Congenital Bleeding DisorderPhase 1paradigm™7NCT03075670
A Trial Comparing Nonacog Beta Pegol (N9-GP) and ALPROLIX® in Patients With Haemophilia B
A Phase 1 study testing N9-GP and ALPROLIX® in people with Congenital Bleeding Disorder and Haemophilia B, run by Novo Nordisk A/S at 12 sites in 3 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years, men only
- Conditions the study is for
- Congenital Bleeding Disorder, Haemophilia B
- What is being tested?
- N9-GP and ALPROLIX®
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 12 sitesin 3 countries
- Study dates
- 7 Mar 2017to 8 Dec 2017
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
12 sites in 3 countries.
12 sites in 3 countries
United States7 sites
Novo Nordisk Investigational Site
Chicago, Illinois, 60612
Novo Nordisk Investigational Site
East Lansing, Michigan, 48823
Novo Nordisk Investigational Site
Oklahoma City, Oklahoma, 73104
Novo Nordisk Investigational Site
Peoria, Illinois, 61615
Novo Nordisk Investigational Site
Philadelphia, Pennsylvania, 19104
Novo Nordisk Investigational Site
Phoenix, Arizona, 85016-7710
Novo Nordisk Investigational Site
Rochester, Minnesota, 55905-0001
Germany4 sites
Novo Nordisk Investigational Site
Berlin, 10249
Novo Nordisk Investigational Site
Duisburg, 47051
Novo Nordisk Investigational Site
Hanover, 30159
Novo Nordisk Investigational Site
Mörfelden-Walldorf, 64546
About this study
Official title: 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.
- Conditions
- Congenital Bleeding Disorder, Haemophilia B
- Being tested
- N9-GP, ALPROLIX®
- Medical subject headings
- Hemophilia B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
N9-GPDrug
A single dose of 50 IU/kg for intravenous (i.v.) injection
ALPROLIX®Drug
A single dose of 50 IU/kg for intravenous (i.v.) injection
| Study group | Role | What they receive |
|---|---|---|
| N9-GP | Experimental | Not described Receives: Drug: N9-GP |
| ALPROLIX® | Active comparator | Not described Receives: Drug: ALPROLIX® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the factor IX activity-time curve from 0 to infinity dose-normalised to 50 IU/kg
Calculated based on plasma FIX activity measured in blood
Measured: From time 0 (dosing) up to 240 hours post-dose
Secondary outcomes (17)
Maximum activity dose-normalised to 50 IU/kg (Cmax,norm)
Calculated based on plasma FIX activity measured in blood
Measured: From time 0 (dosing) up to 240 hours post-dose
Incremental recovery at 30 minutes (IR30min)
Calculated based on plasma FIX activity measured in blood
Measured: At 30 minutes
Terminal half-life (t½)
Calculated based on plasma FIX activity measured in blood
Measured: From time 0 (dosing) up to 240 hours post-dose
Clearance (CL)
Calculated based on plasma FIX activity measured in blood
Measured: From time 0 (dosing) up to 240 hours post-dose
Area under the activity-time curve
Calculated based on plasma FIX activity measured in blood
Measured: From time 0 (dosing) up to 240 hours post-dose
Maximum activity (Cmax)
Calculated based on plasma FIX activity measured in blood
Measured: From time 0 (dosing) up to 240 hours post-dose
Activity at 30 minutes (C30min)
Calculated based on plasma FIX activity measured in blood
Measured: at 30 minutes
Activity at 168 hours (C168h)
Calculated based on plasma FIX activity measured in blood
Measured: At 168 hours
Incremental recovery at maximum activity (IRCmax)
Calculated based on plasma FIX activity measured in blood
Measured: From time 0 (dosing) up to 240 hours post-dose
Time of maximum activity (tmax)
Calculated based on plasma FIX activity measured in blood
Measured: From time 0 (dosing) up to 240 hours post-dose
Apparent volume of distribution during terminal phase (Vz)
Calculated based on plasma FIX activity measured in blood
Measured: From time 0 (dosing) up to 240 hours post-dose
Apparent volume of distribution at steady-state (Vss)
Calculated based on plasma FIX activity measured in blood
Measured: From time 0 (dosing) up to 240 hours post-dose
Mean residence time (MRT)
Calculated based on plasma FIX activity measured in blood
Measured: From time 0 (dosing) up to 240 hours post-dose
Terminal elimination rate constant
Calculated based on plasma FIX activity measured in blood
Measured: From time 0 (dosing) up to 240 hours post-dose
Area under the activity-time curve from 0 to infinity
Calculated based on plasma FIX activity measured in blood
Measured: From time 0 (dosing) up to 240 hours post-dose
Area under the activity-time curve from 0 to t last
Calculated based on plasma FIX activity measured in blood
Measured: From time 0 (dosing) up to 240 hours post-dose
Number of adverse events
Count and % of Adverse events
Measured: From time 0 (dosing) up to 240 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2017
- Study start7 Mar 2017
- Primary completion8 Dec 2017
- Study completion8 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Congenital Bleeding DisorderStudies of the same condition, open and under way.
