Health Condition 1: D70-D77- Other disorders of blood and blood-forming organs Health Condition 2: null- Patients with the diagnosis of congenital moderate or severe Haemophilia A
Conditions
Interventions
Intervention1: novoeight: Turoctocog alfa (Investigational medicinal product,IMP), test product, 2000 IU/vial, Powder for
solution for injection,Intravenous
injection, Vial
Sodium chloride, 0.9%, Sol
Sponsors
Novo Nordisk India Private Ltd
Eligibility
Inclusion criteria
Inclusion criteria: For an eligible patient, all inclusion criteria must be answered â??yesâ??. 1. Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial. 2. Male, age above or equal to 12 years at the time of signing informed consent. 3. Patients with the diagnosis of congenital moderate or severe Haemophilia A based on medical records. (FVIII is less than or equal to 5%). 4. Documented history of at least 150 EDs to FVIII containing products.
Exclusion criteria
Exclusion criteria: For an eligible patient, all exclusion criteria must be answered â??noâ??. 1. Confirmed inhibitors to FVIII (is greater than or equal to 0.6 BU) at screening as assessed by central laboratory. 2. History of FVIII inhibitors. 3. Known or suspected hypersensitivity to trial product(s) or related products. 4. Previous participation in this trial. Participation is defined as signed informed consent. 5. Participation in any clinical trial of an approved or non-approved investigational medicinal product within 1 month before screening (visit 1). 6. Any disorder, except for conditions associated with haemophilia A, which in the investigatorâ??s opinion might jeopardise patientâ??s safety or compliance with the protocol. 7. Immunocompromised patients due to HIV infection (defined as viral load is greater than or equal to 400.000 copies/mL and/or CD4+ lymphocyte count is less than or equal to 200/microL). HIV status and CD4+ lymphocyte count /viral load results may be obtained at screening or from available medical records; results must be not older than 6 months. 8. Known congenital or acquired coagulation disorders other than haemophilia A. 9. Mental incapacity, unwillingness to cooperate, or a language barrier precluding adequate understanding and cooperation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Occurrence of confirmed FVIII inhibitor development (is greater than or equal to 0.6 BU) during 8 weeks of treatment.Timepoint: 8 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Frequency of adverse drug reactions (AR) and serious adverse reactions (SAR) reported until follow-up, 12 weeks after first treatmentTimepoint: 12 weeks;Frequency of allergic or infusion reactions related to the trial product reported until follow-up,12 weeks after first treatmentTimepoint: 12 weeks;Successful haemostatic effect of turoctocog alfa in the treatment of bleeding episodes during 8 weeks of treatmentTimepoint: 8 weeks;Total annualised consumption of turoctocog alfa measured during the 8 weeks of treatmentTimepoint: 8 weeks | — |
Countries
India
Contacts
Public ContactDr Anil N Shinde
Novo Nordisk India Private Ltd
Outcome results
None listed