Trial · NCT02141074
Safety and Efficacy of Nonacog Beta Pegol (N9-GP) in Previously Untreated Patients With Haemophilia B
NCT02141074, Phase 3, Completed, Novo Nordisk A/S; results first posted 2023-12-29
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Safety and Efficacy of Nonacog Beta Pegol (N9-GP) in Previously Untreated Patients With Haemophilia B. Trials, record NCT02141074. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02141074
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Efficacy of Nonacog Beta Pegol (N9-GP) in Previously Untreated Patients With Haemophilia B
- NCT number
- NCT02141074
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 54 participants, actual
- Lead sponsor
- Novo Nordisk A/S
- Conditions
- Congenital Bleeding Disorder, Haemophilia B
- Interventions
- nonacog beta pegol
- First posted
- 2014-05-19
- Last updated
- 2025-12-23
- Other registries' IDs
- eudract:2012-004867-38
- Results first posted
- 2023-12-29
Source ClinicalTrials.gov
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Incidence of Inhibitory Antibodies Against Coagulation Factor IX (FIX) (50 Exposure Days) | When minimum 20 previously untreated patients (PUPs) have reached at least 50 exposure days (ED) (up to 156 weeks) | Number of participants with incidence of inihibitory antibodies against FIX after 50 ED is presented and defined as an inhibitory antibody titre greater than equal to 0.6 Bethesda unit (BU) at two consecutive tests performed at the central laboratory and also tested positive for nonacog beta pegol binding antibodies. |
| Primary | Number of Participants With Incidence of Inhibitory Antibodies Against FIX (100 ED) | When minimum 40 PUPs have reached at least 100 ED (up to 208 weeks) | Number of participants with incidence of inihibitory antibodies against FIX after 100 ED is presented and defined as an inhibitory antibody titre greater than equal to 0.6 Bethesda unit (BU) at two consecutive tests performed at the central laboratory and also tested positive for nonacog beta pegol binding antibodies. |
| Primary | Number of Participants With Incidence of Inhibitory Antibodies Against FIX (At End of Trial) | At end of trial (up to 434 weeks) | Number of participants with incidence of inihibitory antibodies against FIX at end of trial is presented and defined as an inhibitory antibody titre greater than equal to 0.6 Bethesda unit (BU) at two consecutive tests performed at the central laboratory and also tested positive for nonacog beta pegol binding antibodies. |
| Secondary | Number of Adverse Events | When minimum 20 PUPs have reached at least 50 ED (up to 156 weeks); when minimum 40 PUPs have reached at least 100 ED (up to 208 weeks); at end of trial (up to 434 weeks) | Number of adverse events after 50 ED, after 100 ED, and at end of trial is presented. An adverse event was defined as any untoward medical occurrence in a participant who was administered a product, and which does not necessarily have a causal relationship with this treatment. All presented adverse events are treatment emergent adverse events, defined as an event that occured while the participant was on treatment in the period from first dosing with nonacog beta pegol to the end of trial/discontinuation of treatment. |
| Secondary | Frequency of Adverse Events | When minimum 20 PUPs have reached at least 50 ED (up to 156 weeks); when minimum 40 PUPs have reached at least 100 ED (up to 208 weeks); at end of trial (up to 434 weeks) | Frequency of adverse events after 50 ED, after 100 ED, and at end of trial is presented. Frequency of adverse events was expressed as number of adverse events per participant years of exposure (total number of events /total time in trial). An adverse event was defined as any untoward medical occurrence in a participant who was administered a product, and which does not necessarily have a causal relationship with this treatment. All presented adverse events are treatment emergent adverse events, defined as an event that occured while the participant was on treatment in the period from first dosing with nonacog beta pegol to the end of trial/discontinuation of treatment. |
