A Trial Evaluating Efficacy and Safety of Prophylactic Administration of Concizumab in Patients with Severe Haemophilia A without Inhibitors

A Multi-Centre Trial Evaluating Efficacy and Safety of Prophylactic Administration of Concizumab in Patients with Severe Haemophilia A without Inhibitors - explorer™5

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-000614-29-SE

Enrollment

Registered

2017-06-01

Start date

2017-06-12

Completion date

Unknown

Last updated

2020-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Haemophilia A MedDRA version: 20.0 Level: LLT Classification code 10018938 Term: Haemophilia A (Factor VIII) System Organ Class: 100000004850

Interventions

Product Name: concizumab B 100 mg/mL Pharmaceutical Form: Solution for injection INN or Proposed INN: concizumab CAS Number: *MASKED* Other descriptive name: CONCIZUMAB Concentration unit: mg/ml mill

Eligibility

Sex/Gender

Male

Inclusion 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 patients aged 18 years or older at the time of signing informed consent, diagnosed with severe haemophilia A (FVIII activity below 1%), based on medical records or results at screening 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 30 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 3

Exclusion criteria

Exclusion criteria: - Known or suspected hypersensitivity to trial product(s) or related products - Known inherited or acquired bleeding disorder other than haemophilia A - Presence of inhibitors (neutralising antibodies) to Factor VIII (equal to or above 0.6 Bethesda Units) at screening measured by the Nijmegen method

Design outcomes

Primary

Measure	Time frame
Main Objective: To assess the efficacy of concizumab administered s.c. once daily in preventing bleeding episodes in patients with severe haemophilia A without inhibitors;Secondary Objective: - To assess the longer-term efficacy of concizumab in patients with severe haemophilia A without inhibitors - To assess the safety of concizumab in patients with severe haemophilia A without inhibitors - To assess the immunogenicity of concizumab in patients with severe haemophilia A without 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	—

Measure

Time frame

Main Objective: To assess the efficacy of concizumab administered s.c. once daily in preventing bleeding episodes in patients with severe haemophilia A without inhibitors;Secondary Objective: - To assess the longer-term efficacy of concizumab in patients with severe haemophilia A without inhibitors - To assess the safety of concizumab in patients with severe haemophilia A without inhibitors - To assess the immunogenicity of concizumab in patients with severe haemophilia A without 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

Measure	Time frame
Secondary end point(s): 1. The number of spontaneous bleeding episodes 2. The 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	—

Countries

European Union, Germany, Japan, Spain, Sweden, Thailand, Turkey, Ukraine, United Kingdom, United States

Contacts

Public ContactGlobal Clinical Registry (GCR,1452)

Novo Nordisk A/S

clinicaltrials@novonordisk.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026