Congenital Bleeding DisorderPhase 3paradigm™ 2NCT01333111
Safety and Efficacy of NNC-0156-0000-0009 in Haemophilia B Patients
A Phase 3 study testing nonacog beta pegol in people with Congenital Bleeding Disorder and Haemophilia B, run by Novo Nordisk A/S at 43 sites in 15 countries.
Trial summary
This trial is conducted in Africa, Asia, Europe, Japan and North America. The aim of this trial is to evaluate the safety and efficacy, including pharmacokinetics (the rate at which the body eliminates the trial drug), of NNC-0156-0000-0009 (nonacog beta pegol) when used for treatment and prophylaxis of bleeding… Read more about this study
- Who is it for?
- Ages 13 to 70 years, men only
- Conditions the study is for
- Congenital Bleeding Disorder, Haemophilia B
- What is being tested?
- nonacog beta pegol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 43 sitesin 15 countries
- Study dates
- 27 Apr 2011to 31 Mar 2013
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 13 to 70 years
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Male patients with moderately severe or severe congenital haemophilia B with a factor IX activity of 2% or below according to medical records
- History of at least 150 exposure days to other factor IX products
- Patients currently treated on-demand with at least 6 bleeding episodes during the last 12 months or at least 3 bleeding episodes during the last 6 months, or patients currently on prophylaxis
Who cannot join
- Known history of factor IX inhibitors based on existing medical records, laboratory report reviews and patient and legally acceptable representative (LAR) interviews
- HIV (Human immunodeficiency virus) positive, with a viral load equal to or above 400,000 copies/mL and/or CD4+ lymphocyte count equal to or below 200/microL
- Congenital or acquired coagulation disorders other than haemophilia B
- Previous arterial thrombotic events (e.g. myocardial infarction and intracranial thrombosis) or previous deep venous thrombosis or pulmonary embolism (as defined by available medical records)
- Immune modulating or chemotherapeutic medication
Trial locations and contacts
43 sites in 15 countries.
43 sites in 15 countries
United States12 sites
Novo Nordisk Investigational Site
Augusta, Georgia, 30912
Novo Nordisk Investigational Site
Baltimore, Maryland, 21287
Novo Nordisk Investigational Site
Hershey, Pennsylvania, 17033
Novo Nordisk Investigational Site
Houston, Texas, 77030
Novo Nordisk Investigational Site
Iowa City, Iowa, 52242
Novo Nordisk Investigational Site
Jacksonville, Florida, 32207
Novo Nordisk Investigational Site
Los Angeles, California, 90027-6016
Novo Nordisk Investigational Site
Minneapolis, Minnesota, 55404
Novo Nordisk Investigational Site
New York, New York, 10029
Novo Nordisk Investigational Site
Newark, New Jersey, 07102
Novo Nordisk Investigational Site
Omaha, Nebraska, 68198-5456
Novo Nordisk Investigational Site
Syracuse, New York, 13210
United Kingdom6 sites
Novo Nordisk Investigational Site
Basingstoke, RG24 9NA
Novo Nordisk Investigational Site
Cardiff, CF14 4XW
Novo Nordisk Investigational Site
London, NW3 2QG
Novo Nordisk Investigational Site
London, SE1 7EH
Novo Nordisk Investigational Site
Manchester, M13 9WL
Novo Nordisk Investigational Site
Oxford, OX3 7LJ
Japan5 sites
Novo Nordisk Investigational Site
Kawasaki-shi, Kanagawa, 216-8511
Novo Nordisk Investigational Site
Nagoya-shi, Aichi, 466 8560
Novo Nordisk Investigational Site
Nishinomiya-shi, 663 8051
Novo Nordisk Investigational Site
Shinjuku-ku, Tokyo, 160 0023
Novo Nordisk Investigational Site
Suginami-ku, Tokyo, 167 0035
Germany4 sites
Novo Nordisk Investigational Site
Bonn, 53127
Novo Nordisk Investigational Site
Duisburg, 47051
Novo Nordisk Investigational Site
