > 1.4 hypoalbuminemia, portal
vein hypertension including presence of otherwise unexplained splenomegaly and history
of esophageal varices.
6. Participant has severe chronic hepatic dysfunction [eg, ≥ 5 times upper limit of
normal alanine aminotransferase (ALT), as confirmed by central laboratory at
screening, or a documented INR > 1.5].
7. Participant has severe renal impairment (serum creatinine > 2.0 mg/dL), as confirmed
by central laboratory at screening.
8. Participant has been diagnosed with an inherited or acquired hemostatic defect other
than hemophilia B.
9. Participant's platelet count is < 100,000/mL.
10. Participant has a clinically significant medical, psychiatric, or cognitive illness,
or recreational drug/alcohol use that, in the opinion of the investigator, would
affect participant's safety or compliance.
11. Participant is currently receiving, or is scheduled to receive during the course of
the study, an immunomodulating drug (eg, corticosteroid agents at a dose equivalent to
hydrocortisone greater than 10 mg/day, or α-interferon) other than antiretroviral
chemotherapy.
12. Participant has participated in another clinical study involving an investigational
product (IP) or investigational device within 30 days prior to enrollment or is
scheduled to participate in another clinical study involving an IP or investigational
device during the course of this study.
13. Participant is a family member or employee of the investigator.
Gender
All
Ages
N/A - N/A
Accepts Healthy Volunteers
No
Contacts
Study Director, ,
Location Countries
India
Location Countries
India
Administrative Informations
NCT ID
NCT03565237
Organization ID
251602
Responsible Party
Sponsor
Study Sponsor
Baxalta now part of Shire
Collaborators
Baxalta Innovations GmbH, now part of Shire
Study Sponsor
Study Director, Study Director, Takeda
Verification Date
August 2022