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Efficacy and Safety of Turoctocog Alfa for Prophylaxis and Treatment of Bleeding Episodes in Previously Treated Chinese Patients With Haemophilia A (guardian TM 7)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02938585
Recruitment Status : Completed
First Posted : October 19, 2016
Last Update Posted : January 25, 2019
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

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%).

Condition or disease Intervention/treatment Phase
Congenital Bleeding Disorder Haemophilia A Drug: turoctocog alfa Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 68 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Turoctocog Alfa for Prophylaxis and Treatment of Bleeding Episodes in Previously Treated Chinese Patients With Haemophilia A
Actual Study Start Date : December 12, 2016
Actual Primary Completion Date : March 16, 2018
Actual Study Completion Date : December 12, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding Hemophilia

Arm Intervention/treatment
Experimental: Prophylactic treatment Drug: 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.

Experimental: On-demand treatment Drug: turoctocog alfa
Treatment is administered intravenously (i.v.) during bleeds and occasionally as a preventative treatment (e.g. before physical activity)




Primary Outcome Measures :
  1. Haemostatic effect of turoctocog alfa (none, moderate, good or excellent) in treatment of bleeds [ Time Frame: 24 months ]
    Haemostatic effect of turoctocog alfa when used for treatment of bleeds, assessed on a fourpoint scale for haemostatic response (excellent, good, moderate and none) during the trial period of 24 months


Secondary Outcome Measures :
  1. Incidence rate of inhibitory antibodies against FVIII [ Time Frame: 24 months ]
    Incidence rate of inhibitory antibodies against FVIII (≥0.6 Bethesda unit (BU)) during the trial period of 24 months

  2. Number of bleeds (total bleeds assessed as annual bleeding rate) per patient [ Time Frame: 24 months ]
    Number of bleeds (total bleeds assessed as annual bleeding rate) per patient during the trial period of 24 months

  3. Consumption of turoctocog alfa for bleeding treatment [ Time Frame: 24 months ]
    Consumption of turoctocog alfa for bleeding treatment (average dose to treat a bleed, number of injections and IU/kg per bleed)

  4. Consumption of turoctocog alfa during prophylaxis treatment [ Time Frame: 24 months ]
    Consumption of turoctocog alfa during prophylaxis treatment (average prophylaxis dose and IU/kg per month and per year) per patient

  5. Total consumption of turoctocog alfa [ Time Frame: 24 months ]
    Total consumption of turoctocog alfa (IU/kg per month and per year) per patient

  6. Frequency of adverse events (AEs) and serious adverse events (SAEs) [ Time Frame: 24 months ]
    Frequency of adverse events (AEs) and serious adverse events (SAEs) reported during the trial period of 24 months



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02938585


Locations
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China, Beijing
Novo Nordisk Investigational Site
Beijing, Beijing, China, 100045
China, Chongqing
Novo Nordisk Investigational Site
Chonqqing, Chongqing, China, 400014
China, Fujian
Novo Nordisk Investigational Site
Fuzhou, Fujian, China, 350001
China, Guangdong
Novo Nordisk Investigational Site
Guangzhou, Guangdong, China, 510515
China, Guizhou
Novo Nordisk Investigational Site
Guiyang, Guizhou, China, 550004
China, Hubei
Novo Nordisk Investigational Site
Wuhan, Hubei, China, 430030
China, Qinghai
Novo Nordisk Investigational Site
Xining, Qinghai, China, 810007
China, Shanghai
Novo Nordisk Investigational Site
Shanghai, Shanghai, China, 200025
China, Tianjin
Novo Nordisk Investigational Site
Tianjing, Tianjin, China, 300020
China, Yunnan
Novo Nordisk Investigational Site
Kunming, Yunnan, China, 650032
China, Zhejiang
Novo Nordisk Investigational Site
Hangzhou, Zhejiang, China, 310003
Sponsors and Collaborators
Novo Nordisk A/S

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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT02938585     History of Changes
Other Study ID Numbers: NN7008-4028
U1111-1150-0765 ( Other Identifier: WHO )
CTR20160811 ( Other Identifier: CFDA )
2013-004791-35 ( Registry Identifier: European Medicines Agency (EudraCT) )
First Posted: October 19, 2016    Key Record Dates
Last Update Posted: January 25, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Hemorrhage
Hemophilia A
Blood Coagulation Disorders
Hemostatic Disorders
Pathologic Processes
Blood Coagulation Disorders, Inherited
Hematologic Diseases
Coagulation Protein Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn
Vascular Diseases
Cardiovascular Diseases
Factor VIII
Coagulants