Brief Title
Efficacy and Safety of Turoctocog Alfa for Prophylaxis and Treatment of Bleeding Episodes in Previously Treated Chinese Patients With Haemophilia A
Official Title
Efficacy and Safety of Turoctocog Alfa for Prophylaxis and Treatment of Bleeding Episodes in Previously Treated Chinese Patients With Haemophilia A
Brief Summary
This trial is conducted in China. The aim of this trial is to evaluate the clinical efficacy of turoctocog alfa in treatment of bleeding episodes in Chinese patients with severe haemophilia A (FVIII≤1%).
Study Phase
Phase 3
Study Type
Interventional
Primary Outcome
Haemostatic Effect of Turoctocog Alfa (Treatment of Bleeds): 6 Months
Secondary Outcome
Haemostatic Effect of Turoctocog Alfa (Treatment of Bleeds): 24 Months
Condition
Congenital Bleeding Disorder
Intervention
turoctocog alfa
Study Arms / Comparison Groups
Prophylactic treatment
Description:
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
68
Start Date
December 12, 2016
Completion Date
December 12, 2018
Primary Completion Date
March 16, 2018
Eligibility Criteria
Inclusion Criteria: - Male patients - Age from 0 years - With the diagnosis of severe congenital haemophilia A (FVIII≤1%) - History of exposure days (ED) to any FVIII products fulfilling the criteria of previously treated patients: - Patients of 12 years or above: 100 exposures days (ED) or more - Patients below 12 years: 50 exposure days (ED) or more Exclusion Criteria: - Inhibitors to factor VIII (≥0.6 BU) at screening as assessed by central laboratory - Known history of FVIII inhibitors
Gender
Male
Ages
N/A - N/A
Accepts Healthy Volunteers
No
Contacts
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Location Countries
China
Location Countries
China
Administrative Informations
NCT ID
NCT02938585
Organization ID
NN7008-4028
Secondary IDs
U1111-1150-0765
Responsible Party
Sponsor
Study Sponsor
Novo Nordisk A/S
Study Sponsor
, ,
Verification Date
July 2020