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

NCT ID: NCT03196284

Last Updated: 2021-10-22

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-10

Study Completion Date

2020-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Congenital Bleeding Disorder Haemophilia A With Inhibitors Haemophilia B With Inhibitors

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Concizumab

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

Group Type EXPERIMENTAL

Concizumab

Intervention Type DRUG

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

Eptacog alfa

Intervention Type DRUG

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

Eptacog alfa and concizumab

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

Group Type ACTIVE_COMPARATOR

Concizumab

Intervention Type DRUG

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

Eptacog alfa

Intervention Type DRUG

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

Interventions

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Concizumab

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

Intervention Type DRUG

Eptacog alfa

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Inclusion Criteria: - Informed consent obtained before any trial related activities.

Exclusion Criteria

Trial related activities are any procedures that are carried out as part of the trial, including activities to determine the suitability for the trial - Male haemophilia A or B patients with inhibitors aged 18 years or older at the time of signing informed consent - Patients currently in need of treatment with bypassing agents Exclusion Criteria: - Known or suspected hypersensitivity to trial product(s) or related products - Known inherited or acquired bleeding disorder other than haemophilia - Ongoing or planned immune tolerance induction therapy or prophylaxis with FVIII or FIX
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Novo Nordisk A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Novo Nordisk Investigational Site

Los Angeles, California, United States

Site Status

Novo Nordisk Investigational Site

Indianapolis, Indiana, United States

Site Status

Novo Nordisk Investigational Site

Iowa City, Iowa, United States

Site Status

Novo Nordisk Investigational Site

Vienna, , Austria

Site Status

Novo Nordisk Investigational Site

Toronto, Ontario, Canada

Site Status

Novo Nordisk Investigational Site

Zagreb, , Croatia

Site Status

Novo Nordisk Investigational Site

Århus N, , Denmark

Site Status

Novo Nordisk Investigational Site

Athens, , Greece

Site Status

Novo Nordisk Investigational Site

Tel Litwinsky, , Israel

Site Status

Novo Nordisk Investigational Site

Florence, , Italy

Site Status

Novo Nordisk Investigational Site

Milan, , Italy

Site Status

Novo Nordisk Investigational Site

Aichi, , Japan

Site Status

Novo Nordisk Investigational Site

Nara, , Japan

Site Status

Novo Nordisk Investigational Site

Tokyo, , Japan

Site Status

Novo Nordisk Investigational Site

Georgetown, Penang, , Malaysia

Site Status

Novo Nordisk Investigational Site

Kota Kinabalu, , Malaysia

Site Status

Novo Nordisk Investigational Site

Madrid, , Spain

Site Status

Novo Nordisk Investigational Site

Seville, , Spain

Site Status

Novo Nordisk Investigational Site

Solna, , Sweden

Site Status

Novo Nordisk Investigational Site

Lviv, , Ukraine

Site Status

Novo Nordisk Investigational Site

London, , United Kingdom

Site Status

Novo Nordisk Investigational Site

Sheffield, , United Kingdom

Site Status

Countries

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United States Austria Canada Croatia Denmark Greece Israel Italy Japan Malaysia Spain Sweden Ukraine United Kingdom

References

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Shapiro AD, Angchaisuksiri P, Astermark J, Benson G, Castaman G, Eichler H, Jimenez-Yuste V, Kavakli K, Matsushita T, Poulsen LH, Wheeler AP, Young G, Zupancic-Salek S, Oldenburg J, Chowdary P. Long-term efficacy and safety of subcutaneous concizumab prophylaxis in hemophilia A and hemophilia A/B with inhibitors. Blood Adv. 2022 Jun 14;6(11):3422-3432. doi: 10.1182/bloodadvances.2021006403.

Reference Type DERIVED
PMID: 35290453 (View on PubMed)

Shapiro AD, Angchaisuksiri P, Astermark J, Benson G, Castaman G, Chowdary P, Eichler H, Jimenez-Yuste V, Kavakli K, Matsushita T, Poulsen LH, Wheeler AP, Young G, Zupancic-Salek S, Oldenburg J. Subcutaneous concizumab prophylaxis in hemophilia A and hemophilia A/B with inhibitors: phase 2 trial results. Blood. 2019 Nov 28;134(22):1973-1982. doi: 10.1182/blood.2019001542.

Reference Type DERIVED
PMID: 31444162 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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U1111-1179-2925

Identifier Type: OTHER

Identifier Source: secondary_id

2016-000510-30

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

JapicCTI-173681

Identifier Type: REGISTRY

Identifier Source: secondary_id

NN7415-4310

Identifier Type: -

Identifier Source: org_study_id