NCT02035384|Completed

Safety and Efficacy of Turoctocog Alfa During Long-Term Treatment of Severe and Moderately Severe Haemophilia A

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A Multi-centre Non-interventional Study of Safety and Efficacy of Turoctocog Alfa (rFVIII) During Long-Term Treatment of Severe and Moderately Severe Haemophilia A (FVIII =<2%)

Novo Nordisk A/S ClinicalTrials.gov

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3 other identifiers

NN7008-3553U1111-1126-0353ENCEPP/SDPP/5501

Study Type

observational

Target

Locations

14 countries

Sites

Timeline

RegisteredJan 2014

StartedJun 2014

CompletionJan 2020

Brief Summary

This study is conducted in Europe, and North and South America. The aim of this study is to provide additional documentation of the immunogenicity, and obtain additional clinical data, of turoctocog alfa in the setting of normal clinical practise in patients previously treated with a factor VIII agent (FVIII).

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P25-P50 for all trials

Timeline

Completed

Started Jun 2014

Longer than P75 for all trials

Geographic Reach

14 countries

39 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

5.6 years study duration

First Submitted

Initial submission to the registry

January 10, 2014

Completed

4 days until next milestone

First Posted

Study publicly available on registry

January 14, 2014

Completed

5 months until next milestone

Study Start

First participant enrolled

June 5, 2014

Completed

5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2020

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2020

Completed

Last Updated

April 27, 2020

Status Verified

April 1, 2020

Enrollment Period

5.6 years

First QC Date

January 10, 2014

Last Update Submit

April 24, 2020

Conditions

Congenital Bleeding Disorder Haemophilia A

Outcome Measures

Primary Outcomes (1)

Incidence rate of FVIII inhibitors (at least 0.6 Bethesda Units (BU) for central laboratory analyses, or above the specific local laboratory reference range) represented as the percentage of patients developing inhibitors
Within approximately 7 years

Secondary Outcomes (6)

Number of adverse reactions reported
During approximately 7 years
Number of serious adverse reactions reported
During approximately 7 years
Haemostatic effect of turoctocog alfa in the treatment of bleeds as assessed by the patient or the physician according to a predefined four point scale: Excellent, Good, Moderate, or None
Within approximately 7 years
Haemostatic effect of turoctocog alfa during surgical procedures as assessed by an evaluation according to a predefined four point scale: Excellent, Good, Moderate, or None
Within approximately 7 years
Annualised bleeding rate for patients using turoctocog alfa for preventive treatment
Within approximately 7 years
+1 more secondary outcomes

Study Arms (1)

All patients

Drug: turoctocog alfa

Interventions

turoctocog alfaDRUG

Patients will be treated with commercially available turoctocog alfa as prescribed by the treating physician in clinical daily practice and preferably according to the label for turoctocog alfa in the respective countries.

All patients

Eligibility Criteria

Sexmale

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

Sampling MethodProbability Sample

Study Population

Previously FVIII treated (more than 150 exposure days) patients with severe and moderately severe haemophilia A with FVIII below or equal to 2%.

You may qualify if:

Informed consent obtained before any study-related activities. Study-related activities are any procedure related to recording of data according to the protocol
Previously FVIII treated (150 exposure days at the time of first dosing with turoctocog alfa) male patients with the diagnosis of severe and moderately severe haemophilia A (FVIII below or equal to 2%)
The decision to initiate treatment with commercially available turoctocog alfa has been made by the patient/parent and the patient's treating physician before and independently from the decision to include the patient in this study
A negative FVIII inhibitor test obtained not more than four weeks prior to first dosing with turoctocog alfa

You may not qualify if:

Contraindications for use according to the approved product information text (US Package insert (PI), European Summary of Product Characteristics (SmPC), or corresponding local prescribing information)
Treatment with any investigational drug within 30 days prior to enrolment into the study
Previous participation in any clinical trial with turoctocog alfa
Treatment with other FVIII products after initiation of treatment with turoctocog alfa

Contact the study team to confirm eligibility.