Efficacy and Safety of NNC 0078-0000-0007 in Treatment of Acute Bleeding Episodes in Patients born with Haemophilia and having Inhibitors

• Conditions: Congenital Haemophilia and Inhibitors; MedDRA version: 13.1Level: PTClassification code 10056492Term: Haemophilia A with anti factor VIIISystem Organ Class: 10010331 - Congenital, familial and genetic disorders; MedDRA version: 13.1Level: PTClassification code 10056494Term: Haemophilia B with anti factor IXSystem Organ Class: 10010331 - Congenital, familial and genetic disorders; Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2010-023803-92-GR
• Lead Sponsor: ovo Nordisk A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-05-25
• Last Update Posted: 25 March 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 60

Inclusion Criteria

• 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 entry • 12 years of age or older
Are the trial subjects under 18? yes
Number of subjects for this age range: 10
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

• 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 < 50,000 platelets/µl (at the screening visit) • ALAT > 3 times the upper normal limit (according to laboratory reference ranges) • FVIII/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 positive with current CD4+ count < 200/mL (defined by medical records

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To demonstrate the efficacy of NNC 0078-0000-0007 in controlling acute bleeding episodes in patients with haemophilia and inhibitors.;Secondary Objective: • To confirm the safety of NNC 0078-0000-0007 when administered for treatment of acute bleeds • To evaluate the immunogenicity of NNC 0078-0000-0007 (formation of neutralising antibodies) • To evaluate health economic impact of treatment with NNC 0078-0000-0007;Primary end point(s): Effective bleeding control defined as no additional haemostatic medication (other than<br>trial product) given within 12 hours after first dose of trial product;Timepoint(s) of evaluation of this end point: 12 hours after first dose of trial product administration

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1. Effective and sustained bleeding control<br>2. Number of doses of trial product given for each acute bleed<br>3 Adverse Events and Immunogenicity;Timepoint(s) of evaluation of this end point: 1. after 24 hrs and 48 hrs after trial product administration<br>2. within 9 hrs after first trial product administration<br>3. will be assessed for each patient throughout the trial