Trial · NCT02137850
Safety and Efficacy of Turoctocog Alfa Pegol (N8-GP) in Previously Untreated Patients With Haemophilia A
NCT02137850, Phase 3, Completed, Novo Nordisk A/S; results first posted 2024-10-31
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Safety and Efficacy of Turoctocog Alfa Pegol (N8-GP) in Previously Untreated Patients With Haemophilia A. Trials, record NCT02137850. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02137850
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Efficacy of Turoctocog Alfa Pegol (N8-GP) in Previously Untreated Patients With Haemophilia A
- NCT number
- NCT02137850
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 124 participants, actual
- Lead sponsor
- Novo Nordisk A/S
- Conditions
- Congenital Bleeding Disorder, Haemophilia A
- Interventions
- turoctocog alfa pegol
- First posted
- 2014-05-14
- Last updated
- 2025-12-23
- Other registries' IDs
- eudract:2013-004025-88
- Results first posted
- 2024-10-31
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Inhibitory Antibodies Against Coagulation Factor VIII (FVIII) | From start of the treatment up to 7 years | Number of participants with inhibitory antibodies against coagulation factor VIII (FVIII) was reported during the main and extension phase of the trial. |
| Secondary | Number of Adverse Events Including Serious Adverse Events and Medical Events of Special Interest | From start of the treatment up to 8.9 years | Number of adverse events including serious adverse events and medical events of special interest reported during the main and extension phase of the trial. An adverse event (AE) is any untoward medical occurrence in a patient administered a product, and which does not necessarily have a causal relationship with this treatment. Serious adverse event (SAE) is an experience that at any dose results in any of the following: Death, a life-threatening experience, in-patient hospitalisation or prolongation of existing hospitalisation, persistent or significant disability or incapacity, congenital anomaly or birth defect and important medical events that may not result in death, be life threatening or require hospitalisation. Medical event of special interest (MESI) is an event which, in the evaluation of safety, has a special focus. |
| Secondary | Number of Participants With Confirmed High Titre Inhibitors (Defined as Inhibitor Titre Above 5 Bethesda Units (BU) | From start of the treatment up to 8.9 years | Number of participants with confirmed high titre inhibitors (defined as inhibitor titre above 5 Bethesda Units (BU) was reported during the main and extension phase of the trial. |
| Secondary | Number of Breakthrough Bleeding Episodes During Prophylaxis With N8-GP (Annualised Bleeding Rate) | From start of the treatment up to 8.9 years | The number of bleeding episodes per year reported during the prophylactic treatment with N8-GP was reported. |
| Secondary | Haemostatic Effect of N8-GP in Treatment of Bleeding Episodes, Assessed by a Predefined 4-point Haemostatic Response Scale ("Excellent", "Good", "Moderate" and "None") | From start of the treatment up to 8.9 years | Haemostatic effect of turoctocog alfa pegol for treatment of bleeding episodes was assessed by 4-point response scale: none, moderate, good or excellent. Excellent: Abrupt pain relief and/or clear improvement in objective signs of bleeding within approximately 8 hours after a single injection; Good: Definite pain relief and/or improvement in signs of bleeding within approximately 8 hours after a single injection, but possibly requiring more than one injection for complete resolution; Moderate: Probable or slight beneficial effect within approximately 8 hours after the first injection, but usually requiring more than one injection; None: No improvement, or worsening of symptoms. Number of bleeding episodes in each category is reported. |
| Secondary | Consumption of N8-GP for Prophylaxis (International Unit Per Kilogram (IU/Kg)) | From start of the treatment up to 8.9 years | Consumption of N8-GP for prophylaxis is reported. Consumption used for treatment includes all doses given. Yearly consumption is only calculated for patients with a exposure time of at least 30 days. Average dose consumption in IU/kg during main and extension phase is reported. |
| Secondary | Consumption of N8-GP for Prophylaxis (Number of Injections) | From start of the treatment up to 8.9 years | Consumption of N8-GP for prophylaxis is reported. Consumption used for treatment includes all doses given. Yearly consumption is only calculated for patients with a exposure time of at least 30 days. Number of injections consumption per patient during main and extension phase is reported. |
