Brief Title
Research Study to Look at Side Effects During Regular Injection With Factor VIII Medicine Named Turoctocog Alfa for a 8 Weeks Period
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
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.
Study Phase
Phase 4
Study Type
Interventional
Primary Outcome
Occurrence of Confirmed FVIII Inhibitor Development (≥ 0.6 BU)
Secondary Outcome
Incidence of Adverse Drug Reactions (ARs) and Serious Adverse Reactions (SARs)
Condition
Congenital Bleeding Disorder
Intervention
turoctocog alfa
Study Arms / Comparison Groups
Turoctocog alfa
Description: Previously treated moderate or severe haemophilia A patients will receive routine prophylaxis treatment and treatment of bleeding episodes.
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
60
Start Date
March 1, 2018
Completion Date
April 22, 2019
Primary Completion Date
March 25, 2019
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 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
Gender
Male
Ages
12 Years - N/A
Accepts Healthy Volunteers
No
Contacts
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Location Countries
India
Location Countries
India
Administrative Informations
NCT ID
NCT03449342
Organization ID
NN7008-4304
Secondary IDs
2017-002281-46
Responsible Party
Sponsor
Study Sponsor
Novo Nordisk A/S
Study Sponsor
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Verification Date
April 2020