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A Prospective, Multicenter, Open-label, Phase IV Post-authorization Safety Study Conducted in India to Assess the Safety and Treatment Outcomes of Octocog Alfa in Real-world Practice for On-demand Treatment of Acute Bleeds in Previously Treated Severe Hemophilia A Patients in India
Hemophilia A is a genetic condition that makes it hard for blood to clot properly. This happens because the body does not have enough of a protein called Factor VIII, which helps stop bleeding. The main goal of treating someone with hemophilia is to stop and prevent bleeding by giving them the missing Factor VIII. This treatment can be given when a person starts bleeding (called on-demand treatment), or it can be given regularly to prevent bleeding (called prophylactic therapy). In India, most people with hemophilia A get treatment only when they have a bleeding episode, and only a few receive regular preventive treatment. Octocog alfa (also known as BAY 81-8973) is a modern, laboratory-made version of Factor VIII. It is made without using any human or animal materials and has special features that help it work better in the body. In India, Octocog alfa is approved for use in adults and children with hemophilia A to: * Treat and control bleeding episodes when they happen * Manage bleeding during surgery * Prevent bleeding by giving regular treatment The safety and effectiveness of Octocog alfa have been shown in several global studies. This new study is required by Indian health authorities to collect information about how safe Octocog alfa is and how well it works in people with hemophilia A who have already received treatment. The study will look at how Octocog alfa is used in real-life medical practice in India, including how doctors prescribe it, how patients use it, and what treatment results they have.
Age
18 - No limit years
Sex
MALE
Healthy Volunteers
No
Department of Medicine Assam Medical College & Hospital
Dibrugarh, India
Government of Medical College Kozhikode
Kozhikode, India
Sanjay Gandhi Post Graduate Institute & Medical Sciences
Lucknow, India
Christian Medical College & Hospital
Ludhiana, India
All India Institute Of Medical Sciences
New Delhi, India
Sahyadri Super Speciality Hospital
Pune, India
Start Date
March 10, 2026
Primary Completion Date
December 31, 2026
Completion Date
December 31, 2026
Last Updated
March 3, 2026
33
ESTIMATED participants
Octocog alfa
DRUG
Lead Sponsor
Bayer
NCT06703606
NCT06136507
NCT02083965
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