- More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03075670
- Sponsor's protocol ID
- NN7999-4260
- Other IDs
- 2016-001149-25, U1111-1180-7154, 2016
- Acronym
- paradigm™7
- Status last verified
- May 2023
- First submitted
- 3 Mar 2017
- Last updated
- 26 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Publications
Escuriola Ettingshausen C, Hegemann I, Simpson ML, Cuker A, Kulkarni R, Pruthi RK, Garly ML, Meldgaard RM, Persson P, Klamroth R. Favorable pharmacokinetics in hemophilia B for nonacog beta pegol versus recombinant factor IX-Fc fusion protein: A randomized trial. Res Pract Thromb Haemost. 2019 Mar 23;3(2):268-276. doi: 10.1002/rth2.12192. eCollection 2019 Apr.
PubMed 31011711
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Trial Comparing the Pharmacokinetics of Nonacog Beta Pegol (N9-GP) and ALPROLIX® in Patients With Haemophilia B
- ClinicalTrials.gov ID
- NCT03075670
- Acronym / sponsor ID
- paradigm™7 / NN7999-4260
- Conditions
- Congenital Bleeding Disorder, Haemophilia B
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 7 Mar 2017 (actual)
- Primary completion
- 8 Dec 2017 (actual)
- Study completion
- 8 Dec 2017 (actual)
- First posted
- 9 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| N9-GP | Experimental | Drug: N9-GP |
| ALPROLIX® | Active comparator | Drug: ALPROLIX® |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| N9-GPA single dose of 50 IU/kg for intravenous (i.v.) injection | Drug | N9-GP |
| ALPROLIX®A single dose of 50 IU/kg for intravenous (i.v.) injection | Drug | ALPROLIX® |
Primary outcome
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
17 secondary outcomes
Maximum activity dose-normalised to 50 IU/kg (Cmax,norm)
Time frame: From time 0 (dosing) up to 240 hours post-dose
Incremental recovery at 30 minutes (IR30min)
Time frame: At 30 minutes
Terminal half-life (t½)
Time frame: From time 0 (dosing) up to 240 hours post-dose
Clearance (CL)
Time frame: 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
Maximum activity (Cmax)
Time frame: From time 0 (dosing) up to 240 hours post-dose
Activity at 30 minutes (C30min)
Time frame: at 30 minutes
Activity at 168 hours (C168h)
Time frame: At 168 hours
Incremental recovery at maximum activity (IRCmax)
Time frame: 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
Apparent volume of distribution during terminal phase (Vz)
Time frame: 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
Mean residence time (MRT)
Time frame: 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
Area under the activity-time curve from 0 to infinity
Time frame: 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
Number of adverse events
Time frame: From time 0 (dosing) up to 240 hours post-dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2023.
- Derived from this study: PubMed 31011711Escuriola Ettingshausen C, Hegemann I, Simpson ML, Cuker A, Kulkarni R, Pruthi RK, Garly ML, Meldgaard RM, Persson P, Klamroth R. Favorable pharmacokinetics in hemophilia B for nonacog beta pegol versus recombinant factor IX-Fc fusion protein: A randomized trial. Res Pract Thromb Haemost. 2019 Mar 23;3(2):268-276. doi: 10.1002/rth2.12192. eCollection 2019 Apr.
- Individual participant dataSharing planned: Yes. According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
12 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing N9-GP and ALPROLIX® in people with Congenital Bleeding Disorder and Haemophilia B, run by Novo Nordisk A/S at 12 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States, Germany, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03075670, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2023.