Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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EUCTR |
Last refreshed on:
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19 February 2018 |
Main ID: |
EUCTR2016-000510-30-GR |
Date of registration:
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04/07/2017 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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A Trial Evaluating the Efficacy and Safety of Prophylactic Administration of Concizumab in Haemophilia A and B Patients with Inhibitors
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Scientific title:
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A Multi-Centre, Randomised, Open-Label, Controlled Trial Evaluating the Efficacy and Safety of Prophylactic Administration of Concizumab in Haemophilia A and B Patients with Inhibitors - explorer™4 |
Date of first enrolment:
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01/08/2017 |
Target sample size:
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26 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2016-000510-30 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: yes Cross over: no Other: yes Other trial design description: With potential dose escalation If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no Number of treatment arms in the trial: 2
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
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Countries of recruitment
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Austria
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Canada
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Croatia
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Denmark
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European Union
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Greece
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Israel
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Japan
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Malaysia
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Spain
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Sweden
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Ukraine
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United States
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Contacts
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Name:
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Global Clinical Registry (GCR,1452)
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Address:
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Novo Allé
2880
Bagsværd
Denmark |
Telephone:
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Email:
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clinicaltrials@novonordisk.com |
Affiliation:
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Novo Nordisk A/S |
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Name:
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Global Clinical Registry (GCR,1452)
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Address:
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Novo Allé
2880
Bagsværd
Denmark |
Telephone:
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Email:
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clinicaltrials@novonordisk.com |
Affiliation:
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Novo Nordisk A/S |
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Key inclusion & exclusion criteria
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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
Age minimum:
Age maximum:
Gender:
Female: no Male: yes
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Health Condition(s) or Problem(s) studied
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Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
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Haemophilia A with inhibitors
Haemophilia B with inhibitors MedDRA version: 20.0
Level: LLT
Classification code 10053751
Term: Hemophilia A with anti factor VIII
System Organ Class: 100000011928
MedDRA version: 20.0
Level: LLT
Classification code 10053752
Term: Hemophilia B with anti factor IX
System Organ Class: 100000011929
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Intervention(s)
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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 milligram(s)/millilitre Concentration type: equal Concentration number: 100-
Trade Name: NovoSeven 5 mg Pharmaceutical Form: Powder and solvent for solution for injection INN or Proposed INN: eptacog alfa (activated) CAS Number: 102786-61-8 Other descriptive name: EPTACOG ALFA (ACTIVATED) Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 1.0-
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Primary Outcome(s)
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Secondary Objective: 1. To assess the longer-term efficacy of concizumab in haemophilia patients with inhibitors 2. To assess the safety of concizumab in haemophilia patients with inhibitors 3. To assess the safety of administering recombinant factor VIIa (rFVIIa) to haemophilia patients with inhibitors that are exposed to concizumab 4. To assess the immunogenicity of concizumab in haemophilia patients with inhibitors
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Primary end point(s): The number of bleeding episodes
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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
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Timepoint(s) of evaluation of this end point: During at least 24 weeks from treatment onset
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Secondary Outcome(s)
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Secondary end point(s): 1. The number of spontaneous bleeding episodes
2. Number of treatment emergent adverse events (TEAEs)
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Timepoint(s) of evaluation of this end point: 1.+ 2. During at least 24 weeks from treatment onset
All endpoints referring to the time frame of at least 24 weeks will be evaluated in the main part of
the trial, defined to end when the last patient has completed a minimum of 24 weeks of dosing
treatment with trial product (or has withdrawn). In addition, number of bleeding episodes during 76
weeks of treatment with prophylactic concizumab will be analysed.
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Secondary ID(s)
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2016-000510-30-SE
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NN7415-4310
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Source(s) of Monetary Support
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Novo Nordisk A/S
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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