CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 36 enrolled
Drug / intervention
Concizumab +1 moredrug
Likely dose
Concizumab 0.15 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03196297
NCT03196297Phase 2Completed

A Multi-Centre Trial Evaluating Efficacy and Safety of Prophylactic Administration of Concizumab in Patients With Severe Haemophilia A Without Inhibitors

Novo Nordisk A/S·interventional·Posted Jun 22, 2017·Updated Nov 16, 2021

In Brief

A Phase 2 clinical trial evaluating Concizumab and Turoctocog alfa for Haemostasis and Haemophilia A. Completed, enrolled 36 participants across 31 sites in 11 countries.

Detailed Summary

This trial is conducted in Asia, Europe and the United States of America (USA). 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 patients with severe haemophilia A without inhibitors.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesFrance, Germany, Italy, Japan, Spain, Sweden, Thailand, Turkey (Türkiye), Ukraine, United Kingdom, United States
Collaborators--

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedJun 22, 2017
Enrollment StartAug 16, 2017
Primary CompletionJun 22, 2018
Study CompletionJun 3, 2020
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 9.0 years ago

Interventions

Concizumabdrug

0.15 mg/kg (with potential stepwise dose administration to 0.25 mg/kg) administered daily s.c (subcutaneously, under the skin). Treatment duration is 24 weeks in the main phase, and 52 weeks in the extension phase

Turoctocog alfadrug

Breakthrough bleeding episodes will be treated by the patients at home with turoctocog alfa at the discretion of the study doctor, who will also choose dose levels