Trial · NCT01395810
Safety and Efficacy of NNC-0156-0000-0009 After Long-Term Exposure in Patients With Haemophilia B: An Extension to Trials NN7999-3747 and NN7999-3773
NCT01395810, Phase 3, Completed, Novo Nordisk A/S; results first posted 2018-05-09
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Safety and Efficacy of NNC-0156-0000-0009 After Long-Term Exposure in Patients With Haemophilia B: An Extension to Trials NN7999-3747 and NN7999-3773. Trials, record NCT01395810. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01395810
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Efficacy of NNC-0156-0000-0009 After Long-Term Exposure in Patients With Haemophilia B: An Extension to Trials NN7999-3747 and NN7999-3773
- NCT number
- NCT01395810
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 71 participants, actual
- Lead sponsor
- Novo Nordisk A/S
- Conditions
- Congenital Bleeding Disorder, Haemophilia B
- Interventions
- nonacog beta pegol, nonacog beta pegol, nonacog beta pegol
- First posted
- 2011-07-18
- Last updated
- 2018-05-09
- Other registries' IDs
- eudract:2010-023072-17
- Results first posted
- 2018-05-09
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence of Inhibitory Antibodies Against FIX Defined as Titre Above or Equal to 0.6 BU (Bethesda Units) | From Day 1 up to 2 years | The primary endpoint was incidence of inhibitors against coagulation factor nine (FIX) defined as titre ≥0.6 Bethesda unit (BU). Number of subjects who developed inhibitors against FIX are reported. |
| Secondary | Haemostatic Effect of Nonacog Beta Pegol When Used for Treatment of Bleeding Episodes, Assessed as Success/Failure Based on a Four-point Scale for Haemostatic Response (Excellent, Good, Moderate, Poor) | From Day 1 up to 2 years | The haemostatic effect was evaluated by a four-point scale where an "excellent" or "good" outcome translated into a successful treatment, and a "moderate" or "poor" outcome was considered a treatment failure. The values mentioned below do not include bleeds with missing response. |
| Secondary | Number of Bleeding Episodes During Routine Prophylaxis | From Day 1 up to 2 years | Annualized bleeding rate is the total number of bleeding episodes/total exposure time. It is analysed by a Poisson regression model with dose as a factor allowing for over-dispersion and using treatment duration as an offset. Median annualized bleeding rate is the median of individual annualized bleeding rates. Numbers are based on the treatment arm at the time of each bleed. |
| Secondary | FIX Trough Levels | From Day 1 up to 2 years | During the trial, the pre-dose FIX levels was measured with the one-stage clotting assay. Measurements taken at least 5 days and no more than 10 days after last dose as well as at least 14 days after last bleeding episode were included in this analysis. The mean FIX trough levels were estimated based on the mixed effects model on the log-transformed plasma concentration with subject as a random effect. The mean FIX trough level was presented back-transformed to the natural scale. |
| Secondary | Incidence of Adverse Events (AEs) | From Day 1 up to 2 years | AEs were summarized by frequency of events and frequency of patients with any event. Incidence of AEs was expressed as number of AEs per subject years of exposure (total number of events /total time in trial). |
| Secondary | Incidence of Serious Adverse Events (SAEs) | From Day 1 up to 2 years | AEs were summarized by frequency of events and frequency of patients with any event. Incidence of serious AEs was expressed as number of serious AEs per subject years of exposure (total number of events /total time in trial). |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Incidence of Inhibitory Antibodies Against FIX Defined as Titre Above or Equal to 0.6 BU (Bethesda Units) | From Day 1 up to 2 years | Safety Analysis Set consisted of all subjects exposed to nonacog beta pegol. Subjects who switched arms were represented in multiple columns. | Patients with inhibitory antibodies | NUMBER |
| SECONDARY | Haemostatic Effect of Nonacog Beta Pegol When Used for Treatment of Bleeding Episodes, Assessed as Success/Failure Based on a Four-point Scale for Haemostatic Response (Excellent, Good, Moderate, Poor) | From Day 1 up to 2 years | Full analysis set consisted of all subjects exposed to nonacog beta pegol. Subjects who switched arms were represented in multiple columns. | Percentage of bleeding episodes | NUMBER |
| SECONDARY | Number of Bleeding Episodes During Routine Prophylaxis | From Day 1 up to 2 years | Full analysis set consisted of all subjects exposed to nonacog beta pegol. Subjects who switched arms were represented in multiple columns. | bleeds/patient/year | MEDIAN |
| SECONDARY | FIX Trough Levels | From Day 1 up to 2 years | Full analysis set consisted of all subjects exposed to nonacog beta pegol. This endpoint was analysed only for the prophylaxis arms (i.e.,10 IU/kg, 40 IU/kg). No pre-dose measurements were collected for patients on 80 IU/kg every second week prophylaxis. | IU/mL | MEAN |
| SECONDARY | Incidence of Adverse Events (AEs) | From Day 1 up to 2 years | Safety Analysis Set consisted of all subjects who were exposed to nonacog beta pegol. Subjects who switched arms were represented in multiple columns. | Events per subject year of exposure | NUMBER |