| Secondary | Number of Serious Adverse Events | When minimum 20 PUPs have reached at least 50 ED (up to 156 weeks); when minimum 40 PUPs have reached at least 100 ED (up to 208 weeks); at end of trial (up to 434 weeks) | Number of serious adverse events after 50 ED, after 100 ED, and at end of trial is presented. A serious adverse event was an experience that at any dose resulted in: death; life-threatening experience; in-patient hospitalisation or prolongation of existing hospitalisation; a persistent or significant disability/incapacity; congenital anomaly/birth defect; important medical events that may not result in death, be life-threatening/require hospitalisation could be considered a serious adverse event based upon appropriate medical judgement. |
| Secondary | Frequency of Serious Adverse Events | When minimum 20 PUPs have reached at least 50 ED (up to 156 weeks); when minimum 40 PUPs have reached at least 100 ED (up to 208 weeks); at end of trial (up to 434 weeks) | Frequency of serious adverse events after 50 ED, after 100 ED, and at end of trial is presented. Frequency of serious adverse events was expressed as number of serious adverse events per participant years of exposure (total number of events /total time in trial). A serious adverse event was an experience that at any dose resulted in: death; life-threatening experience; in-patient hospitalisation or prolongation of existing hospitalisation; a persistent or significant disability/incapacity; congenital anomaly/birth defect; important medical events that may not result in death, be life-threatening/require hospitalisation could be considered a serious adverse event based upon appropriate medical judgement. |
| Secondary | Number of Medical Events of Special Interest | When minimum 20 PUPs have reached at least 50 ED (up to 156 weeks); when minimum 40 PUPs have reached at least 100 ED (up to 208 weeks); at end of trial (up to 434 weeks) | Number of medical events of special interest after 50 ED, after 100 ED, and at end of trial is presented. A medical event of special interest (MESI) was an event that, in the evaluation of safety, has a special focus. A MESI was an adverse event (serious or non-serious adverse event) that fulfils one or more of the following MESI criteria: 1. Medication errors concerning the trial product; 2. Inhibitor formation against FIX; 3. Thromboembolic events; 4. Anaphylactic reaction; 5. Allergic reaction including, but not limited to, any acute immunoglobulin E mediated reaction of delayed-type hypersensitivity (clinical signs may include various types of skin rashes) that does not meet the definition of anaphylaxis; 6. CNS-related adverse events including, but not limited to, any learning and behavioral deficits; 7. Renal adverse events including new onset of renal disorder or renal impairment or acute and chronic renal failure. |
| Secondary | Frequency of Medical Events of Special Interest | When minimum 20 PUPs have reached at least 50 ED (up to 156 weeks); when minimum 40 PUPs have reached at least 100 ED (up to 208 weeks); at end of trial (up to 434 weeks) | Frequency of medical events of special interest after 50 ED, after 100 ED, and at end of trial is presented. It was expressed as number of MESI per participant years of exposure (total number of events/total time in trial). A MESI was an event that, in the evaluation of safety, has a special focus. A MESI was an adverse event that fulfils one or more of the MESI criteria: 1. Medication errors concerning the trial product; 2. Inhibitor formation against FIX; 3. Thromboembolic events; 4. Anaphylactic reaction; 5. Allergic reaction including, but not limited to, any acute immunoglobulin E mediated reaction of delayed-type hypersensitivity (clinical signs may include various types of skin rashes) that does not meet the definition of anaphylaxis; 6. CNS-related adverse events including, but not limited to, any learning and behavioral deficits; 7. Renal adverse events including new onset of renal disorder or renal impairment or acute and chronic renal failure. |
| Secondary | Number of Breakthrough Bleeding Episodes During Prophylaxis (Annualised Bleeding Rate) | When minimum 20 PUPs have reached at least 50 ED (up to 156 weeks); when minimum 40 PUPs have reached at least 100 ED (up to 208 weeks); at end of trial (up to 434 weeks) | Number of breakthrough bleeding episodes during prophylaxis (annualised bleeding rate) after 50 ED, after 100 ED, and at end of trial is presented. Annualised bleeding rate is the number of bleeding episodes per year. |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 registered outcomesOutcomes16
