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NCT04082429 · ClinicalTrials.gov registry record · Phase 3
Research Study to Look at How Well the Drug Concizumab Works in Your Body if You Have Haemophilia Without Inhibitors
A Phase 3 study of Haemophilia A Without Inhibitors and Haemophilia B Without Inhibitors, sponsored by Novo Nordisk A/S.
- Active
- Registry status
- Phase 3
- Development phase
- 156
- Enrollment target
- 20
- Study locations
NCT04082429: Active Phase 3 study of Haemophilia A Without Inhibitors and Haemophilia B Without Inhibitors, sponsored by Novo Nordisk A/S.
NCT04082429 is a Phase 3 study of Haemophilia A Without Inhibitors and Haemophilia B Without Inhibitors that is active but no longer recruiting, run by Novo Nordisk A/S. The registered enrollment target is 156 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (80% lower). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04082429, a Phase 3 study of Haemophilia A Without Inhibitors and Haemophilia B Without Inhibitors, is active but no longer recruiting, sponsored by Novo Nordisk A/S.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 156 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 without 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 have to inject themselves with the study medicine 1 time every day under the skin. This 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 up to 8 years. The length of time the participant will be in the study depends on when they agreed to take part and when the medicine is available for purchase in their country (or 31 December 2027 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. If the participant attends extra visits due to the prescription medicine not being available for purchase in their country, these will be 14 weeks apart. Participants will be asked to record information in 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 for haemophilia A participants without inhibitors is presented. The observation period used for reporting this endpoint is on-treatment without ancillary therapy excluding data before restart (OTwoATexBR). It is defined as the time period after the restart where participants are treated by concizumab treatment or are treated by on-demand treatment and additionally have not used factor-containing products not related to treatment of a bl
Conditions Studied
Interventions
- DRUG Concizumab
Study Locations (20)
Other
- Haematology and Blood Bank Department - Algiers
- CHU Constantine BEN BADIS/ Hematology department - Constantine
- University Clinical Center of Republic Srpska (205) - Banja Luka
- UMHAT Tsaritsa Yoanna - ISUL EAD, Pediatric clinical hematology and oncology - Sofia
- UMHAT Sveta Marina EAD, Clinic of Pediatric Clinical Hematology and Oncology - Varna
California
- Children's Hospital Los Angeles - Endocrinology - Los Angeles
- Center for Inherited Blood Disorders - Orange
Michigan
- Children's Hospital of Michigan - Detroit
- Michigan State University - Lansing
Victoria
- The Alfred - Melbourne
- Royal Children's Hospital - Parkville
Georgia
- Center for Blood Disorders Augusta University - Augusta
Indiana
- Indiana Hemophilia-Thromb Ctr - Indianapolis
Iowa
- University of Iowa_Iowa City - Iowa City
North Carolina
- Novant Hlth Vasc Ins Charlotte - Charlotte
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 156 participants |
| Start Date | 2019-11-13 |
| Est. Completion | 2028-02-21 |
| Phase | Phase 3 |
What the registry record for NCT04082429 still lists
NCT04082429 is an interventional study that assigns participants to a tested intervention. The registered 156 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (80% lower).
The record links to 2 conditions, with Haemophilia A Without Inhibitors appearing as the primary indexed condition, and to 1 intervention - of which Concizumab is the first listed.
NCT04082429 names 20 study sites across 13 states, led by Other, California, Michigan.
Frequently Asked Questions
What is clinical trial NCT04082429 about?
NCT04082429 is a clinical study titled "Research Study to Look at How Well the Drug Concizumab Works in Your Body if You Have Haemophilia Without Inhibitors". This study will test how well a new medicine called concizumab works in the body of people with haemophilia A or B without 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) wil...
What is the current status of trial NCT04082429?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 156 participants. The study started on 2019-11-13. Estimated completion is 2028-02-21.
What conditions does trial NCT04082429 study?
This clinical trial studies the following conditions: Haemophilia A Without Inhibitors, Haemophilia B Without Inhibitors.
What interventions are being tested in trial NCT04082429?
The interventions under investigation include: Concizumab (DRUG).
Who is sponsoring clinical trial NCT04082429?
This trial is sponsored by Novo Nordisk A/S, which has 431 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04082429 being conducted?
This trial has 20 study locations across California, Georgia, Indiana, Iowa, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04082429's enrollment target sits among peer trials
156 1507th of 2000 higher than 492 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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