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

Phase 1

Conditions: Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Haemophilia A with inhibitorsHaemophilia B with inhibitors
MedDRA version: 20.0Level: LLTClassification code 10053751Term: Hemophilia A with anti factor VIIISystem Organ Class: 100000011928
MedDRA version: 20.0Level: LLTClassification code 10053752Term: Hemophilia B with anti factor IXSystem Organ Class: 100000011929

Registration Number: EUCTR2016-000510-30-GR

Lead Sponsor: ovo Nordisk A/S

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Male

Target Recruitment: 26

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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 24
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 2

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the efficacy of concizumab administered s.c. once daily in preventing bleeding episodes in haemophilia A and B patients with inhibitors;Secondary Objective: 1. To assess the longer-term efficacy of concizumab in haemophilia patients with inhibitors<br>2. To assess the safety of concizumab in haemophilia patients with inhibitors<br>3. To assess the safety of administering recombinant factor VIIa (rFVIIa) to haemophilia patients with inhibitors that are exposed to concizumab<br>4. To assess the immunogenicity of concizumab in haemophilia patients with inhibitors;Primary end point(s): The number of bleeding episodes;Timepoint(s) of evaluation of this end point: During at least 24 weeks from treatment onset

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1. The number of spontaneous bleeding episodes <br>2. Number of treatment emergent adverse events (TEAEs);Timepoint(s) of evaluation of this end point: 1.+ 2. During at least 24 weeks from treatment onset <br><br>All endpoints referring to the time frame of at least 24 weeks will be evaluated in the main part of<br>the trial, defined to end when the last patient has completed a minimum of 24 weeks of dosing<br>treatment with trial product (or has withdrawn). In addition, number of bleeding episodes during 76<br>weeks of treatment with prophylactic concizumab will be analysed.