Giessen, 35392
Novo Nordisk Investigational Site
Hanover, 30625
Turkey (Türkiye)3 sites
Novo Nordisk Investigational Site
Ankara, 06500
Novo Nordisk Investigational Site
Kayseri, 38010
Novo Nordisk Investigational Site
Konya, 42090
France2 sites
Novo Nordisk Investigational Site
Le Kremlin-Bicêtre, 94270
Novo Nordisk Investigational Site
Lyon, 69003
Italy2 sites
Novo Nordisk Investigational Site
Florence, 50134
Novo Nordisk Investigational Site
Milan, 20124
Russia2 sites
Novo Nordisk Investigational Site
Moscow, 105077
Novo Nordisk Investigational Site
Saint Petersburg, 191119
South Africa1 site
Novo Nordisk Investigational Site
Parktown Johannesburg, Gauteng, 2193
About this study
Official title: A Multi-centre, Single-blind Trial Evaluating Safety and Efficacy, Including Pharmacokinetics, of NNC-0156-0000-0009 When Used for Treatment and Prophylaxis of Bleeding Episodes in Patients With Haemophilia B
This trial is conducted in Africa, Asia, Europe, Japan and North America. The aim of this trial is to evaluate the safety and efficacy, including pharmacokinetics (the rate at which the body eliminates the trial drug), of NNC-0156-0000-0009 (nonacog beta pegol) when used for treatment and prophylaxis of bleeding episodes in patients with haemophilia B.
- Conditions
- Congenital Bleeding Disorder, Haemophilia B
- Being tested
- nonacog beta pegol
- Medical subject headings
- Hemophilia B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nonacog beta pegolDrug
Also called NNC-0156-0000-0009
One single dose administered intravenously (into the vein) once weekly. Patients will receive instruction on how to treat any bleeding episode they may experience
nonacog beta pegolDrug
Also called NNC-0156-0000-0009
One single dose administered intravenously (into the vein) once weekly. Patients will receive instruction on how to treat any bleeding episode they may experience
nonacog beta pegolDrug
Also called NNC-0156-0000-0009
Patients will treat themselves with either a low or a high dose dependent on the severity of the bleeding episode
| Study group | Role | What they receive |
|---|---|---|
| Prophylaxis, high dose (trial duration 52 weeks) | Experimental | Not described Receives: Drug: nonacog beta pegol |
| Prophylaxis, low dose (trial duration 52 weeks) | Experimental | Not described Receives: Drug: nonacog beta pegol |
| On-demand (trial duration 28 weeks) | Experimental | Not described Receives: Drug: nonacog beta pegol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Inhibitory Antibodies Against Factor IX Defined as Titre Equal to or Above 0.6 BU (Bethesda Units)
Inhibitors were analysed with either the Nijmegen modified factor IX Bethesda assay or a heat/cold Nijmegen modified factor IX Bethesda assay. Number of subjects who developed inhibitory antibodies against factor IX are reported.
Measured: 52 weeks after treatment start for patients on prophylaxis
Incidence of Inhibitory Antibodies Against Factor IX Defined as Titre Equal to or Above 0.6 BU (Bethesda Units)
Inhibitors were analysed with either the Nijmegen modified factor IX Bethesda assay or a heat/cold Nijmegen modified factor IX Bethesda assay. Number of subjects who developed inhibitory antibodies against factor IX are reported.
Measured: 28 weeks after treatment start on on-demand treatment
Secondary outcomes (10)
Haemostatic Effect of NNC-0156-0000-0009 When Used for Prophylaxis of Bleeding Episodes, Assessed as Success/Failure Based on a Four-point Scale for Haemostatic Response
Haemostatic response after treatment of a bleed with nonacog beta pegol was evaluated on a 4 point scale as excellent, good, moderate or poor. A success rate was calculated based on counting good or excellent as successes and poor and moderate as failures.
