Brief Summary

This trial is conducted in China. The aim of this trial is to evaluate the clinical efficacy of turoctocog alfa in treatment of bleeding episodes in Chinese patients with severe haemophilia A (FVIII≤1%).

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 Dec 2016

Geographic Reach

1 country

11 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 years study duration

First Submitted

Initial submission to the registry

October 17, 2016

Completed

2 days until next milestone

First Posted

Study publicly available on registry

October 19, 2016

Completed

2 months until next milestone

Study Start

First participant enrolled

December 12, 2016

Completed

1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 16, 2018

Completed

9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 12, 2018

Completed

9 months until next milestone

Results Posted

Study results publicly available

August 26, 2019

Completed

Last Updated

July 27, 2020

Status Verified

July 1, 2020

Enrollment Period

1.3 years

First QC Date

October 17, 2016

Results QC Date

March 15, 2019

Last Update Submit

July 24, 2020

Conditions

Congenital Bleeding Disorder Haemophilia A

Outcome Measures

Primary Outcomes (1)

Haemostatic Effect of Turoctocog Alfa (Treatment of Bleeds): 6 Months
The haemostatic effect of turoctocog alfa when used for treatment of bleeding episodes in both prophylaxis and on-demand regimen was evaluated during month 0-6. The effect was assessed on a four-point scale for haemostatic response, excellent, good, moderate and none.
Month 0-6

Secondary Outcomes (44)

Haemostatic Effect of Turoctocog Alfa (Treatment of Bleeds): 24 Months
Month 0-24
Incidence Rate of Inhibitory Antibodies Against FVIII (≥0.6 BU): 6 Months
Month 0-6
Incidence Rate of Inhibitory Antibodies Against FVIII (≥0.6 BU): 24 Months
Month 0-24
Number of Bleeds (Total Bleeds Assessed as Annual Bleeding Rate) Per Participant: 6 Months
Month 0-6
Number of Bleeds (Total Bleeds Assessed as Annual Bleeding Rate) Per Participant: 24 Months
Month 0-24
+39 more secondary outcomes

Study Arms (2)

Prophylactic treatment

EXPERIMENTAL

Drug: turoctocog alfa

On-demand treatment

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.

Prophylactic treatment

Eligibility Criteria

Sexmale

Healthy VolunteersNo

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

You may qualify if:

Male patients
Age from 0 years
With the diagnosis of severe congenital haemophilia A (FVIII≤1%)
History of exposure days (ED) to any FVIII products fulfilling the criteria of previously treated patients:
Patients of 12 years or above: 100 exposures days (ED) or more
Patients below 12 years: 50 exposure days (ED) or more

You may not qualify if:

Inhibitors to factor VIII (≥0.6 BU) at screening as assessed by central laboratory
Known history of FVIII inhibitors

Contact the study team to confirm eligibility.