A Trial Evaluating Efficacy and Safety of Prophylactic Administration of Concizumab in Patients with Severe Haemophilia A without Inhibitors

Phase 1

• Conditions: Haemophilia A; MedDRA version: 20.0 Level: LLT Classification code 10018938 Term: Haemophilia A (Factor VIII) System Organ Class: 100000004850; Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]

• Registration Number: EUCTR2016-000614-29-DE
• Lead Sponsor: ovo Nordisk A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-06-02
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 33

Inclusion Criteria

- 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 the suitability for the trial
- Male patients aged 18 years or older at the time of signing informed consent, diagnosed with severe haemophilia A (FVIII activity below 1%), based on medical records or results at screening
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 3

Exclusion Criteria

- Known or suspected hypersensitivity to trial product(s) or related products
- Known inherited or acquired bleeding disorder other than haemophilia A
- Presence of inhibitors (neutralising antibodies) to Factor VIII (equal to or above 0.6 Bethesda Units) at screening measured by the Nijmegen method

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the efficacy of concizumab administered s.c. once daily in preventing bleeding episodes in patients with severe haemophilia A without inhibitors;Primary end point(s): The number of bleeding episodes;<br> Secondary Objective: - To assess the longer-term efficacy of concizumab in patients with severe haemophilia A without inhibitors<br> - To assess the safety of concizumab in patients with severe haemophilia A without inhibitors <br> - To assess the immunogenicity of concizumab in patients with severe haemophilia A without inhibitors<br> ;Timepoint(s) of evaluation of this end point: During at least 24 weeks from treatment onset

Secondary Outcome Measures

Name	Time	Method
<br> Secondary end point(s): 1. The number of spontaneous bleeding episodes <br> 2. The number of treatment emergent adverse events (TEAEs)<br> ;Timepoint(s) of evaluation of this end point: 1.+ 2. During at least 24 weeks from treatment onset