A Trial Comparing Nonacog Beta Pegol (N9-GP) and ALPROLIX® in Patients With Haemophilia B (paradigm™7)

May 24, 2023 updated by: Novo Nordisk A/S

A Trial Comparing the Pharmacokinetics of Nonacog Beta Pegol (N9-GP) and ALPROLIX® in Patients With Haemophilia B

This trial is conducted in Europe and the United States of America. The aim of this trial is to compare the pharmacokinetics (the exposure of the trial drug in the body) of nonacog beta pegol (N9-GP) and ALPROLIX® in patients with haemophilia B.

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
      • Duisburg, Germany, 47051
        • Novo Nordisk Investigational Site
      • Hannover, Germany, 30159
        • Novo Nordisk Investigational Site
      • Mörfelden-Walldorf, Germany, 64546
        • Novo Nordisk Investigational Site
  • Switzerland
      • Zürich, Switzerland, 8091
        • Novo Nordisk Investigational Site
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85016-7710
        • Novo Nordisk Investigational Site
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Novo Nordisk Investigational Site
      • Peoria, Illinois, United States, 61615
        • Novo Nordisk Investigational Site
    • Michigan
      • East Lansing, Michigan, United States, 48823
        • Novo Nordisk Investigational Site
    • Minnesota
      • Rochester, Minnesota, United States, 55905-0001
        • Novo Nordisk Investigational Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Novo Nordisk Investigational Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • 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

Description

Inclusion Criteria:

  • Male, aged 18-70 years (both inclusive) at the time of signing informed consent
  • Patients with the diagnosis of congenital haemophilia B with factor IX activity below or equal to 2%, based on medical records
  • History of more than 150 exposures days to any factor IX containing products

Exclusion Criteria:

  • Known history of factor IX inhibitors
  • Inhibitors to factor IX (above or equal to 0.6 BU) at screening measured by the Nijmegen modified Bethesda method
  • Immunocompromised (CD4+ T cells below or equal to 200/μL)
  • Known congenital or acquired coagulation disorders other than haemophilia B
  • Body mass index above 35 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: N9-GP
Drug: N9-GP
A single dose of 50 IU/kg for intravenous (i.v.) injection
Active Comparator: ALPROLIX®
Drug: ALPROLIX®
A single dose of 50 IU/kg for intravenous (i.v.) 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
Measure Description
Time Frame
Area under the factor IX activity-time curve from 0 to infinity dose-normalised to 50 IU/kg
Time Frame: From time 0 (dosing) up to 240 hours post-dose
Calculated based on plasma FIX activity measured in blood
From time 0 (dosing) up to 240 hours post-dose

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
Measure Description
Time Frame
Maximum activity dose-normalised to 50 IU/kg (Cmax,norm)
Time Frame: From time 0 (dosing) up to 240 hours post-dose
Calculated based on plasma FIX activity measured in blood
From time 0 (dosing) up to 240 hours post-dose
Incremental recovery at 30 minutes (IR30min)
Time Frame: At 30 minutes
Calculated based on plasma FIX activity measured in blood
At 30 minutes
Terminal half-life (t½)
Time Frame: From time 0 (dosing) up to 240 hours post-dose
Calculated based on plasma FIX activity measured in blood
From time 0 (dosing) up to 240 hours post-dose
Clearance (CL)
Time Frame: From time 0 (dosing) up to 240 hours post-dose
Calculated based on plasma FIX activity measured in blood
From time 0 (dosing) up to 240 hours post-dose
Area under the activity-time curve
Time Frame: From time 0 (dosing) up to 240 hours post-dose
Calculated based on plasma FIX activity measured in blood
From time 0 (dosing) up to 240 hours post-dose
Maximum activity (Cmax)
Time Frame: From time 0 (dosing) up to 240 hours post-dose
Calculated based on plasma FIX activity measured in blood
From time 0 (dosing) up to 240 hours post-dose
Activity at 30 minutes (C30min)
Time Frame: at 30 minutes
Calculated based on plasma FIX activity measured in blood
at 30 minutes
Activity at 168 hours (C168h)
Time Frame: At 168 hours
Calculated based on plasma FIX activity measured in blood
At 168 hours
Incremental recovery at maximum activity (IRCmax)
Time Frame: From time 0 (dosing) up to 240 hours post-dose
Calculated based on plasma FIX activity measured in blood
From time 0 (dosing) up to 240 hours post-dose
Time of maximum activity (tmax)
Time Frame: From time 0 (dosing) up to 240 hours post-dose
Calculated based on plasma FIX activity measured in blood
From time 0 (dosing) up to 240 hours post-dose
Apparent volume of distribution during terminal phase (Vz)
Time Frame: From time 0 (dosing) up to 240 hours post-dose
Calculated based on plasma FIX activity measured in blood
From time 0 (dosing) up to 240 hours post-dose
Apparent volume of distribution at steady-state (Vss)
Time Frame: From time 0 (dosing) up to 240 hours post-dose
Calculated based on plasma FIX activity measured in blood
From time 0 (dosing) up to 240 hours post-dose
Mean residence time (MRT)
Time Frame: From time 0 (dosing) up to 240 hours post-dose
Calculated based on plasma FIX activity measured in blood
From time 0 (dosing) up to 240 hours post-dose
Terminal elimination rate constant
Time Frame: From time 0 (dosing) up to 240 hours post-dose
Calculated based on plasma FIX activity measured in blood
From time 0 (dosing) up to 240 hours post-dose
Area under the activity-time curve from 0 to infinity
Time Frame: From time 0 (dosing) up to 240 hours post-dose
Calculated based on plasma FIX activity measured in blood
From time 0 (dosing) up to 240 hours post-dose
Area under the activity-time curve from 0 to t last
Time Frame: From time 0 (dosing) up to 240 hours post-dose
Calculated based on plasma FIX activity measured in blood
From time 0 (dosing) up to 240 hours post-dose
Number of adverse events
Time Frame: From time 0 (dosing) up to 240 hours post-dose
Count and % of Adverse events
From time 0 (dosing) up to 240 hours post-dose

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

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 (Actual)

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.
March 7, 2017

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.
December 8, 2017

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.
December 8, 2017

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).
March 3, 2017

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.
March 8, 2017

First Posted (Actual)

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.
March 9, 2017

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.
May 26, 2023

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.
May 24, 2023

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.
May 1, 2023

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.
  • NN7999-4260
  • 2016-001149-25 (EudraCT Number)
  • U1111-1180-7154 (Other Identifier: World Health Organization (WHO))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

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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Locations

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