| SECONDARY | Incidence of Serious Adverse Events (SAEs) | From Day 1 up to 2 years | Safety Analysis set consisted of all subjects exposed to nonacog beta pegol. Subjects who switched arms were represented in multiple columns. | Events per subject year of exposure | NUMBER |
Source ClinicalTrials.gov
Results by group27
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Incidence of Inhibitory Antibodies Against FIX Defined as Titre Above or Equal to 0.6 BU (Bethesda Units) | Prophylaxis 10 IU/kg | 0 | Patients with inhibitory antibodies | ||
| Incidence of Inhibitory Antibodies Against FIX Defined as Titre Above or Equal to 0.6 BU (Bethesda Units) | Prophylaxis 40 IU/kg | 0 | Patients with inhibitory antibodies | ||
| Incidence of Inhibitory Antibodies Against FIX Defined as Titre Above or Equal to 0.6 BU (Bethesda Units) | Prophylaxis 80 IU/kg | 0 | Patients with inhibitory antibodies | ||
| Incidence of Inhibitory Antibodies Against FIX Defined as Titre Above or Equal to 0.6 BU (Bethesda Units) | On-demand | 0 | Patients with inhibitory antibodies | ||
Haemostatic Effect of Nonacog Beta Pegol When Used for Treatment of Bleeding Episodes, Assessed as Success/Failure Based on a Four-point Scale for Haemostatic Response (Excellent, Good, Moderate, Poor) | Prophylaxis 10 IU/kg | Success | 97.1 | Percentage of bleeding episodes | |
Haemostatic Effect of Nonacog Beta Pegol When Used for Treatment of Bleeding Episodes, Assessed as Success/Failure Based on a Four-point Scale for Haemostatic Response (Excellent, Good, Moderate, Poor) | Prophylaxis 40 IU/kg | Success | 94.8 | Percentage of bleeding episodes | |
Haemostatic Effect of Nonacog Beta Pegol When Used for Treatment of Bleeding Episodes, Assessed as Success/Failure Based on a Four-point Scale for Haemostatic Response (Excellent, Good, Moderate, Poor) | Prophylaxis 80 IU/kg | Success | 100 | Percentage of bleeding episodes | |
Haemostatic Effect of Nonacog Beta Pegol When Used for Treatment of Bleeding Episodes, Assessed as Success/Failure Based on a Four-point Scale for Haemostatic Response (Excellent, Good, Moderate, Poor) | On-demand | Success | 93.2 | Percentage of bleeding episodes | |
Haemostatic Effect of Nonacog Beta Pegol When Used for Treatment of Bleeding Episodes, Assessed as Success/Failure Based on a Four-point Scale for Haemostatic Response (Excellent, Good, Moderate, Poor) | Total | Success | 94.6 | Percentage of bleeding episodes | |
Haemostatic Effect of Nonacog Beta Pegol When Used for Treatment of Bleeding Episodes, Assessed as Success/Failure Based on a Four-point Scale for Haemostatic Response (Excellent, Good, Moderate, Poor) | Prophylaxis 10 IU/kg | Failure | 2.9 | Percentage of bleeding episodes |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 results by groupParticipant flow16
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Prophylaxis 10 IU/kg | 18 | |
| Overall Study | STARTED | Prophylaxis 40 IU/kg | 48 | |
| Overall Study | STARTED | Prophylaxis 80 IU/kg | 0 | |
| Overall Study | STARTED | On-demand | 5 | |
| Overall Study | After Switching the Arms | Prophylaxis 10 IU/kg | 21 | |
| Overall Study | After Switching the Arms | Prophylaxis 40 IU/kg | 52 | |
| Overall Study | After Switching the Arms | Prophylaxis 80 IU/kg | 2 | |
| Overall Study | After Switching the Arms | On-demand | 5 | |
| Overall Study | COMPLETED | Prophylaxis 10 IU/kg | 16 | |
| Overall Study | COMPLETED | Prophylaxis 40 IU/kg | 44 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 participant flowAdverse events100
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 | Asthenopia | Eye disorders | Prophylaxis 10 U/kg | 0 | 21 | 0 |
| other | Asthenopia | Eye disorders | Prophylaxis 40 U/kg | 0 | 52 | 0 |
| other | Asthenopia | Eye disorders | Prophylaxis 80 U/kg | 0 | 2 | 0 |
| other | Asthenopia | Eye disorders | On-demand | 1 | 5 | 1 |
| other | Bronchitis | Infections and infestations | Prophylaxis 10 U/kg | 0 | 21 | 0 |
| other | Bronchitis | Infections and infestations | Prophylaxis 40 U/kg | 0 | 52 | 0 |
| other | Bronchitis | Infections and infestations | Prophylaxis 80 U/kg | 0 | 2 | 0 |
| other | Bronchitis | Infections and infestations | On-demand | 1 | 5 | 1 |
| other | Chest discomfort | General disorders | Prophylaxis 10 U/kg | 0 | 21 | 0 |
| other | Chest discomfort | General disorders | Prophylaxis 40 U/kg | 0 | 52 | 0 |
1 to 10 of 100Source ClinicalTrials.gov
See all 100 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Prophylaxis 10 U/kg | ||
| Total, all-cause mortality | Prophylaxis 40 U/kg | ||
| Total, all-cause mortality | Prophylaxis 80 U/kg | ||
| Total, all-cause mortality | On-demand | ||
| Total, other adverse events | Prophylaxis 10 U/kg | 8 | 21 |
| Total, other adverse events | Prophylaxis 40 U/kg | 8 | 52 |
| Total, other adverse events | Prophylaxis 80 U/kg | 0 | 2 |
| Total, other adverse events | On-demand | 5 | 5 |
| Total, serious adverse events | Prophylaxis 10 U/kg | 1 | 21 |
| Total, serious adverse events | Prophylaxis 40 U/kg | 5 | 52 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers2
The papers the trial lists on ClinicalTrials.gov.
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT01395810
GET https://conductscience.org/api/trials/v1/NCT01395810/results?page=2