Health Condition 1: D66- Hereditary factor VIII deficiency
Conditions
Interventions
Intervention1: Nuwiq: Prevention of bleeding in patients with severe haemophilia A undergoing major surgery while receiving emicizumab prophylaxis.Nuwiq will be administered intravenously. Dosing will
Sponsors
Allucent India Private Limited
Allucent India Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1)Severe haemophilia A (FVIII activity [FVIII:C] less than 1%) according to medical history 2)Male patients at least 12 years of age 3)Previous treatment with any FVIII product(s) for at least 150 exposure days 4)On regular prophylaxis with emicizumab for at least 1 month prior to a scheduled major elective surgery requiring FVIII treatment 5)Freely given written informed consent of the patient, or parent or legal representative where applicable, obtained in accordance with local regulations Surgery is defined as major if any of the following criteria are met: Requiring general or spinal anaesthesia Requiring opening into the great body cavities Orthopaedic interventions involving joints (ankle, knee, hip, wrist, elbow, shoulder) Surgeries or conditions in which the patients life is at stake
Exclusion criteria
Exclusion criteria: 1)Coagulation disorder other than haemophilia A 2)Present or past FVIII inhibitor (morethan or equal to 0.6 Bethesda units [BU]per mL) according to medical history 3)Severe liver or kidney disease (alanine aminotransferase [ALT] and or aspartate aminotransferase [AST] levels more than 5 times the upper limit of normal; or creatinine more than 120 µmolperL) 4)Known hypersensitivity to Nuwiqs active substance or its excipients (sucrose, sodium chloride, calcium chloride dihydrate, arginine hydrochloride, sodium citrate dihydrate, poloxamer 188) 5)Already had surgery in this study 6)Current participation in another interventional clinical trial 7)Treatment with any investigational medicinal product (IMP) within 30 days prior to screening visit
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The overall haemostatic efficacy of Nuwiq in severe haemophilia A patients receiving emicizumab prophylaxis and undergoing major surgery. Efficacy will be assessed at the end of surgery by the surgeon and at the end of the POP (up to 24 hours after the last injection of Nuwiq) by the investigator (haematologist) using a 4 point ordinal haemostatic efficacy scale. Overall haemostatic efficacy will be adjudicated by the Independent Data Monitoring Committee using a predefined algorithm. Timepoint: During surgery and up to 24 hours after last injection of Nuwiq | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary endpoints of this study are: 1) Assessment of intraoperative haemostatic efficacy of Nuwiq using a 4 point ordinal scale 2) Assessment of postoperative haemostatic efficacy of Nuwiq using a 4 point ordinal scale 3) Number of allogeneic blood products (red blood cells, platelets, & other blood products) transfused. 4) Perioperative FVIII plasma levels immediately before & after Nuwiq injections 5) Perioperative TG immediately before & after Nuwiq injections 6) Perioperative haemostatic efficacy assessed using the 4 point scale recommended by the WFH 7) Incidence of adverse events (AEs) 8) Incidence of thrombotic events 9) Incidence of FVIII inhibitor formation Timepoint: 1) During surgery: From first skin incision to last suture 2) From end of surgery until 24 hours after the last injection of Nuwiq 3) From day of surgery until 24 hours after the last injection of Nuwiq 4) Less than 30 minutes before & less than 30 minutes after Nuwiq injection 5) Less than 30 minutes before & less than 30 minutes after Nuwiq injection 6) Perioperative 7) 8) 9) From start of first Nuwiq injection to 30 days following the surgical procedure | — |
Countries
Croatia, Finland, France, Germany, India, Italy, Macedonia, Serbia, Spain, United Kingdom, United States of America
Contacts
Public ContactSiva Subramanian
Allucent India Pvt Ltd
Outcome results
None listed