Investigation of the Pharmacokinetics of Turoctocog Alfa in Subjects With Haemophilia A

February 9, 2017 updated by: Novo Nordisk A/S

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
15

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 10249
        • Novo Nordisk Investigational Site
      • Frankfurt/M., Germany, 60590
        • Novo Nordisk Investigational Site
  • Latvia
      • Riga, Latvia, 1006
        • Novo Nordisk Investigational Site
  • Malaysia
      • Kuala Lumpur, Malaysia, 50400
        • Novo Nordisk Investigational Site
  • Spain
      • Madrid, Spain, 28046
        • Novo Nordisk Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • 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
  • 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)

Exclusion Criteria:

  • Detectable inhibitors to FVIII (above or equal to 0.6 Bethesda Units (BU))
  • History of FVIII inhibitors
  • Severe current hepatic dysfunction or severe hepatic disease during the last 12 months
  • Known or suspected allergy to trial product (FVIII) or related products
  • Subjects receiving immune modulating medication or immune tolerance induction (ITI) regimens
  • Body mass index (BMI) above 30 kg/m^2

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Lot A
Each subject will receive two single doses of turocotocog alfa from two lots of trial product on two separate days.
Drug: turoctocog alfa
Trial product, 2000 IU/vial will be administered as an i.v. (intravenous) bolus injection.
Drug: turoctocog alfa
Trial product, 3000 IU/vial will be administered as an i.v. (intravenous) bolus injection.
Experimental: Lot B
Each subject will receive two single doses of turocotocog alfa from two lots of trial product on two separate days.
Drug: turoctocog alfa
Trial product, 2000 IU/vial will be administered as an i.v. (intravenous) bolus injection.
Drug: turoctocog alfa
Trial product, 3000 IU/vial will be administered as an i.v. (intravenous) bolus injection.
Experimental: Lot C
Each subject will receive two single doses of turocotocog alfa from two lots of trial product on two separate days.
Drug: turoctocog alfa
Trial product, 2000 IU/vial will be administered as an i.v. (intravenous) bolus injection.
Drug: turoctocog alfa
Trial product, 3000 IU/vial will be administered as an i.v. (intravenous) bolus injection.
Experimental: Lot D
Each subject will receive two single doses of turocotocog alfa from two lots of trial product on two separate days.
Drug: turoctocog alfa
Trial product, 2000 IU/vial will be administered as an i.v. (intravenous) bolus injection.
Drug: turoctocog alfa
Trial product, 3000 IU/vial will be administered as an i.v. (intravenous) bolus injection.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Dose normalised area under the curve (AUC/actual dose) based on chromogenic assay
Time Frame: up to 48 hours after i.v. administration
up to 48 hours after i.v. administration

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Dose normalised area under the FVIII activity-time curve (AUC/actual dose) based on one stage clot assay
Time Frame: up to 48 hours after i.v. administration
up to 48 hours after i.v. administration
Incremental recovery (IR30min) (defined as the peak FVIII level recorded 30 min after injection and reported as[IU/mL]/[IU/kg])
Time Frame: up to 48 hours after i.v. administration
up to 48 hours after i.v. administration
Area under the FVIII activity-time curve (AUC)
Time Frame: up to 48 hours after i.v. administration
up to 48 hours after i.v. administration
Terminal half-life of FVIII (t½)
Time Frame: up to 48 hours after i.v. administration
up to 48 hours after i.v. administration
Clearance of FVIII (CL)
Time Frame: up to 48 hours after i.v. administration
up to 48 hours after i.v. administration
Incidence of adverse events (AEs) including FVIII inhibitors
Time Frame: After approximately 3 months (at end of trial)
After approximately 3 months (at end of trial)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 21, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 21, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 26, 2012

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 10, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 9, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NN7008-4015
  • 2012-001444-21 (EudraCT Number)
  • U1111-1129-1517 (Other Identifier: WHO)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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