- Excellent - abrupt pain relief and/or clear improvement in objective signs of bleeding within 8 hours after a single injection
- Good - noticeable pain relief and/or improvement in signs of bleeding within 8 hours after a single injection
- Moderate - probable or slight beneficial effect within the first 8 hours after the first injection but requiring more than one injection within 8 hours
- Poor - no improvement, or worsening of symptoms within 8 hours after two injections.
The success rate and 95% confidence interval (CI) are reported here.
Measured: 52 weeks after treatment start for patients on prophylaxis
Haemostatic Effect of NNC-0156-0000-0009 When Used for Treatment of Bleeding Episodes, Assessed as Success/Failure Based on a Four-point Scale for Haemostatic Response
Haemostatic response after treatment of a bleed with nonacog beta pegol was evaluated on a 4 point scale as excellent, good, moderate or poor. A success rate was calculated based on counting good or excellent as successes and poor and moderate as failures.
- Excellent - abrupt pain relief and/or clear improvement in objective signs of bleeding within 8 hours after a single injection
- Good - noticeable pain relief and/or improvement in signs of bleeding within 8 hours after a single injection
- Moderate - probable or slight beneficial effect within the first 8 hours after the first injection but requiring more than one injection within 8 hours
- Poor - no improvement, or worsening of symptoms within 8 hours after two injections.
The success rate and 95% confidence interval (CI) are reported here.
Measured: 28 weeks after treatment start on on-demand treatment
Number of Bleeding Episodes Per Patient During Routine Prophylaxis
The number of bleeding episodes per patient during routine prophylaxis was assessed using the individual annualised bleeding rates (spontaneous and traumatic bleeding episodes per patient per year).
Measured: 52 weeks after treatment start for patients on prophylaxis
Factor IX Trough Levels
The mean pre-dose factor IX levels was measured with the one-stage clotting assay during the trial. Lowest factor IX activity recorded during single-dose and steady state, immediately before next dose was given. The analysis was based on a mixed model on the log-transformed plasma factor IX activity with subject as a random effect. The estimated mean factor IX trough level was presented back-transformed to the natural scale.
Measured: 52 weeks after treatment start for patients on prophylaxis
Incidence of Adverse Events (AEs)
The incidence of adverse events were summarised by the rate of AEs (number of AEs per patient years of exposure [PYE]). Number of adverse events per PYE is number of adverse events /total time in trial. All adverse events reported are treatment emergent (any adverse events which occurred after trial product administration).
Measured: at 56 weeks ±2 weeks for patients on prophylaxis
Incidence of Adverse Events (AEs)
The incidence of adverse events were summarised by the rate of AEs (number of AEs per PYE). Number of adverse events per PYE is number of adverse events /total time in trial. All adverse events reported are treatment emergent (any adverse events which occurred after trial product administration).
Measured: at 32 weeks ±2 weeks for patients on on-demand treatment
Incidence of Serious Adverse Events (SAEs)
SAE was defined as an AE that resulted in any of the following: death, a life-threatening experience, in-subject hospitalization/prolongation of existing hospitalisation, persistent/significant disability/incapacity/congenital anomaly/birth defect. The incidence of SAEs were summarised by the rate of SAEs (number of SAEs per PYE). Number of SAEs per PYE is number of SAEs/total time in trial. All SAEs reported are treatment emergent (any serious adverse events which occurred after trial product administration).
Measured: at 56 weeks ±2 weeks for patients on prophylaxis
Incidence of Serious Adverse Events (SAEs)
SAE was defined as an AE that resulted in any of the following: death, a life-threatening experience, in-subject hospitalization/prolongation of existing hospitalisation, persistent/significant disability/incapacity/congenital anomaly/birth defect. The incidence of SAEs were summarised by the rate of SAEs (number of SAEs per PYE). Number of SAEs per PYE is number of SAEs/total time in trial. All SAEs reported are treatment emergent (any serious adverse events which occurred after trial product administration).
Measured: at 32 weeks ±2 weeks for patients on on-demand treatment
Host Cell Proteins (HCP) Antibodies
Subjects who were positive for anti-Host Cell Protein (HCP) antibodies.
