Trial Investigating Safety, Pharmacokinetics and Pharmacodynamics of Concizumab Administered Subcutaneously to Haemophilia A Subjects

Phase 1

Completed

• Conditions: Congenital Bleeding Disorder; Haemophilia A
• Interventions: Drug: placebo; Drug: Concizumab

• Registration Number: NCT02490787
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

This trial is conducted globally. The aim of this trial is to investigate safety, pharmacokinetics (the exposure of the trial drug in the body) and pharmacodynamics (the effect of the investigated drug on the body) of concizumab administered subcutaneously to haemophilia A subjects.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-07-02
• Study First Submitted QC: 2015-07-02
• Study First Posted: 2015-07-07
• Study Start: 2015-09-10
• Primary Completion: 2016-10-14
• Study Completion: 2016-10-14
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-20
• Last Update Posted: 2017-07-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 24

Inclusion Criteria

• Male subjects diagnosed with haemophilia A without inhibitors present at screening and currently treated on-demand
• Subjects with a baseline level of factor VIII below or equal to 2 % based on medical records
• Age between 18 and 64 years both inclusive, at the time of signing informed consent
• Body weight between 50 and 100 kg, both inclusive

Exclusion Criteria

• Known or suspected hypersensitivity to trial product or related products
• Platelet count below 50x10^9/L at screening
• Any clinical signs or known history of thromboembolic events, or subjects considered at high risk of thromboembolic events as judged by the investigator
• Subjects at increased risk of cardiovascular disease as judged by the investigator

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Placebo	placebo	-
Concizumab	placebo	-
Concizumab	Concizumab	-

Primary Outcome Measures

Name	Time	Method
Number of adverse events (AEs)	From first trial drug administration (day 1) to 11 weeks after the first trial product administration

Secondary Outcome Measures

Name	Time	Method
Trough level of concizumab	Prior to the last s.c. dose administration (day 42)
Frequency of binding non-neutralizing anti-concizumab antibodies	From first trial drug administration (day 1) to 11 weeks after the first trial product administration

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇬🇧 Southampton, United Kingdom