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Adverse Event Data Collection From the EUHASS Registry on Turoctocog Alfa Pegol

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: NCT04682145
Recruitment Status : Enrolling by invitation
First Posted : December 23, 2020
Last Update Posted : December 23, 2020
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Tracking Information
First Submitted Date December 22, 2020
First Posted Date December 23, 2020
Last Update Posted Date December 23, 2020
Actual Study Start Date December 9, 2020
Estimated Primary Completion Date April 1, 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 22, 2020)
Adverse events (AEs) reported to the registry with suspected relation to turoctocog alfa pegol, Adverse Drug Reactions (ADRs), in patients with haemophilia A for renal, hepatic and neurological events. [ Time Frame: From start to end of data collection (December 2019 to January 2025) ]
Count
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: December 22, 2020)
Other AEs reported to the registry during the study period with suspected relation to turoctocog alfa pegol in patients with haemophilia A [ Time Frame: From start to end of data collection (December 2019 to January 2025) ]
Count. Includes ADRs of special interest (de novo FVIII inhibitors equal to or above 0.6 Bethesda Units (BU)); anaphylaxis and other allergic reactions; thromboembolic events).
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Adverse Event Data Collection From the EUHASS Registry on Turoctocog Alfa Pegol
Official Title Adverse Event Data Collection From the EUHASS Registry on Turoctocog Alfa Pegol
Brief Summary This non-interventional study concerns a safety data collection based on adverse event data from a third-party registry (European Haemophilia Safety Surveillance System, EUHASS) that includes information about adverse events from patients with haemophilia A treated with turoctocog alfapegol. There is no extra burden to the patients by participating in this registry-based data collection.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population All patients with haemophilia A treated with turoctocog alfa pegol and reporting adverse events to EUHASS.
Condition Haemophilia A
Intervention Drug: Turoctocog alfa pegol
Patients will be treated with commercially available turoctocog alfa pegol according to routine clinical practice at the discretion of the treating physician. A decision to initiate treatment with commercially available turoctocog alfa pegol 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 the registry in scope.
Study Groups/Cohorts Haemophilia A patients
All patients with haemophilia A treated with turoctocog alfa pegol and reporting adverse events to EUHASS
Intervention: Drug: Turoctocog alfa pegol
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Enrolling by invitation
Estimated Enrollment
 (submitted: December 22, 2020)
50
Original Estimated Enrollment Same as current
Estimated Study Completion Date April 1, 2025
Estimated Primary Completion Date April 1, 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Participation in the European Haemophilia Safety Surveillance System (EUHASS).

Exclusion Criteria:

  • N/A
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Denmark
Removed Location Countries  
 
Administrative Information
NCT Number NCT04682145
Other Study ID Numbers NN7088-4557
U1111-1235-5939 ( Other Identifier: World Health Organization (WHO) )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Yes
Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
URL: http://novonordisk-trials.com
Responsible Party Novo Nordisk A/S
Study Sponsor Novo Nordisk A/S
Collaborators Not Provided
Investigators
Study Director: Clinical Reporting Anchor & Disclosure (1452) Novo Nordisk A/S
PRS Account Novo Nordisk A/S
Verification Date December 2020