Measured: 52 weeks after treatment start for patients on prophylaxis
Host Cell Proteins (HCP) Antibodies
Subjects who were positive for anti-HCP antibodies.
Measured: 28 weeks after treatment start on on-demand treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2011 (estimated)
- Study start27 Apr 2011
- Primary completion31 Mar 2013
- Study completion31 Mar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Global Clinical Registry (GCR, 1452), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01333111
- Sponsor's protocol ID
- NN7999-3747
- Other IDs
- 2010-023069-24, U1111-1119-6415, JapicCTI-111644
- Acronym
- paradigm™ 2
- Status last verified
- Jun 2017
- First submitted
- 8 Apr 2011
- Last updated
- 28 Jul 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Collins PW, Young G, Knobe K, Karim FA, Angchaisuksiri P, Banner C, Gursel T, Mahlangu J, Matsushita T, Mauser-Bunschoten EP, Oldenburg J, Walsh CE, Negrier C; paradigm 2 Investigators. Recombinant long-acting glycoPEGylated factor IX in hemophilia B: a multinational randomized phase 3 trial. Blood. 2014 Dec 18;124(26):3880-6. doi: 10.1182/blood-2014-05-573055. Epub 2014 Sep 26.
PubMed 25261199
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-centre, Single-blind Trial Evaluating Safety and Efficacy, Including Pharmacokinetics, of NNC-0156-0000-0009 When Used for Treatment and Prophylaxis of Bleeding Episodes in Patients With Haemophilia B
- ClinicalTrials.gov ID
- NCT01333111
- Acronym / sponsor ID
- paradigm™ 2 / NN7999-3747
- Conditions
- Congenital Bleeding Disorder, Haemophilia B
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 27 Apr 2011 (actual)
- Primary completion
- 31 Mar 2013 (actual)
- Study completion
- 31 Mar 2013 (actual)
- First posted
- 11 Apr 2011 (estimated)
- Results
- Posted 28 Jul 2017
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 Africa, Asia, Europe, Japan and North America. The aim of this trial is to evaluate the safety and efficacy, including pharmacokinetics (the rate at which the body eliminates the trial drug), of NNC-0156-0000-0009 (nonacog beta pegol) when used for treatment and prophylaxis of bleeding episodes in patients with haemophilia B.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Prophylaxis, high dose (trial duration 52 weeks) | Experimental | Drug: nonacog beta pegol |
| Prophylaxis, low dose (trial duration 52 weeks) | Experimental | Drug: nonacog beta pegol |
| On-demand (trial duration 28 weeks) | Experimental | Drug: nonacog beta pegol |
Who may qualify
- Ages
- 13 to 70 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Male patients with moderately severe or severe congenital haemophilia B with a factor IX activity of 2% or below according to medical records
- History of at least 150 exposure days to other factor IX products
- Patients currently treated on-demand with at least 6 bleeding episodes during the last 12 months or at least 3 bleeding episodes during the last 6 months, or patients currently on prophylaxis
Key exclusion criteria (5 listed)
- Known history of factor IX inhibitors based on existing medical records, laboratory report reviews and patient and legally acceptable representative (LAR) interviews
- HIV (Human immunodeficiency virus) positive, with a viral load equal to or above 400,000 copies/mL and/or CD4+ lymphocyte count equal to or below 200/microL
- Congenital or acquired coagulation disorders other than haemophilia B
- Previous arterial thrombotic events (e.g. myocardial infarction and intracranial thrombosis) or previous deep venous thrombosis or pulmonary embolism (as defined by available medical records)
- Immune modulating or chemotherapeutic medication
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 |
|---|---|---|
| nonacog beta pegolAlso: NNC-0156-0000-0009One single dose administered intravenously (into the vein) once weekly. Patients will receive instruction on how to treat any bleeding episode they may experience | Drug | Prophylaxis, high dose (trial duration 52 weeks) |
| nonacog beta pegolAlso: NNC-0156-0000-0009One single dose administered intravenously (into the vein) once weekly. Patients will receive instruction on how to treat any bleeding episode they may experience | Drug | Prophylaxis, low dose (trial duration 52 weeks) |
| nonacog beta pegolAlso: NNC-0156-0000-0009Patients will treat themselves with either a low or a high dose dependent on the severity of the bleeding episode | Drug | On-demand (trial duration 28 weeks) |
Primary outcome
Incidence of Inhibitory Antibodies Against Factor IX Defined as Titre Equal to or Above 0.6 BU (Bethesda Units)
Time frame: 52 weeks after treatment start for patients on prophylaxis
Inhibitors were analysed with either the Nijmegen modified factor IX Bethesda assay or a heat/cold Nijmegen modified factor IX Bethesda assay. Number of subjects who developed inhibitory antibodies against factor IX are reported.
