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Research Study to Look at How Well the Drug Concizumab Works in Your Body if You Have Haemophilia Without Inhibitors
NCT04082429 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04082429
The ClinicalTrials.gov registry entry for NCT04082429 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 156 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novo Nordisk A/S, which has 189 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04082429 reports 20 study locations spanning 13 distinct geographic areas — top geographies include Other, California, Michigan. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04082429?
The interventions under investigation include: Concizumab (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04082429?
This trial is sponsored by Novo Nordisk A/S, which has 189 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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