Trial · NCT03528551
A Research Study Looking at How a Factor VIII Medicine Called Turoctocog Alfa Pegol (N8-GP) Works in People With Haemophilia A
NCT03528551, Phase 3, Completed, Novo Nordisk A/S; results first posted 2021-11-26
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Research Study Looking at How a Factor VIII Medicine Called Turoctocog Alfa Pegol (N8-GP) Works in People With Haemophilia A. Trials, record NCT03528551. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03528551
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Research Study Looking at How a Factor VIII Medicine Called Turoctocog Alfa Pegol (N8-GP) Works in People With Haemophilia A
- NCT number
- NCT03528551
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 160 participants, actual
- Lead sponsor
- Novo Nordisk A/S
- Conditions
- Congenital Bleeding Disorder, Haemophilia A
- Interventions
- Turoctocog alfa pegol, Turoctocog alfa pegol, Turoctocog alfa pegol
- First posted
- 2018-05-18
- Last updated
- 2022-12-22
- Other registries' IDs
- eudract:2017-003788-36
- Results first posted
- 2021-11-26
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Adverse Events Reported | Week 0 to week 108 | An adverse event (AE) was defined as any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a product, whether or not considered related to the product. All AEs mentioned here are treatment emergent adverse events (TEAEs). The TEAE is defined as an event reported from date of first trial product administration until end of the treatment visit (week 104) or follow-up visit if relevant (1 month after end of the treatment). |
| Secondary | Number of Participants With Inhibitory Antibodies Against Coagulation Factor VIII (FVIII) ≥0.6 Bethesda Units (BU) | Week 0 to week 104 | The Incidence of inhibitors against coagulation factor eight (FVIII) is defined as titre greater than or equal to (≥) 0.6 Bethesda unit. The inhibitor antibodies were measured using a heat modified Nijmegen FVIII Bethesda assay. The number of participants who developed inhibitors against FVIII are reported. |
| Secondary | Number of Bleeding Episodes on Prophylaxis | Week 0 to week 104 | Number of bleeding episodes per participant in the prophylaxis regimen was evaluated during 104 weeks. |
| Secondary | Number of Spontaneous Bleeding Episodes on Prophylaxis | Week 0 to week 104 | Spontaneous bleeding referred as bleeding episodes that occurred without apparent cause. The number of spontaneous bleeding episodes were evaluated during 104 weeks. |
| Secondary | Haemostatic Effect of N8-GP When Used for Treatment of Bleeding Episodes Assessed as: Excellent, Good, Moderate, or None | Week 0 to week 104 | The haemostatic effect after treatment of a bleed with N8-GP was assessed using a 4-point scale: 'excellent', 'good', 'moderate' or 'none'. The evaluation was done as follows: 1. Excellent: Abrupt pain relief and/or unequivocal improvement in objective signs of bleeding within approximately 8 hours after a single injection. 2. Good: Definite pain relief and/or improvement in signs of bleeding within approximately 8 hours after an injection, but possibly requiring more than one injection for complete resolution. 3. Moderate: Probable or slight beneficial effect within approximately 8 hours after the first injection; usually requiring more than one injection 4. None: No improvement or worsening of symptoms. |
| Secondary | Mean Number of N8-GP Injections Required Per Bleeding Episode | Week 0 to week 104 | The mean number of N8-GP injections required per bleeding episode from start to stop of a bleed for participants was presented from week 0 to week 104. |
| Secondary | Pre-dose FVIII Activity Levels on N8-GP Prophylaxis | Week 0 to week 104 | The pre-dose FVIII activity levels were assessed in International units per millilitre (IU/mL) units from week 0 to week 104 to get an estimate of the pre-dose level for N8-GP at steady-state using mixed model. |
