Severe Hemophilia AHEMOCT INDIANCT07446010
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
An observational study of Severe Hemophilia A, run by Bayer.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Severe Hemophilia A
- What is being tested?
- Octocog alfa
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 5 Apr 2027to 31 Mar 2028
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Male adult patients (aged ≥18 years) with severe Hemophilia A in India, who have been previously treated for at least 100 exposure days to FVIII concentrate(s) and are prescribed Octocog alfa for managing bleeding episodes
Who may be able to join
- 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
Who cannot join
- 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
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- 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 locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official 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
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.
- Conditions
- Severe Hemophilia A
- Being tested
- Octocog alfa
- Medical subject headings
- Hemophilia A
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Octocog alfaDrug
Also called BAY 81-8973, Kovaltry, Antihaemorrhagic agent, blood coagulation factor VIII
unmodified, full-length recombinant human FVIII (rFVIII) dosing according to local label and treating physician
| Study group | Role | What they receive |
|---|---|---|
| Male adult patients (aged ≥18 years) with severe Hemophilia A in India, who have been previously tre | Not described Receives: Drug: Octocog alfa |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of treatment emergent adverse event (TEAEs) and serious adverse events (TESAEs)
Measured: 12 weeks
Severity of treatment emergent adverse event (TEAEs) and serious adverse events (TESAEs)
Measured: 12 weeks
Treatment administered for treatment emergent adverse event (TEAEs) and serious adverse events (TESAEs)
Measured: 12 weeks
Laboratory test results related to adverse events of special interest (AESIs)rse events (TESAEs)
Measured: 12 weeks
Secondary outcomes (7)
Total number of infusions per bleed
Measured: 12 weeks
Dose of Octocog alfa (IU/kg) per bleed
Measured: 12 weeks
Location of bleeds
Measured: 12 weeks
Type of bleeds
Measured: 12 weeks
Severity of bleeds
Measured: 12 weeks
Duration of bleeds
Measured: 12 weeks
Investigator rating of response
poor, moderate, good, excellent
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2026
- Study start5 Apr 2027 (estimated)
- Primary completion31 Mar 2028 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe Hemophilia AStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Clinical Research Organization - JSS Medical Research
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07446010
- Sponsor's protocol ID
- 23153
- Acronym
- HEMOCT INDIA
- Status last verified
- 9 Jan 2026
- First submitted
- 11 Feb 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- Individual data sharing
- No: Currently, there is no established plan for the sharing of Individual Patient Data (IPD) from this study. The availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA 'Principles for responsible clinical trial data sharing.' This pertains to the scope, timepoint, and process of data access. As such, Bayer commits to considering requests from qualified researchers for patient- / study-level clinical trial data, and documents from clinical trials involving medicines and indications approved in the US and EU. However, this commitment does not reflect an active IPD sharing plan. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Researchers can use www.vivli.org to request access to IPD and documents from clinical studies to conduct research. Information on Bayer's criteria for listing studies is provided in the member section of the portal.