Trial · NCT00984126
Safety and Efficacy of Turoctocog Alfa (N8) in Prevention and On-demand Treatment of Bleeding Episodes in Subjects With Haemophilia A: An Extension to Trials NN7008-3543, NN7008-3545, NN7008-3600, NN7008-3893 and NN7008-4015
NCT00984126, Phase 3, Completed, Novo Nordisk A/S; results first posted 2017-07-27
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Safety and Efficacy of Turoctocog Alfa (N8) in Prevention and On-demand Treatment of Bleeding Episodes in Subjects With Haemophilia A: An Extension to Trials NN7008-3543, NN7008-3545, NN7008-3600, NN7008-3893 and NN7008-4015. Trials, record NCT00984126. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00984126
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
Safety and Efficacy of Turoctocog Alfa (N8) in Prevention and On-demand Treatment of Bleeding Episodes in Subjects With Haemophilia A: An Extension to Trials NN7008-3543, NN7008-3545, NN7008-3600, NN7008-3893 and NN7008-4015
- NCT number
- NCT00984126
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 214 participants, actual
- Lead sponsor
- Novo Nordisk A/S
- Conditions
- Congenital Bleeding Disorder, Haemophilia A
- Interventions
- turoctocog alfa, turoctocog alfa
- First posted
- 2009-09-25
- Last updated
- 2017-07-27
- Other registries' IDs
- eudract:2008-005945-46
- Results first posted
- 2017-07-27
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Frequency of Development of FVIII Inhibitors (Greater Than or Equal to 0.6 Bethesda Units (BU)/mL) | After 90 months | The frequency of inhibitors was calculated as number of patients with inhibitors during the trial divided by number of patients in the trial. This endpoint was measured during the trial. |
| Secondary | Frequency of Adverse Events and Serious Adverse Events | After 90 months | The number of adverse events and serious adverse events reported during the main trial and the on-demand sub-trial (during 90 months). |
| Secondary | Annualised Bleeding Rate Reported During the Prevention Period (Only Applicable for Subjects in the Preventive Regimen) | After 90 months | The number of bleeding episodes per year reported during the prevention period (during 90 months). |
| Secondary | Haemostatic Response to Turoctocog Alfa (None, Moderate, Good or Excellent) in Treatment of Bleeds. | After 90 months | Haemostatic response to turoctocog alfa (none, moderate, good or excellent) in treatment of bleeds using a four-point response scale: none, moderate, good or excellent. The evaluation was done by patient, caregiver and/or investigator based on experience as follows: 1. Excellent: Abrupt pain relief and/or unequivocal improvement in objective signs of bleeding within approximately 8 hours after a single infusion 2. Good: Definite pain relief and/or improvement in signs of bleeding within approximately 8 hours after an infusion, but possibly requiring more than 1 infusion for complete resolution. 3. Moderate: Probable or slight beneficial effect within approximately 8 hours after the first infusion; usually requiring more than 1 infusion. 4. None: No improvement, or worsening of symptoms. This endpoint is measured during the preventive and on-demand sub-trial (during 90 months). |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Frequency of Development of FVIII Inhibitors (Greater Than or Equal to 0.6 Bethesda Units (BU)/mL) | After 90 months | Full analysis set | subjects | NUMBER |
| SECONDARY | Frequency of Adverse Events and Serious Adverse Events | After 90 months | Safety Analysis Set includes all dosed subjects with data after dosing. | Number of Events | NUMBER |
| SECONDARY | Annualised Bleeding Rate Reported During the Prevention Period (Only Applicable for Subjects in the Preventive Regimen) | After 90 months | Full Analysis Set. Number of subjects analysed=Subjects who received preventive regimen and were evaluable for the outcome. | Bleeding episodes/year | MEDIAN |
| SECONDARY | Haemostatic Response to Turoctocog Alfa (None, Moderate, Good or Excellent) in Treatment of Bleeds. | After 90 months | Full Aanalysis Set. The endpoint was measured for preventive and on-demand regimen for comparison of the efficacy of turoctocog alfa between regimens. Number of subjects analysed=subjects who received preventive and on-demand regimen and were evaluable for this outcome. | Number of bleeds | NUMBER |
