A Trial Evaluating the Efficacy and Safety of Prophylactic Administration of Concizumab in Haemophilia A and B Patients With Inhibitors (explorer™4)

Novo Nordisk

Status and phase: Completed; Phase 2

Conditions: Haemophilia B With Inhibitors; Haemophilia A With Inhibitors; Congenital Bleeding Disorder

Treatments: Drug: Eptacog alfa; Drug: Concizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT03196284

NN7415-4310

U1111-1179-2925 (Other Identifier)

JapicCTI-173681 (Registry Identifier)

2016-000510-30 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 26 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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26 participants in 2 patient groups

Concizumab

Experimental group

Description:

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

Treatment:

Drug: Eptacog alfa

Drug: Concizumab

Eptacog alfa and concizumab

Active Comparator group

Description:

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

Treatment:

Drug: Eptacog alfa

Drug: Concizumab