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Research Study to Look at Side Effects During Regular Injection With Factor VIII Medicine Named Turoctocog Alfa for a 8 Weeks Period (guardian 10)

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ClinicalTrials.gov Identifier: NCT03449342
Recruitment Status : Active, not recruiting
First Posted : February 28, 2018
Last Update Posted : March 14, 2019
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Brief Summary:
This study will test the well-known medicine turoctocog alfa for any side effects. The purpose is to test turoctocog alfa for any side effects in the Indian population. The participants will get turoctocog alfa. Turoctocog alfa is already a well-known medicine in India, and can be prescribed by the study doctor. The participants will get an injection every second day or 3 times per week. This is decided by the study doctor. The study doctor will decide the amount and how often the participants must take the medicine. The study will last for about 16 weeks. The participants will have 5 visits with the study doctor. If the participants agree to participate in this study, the participants will receive the first injection at the second visit, thereafter the participants will be trained to do the injection by themself.

Condition or disease Intervention/treatment Phase
Congenital Bleeding Disorder Haemophilia A Drug: turoctocog alfa Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety of Turoctocog Alfa for Prophylaxis and Treatment of Bleeding Episodes in Previously Treated Patients With Moderate or Severe Haemophilia A in India
Actual Study Start Date : March 1, 2018
Estimated Primary Completion Date : March 25, 2019
Estimated Study Completion Date : April 22, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding Hemophilia

Arm Intervention/treatment
Experimental: Turoctocog alfa
Previously treated moderate or severe haemophilia A patients will receive routine prophylaxis treatment and treatment of bleeding episodes.
Drug: turoctocog alfa
Patients will receive standard prophylaxis treatment and treatment of bleeding episodes, according to label. Trial product will be administered as intravenous injections (i.v.)




Primary Outcome Measures :
  1. Occurrence of confirmed FVIII inhibitor development (above or equal to 0.6 BU) [ Time Frame: Weeks 0-8 ]
    Count of presence of inhibitors


Secondary Outcome Measures :
  1. Frequency of adverse drug reactions (AR) [ Time Frame: Weeks 0-12 ]
    Count and % of events

  2. Frequency of serious adverse reactions (SAR) [ Time Frame: Weeks 0-12 ]
    Count and % of events

  3. Successful haemostatic effect of turoctocog alfa [ Time Frame: Weeks 0-8 ]
    Number of bleeds with response (success/failure)

  4. Total annualised consumption of turoctocog alfa [ Time Frame: Weeks 0-8 ]
    Measured in standardised units

  5. Frequency of allergic or infusion reactions related to the trial product [ Time Frame: Weeks 0-12 ]
    Count and % of events



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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 suitability for the trial - Male, age above or equal to 12 years at the time of signing informed consent - Patients with the diagnosis of congenital moderate or severe Haemophilia A based on medical records. (FVIII below or equal to 5%) - Documented history of at least 150 EDs (exposure days) to FVIII containing products Exclusion Criteria: - Confirmed inhibitors to FVIII (above or equal to 0.6 BU) at screening as assessed by central laboratory - History of FVIII inhibitors - Known or suspected hypersensitivity to trial product(s) or related products - Previous participation in this trial. Participation is defined as signed informed consent - Participation in any clinical trial of an approved or non-approved investigational medicinal product within 1 month before screening (visit 1) - Any disorder, except for conditions associated with haemophilia A, which in the investigator's opinion might jeopardise patient's safety or compliance with the protocol - Immunocompromised patients due to HIV infection (defined as viral load above or equal to 400.000 copies/mL and/or CD4+ lymphocyte count below or equal to 200/μL). HIV status and CD4+ lymphocyte count /viral load results may be obtained at screening or from available medical records; results must be not older than 6 months - Known congenital or acquired coagulation disorders other than haemophilia A - Mental incapacity, unwillingness to cooperate, or a language barrier precluding adequate understanding and cooperation

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): NCT03449342


Locations
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India
Novo Nordisk Investigational Site
Bangalore, Karnataka, India, 560034
Novo Nordisk Investigational Site
Cochin, Kerala, India, 682041
Novo Nordisk Investigational Site
Mumbai, Maharashtra, India, 400012
Novo Nordisk Investigational Site
Pune, Maharashtra, India, 411004
Novo Nordisk Investigational Site
New Dehli, New Delhi, India, 110029
Novo Nordisk Investigational Site
Ludhiana, Punjab, India, 141008
Novo Nordisk Investigational Site
Vellore, Tamil Nadu, India, 632004
Novo Nordisk Investigational Site
Kolkata, West Bengal, India, 70014
Novo Nordisk Investigational Site
Kolkatta, West Bengal, India, 70014
Novo Nordisk Investigational Site
New Delhi, India, 110029
Sponsors and Collaborators
Novo Nordisk A/S

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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT03449342     History of Changes
Other Study ID Numbers: NN7008-4304
2017-002281-46 ( Registry Identifier: EudraCT )
U1111-1179-5950 ( Other Identifier: World Health organization (WHO) )
First Posted: February 28, 2018    Key Record Dates
Last Update Posted: March 14, 2019
Last Verified: March 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: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

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