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NCT04083781 · ClinicalTrials.gov registry record · Phase 3

Research Study to Look at How Well the Drug Concizumab Works in Your Body if You Have Haemophilia With Inhibitors

A Phase 3 study of Haemophilia A With Inhibitors and Haemophilia B With Inhibitors, sponsored by Novo Nordisk A/S.

Active
Registry status
Phase 3
Development phase
134
Enrollment target
20
Study locations

NCT04083781 is a Phase 3 study of Haemophilia A With Inhibitors and Haemophilia B With Inhibitors that is active but no longer recruiting, run by Novo Nordisk A/S. The registered enrollment target is 134 participants, below the 182-participant average among 3 other Haemophilia A With Inhibitors trials with a reported enrollment target (26% lower). The trial reports 20 study locations across 11 states.

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The verdict

NCT04083781, a Phase 3 study of Haemophilia A With Inhibitors and Haemophilia B With Inhibitors, is active but no longer recruiting, sponsored by Novo Nordisk A/S.

ACTIVE NOT RECRUITING
Registry status
Phase 3
Development phase
134 participants
Enrollment target
20
Study locations

Study Summary

This study will test how well a new medicine called concizumab works in the body of people with haemophilia A or B with inhibitors. The purpose is to show that concizumab can prevent bleeds in the body and is safe to use. Participants who usually only take medicine to treat bleeds (on-demand) will be placed in one of two groups. In one group, participants will get study medicine from the start of the study. In the other group, participants will continue with their normal medicine and get study medicine after 6 months. Which treatment the participant gets is decided by chance. Participants who usually take medicine to prevent bleeds (prophylaxis treatment) or who are already being treated with concizumab (study medicine) will receive the study medicine from the start of the study. Participants will get 1 injection with the study medicine every day under the skin. This participants will have to do themselves and can be done at home. The study doctor will hand out the medicine in the form of a pen-injector. The pen-injector will contain the study medicine. The study will last for about seven years. The length of time the participants will be in the study depends on when they agreed to take part or when the medicine is available for purchase in their country (31 December 2026 at the latest). The time between visits will be approximately 4 weeks for the first 6 to 12 months, depending on the group participants are in and approximately 8 weeks for the rest of the study. Participants will be asked to record information into an electronic diary during the study and may also be asked to wear an activity tracker.

Conditions Studied

Haemophilia A With Inhibitors Haemophilia B With Inhibitors

Interventions

  • DRUG Concizumab

Study Locations (20)

Other

  • Haematology and Blood Bank Department - Algiers
  • CHU Constantine BEN BADIS/ Hematology department - Constantine
  • Klin. Abt. f. Hämatologie und Hämostaseologie, AKH Wien - Vienna
  • UMHAT Tsaritsa Yoanna - ISUL EAD, Pediatric clinical hematology and oncology - Sofia
  • KBC Zagreb, Rebro, Hemofilija centar - Zagreb
  • KBC Zagreb, Zavod za pedijatrijsku hematologiju - Zagreb
  • Ustav Hematologie a krevni tranfuze - Prague
  • Fakultni nemocnice v Motole - Prague
  • Skejby Blodsygdomme, blødercentret - Aarhus N

Victoria

  • The Alfred - Melbourne
  • Royal Children's Hospital - Parkville

California

  • Center for Inherited Blood Dis - Orange

Georgia

  • Children's Healthcare Atlanta - Atlanta

Indiana

  • Indiana Hemophilia-Thromb Ctr - Indianapolis

Missouri

  • Washington University School of Medicine_St. Louis - St Louis

North Carolina

  • St. Jude Affiliate Clinic at Novant Health Hemby Children's - Charlotte

Tennessee

  • TriStar Medical Group Children's Specialist - Nashville

Trial Details

FieldValue
Enrollment Target 134 participants
Start Date 2019-10-21
Est. Completion 2027-02-21
Phase Phase 3

Sponsor

Novo Nordisk A/S

431 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04083781

The ClinicalTrials.gov registry entry for NCT04083781 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 134 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 182-participant average among 3 other Haemophilia A With Inhibitors trials with a reported enrollment target (26% lower). The listed sponsor is Novo Nordisk A/S, which has 431 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Haemophilia A With Inhibitors appearing as the primary indexed condition, and to 1 intervention - of which Concizumab is the first listed.

NCT04083781 reports 20 study locations spanning 11 distinct geographic areas - top geographies include Other, Victoria, California.

Frequently Asked Questions

What is clinical trial NCT04083781 about?

NCT04083781 is a clinical study titled "Research Study to Look at How Well the Drug Concizumab Works in Your Body if You Have Haemophilia With Inhibitors". This study will test how well a new medicine called concizumab works in the body of people with haemophilia A or B with inhibitors. The purpose is to show that concizumab can prevent bleeds in the body and is safe to use. Participants who usually only take medicine to treat bleeds (on-demand) will b...

What is the current status of trial NCT04083781?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 134 participants. The study started on 2019-10-21. Estimated completion is 2027-02-21.

What conditions does trial NCT04083781 study?

This clinical trial studies the following conditions: Haemophilia A With Inhibitors, Haemophilia B With Inhibitors.

What interventions are being tested in trial NCT04083781?

The interventions under investigation include: Concizumab (DRUG).

Who is sponsoring clinical trial NCT04083781?

This trial is sponsored by Novo Nordisk A/S, which has 431 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04083781 being conducted?

This trial has 20 study locations across California, Georgia, Indiana, Missouri, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.