Efficacy and safety of NNC 0078-0000-0007 in patients with congenital haemophilia and inhibitors
- Conditions
- Health Condition 1: D50-D89- Diseases of the blood and blood-forming organs and certain disorders involving the immune mechanismHealth Condition 2: null- Male patient with clinical diagnosis of congenital haemophilia A or B and inhibitors to coagulation factors VIII or IX
- Registration Number
- CTRI/2011/12/002283
- Lead Sponsor
- ovo Nordisk India Private Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Other (Terminated)
- Sex
- Not specified
- Target Recruitment
- 0
Male patient with clinical diagnosis of congenital haemophilia A or B and inhibitors to coagulation factors VIII or IX
-Minimum of five bleeds requiring haemostatic drug treatment within the previous 12 months at trial start
-Previous participation in this trial defined as withdrawal after administration of trial product
-Patient has received an investigational medicinal product within 30 days prior to this trial
-Congenital or acquired coagulation disorders other than haemophilia A or B
-Any clinical signs or known history of arterial thrombotic events or of deep venous thrombosis or pulmonary embolism (as defined by available medical records)
-Platelet count of less than 50,000 platelets/mcL (at the screening visit)
-ALAT (alanine-transaminase) of more than 3 times the upper normal limit (according to laboratory reference ranges)
-Factor VIII/IX Immune Tolerance Induction regimen planned to occur during the trial
-Ongoing bleeding prophylaxis regimens or planned bleeding prophylaxis to occur during the trial
-HIV (Human Immunodeficiency Virus) positive with current CD4+ count of less than 200/mcL (defined by medical records)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Effective bleeding control defined as no additional haemostatic medication (other than trial product) givenTimepoint: within 12 hours of first trial product administration <br/ ><br>
- Secondary Outcome Measures
Name Time Method -Effective and sustained bleeding control <br/ ><br>-Number of doses of trial product given for each acute bleed <br/ ><br>-Number of adverse events <br/ ><br>-ImmunogenicityTimepoint: -up to 48 hours after first trial product administration <br/ ><br>-up to 6 hours after first trial product administration <br/ ><br>-after approximately 21 months (at end of trial) <br/ ><br>-after approximately 21 months (at end of trial)