NCT00984126|CompletedPhase 3Results

Safety and Efficacy of Turoctocog Alfa (N8) in Prevention and On-demand Treatment of Bleeding Episodes in Subjects With Haemophilia A: An Extension to Trials NN7008-3543, NN7008-3545, NN7008-3600, NN7008-3893 and NN7008-4015

Safety and Efficacy of N8 in Prevention and On-demand Treatment of Bleeding Episodes in Subjects With Haemophilia A

Novo Nordisk A/S ClinicalTrials.gov

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4 other identifiers

NN7008-35682008-005945-46U1111-1111-9377JapicCTI-101357

Study Type

interventional

Target

214

Locations

20 countries

Sites

Timeline

RegisteredSep 2009

StartedOct 2009

CompletionJun 2016

Brief Summary

This trial is conducted in Asia, Europe, Japan, Oceania, North America and South America. The aim of the trial is to investigate the safety and efficacy of turoctocog alfa (N8) in Haemophilia A patients. The trial is an extension to trials NN7008-3543 (start: March 2009, stop: September 2011) and NN7008-3545 (start: May 2010, stop: November 2011) and the pharmacokinetic trials NN7008-3600 (start: November 2010, stop: October 2011), NN7008-3893 (start: June 2011, stop: September 2011) and NN7008-4015 (start: August 2012, stop: March 2013).

Trial Health

On Track

Trial Health Score

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

Enrollment

214

participants targeted

Target at P25-P50 for phase_3

Timeline

Completed

Started Oct 2009

Longer than P75 for phase_3

Geographic Reach

20 countries

57 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

6.7 years study duration

First Submitted

Initial submission to the registry

September 21, 2009

Completed

4 days until next milestone

First Posted

Study publicly available on registry

September 25, 2009

Completed

1 month until next milestone

Study Start

First participant enrolled

October 26, 2009

Completed

6.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 28, 2016

Completed

1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 29, 2016

Completed

1.1 years until next milestone

Results Posted

Study results publicly available

July 27, 2017

Completed

Last Updated

July 27, 2017

Status Verified

June 1, 2017

Enrollment Period

6.7 years

First QC Date

September 21, 2009

Results QC Date

June 27, 2017

Last Update Submit

June 27, 2017

Conditions

Congenital Bleeding Disorder Haemophilia A

Outcome Measures

Primary Outcomes (1)

Frequency of Development of FVIII Inhibitors (Greater Than or Equal to 0.6 Bethesda Units (BU)/mL)
The frequency of inhibitors was calculated as number of patients with inhibitors during the trial divided by number of patients in the trial. This endpoint was measured during the trial.
After 90 months

Secondary Outcomes (3)

Frequency of Adverse Events and Serious Adverse Events
After 90 months
Annualised Bleeding Rate Reported During the Prevention Period (Only Applicable for Subjects in the Preventive Regimen)
After 90 months
Haemostatic Response to Turoctocog Alfa (None, Moderate, Good or Excellent) in Treatment of Bleeds.
After 90 months

Study Arms (1)

Turoctocog alfa

EXPERIMENTAL

Drug: turoctocog alfa

Interventions

turoctocog alfaDRUG

The preventative treatment is administered intravenously (i.v.) at specific intervals either every second day or three times a week. Bleeding treatment will be administered if a bleed should occur.

Turoctocog alfa

Eligibility Criteria

Age6 Months - 70 Years

Sexmale

Healthy VolunteersNo

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

You may qualify if:

Informed Consent obtained before any trial-related activities
Completion of trial NN7008-3543 or paediatric trial NN7008-3545 or Japanese trial NN7008-3600 or pharmacokinetic trial NN7008-3893 or NN7008-4015

You may not qualify if:

Previous participation in the current trial (defined as withdrawal) or withdrawn subjects from NN7008-3522, NN7008-3543, NN7008-3545, NN7008-3600, NN7008-3893 or NN7008-4015 after administration of trial product

Contact the study team to confirm eligibility.