Not Yet Recruiting

Severe Hemophilia A

Bayer Identifier:

23153

ClinicalTrials.gov Identifier:

NCT07446010

EudraCT Number:

Not Available

EU CT Number:

Not Available

Post Approval phase 4 study to learn more about how safe Octocog alfa is, and how well it works in patients with severe Hemophilia A in India

Trial purpose

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.

Key Participants Requirements

Sex

All

Age

18 - N/A (No Limit)

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.

Trial summary

Enrollment Goal

Trial Dates

April 2027 - March 2028

Phase

Phase IV

Could I Receive a placebo

Products

Octocog alfa, BAY 2350145

Accepts Healthy Volunteer

N/A

Primary Outcome

Duration of treatment emergent adverse event (TEAEs) and serious adverse events (TESAEs)
Time Frame:
12 weeks
Severity of treatment emergent adverse event (TEAEs) and serious adverse events (TESAEs)
Time Frame:
12 weeks
Treatment administered for treatment emergent adverse event (TEAEs) and serious adverse events (TESAEs)
Time Frame:
12 weeks
Laboratory test results related to adverse events of special interest (AESIs)rse events (TESAEs)
Time Frame:
12 weeks

Secondary Outcome

Total number of infusions per bleed
Time Frame:
12 weeks
Dose of Octocog alfa (IU/kg) per bleed
Time Frame:
12 weeks
Location of bleeds
Time Frame:
12 weeks
Type of bleeds
Time Frame:
12 weeks
Severity of bleeds
Time Frame:
12 weeks
Duration of bleeds
Time Frame:
12 weeks
Investigator rating of response
poor, moderate, good, excellent
Time Frame:
12 weeks

Trial design

Post Approval phase 4 study for Kovaltry in Indian patients with Hemophilia A

Trial Type

Observational

Intervention Type

Drug

Trial Purpose

N/A

Allocation

N/A

Blinding

Open Label

Assignment

N/A

Trial Arms

N/A