Post Approval Observational Study to Learn More About How Safe Octocog Alfa is and How Well it Wo… (NCT07446010) | Clinical Trial Compass
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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
India33 participantsStarted 2026-09-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Duration of treatment emergent adverse event (TEAEs) and serious adverse events (TESAEs)
Timeframe: 12 weeks
2
Severity of treatment emergent adverse event (TEAEs) and serious adverse events (TESAEs)
Timeframe: 12 weeks
3
Outcome of treatment emergent adverse event (TEAEs) and serious adverse events (TESAEs)
Timeframe: 12 weeks
4
Treatment administered for treatment emergent adverse event (TEAEs) and serious adverse events (TESAEs)
Timeframe: 12 weeks
5
Laboratory test results related to adverse events of special interest (AESIs)rse events (TESAEs)