Source ClinicalTrials.gov
Results by group58
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Frequency of Development of FVIII Inhibitors (Greater Than or Equal to 0.6 Bethesda Units (BU)/mL) | Small Children (0 - <6 Years) | 0 | subjects | ||
| Frequency of Development of FVIII Inhibitors (Greater Than or Equal to 0.6 Bethesda Units (BU)/mL) | Older Children (6 - <12 Years) | 0 | subjects | ||
| Frequency of Development of FVIII Inhibitors (Greater Than or Equal to 0.6 Bethesda Units (BU)/mL) | Adolescents (12 - <18 Years) | 0 | subjects | ||
| Frequency of Development of FVIII Inhibitors (Greater Than or Equal to 0.6 Bethesda Units (BU)/mL) | Adults (≥18 Years) | 0 | subjects | ||
| Frequency of Adverse Events and Serious Adverse Events | Small Children (0 - <6 Years) | Adverse events | 180 | Number of Events | |
| Frequency of Adverse Events and Serious Adverse Events | Older Children (6 - <12 Years) | Adverse events | 204 | Number of Events | |
| Frequency of Adverse Events and Serious Adverse Events | Adolescents (12 - <18 Years) | Adverse events | 240 | Number of Events | |
| Frequency of Adverse Events and Serious Adverse Events | Adults (≥18 Years) | Adverse events | 636 | Number of Events | |
| Frequency of Adverse Events and Serious Adverse Events | Small Children (0 - <6 Years) | Serious adverse events | 6 | Number of Events | |
| Frequency of Adverse Events and Serious Adverse Events | Older Children (6 - <12 Years) | Serious adverse events | 8 | Number of Events |
1 to 10 of 58Source ClinicalTrials.gov
See all 58 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Small Children (0 - <6 Years) | 27 | |
| Overall Study | STARTED | Older Children (6 - <12 Years) | 28 | |
| Overall Study | STARTED | Adolescents (12 - <18 Years) | 23 | |
| Overall Study | STARTED | Adults (≥18 Years) | 135 | |
| Overall Study | COMPLETED | Small Children (0 - <6 Years) | 20 | |
| Overall Study | COMPLETED | Older Children (6 - <12 Years) | 20 | |
| Overall Study | COMPLETED | Adolescents (12 - <18 Years) | 16 | |
| Overall Study | COMPLETED | Adults (≥18 Years) | 76 | |
| Overall Study | NOT COMPLETED | Small Children (0 - <6 Years) | 7 | |
| Overall Study | NOT COMPLETED | Older Children (6 - <12 Years) | 8 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events392
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 | Small Children (0 - <6 Years) | 2 | 27 | 3 |
| other | Abdominal pain | Gastrointestinal disorders | Older Children (6 - <12 Years) | 1 | 28 | 1 |
| other | Abdominal pain | Gastrointestinal disorders | Adolescents (12 - <18 Years) | 1 | 23 | 1 |
| other | Abdominal pain | Gastrointestinal disorders | Adults (≥18 Years) | 4 | 135 | 4 |
| other | Abdominal pain upper | Gastrointestinal disorders | Small Children (0 - <6 Years) | 1 | 27 | 1 |
| other | Abdominal pain upper | Gastrointestinal disorders | Older Children (6 - <12 Years) | 0 | 28 | 0 |
| other | Abdominal pain upper | Gastrointestinal disorders | Adolescents (12 - <18 Years) | 2 | 23 | 2 |
| other | Abdominal pain upper | Gastrointestinal disorders | Adults (≥18 Years) | 2 | 135 | 2 |
| other | Anaemia | Blood and lymphatic system disorders | Small Children (0 - <6 Years) | 2 | 27 | 2 |
| other | Anaemia | Blood and lymphatic system disorders | Older Children (6 - <12 Years) | 1 | 28 | 2 |
1 to 10 of 392Source ClinicalTrials.gov
See all 392 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Small Children (0 - <6 Years) | ||
| Total, all-cause mortality | Older Children (6 - <12 Years) | ||
| Total, all-cause mortality | Adolescents (12 - <18 Years) | ||
| Total, all-cause mortality | Adults (≥18 Years) | ||
| Total, other adverse events | Small Children (0 - <6 Years) | 23 | 27 |
| Total, other adverse events | Older Children (6 - <12 Years) | 25 | 28 |
| Total, other adverse events | Adolescents (12 - <18 Years) | 20 | 23 |
| Total, other adverse events | Adults (≥18 Years) | 94 | 135 |
| Total, serious adverse events | Small Children (0 - <6 Years) | 5 | 27 |
| Total, serious adverse events | Older Children (6 - <12 Years) | 9 | 28 |
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/NCT00984126
GET https://conductscience.org/api/trials/v1/NCT00984126/results?page=2