Brief Title
A Trial Evaluating Efficacy and Safety of Prophylactic Administration of Concizumab in Patients With Severe Haemophilia A Without Inhibitors
Official Title
A Multi-Centre Trial Evaluating Efficacy and Safety of Prophylactic Administration of Concizumab in Patients With Severe Haemophilia A Without Inhibitors
Brief Summary
This trial is conducted in Asia, Europe and the United States of America (USA). The aim of the trial is to assess the efficacy of concizumab administered s.c. (subcutaneously, under the skin) once daily in preventing bleeding episodes in patients with severe haemophilia A without inhibitors.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
The Number of Bleeding Episodes During at Least 24 Weeks From Treatment Onset
Secondary Outcome
The Number of Bleeding Episodes During at Least 76 Weeks From Treatment Onset
Condition
Haemostasis
Intervention
Concizumab
Study Arms / Comparison Groups
Concizumab
Description: Daily administration of concizumab to both on-demand and prophylaxis patients
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
36
Start Date
August 16, 2017
Completion Date
June 3, 2020
Primary Completion Date
June 22, 2018
Eligibility Criteria
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 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
Gender
Male
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
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Location Countries
France
Location Countries
France
Administrative Informations
NCT ID
NCT03196297
Organization ID
NN7415-4255
Secondary IDs
U1111-1179-3872
Responsible Party
Sponsor
Study Sponsor
Novo Nordisk A/S
Study Sponsor
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Verification Date
November 2021