Trials / Completed
CompletedNCT03196284
A Trial Evaluating the Efficacy and Safety of Prophylactic Administration of Concizumab in Haemophilia A and B Patients With Inhibitors
A Multi-Centre, Randomised, Open-Label, Controlled Trial Evaluating the Efficacy and Safety of Prophylactic Administration of Concizumab in Haemophilia A and B Patients With Inhibitors
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 26 (actual)
- Sponsor
- Novo Nordisk A/S · Industry
- Sex
- Male
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This trial is conducted in Africa, Asia, Europe and North America. The aim of the trial is to assess the efficacy of concizumab administered s.c. (subcutaneously, under the skin) once daily in preventing bleeding episodes in haemophilia A and B patients with inhibitors.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Concizumab | A loading dose of 0.5 mg/kg will be given as the first dose, followed by 0.15 mg/kg (with potential stepwise dose escalation to 0.25 mg/kg) administered daily s.c. (subcutaneously, under the skin). Treatment duration is 24 weeks in the main trial, and up to 52 weeks in the extension phase |
| DRUG | Eptacog alfa | A single dose of 90 μg/kg eptacog alfa one week after dosing with concizumab. On-demand treatment during bleeding episodes in both treatment arms |
Timeline
- Start date
- 2017-08-10
- Primary completion
- 2018-09-19
- Completion
- 2020-01-31
- First posted
- 2017-06-22
- Last updated
- 2021-10-22
- Results posted
- 2021-10-22
Locations
22 sites across 14 countries: United States, Austria, Canada, Croatia, Denmark, Greece, Israel, Italy, Japan, Malaysia, Spain, Sweden, Ukraine, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03196284. Inclusion in this directory is not an endorsement.