NCT03196297|CompletedPhase 2ResultsDMCFDA Drug

A Trial Evaluating Efficacy and Safety of Prophylactic Administration of Concizumab in Patients With Severe Haemophilia A Without Inhibitors

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A Multi-Centre Trial Evaluating Efficacy and Safety of Prophylactic Administration of Concizumab in Patients With Severe Haemophilia A Without Inhibitors

Novo Nordisk A/S ClinicalTrials.gov

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4 other identifiers

NN7415-4255U1111-1179-38722016-000614-29JapicCTI-173682

Study Type

interventional

Target

Locations

11 countries

Sites

Timeline

RegisteredJun 2017

StartedAug 2017

CompletionJun 2020

Brief Summary

This trial is conducted in Asia, Europe and the United States of America (USA). 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 patients with severe haemophilia A without inhibitors.

Trial Health

On Track

Trial Health Score

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

Enrollment

participants targeted

Target at P25-P50 for phase_2

Timeline

Completed

Started Aug 2017

Typical duration for phase_2

Geographic Reach

11 countries

31 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

2.8 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 16, 2017

Completed

10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 22, 2018

Completed

2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 3, 2020

Completed

11 months until next milestone

Results Posted

Study results publicly available

May 10, 2021

Completed

Last Updated

November 16, 2021

Status Verified

November 1, 2021

Enrollment Period

10 months

First QC Date

June 20, 2017

Results QC Date

April 14, 2021

Last Update Submit

November 15, 2021

Conditions

Haemostasis Haemophilia A

Outcome Measures

Primary Outcomes (1)

The Number of Bleeding Episodes During at Least 24 Weeks From Treatment Onset
The number of bleeding episodes that were treated during at least 24 weeks from treatment onset are presented. The data is presented while on last dose level when the bleed occurred.
During at least 24 weeks from treatment onset

Secondary Outcomes (29)

The Number of Bleeding Episodes During at Least 76 Weeks From Treatment Onset
During at least 76 weeks from treatment onset
The Number of Spontaneous Bleeding Episodes During at Least 24 Weeks From Treatment Onset
During at least 24 weeks from treatment onset
The Number of Spontaneous Bleeding Episodes During at Least 76 Weeks From Treatment Onset
During at least 76 weeks from treatment onset
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)
+24 more secondary outcomes

Study Arms (1)

Concizumab

EXPERIMENTAL

Daily administration of concizumab to both on-demand and prophylaxis patients

Drug: ConcizumabDrug: Turoctocog alfa

Interventions

ConcizumabDRUG

0.15 mg/kg (with potential stepwise dose administration to 0.25 mg/kg) administered daily s.c (subcutaneously, under the skin). Treatment duration is 24 weeks in the main phase, and 52 weeks in the extension phase

Concizumab

Turoctocog alfaDRUG

Breakthrough bleeding episodes will be treated by the patients at home with turoctocog alfa at the discretion of the study doctor, who will also choose dose levels

Concizumab

Eligibility Criteria

Age18 Years+

Sexmale

Healthy VolunteersNo

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

Contact the study team to confirm eligibility.