| Secondary | Consumption of N8-GP for Treatment of Bleeding Episodes (International Unit Per Kilogram Per Bleed (IU/kg/Bleed)) | From start of the treatment up to 8.9 years | Consumption of N8-GP for treatment of bleeding episodes (IU/kg/bleed) is reported. Average dose consumption in IU/kg/bleed during main and extension phase is reported. |
| Secondary | Consumption of N8-GP for Treatment of Bleeding Episodes (Number of Injections) | From start of the treatment up to 8.9 years | Consumption of N8-GP for treatment of bleeding episodes (number of injections) is reported. Number of average injections required for treatment of per bleed is reported. |
| Secondary | Total Consumption of N8-GP Per Patient (Prevention and Treatment of Bleeding Episodes) Annualised Value | From start of the treatment up to 8.9 years | Total consumption of N8-GP per patient (prevention and treatment of bleeding episodes) annualised value is presented. Consumption used for treatment includes all doses given. Yearly consumption is only calculated for patients with a exposure time of at least 30 days. Consumption used for treatment per year per patient (IU/kg/year/patient) is reported. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
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 Inhibitory Antibodies Against Coagulation Factor VIII (FVIII) | From start of the treatment up to 7 years | Results were based on safety analysis set (SAS). The SAS consist of all participants exposed to N8-GP. Number of participants analyzed=participants with available data for this endpoint. This outcome is applicable only for the reported arms. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Adverse Events Including Serious Adverse Events and Medical Events of Special Interest | From start of the treatment up to 8.9 years | Results were based on SAS. The SAS consists of all participants exposed to N8-GP. | Events | NUMBER |
| SECONDARY | Number of Participants With Confirmed High Titre Inhibitors (Defined as Inhibitor Titre Above 5 Bethesda Units (BU) | From start of the treatment up to 8.9 years | Results were based on safety analysis set (SAS). The SAS consist of all participants exposed to N8-GP. Number of participants analyzed=participants with available data for this endpoint. This outcome is applicable only for the reported arms. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Breakthrough Bleeding Episodes During Prophylaxis With N8-GP (Annualised Bleeding Rate) | From start of the treatment up to 8.9 years | Results were based on full analysis set (FAS). The FAS consists of all participants exposed to N8-GP. The endpoint is applicable for only reported group. This outcome is applicable only for the reported arms. | bleeds/patient/year | MEDIAN |
| SECONDARY | Haemostatic Effect of N8-GP in Treatment of Bleeding Episodes, Assessed by a Predefined 4-point Haemostatic Response Scale (Excellent, Good, Moderate and None) | From start of the treatment up to 8.9 years | Results were based on full analysis set (FAS). The FAS consists of all participants exposed to N8-GP. Number of participants analyzed=participants with available data for this endpoint. | Bleeding episodes | NUMBER |
| SECONDARY | Consumption of N8-GP for Prophylaxis (International Unit Per Kilogram (IU/Kg)) | From start of the treatment up to 8.9 years | Results were based on full analysis set (FAS). The FAS consists of all participants exposed to N8-GP. The endpoint is applicable for only reported arm. | IU/kg | MEAN |
| SECONDARY | Consumption of N8-GP for Prophylaxis (Number of Injections) | From start of the treatment up to 8.9 years | Results were based on full analysis set (FAS). The FAS consists of all participants exposed to N8-GP. The endpoint is applicable for only reported arm. | Injections/patient | MEAN |
| SECONDARY | Consumption of N8-GP for Treatment of Bleeding Episodes (International Unit Per Kilogram Per Bleed (IU/kg/Bleed)) | From start of the treatment up to 8.9 years | Results were based on full analysis set (FAS). The FAS consists of all participants exposed to N8-GP. This outcome is applicable only for the reported arms. | IU/kg/bleed | MEAN |
| SECONDARY | Consumption of N8-GP for Treatment of Bleeding Episodes (Number of Injections) | From start of the treatment up to 8.9 years | Results were based on full analysis set (FAS). The FAS consists of all participants exposed to N8-GP. | Injections/bleed | MEAN |
| SECONDARY | Total Consumption of N8-GP Per Patient (Prevention and Treatment of Bleeding Episodes) Annualised Value | From start of the treatment up to 8.9 years | Results were based on full analysis set (FAS). The FAS consists of all participants exposed to N8-GP. Number of participants analyzed=participants with available data for this endpoint. This outcome is applicable only for the reported arms. | IU/kg/year/patient | MEAN |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group40
