Study Investigating Novoeight®/NovoEight® (Turoctocog Alfa) in Mexican Haemophilia A Patients


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Verified June 2017 by Novo Nordisk A/S

Sponsor:

Information provided by (Responsible Party):

Novo Nordisk A/S

ClinicalTrials.gov Identifier:

NCT03179748

First received: May 24, 2017

Last updated: June 6, 2017

Last verified: June 2017

The trial is conducted in North America. The aim of the trial is to assess the safety of turoctocog alfa under conditions of routine clinical care in patients with haemophilia A in Mexico

Congenital Bleeding Disorder
Haemophilia A
Drug: turoctocog alfa

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Non-interventional, Multi-Centre, Post-Authorisation Safety Study With Novoeight®/NovoEight® (Turoctocog Alfa) in Mexican Haemophilia A Patients

Primary Outcome Measures:

  • Frequency of adverse reactions [ Time Frame: 3-36 months after enrollment ]

    Count and % of events

Secondary Outcome Measures:

  • Frequency of adverse events [ Time Frame: 3-36 months after enrollment ]

    Count and % of events

  • Efficacy in treatment of bleeds [ Time Frame: 3-36 months after enrollment ]

    Rated: Excellent, Good, Moderate or none

  • Consumption of turoctocog alfa for prophylaxis [ Time Frame: 3-36 months after enrollment ]

    Measured in IU/kg/dose

  • Consumption of turoctocog alfa for treatment of bleeds [ Time Frame: 3-36 months after enrollment ]

    Measured in IU/kg/bleeding episode

  • Consumption of turoctocog alfa for surgery and post-surgical period [ Time Frame: 3-36 months after enrollment ]

    Measured in IU/kg

  • Number of patients with confirmed inhibitors [ Time Frame: 3-36 months after enrollment ]

    Count of presence of inhibitors

  • Number of patients with allergic/hypersensitivity reactions to turoctocog alfa [ Time Frame: 3-36 months after enrollment ]

    Count of episodes

  • Number of bleeding episodes [ Time Frame: 3-36 months after enrollment ]

    Count of episodes

Estimated Enrollment: 8
Anticipated Study Start Date: June 15, 2017
Estimated Study Completion Date: June 1, 2020
Estimated Primary Completion Date: May 31, 2020 (Final data collection date for primary outcome measure)
turoctocog alfa Drug: turoctocog alfa

Patients will be treated with commercially available turoctocog alfa according to local clinical practice at the discretion of the physician

Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample

The study population are haemophilia A patients who based on the indication will benefit from treatment with turoctocog alfa. No limitation has been set to the severity of haemophilia A, gender, age, previously treated and untreated patients.

Inclusion Criteria:

  • Signed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol)
  • Male and female patients with haemophilia A
  • Age range is 0 years and above
  • The decision to initiate treatment with commercially available turoctocog alfa has been made by the patient/Legally Acceptable Representative (LAR) and the treating physician before and independently from the decision to include the patient in this study

Exclusion Criteria:

  • Previous participation in this study. Participation is defined as having given informed consent in this study
  • Known or suspected allergy to turoctocog alfa or related products
  • Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03179748

Novo Nordisk A/S

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT03179748     History of Changes
Other Study ID Numbers: NN7008-4253
U1111-1171-9845 ( Other Identifier: World Health Organization (WHO) )
Study First Received: May 24, 2017
Last Updated: June 6, 2017
Individual Participant Data  
Plan to Share IPD: Yes
Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Additional relevant MeSH terms:

Hemophilia A
Blood Coagulation Disorders
Hemostatic Disorders
Blood Coagulation Disorders, Inherited
Hematologic Diseases
Coagulation Protein Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn
Vascular Diseases
Cardiovascular Diseases
Factor VIII
Coagulants

ClinicalTrials.gov processed this record on June 07, 2017