NCT01138501|CompletedPhase 3Results

Safety and Efficacy of Turoctocog Alfa in Previously Treated Male Children With Haemophilia A

guardian™ 3

A Multi-Centre, Open-Label, Non-Controlled Trial on Safety and Efficacy of N8 in Previously Treated Paediatric Patients With Haemophilia A

Novo Nordisk A/S ClinicalTrials.gov

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3 other identifiers

NN7008-3545U1111-1113-71822009-016383-36

Study Type

interventional

Target

Locations

13 countries

Sites

Timeline

RegisteredJun 2010

StartedJun 2010

CompletionNov 2011

Brief Summary

This trial is conducted in Asia, Europe, and North and South America. The aim of this clinical trial is to investigate the safety and efficacy of turoctocog alfa (recombinant factor VIII, rFVIII (N8)) in male previously treated paediatric subjects with haemophilia A.

Trial Health

On Track

Trial Health Score

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

Enrollment

participants targeted

Target at below P25 for phase_3

Timeline

Completed

Started Jun 2010

Geographic Reach

13 countries

38 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

1.4 years study duration

First Submitted

Initial submission to the registry

May 28, 2010

Completed

4 days until next milestone

Study Start

First participant enrolled

June 1, 2010

Completed

6 days until next milestone

First Posted

Study publicly available on registry

June 7, 2010

Completed

1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2011

Completed

2.6 years until next milestone

Results Posted

Study results publicly available

June 11, 2014

Completed

Last Updated

March 17, 2017

Status Verified

February 1, 2017

Enrollment Period

1.4 years

First QC Date

May 28, 2010

Results QC Date

November 14, 2013

Last Update Submit

February 9, 2017

Conditions

Congenital Bleeding Disorder Haemophilia A

Outcome Measures

Primary Outcomes (1)

The Incidence Rate of FVIII Inhibitors (Greater Than or Equal to 0.6 Bethesda Units (BU))
The incidence rate of FVIII inhibitors was calculated by including all patients with inhibitors in the nominator and including all patients with a minimum 50 exposure plus any patients with less than 50 exposures but with inhibitors in denominator.
The adverse events were collected throughout the trial, corresponding to an average of 138 days per subject.

Secondary Outcomes (1)

Frequency of Adverse Events (AEs)
The adverse events were collected throughout the trial, corresponding to an average of 138 days per subject

Study Arms (1)

rFVIII

EXPERIMENTAL

Drug: turoctocog alfa

Interventions

turoctocog alfaDRUG

Subjects will be treated 3 times per week or every second day with intravenous injections of turoctocog alfa. The dose range for preventive treatment is 25-60 IU/kg body weight depending on treatment regimen.

rFVIII

Eligibility Criteria

AgeUp to 11 Years

Sexmale

Healthy VolunteersNo

Age GroupsChild (0-17)

You may qualify if:

Male patients with severe (baseline FVIII less than or equal to 1%) haemophilia A
Age below 12 years and weight at least 11 kg

You may not qualify if:

Surgery planned to occur during trial participation (exceptions are port placement, dental extractions, and minor, uncomplicated emergent procedures)
Congenital or acquired coagulation disorders other than haemophilia A
Any history of FVIII inhibitors (greater than or equal to 0.6 BU/mL)

Contact the study team to confirm eligibility.