Brief Title
A Study of ADVATE in People With Hemophilia A in India
Official Title
Phase 4, Multicenter, Prospective, Interventional, Post-Marketing Study in Hemophilia A Patients in India Receiving ADVATE as On-Demand or Prophylaxis Under Standard Clinical Practice
Brief Summary
The main aim of this study is to learn more about side effects of Advate when given as
standard treatment to people with hemophilia A who have already been treated.
The study sponsor will not be involved in how participants are treated but will provide
instructions on how the clinics will record what happens during the study. Participants will
need to visit the study doctor 5 times in total during the study. During these visits, study
data will be collected by the study doctor.
Detailed Description
Phase 4, Multicenter, Prospective, Interventional, Post-Marketing Study in Hemophilia A
Patients in India Receiving ADVATE as On-Demand or Prophylaxis Under Standard Clinical
Practice
Study Phase
Phase 4
Study Type
Interventional
Primary Outcome
Number of Participants With Serious Adverse Events (SAE) Least Possibly Related to ADVATE
Secondary Outcome
Number of Participants With Non-serious Adverse Events (AEs) Least Possibly Related to ADVATE
Condition
Hemophilia A
Intervention
ADVATE
Study Arms / Comparison Groups
Haemophilia A Group
Description: Participants with hemophilia A will be treated with ADVATE according to a regimen determined by the study site treating physician study site and in accordance with the national product label under standard clinical practice.
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
50
Start Date
December 30, 2021
Completion Date
October 30, 2023
Primary Completion Date
June 30, 2023
Eligibility Criteria
Inclusion Criteria:
- The participant or legally authorized representative (in case of study participants
less than (<) 18 years of age) gave written informed consent to participate in the
study.
- Participant of any age with hemophilia A.
- Participant defined as a previously treated patient (PTP):
- Participant aged greater than or equal to (>=) 6 years that has been previously
treated with plasma-derived and/or recombinant FVIII concentrate(s) for a minimum
of 150 exposure doses (EDs).
- Participant aged less than <6 years that has been previously treated with
plasma-derived or recombinant FVIII concentrate(s) for a minimum of 50 EDs.
- Participant as negative history of FVIII inhibitors and negative inhibitor at
screening defined as less than 0.6 Bethesda units (BU) per milliliter
(Nijmegen-modified Bethesda assay).
- Participant is human immunodeficiency virus negative (HIV-); or human immunodeficiency
virus positive (HIV+) with stable disease and cluster of differentiation 4 (CD4+)
count >=200 cells per cubic millimeter (mm^3), as confirmed by central laboratory at
screening.
- Participant is hepatitis C virus negative (HCV-) by antibody or polymerase chain
reaction (PCR) testing (if positive, anti-body titer will be confirmed by PCR), as
confirmed by central laboratory at screening; or hepatitis C virus positive (HCV+)
with chronic stable hepatitis.
- Participant is willing and able to comply with the requirements of the protocol.
Exclusion Criteria:
- Participant has known hypersensitivity to mouse or hamster proteins or to any of the
excipients of FVIII (factor VIII) concentrates.
- Participant has been diagnosed with bleeding disorder(s) other than congenital
hemophilia A, such as acquired hemophilia A, von Willebrand´s disease (VWD) or
thrombocytopenia (platelet count <100,000 per milliliter).
- Participant has received treatment for hemophilia A with non-FVIII products or
concentrates (example, emicizumab [Hemlibra®]) in the 6 months prior to screening.
- Participant has severe chronic hepatic dysfunction (example, >=5 times upper limit of
normal alanine aminotransferase [ALT], aspartate aminotransferase [AST] or
international normalized ratio [INR] >1.5 as confirmed by central laboratory at
screening).
- Participant has planned or is likely to have, surgery during the study period.
- Participant has a clinically significant medical, psychiatric, or cognitive illness,
or recreational drug or alcohol use that, in the opinion of the investigator, would
affect participant's safety or compliance.
- Participant currently receiving or is scheduled to receive during the course of the
study, an immunomodulating drug (example, corticosteroid agents at a dose equivalent
to hydrocortisone >10 milligram per day, or α-interferon) other than antiretroviral
chemotherapy.
- 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.
- Participant is a family member or employee of the investigator.
Gender
All
Ages
N/A - N/A
Accepts Healthy Volunteers
No
Contacts
Study Director, +1 866 842 5335, [email protected]
Location Countries
India
Location Countries
India
Administrative Informations
NCT ID
NCT04985682
Organization ID
TAK-761-4009
Responsible Party
Sponsor
Study Sponsor
Baxalta now part of Shire
Study Sponsor
Study Director, Study Director, Takeda
Verification Date
November 2021