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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: Active Phase 3 study of Haemophilia A With Inhibitors and Haemophilia B With Inhibitors, sponsored by Novo Nordisk A/S.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Rate of treated spontaneous and traumatic bleeding episodes is presented. The observation period used for reporting this endpoint is on-treatment without ancillary therapy excl. data on initial regimen for participants exposed to both regimens (OTwoATexIR). It is defined as the time period where participants are treated by either the new concizumab dosing regimen or the initial concizumab dosing regimen (only included if not exposed to the new concizumab dosing regimen) or are treated by on-dema
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 134 participants |
| Start Date | 2019-10-21 |
| Est. Completion | 2027-02-21 |
| Phase | Phase 3 |
What the registry record for NCT04083781 still lists
NCT04083781 is an interventional study that assigns participants to a tested intervention. The registered 134 participants enrollment target is mid-sized for trials with a published cap, below the 182-participant average among 3 other Haemophilia A With Inhibitors trials with a reported enrollment target (26% lower).
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 names 20 study sites across 11 states, led by 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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