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A Research Study on How Well Concizumab Works for You if You Have Haemophilia A or B With or Without Inhibitors

NCT05135559 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 153

Last updated 2025-12-30

No results posted yet for this study

Summary

This study will test how well a new medicine called concizumab works for participants who have haemophilia A or B with or without inhibitors. The purpose is to show that concizumab can prevent bleeds and is safe to use.

Participants will have to inject the study medicine every day under the skin with a pen-injector.

The study will last for at least 2 years and up to about 4 years. The length of time the participant will be in the study depends on if the study medicine will be available for purchase in their country.

Conditions

  • Haemophilia A and B With and Without Inhibitors

Interventions

DRUG

Concizumab

Participants in Arm 1 will be assigned to concizumab prophylaxis starting with a loading dose on treatment day 0 followed by daily injections of an individual maintenance dose. Participants in Arm 2 will be assigned to concizumab prophylaxis with daily injections of an individual maintenance dose.

Sponsors & Collaborators

Principal Investigators

  • Clinical Transparency (dept. 2834) · Novo Nordisk A/S

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-24
Primary Completion
2026-04-21
Completion
2029-11-02
FDA Drug
Yes

Countries

  • United States
  • Algeria
  • Bosnia and Herzegovina
  • Bulgaria
  • Canada
  • Estonia
  • France
  • Greece
  • India
  • Italy
  • Japan
  • Lebanon
  • Lithuania
  • Malaysia
  • North Macedonia
  • Norway
  • Poland
  • Romania
  • South Africa
  • Spain
  • Sweden
  • Thailand
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05135559 on ClinicalTrials.gov