A Study of ADVATE in People With Hemophilia A in India

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.

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

Start Date

September 15, 2021

Completion Date

July 15, 2023

Primary Completion Date

March 15, 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

August 2021