NCT07446010Not yet recruiting
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
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
Source: ClinicalTrials.gov · Last updated 21 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 30 (estimated)
- First submitted
- 11 Feb 2026
- Start date
- 5 Apr 2027
- Primary completion date
- 31 Mar 2028
- Lead sponsor
- Bayer
- Diseases
- Haemophilia
- NCT number
- NCT07446010
What you commit to
- Study type: Observational
- Planned participants: 30
- From 5 Apr 2027 to the primary completion date, 31 Mar 2028
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients who are on ongoing prophylactic treatment with any FVIII concentrate or non-factor treatments like emicizumab.
- 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
Other illness
- Patients with any other diagnosis of bleeding/coagulation disorder other than Hemophilia A.
Lab values
- 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
Other
- Known contraindication according to the local prescriber information
- Patients who are participating in an investigational program with interventions outside of routine clinical practice.
- Patient concerns or other barriers precluding adequate understanding or cooperation.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All
This page is information, not medical advice. Discuss any trial with your doctor.