NCT00840086|CompletedPhase 3Results

Safety and Efficacy of Turoctocog Alfa in Haemophilia A Subjects

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A Multi-centre, Open-label, Non-controlled Trial on Safety and Efficacy of N8 in Prevention and Treatment of Bleeds in Previously Treated Subjects With Haemophilia A. Sub-trial: Safety and Efficacy of N8 in Prevention and Treatment of Bleeding During Surgical Procedures in Subjects With Haemophilia A

Novo Nordisk A/S ClinicalTrials.gov

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3 other identifiers

NN7008-35432008-003960-20101151

Study Type

interventional

Target

150

Locations

17 countries

Sites

Timeline

RegisteredFeb 2009

StartedApr 2009

CompletionSep 2011

Brief Summary

This trial is conducted in Asia, Europe, and North and South America. The trial consists of a main trial and a sub-trial. The main trial investigates safety and efficacy of turoctocog alfa (recombinant factor VIII, rFVIII (N8)) in haemophilia A subjects, while the sub-trial investigates safety and efficacy of turoctocog alfa in prevention and treatment of bleeding episodes during surgical procedures.

Trial Health

On Track

Trial Health Score

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

Enrollment

150

participants targeted

Target at P25-P50 for phase_3

Timeline

Completed

Started Apr 2009

Geographic Reach

17 countries

59 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

2.4 years study duration

First Submitted

Initial submission to the registry

February 6, 2009

Completed

4 days until next milestone

First Posted

Study publicly available on registry

February 10, 2009

Completed

2 months until next milestone

Study Start

First participant enrolled

April 1, 2009

Completed

2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed

3 years until next milestone

Results Posted

Study results publicly available

September 4, 2014

Completed

Last Updated

March 17, 2017

Status Verified

February 1, 2017

Enrollment Period

2.4 years

First QC Date

February 6, 2009

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 188 days per subject.

Secondary Outcomes (1)

Frequency of Adverse Events (AEs)
The adverse events were collected throughout the trial, corresponding to an average of 188 days per subject

Study Arms (1)

rFVIII

EXPERIMENTAL

Drug: turoctocog alfa

Interventions

turoctocog alfaDRUG

Subjects will receive bleeding preventive treatment (home treatment with self-injection i.v.) with turoctocog alfa at a dose of 20-40 IU/kg body weight every second day or 20-50 IU/kg body weight three times per week at the investigator's discretion.

rFVIII

Eligibility Criteria

Age12 Years - 65 Years

Sexmale

Healthy VolunteersNo

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

You may qualify if:

Male subjects with the diagnosis of severe (FVIII less than or equal to 1%) haemophilia A from age 12 (except for Israel where the age limit will be 18 for the first 10 subjects recruited in the trial) to 56 years having a weight of 10 to 120 kg
Documented history of at least 150 exposure days to any other FVIII products (prevention or treatment of bleeds)
No history of FVIII inhibitors greater than or equal to 0.6 BU/mL. The inhibitor should be measured regularly for at least the last 8 years or since the first treatment of haemophilia A
No detectable inhibitors to FVIII (greater than or equal to 0.6 BU/mL) (as assessed by a Central Laboratory at the time of screening)

You may not qualify if:

Congenital or acquired coagulation disorders other than haemophilia A
Creatinine levels 50% above normal level (as defined by central laboratory range)
Known or suspected allergy to trial product (N8) or related products

Contact the study team to confirm eligibility.