Completed

Multi-centre, Open-labelled Trial Investigating the Pharmacokinetics of Four Lots of Turoctocog Alfa in Subjects With Haemophilia A

What is being tested

turoctocog alfa

+ turoctocog alfa

Drug

Who is being recruted

Blood Coagulation Disorders+6

+ Hematologic Diseases

+ Hemic and Lymphatic Diseases

Over 18 Years

+10 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 1

Interventional

Study Start: December 2012

See protocol details

Summary

Principal SponsorNovo Nordisk A/S

Last updated: February 10, 2017

Sourced from a government-validated database.Claim as a partner

Study start date: December 1, 2012

Actual date on which the first participant was enrolled.

This trial is conducted in Europe. The aim of the trial is to investigate the pharmacokinetics (the exposure of the trial drug in the body) of four lots of turoctocog alfa (a human recombinant coagulation factor VIII (FVIII)) in subjects with haemophilia A.

NCT01692925

Principal SponsorNovo Nordisk A/S

Last updated: February 10, 2017

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

15 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Male

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Blood Coagulation DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesCoagulation Protein DisordersBlood Coagulation Disorders, InheritedGenetic Diseases, InbornHemophilia A

Criteria

4 inclusion criteria required to participate

Documented history of at least 150 exposure days to any other FVIII products (prevention or treatment of bleeds)

Immunocompetent (HIV (Human Immunodeficiency Virus) positive subjects should have CD4+ (Cluster of differentiation 4; a glycoprotein expressed on the surface) lymphocyte count > 200/microL)

Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial

Male subjects with the diagnosis of severe haemophilia A (FVIII < 1%) from age 18 years

6 exclusion criteria prevent from participating

Body mass index (BMI) above 30 kg/m^2

Detectable inhibitors to FVIII (above or equal to 0.6 Bethesda Units (BU))

History of FVIII inhibitors

Known or suspected allergy to trial product (FVIII) or related products

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

4 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

Each subject will receive two single doses of turocotocog alfa from two lots of trial product on two separate days.

Group II

Experimental

Each subject will receive two single doses of turocotocog alfa from two lots of trial product on two separate days.

Group III

Experimental

Each subject will receive two single doses of turocotocog alfa from two lots of trial product on two separate days.

Group IV

Experimental

Each subject will receive two single doses of turocotocog alfa from two lots of trial product on two separate days.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 5 locations

Novo Nordisk Investigational Site

Berlin, GermanyOpen Novo Nordisk Investigational Site in Google Maps

Novo Nordisk Investigational Site

Frankfurt/M., Germany

Novo Nordisk Investigational Site

Riga, Latvia

Novo Nordisk Investigational Site

Kuala Lumpur, Malaysia

Completed5 Study Centers