Post Approval Observational Study to Learn More About How Safe Octocog Alfa is and How Well it Works in Patients With Severe Hemophilia A in India

Condition(s) studied

Investigational drug(s) / intervention(s)

Octocog alfa: unmodified, full-length recombinant human FVIII (rFVIII)

Study summary

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.

Eligibility

Primary outcome measure(s)

• Duration of treatment emergent adverse event (TEAEs) and serious adverse events (TESAEs) — 12 weeks
• Severity of treatment emergent adverse event (TEAEs) and serious adverse events (TESAEs) — 12 weeks
  The severity (or intensity) of an AE will be evaluated by the Investigator in accordance with the CTCAE v 5.0. \- Grade 1 (Milde): Asymptomatic or mild symptoms ; clinical or diagnostic observations only ; intervention not indicated. - Grade 2 (Moderate): Minimal, local or invasive intervention indicated, limiting age-appropriate instrumental activities of daily living. - Grade 3 (Severe): Severe or medically significant but not immediately life threatening; hospitalization or prolongation of existing hospitalization indicated ; disabling; limiting self-care activities of daily living. - Grade 4 (Life threatening Consequences): Urgent intervention indicated. -Grade 5 (Death): Related to Adverse Event
• Outcome of treatment emergent adverse event (TEAEs) and serious adverse events (TESAEs) — 12 weeks
  The outcome is defined by the following categories. - Recovered or Resolved: The subject has completely recovered or resolved from the Serious Adverse Event. - Recovered or Resolved with sequelae: As a result of AE , the subject suffered persistent and significant disability / incapacity (e.g., blind, deaf and paralysed ). Any AE recovered with sequelae should be rated as an SAE . - Recovering or Resolving: The subject has begin to recover from the condition or injury , but the event has considered ongoing at a reduced intensity. - Not Recovered or Not Resolved: The AE itself is still present and observable. - Fatal: Death due to SAE, mention the cause of death. Unknown: This term should only be used in cases where the subject is lost to follow up .
• Treatment administered for treatment emergent adverse event (TEAEs) and serious adverse events (TESAEs) — 12 weeks
• Laboratory test results related to adverse events of special interest (AESIs)rse events (TESAEs) — 12 weeks
  hypersensitivity, inhibitor development Tests used will be as per the routine clinical practice followed by the investigator at his/her hospital

Trial sites (6)