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Incidence of Inhibitory Antibodies Against Coagulation Factor IX (FIX) (50 Exposure Days) | When minimum 20 previously untreated patients (PUPs) have reached at least 50 exposure days (ED) (up to 156 weeks) | Safety analysis set included all participants exposed to nonacog beta pegol. Overall Number of Participants Analyzed = participants with available data for this outcome measure. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Incidence of Inhibitory Antibodies Against FIX (100 ED) | When minimum 40 PUPs have reached at least 100 ED (up to 208 weeks) | Safety analysis set included all participants exposed to nonacog beta pegol. Overall Number of Participants Analyzed = participants with available data for this outcome measure. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Incidence of Inhibitory Antibodies Against FIX (At End of Trial) | At end of trial (up to 434 weeks) | Safety analysis set included all participants exposed to nonacog beta pegol. Overall Number of Participants Analyzed = participants with available data for this outcome measure. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Adverse Events | When minimum 20 PUPs have reached at least 50 ED (up to 156 weeks); when minimum 40 PUPs have reached at least 100 ED (up to 208 weeks); at end of trial (up to 434 weeks) | Safety analysis set included all participants exposed to nonacog beta pegol. Overall Number of Participants Analyzed = participants with available data for this outcome measure. | Events | NUMBER |
| SECONDARY | Frequency of Adverse Events | When minimum 20 PUPs have reached at least 50 ED (up to 156 weeks); when minimum 40 PUPs have reached at least 100 ED (up to 208 weeks); at end of trial (up to 434 weeks) | Safety analysis set included all participants exposed to nonacog beta pegol. Overall Number of Participants Analyzed = participants with available data for this outcome measure. | Events per participant years of exposure | NUMBER |
| SECONDARY | Number of Serious Adverse Events | When minimum 20 PUPs have reached at least 50 ED (up to 156 weeks); when minimum 40 PUPs have reached at least 100 ED (up to 208 weeks); at end of trial (up to 434 weeks) | Safety analysis set included all participants exposed to nonacog beta pegol. Overall Number of Participants Analyzed = participants with available data for this outcome measure. | Events | NUMBER |
| SECONDARY | Frequency of Serious Adverse Events | When minimum 20 PUPs have reached at least 50 ED (up to 156 weeks); when minimum 40 PUPs have reached at least 100 ED (up to 208 weeks); at end of trial (up to 434 weeks) | Safety analysis set included all participants exposed to nonacog beta pegol. Overall Number of Participants Analyzed = participants with available data for this outcome measure. | Events per participant years of exposure | NUMBER |
| SECONDARY | Number of Medical Events of Special Interest | When minimum 20 PUPs have reached at least 50 ED (up to 156 weeks); when minimum 40 PUPs have reached at least 100 ED (up to 208 weeks); at end of trial (up to 434 weeks) | Safety analysis set included all participants exposed to nonacog beta pegol. Overall Number of Participants Analyzed = participants with available data for this outcome measure. | Events | NUMBER |
| SECONDARY | Frequency of Medical Events of Special Interest | When minimum 20 PUPs have reached at least 50 ED (up to 156 weeks); when minimum 40 PUPs have reached at least 100 ED (up to 208 weeks); at end of trial (up to 434 weeks) | Safety analysis set included all participants exposed to nonacog beta pegol. Overall Number of Participants Analyzed = participants with available data for this outcome measure. | Events per participant years of exposure | NUMBER |
| SECONDARY | Number of Breakthrough Bleeding Episodes During Prophylaxis (Annualised Bleeding Rate) | When minimum 20 PUPs have reached at least 50 ED (up to 156 weeks); when minimum 40 PUPs have reached at least 100 ED (up to 208 weeks); at end of trial (up to 434 weeks) | Full analysis set included all participants exposed to nonacog beta pegol. Overall Number of Participants Analyzed = participants with available data for this outcome measure. | bleeds/participant/year | MEDIAN |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 outcomesResults by group88
