Research study to look at how well the drug concizumab works in your body if you have haemophilia without inhibitors

Phase 1

• Conditions: Haemophilia AHaemophilia B; MedDRA version: 20.0Level: LLTClassification code 10018938Term: Haemophilia A (Factor VIII)System Organ Class: 100000004850; MedDRA version: 20.0Level: LLTClassification code 10018939Term: Haemophilia B (Factor IX)System Organ Class: 100000004850; Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]

• Registration Number: EUCTR2018-004891-36-FR
• Lead Sponsor: ovo Nordisk A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-11-05
• Last Update Posted: 16 December 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Male
• Target Recruitment: 150

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 suitability for the trial
- Male aged 12 years or older at the time of signing informed consent.
- Congenital severe haemophilia A (FVIII less than 1%) or B (FIX 2% or less)
Are the trial subjects under 18? yes
Number of subjects for this age range: 35
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 105
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

- Known or suspected hypersensitivity to monoclonal antibodies
- Known inherited or acquired coagulation disorder other than congenital haemophilia
- Presence of confirmed inhibitors 0.6 BU or greater at screening

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified