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NCT02490787 Clinical Trial

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

Congenital Bleeding Disorder Clinical Trial

Official title:
A Multi-centre, Randomised, Placebo Controlled, Double Blinded, Multiple Dose Trial Investigating Safety, Pharmacokinetics and Pharmacodynamics of Concizumab Administered Subcutaneously to Haemophilia A Subjects (Explorer™3)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02490787
Other study ID # NN7415-4159
Secondary ID 2014-003793-16U1
Status Completed
Phase Phase 1
First received July 2, 2015
Last updated July 20, 2017
Start date September 10, 2015
Est. completion date October 14, 2016

Study information
Verified date July 2017
Source Novo Nordisk A/S
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 24
Est. completion date October 14, 2016
Est. primary completion date October 14, 2016
Accepts healthy volunteers No
Gender Male
Age group 18 Years to 64 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• Concizumab
Administered subcutaneously (s.c., under the skin) at five different dose levels (ranging from 0.25 to 1.5 mg/kg)
• placebo
Administered subcutaneously (s.c., under the skin)

Locations
Country Name City State
Australia Novo Nordisk Investigational Site Camperdown New South Wales
Australia Novo Nordisk Investigational Site Melbourne Victoria
Austria Novo Nordisk Investigational Site Wien
Croatia Novo Nordisk Investigational Site Zagreb
France Novo Nordisk Investigational Site Bron Cedex
France Novo Nordisk Investigational Site Nantes Cedex 1
France Novo Nordisk Investigational Site Rennes
Germany Novo Nordisk Investigational Site Berlin
Germany Novo Nordisk Investigational Site Duisburg
Germany Novo Nordisk Investigational Site Homburg
Israel Novo Nordisk Investigational Site Tel-Hashomer
Malaysia Novo Nordisk Investigational Site Kuala Lumpur
Malaysia Novo Nordisk Investigational Site Kuching
Netherlands Novo Nordisk Investigational Site Amsterdam
Netherlands Novo Nordisk Investigational Site Nijmegen
Netherlands Novo Nordisk Investigational Site Utrecht
Poland Novo Nordisk Investigational Site Warszawa
Spain Novo Nordisk Investigational Site Madrid
Thailand Novo Nordisk Investigational Site Bangkok
Turkey Novo Nordisk Investigational Site Bornova-IZMIR
Ukraine Novo Nordisk Investigational Site Dnipropetrovsk
Ukraine Novo Nordisk Investigational Site Lviv
United Kingdom Novo Nordisk Investigational Site London
United Kingdom Novo Nordisk Investigational Site London
United Kingdom Novo Nordisk Investigational Site Sheffield
United Kingdom Novo Nordisk Investigational Site Southampton
United States Novo Nordisk Investigational Site Baltimore Maryland
United States Novo Nordisk Investigational Site Houston Texas
United States Novo Nordisk Investigational Site Indianapolis Indiana
United States Novo Nordisk Investigational Site Iowa City Iowa
United States Novo Nordisk Investigational Site Milwaukee Wisconsin
United States Novo Nordisk Investigational Site New York New York
United States Novo Nordisk Investigational Site Portland Oregon
United States Novo Nordisk Investigational Site Torrance California

Sponsors (1)
Lead Sponsor Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Croatia,  France,  Germany,  Israel,  Malaysia,  Netherlands,  Poland,  Spain,  Thailand,  Turkey,  Ukraine,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of adverse events (AEs) From first trial drug administration (day 1) to 11 weeks after the first trial product administration
Secondary Trough level of concizumab Prior to the last s.c. dose administration (day 42)
Secondary Frequency of binding non-neutralizing anti-concizumab antibodies From first trial drug administration (day 1) to 11 weeks after the first trial product administration
See also
  Status Clinical Trial Phase
Completed NCT00978380 - Safety of Monthly Recombinant Factor XIII Replacement Therapy in Subjects With Congenital Factor XIII Deficiency: An Extension to Trial F13CD-1725 Phase 3
Completed NCT02568202 - Bridging Hemophilia B Experiences, Results and Opportunities Into Solutions (B-HERO-S) N/A
Completed NCT01949792 - A Trial Investigating the Pharmacokinetics and Pharmacodynamics of rFVIIa in Patients With Haemophilia A or B With or Without Inhibitors Phase 1
Completed NCT01205724 - Safety and Pharmacokinetics of NNC 0129-0000-1003 in Subjects With Haemophilia A Phase 1
Completed NCT01562587 - Pharmacokinetics of Single Bolus Dose of NovoSeven® in Paediatric and Adult Patients With Haemophilia A or B in a Non- Bleeding State Phase 1
Completed NCT00108797 - Trial of NovoSeven® in Haemophilia - Joint Bleeds Phase 4
Completed NCT01493778 - Safety and Efficacy of Turoctocog Alfa in Prevention and Treatment of Bleeds in Previously Untreated Children With Haemophilia A Phase 3
Completed NCT00951405 - Safety and Efficacy of 3 Different Doses of Long Acting Factor VII in Haemophilia A or B Patients With Inhibitors Phase 2
Completed NCT01876745 - A Study to Evaluate Safety and Efficacy of NovoSeven® in Patients With Glanzmann's Thrombasthenia in Japan N/A
Completed NCT02920398 - A Multi-centre, Comparative, Double Blind, Randomised Cross-over Trial Investigating Single Dose Pharmacokinetics and Safety of Turoctocog Alfa Pegol From the Pivotal Process and Turoctocog Alfa Pegol From the Commercial Process in Patients With Severe Haemophilia A Phase 1
Completed NCT00984126 - Safety and Efficacy of Turoctocog Alfa (N8) in Prevention and On-demand Treatment of Bleeding Episodes in Subjects With Haemophilia A: An Extension to Trials NN7008-3543, NN7008-3545, NN7008-3600, NN7008-3893 and NN7008-4015 Phase 3
Completed NCT01228669 - Safety of NNC 0172-0000-2021 in Healthy Male Subjects and Subjects With Haemophilia A or B Phase 1
Completed NCT01988532 - Impact of Pain on Functional Impairment and Quality of Life in Adults With Hemophilia N/A
Completed NCT01234545 - Observational Study Describing the Usual Clinical Practice Use of NovoSeven® in the Home Treatment of Joint Bleeds in Patients With Haemophilia A or B and Inhibitors N/A
Completed NCT01779921 - Treatment of Congenital Factor VII Deficiency N/A
Completed NCT01563471 - Safety and Tolerability of Intravenous Doses of Activated Recombinant Human Factor VII in Healthy Volunteers Phase 1
Completed NCT02941354 - Evaluating the Pharmacokinetics of NovoEight® (Turoctocog Alfa) in Relation to BMI in Subjects With Haemophilia A Phase 1
Completed NCT02241694 - To Quantify the Range of Main Psychosocial Factors Affecting Patients and Caregivers in Their Daily Lives N/A
Completed NCT01220141 - Observational Study on Safety of Room Temperature Stable NovoSeven® in Patients With Haemophilia A or B N/A
Completed NCT01230021 - Safety of a Single Intravenous Dose of Recombinant Factor XIII in Children With Congenital FXIII A-subunit Deficiency Phase 3

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