| Secondary | Change in Joint Health Status From Start to End of Trial (Based on Haemophilia Joint Health Score) | Week 0, Week 104 | Haemophilia Joint Health Score is a validated outcome tool developed for the assessment of joint health in patients with hemophilia. It comprises an evaluation of the elbow, knee and ankle joints with regards to swelling, muscular atrophy, crepitation and range of motion, joint pain, strength, motion and axial alignment. The score range is from 0 to 24 points (a score of 0 indicates no joint damage. Higher the score higher the joint damage). Change from week 0 to end of trial (week 104) in the domain scores was presented. |
| Secondary | Haemostatic Response During Major Surgical Interventions Assessed as: Excellent, Good, Moderate, or None | Week 0 to week 104 | The Haemostatic response to N8-GP during major surgical interventions was assessed using a 4-point scale: 'excellent', 'good', 'moderate' or 'none'. The evaluation was done as follows: 1. Excellent: Better than expected/predicted in this type of procedure. 2. Good: As expected in this type of procedure 3. Moderate: Less than optimal for the type of procedure but haemostatic response maintained without change of treatment regimen 4. None: Bleeding due to inadequate therapeutic response with adequate dosing, change of regimen required. This endpoint was measured from week 0 to week 104. |
| Secondary | Consumption of N8-GP Per Bleed | Week 0 to week 104 | The average dose of N8-GP consumed for treatment of bleed was assessed in International units per kilogram per bleed(IU/kg/bleed). This endpoint was evaluated from week 0 to week 104. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Adverse Events Reported | Week 0 to week 108 | Safety analysis set (SAS) included all enrolled participants who were exposed to the trial product. | Events | NUMBER |
| SECONDARY | Number of Participants With Inhibitory Antibodies Against Coagulation Factor VIII (FVIII) ≥0.6 Bethesda Units (BU) | Week 0 to week 104 | FAS included all participants exposed to at least one dose of trial product in the current trial. | Participants | NUMBER |
| SECONDARY | Number of Bleeding Episodes on Prophylaxis | Week 0 to week 104 | FAS included all participants exposed to at least one dose of trial product in the current trial. | Episodes | NUMBER |
| SECONDARY | Number of Spontaneous Bleeding Episodes on Prophylaxis | Week 0 to week 104 | FAS included all participants exposed to at least one dose of trial product in the current trial. | Episodes | NUMBER |
| SECONDARY | Haemostatic Effect of N8-GP When Used for Treatment of Bleeding Episodes Assessed as: Excellent, Good, Moderate, or None | Week 0 to week 104 | FAS included all participants exposed to at least one dose of trial product in the current trial. | Episodes | NUMBER |
| SECONDARY | Mean Number of N8-GP Injections Required Per Bleeding Episode | Week 0 to week 104 | FAS included all participants exposed to at least one dose of trial product in the current trial. | Injections per bleed | MEAN |
| SECONDARY | Pre-dose FVIII Activity Levels on N8-GP Prophylaxis | Week 0 to week 104 | FAS included all participants exposed to at least one dose of trial product in the current trial. | IU/mL | MEAN |
| SECONDARY | Change in Joint Health Status From Start to End of Trial (Based on Haemophilia Joint Health Score) | Week 0, Week 104 | FAS included all participants exposed to at least one dose of trial product in the current trial. 'Overall Number of Participants Analyzed' = participants with available data. | Score on a scale | MEAN |
| SECONDARY | Haemostatic Response During Major Surgical Interventions Assessed as: Excellent, Good, Moderate, or None | Week 0 to week 104 | FAS included all participants exposed to at least one dose of trial product in the current trial. | Surgeries | NUMBER |
