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NCT Number: NCT07446010

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

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.

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Key information

Conditions

Hemophilia A Blood Coagulation Disorders Blood Coagulation Disorders, Inherited Coagulation Protein Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Department of Medicine Assam Medical College & Hospital, Dibrugarh, India

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male patients aged 18 years or older with a documented diagnosis of severe Hemophilia A, defined by a baseline Factor VIII (FVIII) activity level of less than 1% (<0.01 IU/mL) in accordance with the Hemophilia Severity Classification
  • Previously treated with FVIII concentrate(s) (plasma derived or recombinant, including Octocog alfa) either on-demand or prophylactically for at least 100 Exposure Days (EDs).
  • Patients for whom the decision to initiate on-demand treatment with Octocog alfa for acute bleeding was made as per the investigator's routine treatment practice. This will include patients who are already on on-demand treatment with Octocog alfa as well.
  • Written informed consent from the patient or legal representative

Exclusion criteria

  • Known contraindication according to the local prescriber information
  • Patients who are participating in an investigational program with interventions outside of routine clinical practice.
  • Patients with any other diagnosis of bleeding/coagulation disorder other than Hemophilia A.
  • Patients who are on ongoing prophylactic treatment with any FVIII concentrate or non-factor treatments like emicizumab.
  • Patients exhibiting any of the following laboratory abnormalities at screening:
  • Known platelet count <100,000 mm3
  • Known Serum Creatinine >2 folds upper the normal limit
  • Known Hepatic AST or ALT >5 folds upper the normal limit
  • Patients who have received an on-demand infusion with any other FVIII (different to Octocog alfa), FVII or Activated prothrombin complex concentrate product (aPCC/FEIBA) 72 hours before the enrollment.
  • History or presence of FVIII inhibitor with a titer ≥ 0.6 with Nijmegen modified Bethesda Assay (NBA), or a clinical history suggestive of an inhibitor necessitating changes to treatment
  • Patient concerns or other barriers precluding adequate understanding or cooperation.

Treatment and study plan

octocog alfa

Drug

unmodified, full-length recombinant human FVIII (rFVIII)

Other names: BAY 81-8973, Kovaltry

Primary outcomes

  1. Duration of treatment emergent adverse event (TEAEs) and serious adverse events (TESAEs)

    Time frame: 12 weeks

  2. Severity of treatment emergent adverse event (TEAEs) and serious adverse events (TESAEs)

    Time frame: 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

  3. Outcome of treatment emergent adverse event (TEAEs) and serious adverse events (TESAEs)

    Time frame: 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 .

  4. Treatment administered for treatment emergent adverse event (TEAEs) and serious adverse events (TESAEs)

    Time frame: 12 weeks

  5. Laboratory test results related to adverse events of special interest (AESIs)rse events (TESAEs)

    Time frame: 12 weeks

    hypersensitivity, inhibitor development

    Tests used will be as per the routine clinical practice followed by the investigator at his/her hospital

Secondary outcomes

  1. Total number of infusions per bleed

    Time frame: 12 weeks

  2. Dose of Octocog alfa (IU/kg) per bleed

    Time frame: 12 weeks

  3. Location of bleeds

    Time frame: 12 weeks

  4. Type of bleeds

    Time frame: 12 weeks

  5. Severity of bleeds

    Time frame: 12 weeks

    Severity is defined and measured as follows. - Mild: Spontaneous bleeding into joints or muscles, predominantly in the absence of identifiable hemostatic challenge. The bleeding stops on its own or with pressure or the bleeding stops or slows to an ooze or trickle after 15 minutes of pressure. It may ooze or trickle for up to 45 min. - Moderate: Occasional spontaneous bleeding; prolonged bleeding with minor trauma or surgery, the bleeding slows or stops wtih presure, but starts again if you remove the pressure or the blood may soak through a few bandages, but it is not fast or out of control. - Severe: blood is pumping from the wound or the bleeding does not stopr or slow down with pressure or blood is quickly soaking through bandage after bandage

  6. Duration of bleeds

    Time frame: 12 weeks

  7. Investigator rating of response

    Time frame: 12 weeks

    poor, moderate, good, excellent

Study contacts

Contact information is provided by the study sponsor or research team.

Bayer Clinical Trials Contact

CONTACT

[email protected]

(+)1-888-84 22937

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 3, 2026
Registry last updated
Jun 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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