Incidence of Inhibitory Antibodies Against Factor IX Defined as Titre Equal to or Above 0.6 BU (Bethesda Units)
Time frame: 28 weeks after treatment start on on-demand treatment
Inhibitors were analysed with either the Nijmegen modified factor IX Bethesda assay or a heat/cold Nijmegen modified factor IX Bethesda assay. Number of subjects who developed inhibitory antibodies against factor IX are reported.
10 secondary outcomes
Haemostatic Effect of NNC-0156-0000-0009 When Used for Prophylaxis of Bleeding Episodes, Assessed as Success/Failure Based on a Four-point Scale for Haemostatic Response
Time frame: 52 weeks after treatment start for patients on prophylaxis
Haemostatic Effect of NNC-0156-0000-0009 When Used for Treatment of Bleeding Episodes, Assessed as Success/Failure Based on a Four-point Scale for Haemostatic Response
Time frame: 28 weeks after treatment start on on-demand treatment
Number of Bleeding Episodes Per Patient During Routine Prophylaxis
Time frame: 52 weeks after treatment start for patients on prophylaxis
Factor IX Trough Levels
Time frame: 52 weeks after treatment start for patients on prophylaxis
Incidence of Adverse Events (AEs)
Time frame: at 56 weeks ±2 weeks for patients on prophylaxis
Incidence of Adverse Events (AEs)
Time frame: at 32 weeks ±2 weeks for patients on on-demand treatment
Incidence of Serious Adverse Events (SAEs)
Time frame: at 56 weeks ±2 weeks for patients on prophylaxis
Incidence of Serious Adverse Events (SAEs)
Time frame: at 32 weeks ±2 weeks for patients on on-demand treatment
Host Cell Proteins (HCP) Antibodies
Time frame: 52 weeks after treatment start for patients on prophylaxis
Host Cell Proteins (HCP) Antibodies
Time frame: 28 weeks after treatment start on on-demand treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 25261199Collins PW, Young G, Knobe K, Karim FA, Angchaisuksiri P, Banner C, Gursel T, Mahlangu J, Matsushita T, Mauser-Bunschoten EP, Oldenburg J, Walsh CE, Negrier C; paradigm 2 Investigators. Recombinant long-acting glycoPEGylated factor IX in hemophilia B: a multinational randomized phase 3 trial. Blood. 2014 Dec 18;124(26):3880-6. doi: 10.1182/blood-2014-05-573055. Epub 2014 Sep 26.
- Clinical Trials at Novo NordiskLink provided by the sponsor.
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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.
Global Clinical Registry (GCR, 1452) study director
Novo Nordisk A/S
43 sites in 15 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing nonacog beta pegol in people with Congenital Bleeding Disorder and Haemophilia B, run by Novo Nordisk A/S at 43 sites in 15 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 28 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 43 sites in United States, United Kingdom, Japan, Germany, Turkey (Türkiye) and 10 more countries. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Jul 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Incidence of Inhibitory Antibodies Against Factor IX Defined as Titre Equal to or Above 0.6 BU (Bethesda Units) (time frame: 52 weeks after treatment start for patients on prophylaxis). The study lists 2 primary outcomes in all. 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 NCT01333111, 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 28 Jul 2017.