Brief Summary

The trial is conducted in Asia, Europe and North America. The aim of the study is to evaluate the safety of administration under the skin of turoctocog alfa pegol (SC N8-GP) in patients with severe haemophilia A.

Trial Health

On Track

Trial Health Score

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

Enrollment

participants targeted

Target at P50-P75 for phase_1

Timeline

Completed

Started Jan 2017

Geographic Reach

6 countries

19 active sites

Status

completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

1.7 years study duration

First Submitted

Initial submission to the registry

December 13, 2016

Completed

2 days until next milestone

First Posted

Study publicly available on registry

December 15, 2016

Completed

2 months until next milestone

Study Start

First participant enrolled

January 30, 2017

Completed

1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2018

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2018

Completed

Last Updated

February 5, 2020

Status Verified

January 1, 2020

Enrollment Period

1.7 years

First QC Date

December 13, 2016

Last Update Submit

January 31, 2020

Conditions

Congenital Bleeding Disorder Haemophilia A

Outcome Measures

Primary Outcomes (1)

Number of adverse events
Count and % of Adverse events
Day 0-Day 28

Secondary Outcomes (25)

Cmax
0-144 hours
Incidence of FVIII inhibitors above or equal to 0.6 BU
Day 0-Day 28
Area under the activity time curve from 0 to infinity
0-144 hours
Area under the activity time curve from 0 to t
0-144 hours
Area under the activity time curve from 0 to last
0-144 hours
+20 more secondary outcomes

Study Arms (1)

N8-GP s.c.

EXPERIMENTAL

Drug: turoctocog alfa pegol

Interventions

turoctocog alfa pegolDRUG

Part A: Participants will receive a single dose of turoctocog alfa pegol, administered subcutaneously (under the skin), at a dose of 12.5, 25 or 50 U/kg. Part B: Participants will receive a daily dose of turoctocog alfa pegol, as identified in Part A, as a subcutaneous (under the skin) injection for a period of 3 months.

N8-GP s.c.

Eligibility Criteria

Age12 Years+

Sexmale

Healthy VolunteersNo

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

You may qualify if:

Male, age above or equal to 18 years at the time of signing informed consent,(part A).
Male, age above or equal to 12 years at the time of signing informed consent,(part B).
Diagnosis of congenital haemophilia A based on medical records (FVIII activity \<1%).
History of more than 150 exposure days to any FVIII containing products.

You may not qualify if:

Previous participation in this trial. Participation is defined as signed informed consent.
(Patients who have completed part A are allowed to also participate in part B. If so, a separate informed consent covering part B must be signed.)
Immune compromised patients due to human immunodeficiency virus (HIV) infection (defined as viral load greater than or equal to 400.000 copies/mL and/or cluster of differentiation 4+ (CD4+) lymphocyte count less than or equal to 200/μL performed at screening or defined by medical records no older than 6 months)
Any history of FVIII inhibitors (defined by medical records within 8 years of randomisation)
Inhibitors to FVIII (greater than or equal to 0.6 Bethesda unit (BU)) at screening, measured by Nijmegen modified Bethesda method at central laboratory.

Contact the study team to confirm eligibility.