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 Inhibitory Antibodies Against Coagulation Factor VIII (FVIII) | Pre-prophylaxis | 11 | Participants | ||
| Number of Participants With Inhibitory Antibodies Against Coagulation Factor VIII (FVIII) | Prophylaxis | 10 | Participants | ||
| Number of Adverse Events Including Serious Adverse Events and Medical Events of Special Interest | Pre-prophylaxis | Adverse events | 116 | Events | |
| Number of Adverse Events Including Serious Adverse Events and Medical Events of Special Interest | Prophylaxis | Adverse events | 644 | Events | |
| Number of Adverse Events Including Serious Adverse Events and Medical Events of Special Interest | Immune Tolerance Induction (ITI) | Adverse events | 32 | Events | |
| Number of Adverse Events Including Serious Adverse Events and Medical Events of Special Interest | Pre-prophylaxis | Serious adverse events | 24 | Events | |
| Number of Adverse Events Including Serious Adverse Events and Medical Events of Special Interest | Prophylaxis | Serious adverse events | 56 | Events | |
| Number of Adverse Events Including Serious Adverse Events and Medical Events of Special Interest | Immune Tolerance Induction (ITI) | Serious adverse events | 3 | Events | |
| Number of Adverse Events Including Serious Adverse Events and Medical Events of Special Interest | Pre-prophylaxis | Medical events of special interest | 17 | Events | |
| Number of Adverse Events Including Serious Adverse Events and Medical Events of Special Interest | Prophylaxis | Medical events of special interest | 47 | Events |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 results by groupParticipant flow36
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Main Phase: Pre-Prophylaxis | STARTED | Pre-prophylaxis | 55 | |
| Main Phase: Pre-Prophylaxis | STARTED | Prophylaxis | 0 | |
| Main Phase: Pre-Prophylaxis | STARTED | Immune Tolerance Induction (ITI) | 0 | |
| Main Phase: Pre-Prophylaxis | COMPLETED | Pre-prophylaxis | 44 | |
| Main Phase: Pre-Prophylaxis | COMPLETED | Prophylaxis | 0 | |
| Main Phase: Pre-Prophylaxis | COMPLETED | Immune Tolerance Induction (ITI) | 0 | |
| Main Phase: Pre-Prophylaxis | NOT COMPLETED | Pre-prophylaxis | 11 | |
| Main Phase: Pre-Prophylaxis | NOT COMPLETED | Prophylaxis | 0 | |
| Main Phase: Pre-Prophylaxis | NOT COMPLETED | Immune Tolerance Induction (ITI) | 0 | |
| Main Phase: Prophylaxis | STARTED | Pre-prophylaxis | 0 |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 participant flowAdverse events249
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 | Anaemia | Blood and lymphatic system disorders | Pre-prophylaxis | 2 | 55 | 3 |
| other | Anaemia | Blood and lymphatic system disorders | Prophylaxis | 0 | 69 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Immune Tolerance Induction (ITI) | 1 | 8 | 2 |
| other | Anaesthetic complication | Injury, poisoning and procedural complications | Pre-prophylaxis | 0 | 55 | 0 |
| other | Anaesthetic complication | Injury, poisoning and procedural complications | Prophylaxis | 0 | 69 | 0 |
| other | Anaesthetic complication | Injury, poisoning and procedural complications | Immune Tolerance Induction (ITI) | 1 | 8 | 1 |
| other | Anti factor VIII antibody positive | Investigations | Pre-prophylaxis | 3 | 55 | 3 |
| other | Anti factor VIII antibody positive | Investigations | Prophylaxis | 1 | 69 | 1 |
| other | Anti factor VIII antibody positive | Investigations | Immune Tolerance Induction (ITI) | 0 | 8 | 0 |
| other | Bronchitis | Infections and infestations | Pre-prophylaxis | 1 | 55 | 1 |
1 to 10 of 249Source ClinicalTrials.gov
See all 249 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Pre-prophylaxis | 0 | 55 |
| Total, all-cause mortality | Prophylaxis | 0 | 69 |
| Total, all-cause mortality | Immune Tolerance Induction (ITI) | 0 | 8 |
| Total, other adverse events | Pre-prophylaxis | 28 | 55 |
| Total, other adverse events | Prophylaxis | 51 | 69 |
| Total, other adverse events | Immune Tolerance Induction (ITI) | 7 | 8 |
| Total, serious adverse events | Pre-prophylaxis | 18 | 55 |
| Total, serious adverse events | Prophylaxis | 34 | 69 |
| Total, serious adverse events | Immune Tolerance Induction (ITI) | 1 | 8 |
Source ClinicalTrials.gov
Papers2
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 comparisons2
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 Confirmed High Titre Inhibitors (Defined as Inhibitor Titre Above 5 Bethesda Units (BU) | Trial comparisons |
| Pre-prophylaxis vs Prophylaxis: Number of Participants With Inhibitory Antibodies Against Coagulation Factor VIII (FVIII) | 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.
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