Efficacy and Safety of Turoctocog Alfa for Prophylaxis and Treatment of Bleeding Episodes in Previously Treated Chinese Patients With Haemophilia A
NCT ID: NCT02938585
Last Updated: 2020-07-27
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
68 participants
INTERVENTIONAL
2016-12-12
2018-12-12
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Prophylactic treatment
turoctocog alfa
The preventative treatment is administered intravenously (i.v.) at specific intervals either every second day or three times a week. Bleeding treatment will be administered if a bleed should occur.
On-demand treatment
turoctocog alfa
Treatment is administered intravenously (i.v.) during bleeds and occasionally as a preventative treatment (e.g. before physical activity)
Interventions
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turoctocog alfa
The preventative treatment is administered intravenously (i.v.) at specific intervals either every second day or three times a week. Bleeding treatment will be administered if a bleed should occur.
turoctocog alfa
Treatment is administered intravenously (i.v.) during bleeds and occasionally as a preventative treatment (e.g. before physical activity)
Eligibility Criteria
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Inclusion Criteria
* 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
* Known history of FVIII inhibitors
MALE
No
Sponsors
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Novo Nordisk A/S
INDUSTRY
Responsible Party
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Locations
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Novo Nordisk Investigational Site
Beijing, Beijing Municipality, China
Novo Nordisk Investigational Site
Chonqqing, Chongqing Municipality, China
Novo Nordisk Investigational Site
Fuzhou, Fujian, China
Novo Nordisk Investigational Site
Guangzhou, Guangdong, China
Novo Nordisk Investigational Site
Guiyang, Guizhou, China
Novo Nordisk Investigational Site
Wuhan, Hubei, China
Novo Nordisk Investigational Site
Xining, Qinghai, China
Novo Nordisk Investigational Site
Shanghai, Shanghai Municipality, China
Novo Nordisk Investigational Site
Tianjin, Tianjin Municipality, China
Novo Nordisk Investigational Site
Kunming, Yunnan, China
Novo Nordisk Investigational Site
Hangzhou, Zhejiang, China
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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U1111-1150-0765
Identifier Type: OTHER
Identifier Source: secondary_id
CTR20160811
Identifier Type: OTHER
Identifier Source: secondary_id
2013-004791-35
Identifier Type: REGISTRY
Identifier Source: secondary_id
NN7008-4028
Identifier Type: -
Identifier Source: org_study_id
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