NCT03196284|CompletedPhase 2ResultsDMCFDA Drug

A Trial Evaluating the Efficacy and Safety of Prophylactic Administration of Concizumab in Haemophilia A and B Patients With Inhibitors

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A Multi-Centre, Randomised, Open-Label, Controlled Trial Evaluating the Efficacy and Safety of Prophylactic Administration of Concizumab in Haemophilia A and B Patients With Inhibitors

Novo Nordisk A/S ClinicalTrials.gov

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4 other identifiers

NN7415-4310U1111-1179-29252016-000510-30JapicCTI-173681

Study Type

interventional

Target

Locations

14 countries

Sites

Timeline

RegisteredJun 2017

StartedAug 2017

CompletionJan 2020

Brief Summary

This trial is conducted in Africa, Asia, Europe and North America. The aim of the trial is to assess the efficacy of concizumab administered s.c. (subcutaneously, under the skin) once daily in preventing bleeding episodes in haemophilia A and B patients with inhibitors.

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_2

Timeline

Completed

Started Aug 2017

Geographic Reach

14 countries

22 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

2.5 years study duration

First Submitted

Initial submission to the registry

June 20, 2017

Completed

2 days until next milestone

First Posted

Study publicly available on registry

June 22, 2017

Completed

2 months until next milestone

Study Start

First participant enrolled

August 10, 2017

Completed

1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 19, 2018

Completed

1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2020

Completed

1.7 years until next milestone

Results Posted

Study results publicly available

October 22, 2021

Completed

Last Updated

October 22, 2021

Status Verified

September 1, 2021

Enrollment Period

1.1 years

First QC Date

June 20, 2017

Results QC Date

August 4, 2021

Last Update Submit

September 24, 2021

Conditions

Congenital Bleeding Disorder Haemophilia A With Inhibitors Haemophilia B With Inhibitors

Outcome Measures

Primary Outcomes (1)

The Number of Bleeding Episodes
The number of bleeding episodes that were treated during at least 24 weeks from treatment onset (week 0) are presented.
During at least 24 weeks from treatment onset (week 0)

Secondary Outcomes (30)

The Number of Bleeding Episodes
During at least 76 weeks from treatment onset (week 0)
The Number of Spontaneous Bleeding Episodes
During at least 24 weeks from treatment onset (week 0)
The Number of Spontaneous Bleeding Episodes
During at least 76 weeks from treatment onset (week 0)
Number of Treatment-emergent Adverse Events (TEAEs) During at Least 24 Weeks From Treatment Onset
During at least 24 weeks from treatment onset (week 0)
Number of Treatment-emergent Adverse Events (TEAEs) During at Least 76 Weeks From Treatment Onset
During at least 76 weeks from treatment onset (week 0)
+25 more secondary outcomes

Study Arms (2)

Concizumab

EXPERIMENTAL

Concizumab administered in both the main phase and extension phase, with eptacog alfa administered on-demand during bleeding episodes

Drug: ConcizumabDrug: Eptacog alfa

Eptacog alfa and concizumab

ACTIVE COMPARATOR

Eptacog alfa administered on-demand during bleeding episodes as the only intervention during the main phase. Concizumab given in the extension phase

Drug: ConcizumabDrug: Eptacog alfa

Interventions

ConcizumabDRUG

A loading dose of 0.5 mg/kg will be given as the first dose, followed by 0.15 mg/kg (with potential stepwise dose escalation to 0.25 mg/kg) administered daily s.c. (subcutaneously, under the skin). Treatment duration is 24 weeks in the main trial, and up to 52 weeks in the extension phase

ConcizumabEptacog alfa and concizumab

Eptacog alfaDRUG

A single dose of 90 μg/kg eptacog alfa one week after dosing with concizumab. On-demand treatment during bleeding episodes in both treatment arms

ConcizumabEptacog alfa and concizumab

Eligibility Criteria

Age18 Years+

Sexmale

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.