| SECONDARY | Consumption of N8-GP Per Bleed | Week 0 to week 104 | FAS included all participants exposed to at least one dose of trial product in the current trial. 'Overall Number of Participants Analyzed' = participants with available data. | IU/kg/bleed | MEAN |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group62
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Adverse Events Reported | N8-GP, Once Weekly | 58 | Events | ||
| Number of Adverse Events Reported | N8-GP, Twice Weekly | 444 | Events | ||
| Number of Adverse Events Reported | N8-GP, Three Times Weekly | 8 | Events | ||
| Number of Participants With Inhibitory Antibodies Against Coagulation Factor VIII (FVIII) ≥0.6 Bethesda Units (BU) | N8-GP, Once Weekly | 0 | Participants | ||
| Number of Participants With Inhibitory Antibodies Against Coagulation Factor VIII (FVIII) ≥0.6 Bethesda Units (BU) | N8-GP, Twice Weekly | 0 | Participants | ||
| Number of Participants With Inhibitory Antibodies Against Coagulation Factor VIII (FVIII) ≥0.6 Bethesda Units (BU) | N8-GP, Three Times Weekly | 0 | Participants | ||
| Number of Bleeding Episodes on Prophylaxis | N8-GP, Once Weekly | 123 | Episodes | ||
| Number of Bleeding Episodes on Prophylaxis | N8-GP, Twice Weekly | 190 | Episodes | ||
| Number of Bleeding Episodes on Prophylaxis | N8-GP, Three Times Weekly | 14 | Episodes | ||
| Number of Spontaneous Bleeding Episodes on Prophylaxis | N8-GP, Once Weekly | 98 | Episodes |
1 to 10 of 62Source ClinicalTrials.gov
See all 62 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | N8-GP, Once Weekly | 25 | |
| Overall Study | STARTED | N8-GP, Twice Weekly | 133 | |
| Overall Study | STARTED | N8-GP, Three Times Weekly | 2 | |
| Overall Study | COMPLETED | N8-GP, Once Weekly | 23 | |
| Overall Study | COMPLETED | N8-GP, Twice Weekly | 114 | |
| Overall Study | COMPLETED | N8-GP, Three Times Weekly | 2 | |
| Overall Study | NOT COMPLETED | N8-GP, Once Weekly | 2 | |
| Overall Study | NOT COMPLETED | N8-GP, Twice Weekly | 19 | |
| Overall Study | NOT COMPLETED | N8-GP, Three Times Weekly | 0 |
Source ClinicalTrials.gov
Adverse events124
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 | Arthralgia | Musculoskeletal and connective tissue disorders | N8-GP, Once Weekly | 2 | 25 | 2 |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | N8-GP, Twice Weekly | 11 | 135 | 12 |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | N8-GP, Three Times Weekly | 1 | 7 | 1 |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Total | 14 | 160 | 15 |
| other | Attention deficit hyperactivity disorder | Psychiatric disorders | N8-GP, Once Weekly | 0 | 25 | 0 |
| other | Attention deficit hyperactivity disorder | Psychiatric disorders | N8-GP, Twice Weekly | 0 | 135 | 0 |
| other | Attention deficit hyperactivity disorder | Psychiatric disorders | N8-GP, Three Times Weekly | 1 | 7 | 1 |
| other | Attention deficit hyperactivity disorder | Psychiatric disorders | Total | 1 | 160 | 1 |
| other | Dental caries | Gastrointestinal disorders | N8-GP, Once Weekly | 3 | 25 | 3 |
| other | Dental caries | Gastrointestinal disorders | N8-GP, Twice Weekly | 0 | 135 | 0 |
1 to 10 of 124Source ClinicalTrials.gov
See all 124 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | N8-GP, Once Weekly | 0 | 25 |
| Total, all-cause mortality | N8-GP, Twice Weekly | 1 | 135 |
| Total, all-cause mortality | N8-GP, Three Times Weekly | 0 | 7 |
| Total, all-cause mortality | Total | 1 | 160 |
| Total, other adverse events | N8-GP, Once Weekly | 9 | 25 |
| Total, other adverse events | N8-GP, Twice Weekly | 46 | 135 |
| Total, other adverse events | N8-GP, Three Times Weekly | 4 | 7 |
| Total, other adverse events | Total | 56 | 160 |
| Total, serious adverse events | N8-GP, Once Weekly | 4 | 25 |
| Total, serious adverse events | N8-GP, Twice Weekly | 15 | 135 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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
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The record and each of its lists are JSON, twenty rows a page. No key.
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