None listed
Conditions
Interventions
Intervention1: Factocel VIII 250 I.U: Dose will be 50 IU/kg by drip-infusion at a rate not exceeding 5 ml/min
Control Intervention1: NIL: NIL
Sponsors
Celestial Biologics Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Moderate to severe Haemophilia A (defined as ≤ 5% of normal factor VIII) 2. Age ≥ 18 years 3. Absence of FVIII infusion within 7 days prior to enrollment in the study 4. No current bleeding 5. Patient able to provide written informed consent
Exclusion criteria
Exclusion criteria: 1. Any haemorrhagic disorder other than Haemophilia A. 2. Past or present history of FVIII inhibitors 3. History of anaphylactic reaction to human FVIII 4. Major renal or hepatic dysfunction, 5. Participation in a clinical trial within 30 days prior to recruitment and during the study, in another investigational drug study that clinically interferes with the study endpoints 6. Any clinically significant disorder which could affect the evaluation or the patient?s safety.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the in-vivo recovery of the Factocel VIII 250 I.U. in patients with moderate to severe Haemophilia ATimepoint: NA | — |
Secondary
| Measure | Time frame |
|---|---|
| NILTimepoint: NIL | — |
Countries
India
Contacts
Public ContactDr Vimal Sanghavi
Outcome results
None listed