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Incidence of Inhibitory Antibodies Against Coagulation Factor IX (FIX) (50 Exposure Days) | Pre-prophylaxis | 2 | Participants | ||
| Number of Participants With Incidence of Inhibitory Antibodies Against Coagulation Factor IX (FIX) (50 Exposure Days) | Prophylaxis | 0 | Participants | ||
| Number of Participants With Incidence of Inhibitory Antibodies Against FIX (100 ED) | Pre-prophylaxis | 2 | Participants | ||
| Number of Participants With Incidence of Inhibitory Antibodies Against FIX (100 ED) | Prophylaxis | 2 | Participants | ||
| Number of Participants With Incidence of Inhibitory Antibodies Against FIX (At End of Trial) | Pre-prophylaxis | 2 | Participants | ||
| Number of Participants With Incidence of Inhibitory Antibodies Against FIX (At End of Trial) | Prophylaxis | 2 | Participants | ||
| Number of Adverse Events | Pre-prophylaxis | 50 ED | 86 | Events | |
| Number of Adverse Events | Prophylaxis | 50 ED | 291 | Events | |
| Number of Adverse Events | Pre-prophylaxis | 100 ED | 131 | Events | |
| Number of Adverse Events | Prophylaxis | 100 ED | 610 | Events |
1 to 10 of 88Source ClinicalTrials.gov
See all 88 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Pre-prophylaxis | STARTED | Pre-prophylaxis | 34 | |
| Pre-prophylaxis | STARTED | Prophylaxis | 0 | |
| Pre-prophylaxis | COMPLETED | Pre-prophylaxis | 31 | |
| Pre-prophylaxis | COMPLETED | Prophylaxis | 0 | |
| Pre-prophylaxis | NOT COMPLETED | Pre-prophylaxis | 3 | |
| Pre-prophylaxis | NOT COMPLETED | Prophylaxis | 0 | |
| Prophylaxis | STARTED | Pre-prophylaxis | 0 | |
| Prophylaxis | STARTED | Prophylaxis | 51 | |
| Prophylaxis | COMPLETED | Pre-prophylaxis | 0 | |
| Prophylaxis | COMPLETED | Prophylaxis | 41 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events154
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Abdominal pain | Gastrointestinal disorders | Pre-prophylaxis | 0 | 34 | 0 |
| other | Abdominal pain | Gastrointestinal disorders | Prophylaxis | 5 | 51 | 6 |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Pre-prophylaxis | 0 | 34 | 0 |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Prophylaxis | 4 | 51 | 4 |
| other | Arthropod bite | Injury, poisoning and procedural complications | Pre-prophylaxis | 0 | 34 | 0 |
| other | Arthropod bite | Injury, poisoning and procedural complications | Prophylaxis | 6 | 51 | 7 |
| other | Bronchitis | Infections and infestations | Pre-prophylaxis | 1 | 34 | 1 |
| other | Bronchitis | Infections and infestations | Prophylaxis | 6 | 51 | 8 |
| other | COVID-19 | Infections and infestations | Pre-prophylaxis | 0 | 34 | 0 |
| other | COVID-19 | Infections and infestations | Prophylaxis | 6 | 51 | 7 |
1 to 10 of 154Source ClinicalTrials.gov
See all 154 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Pre-prophylaxis | 1 | 34 |
| Total, all-cause mortality | Prophylaxis | 1 | 51 |
| Total, other adverse events | Pre-prophylaxis | 22 | 34 |
| Total, other adverse events | Prophylaxis | 46 | 51 |
| Total, serious adverse events | Pre-prophylaxis | 9 | 34 |
| Total, serious adverse events | Prophylaxis | 19 | 51 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 33134776 | BACKGROUND |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons5
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Pre-prophylaxis vs Prophylaxis: Number of Participants With Incidence of Inhibitory Antibodies Against FIX (100 ED) | Trial comparisons |
| Pre-prophylaxis vs Prophylaxis: Number of Participants With Incidence of Inhibitory Antibodies Against FIX (At End of Trial) | Trial comparisons |
| Pre-prophylaxis vs Prophylaxis: deaths from any cause | Trial comparisons |
| Pre-prophylaxis vs Prophylaxis: Number of Participants With Incidence of Inhibitory Antibodies Against Coagulation Factor IX (FIX) (50 Exposure Days) | Trial comparisons |
| Pre-prophylaxis vs Prophylaxis: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02141074
GET https://conductscience.org/api/trials/v1/NCT02141074/results?page=2