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Clinical Trials/EUCTR2019-002641-37-NL
EUCTR2019-002641-37-NLActive, not recruitingPhase 1

Efficacy and safety of once-weekly subcutaneous administration of concizumab prophylaxis in patients with haemophilia A and B, with or without inhibitors - explorer9

ovo Nordisk A/S0 sites80 target enrollmentStarted: March 23, 2020Last updated:
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Conditions

Trial Snapshot

Phase
Phase 1
Status
Active, not recruiting
Enrollment
80
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Sex
Male

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 (18 years or older for the PK/PD cohort).
  • •- Diagnosis of congenital severe haemophilia A (FVIII below 1%) or moderate/severe congenital haemophilia B (FIX equal to or below 2%), or congenital haemophilia with inhibitors.
  • •- Patient has been prescribed, or is in need of, treatment with coagulation factor product or bypassing agent in the last 24 weeks prior to screening.
  • •Are the trial subjects under 18? yes
  • •Number of subjects for this age range: 25
  • •F.1.2 Adults (18-64 years) yes
  • •F.1.2.1 Number of subjects for this age range 50
  • •F.1.3 Elderly (>=65 years) yes
  • •F.1.3.1 Number of subjects for this age range 5

Exclusion Criteria

  • •- Known or suspected hypersensitivity to any constituents of the trial product.
  • •- Known inherited or acquired coagulation disorder other than congenital haemophilia.
  • •- Ongoing or planned Immune Tolerance Induction treatment.

Investigators

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