Trial · NCT00840086
Safety and Efficacy of Turoctocog Alfa in Haemophilia A Subjects
NCT00840086, Phase 3, Completed, Novo Nordisk A/S; results first posted 2014-09-04
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Safety and Efficacy of Turoctocog Alfa in Haemophilia A Subjects. Trials, record NCT00840086. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00840086
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Efficacy of Turoctocog Alfa in Haemophilia A Subjects
- NCT number
- NCT00840086
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 150 participants, actual
- Lead sponsor
- Novo Nordisk A/S
- Conditions
- Congenital Bleeding Disorder, Haemophilia A
- Interventions
- turoctocog alfa
- First posted
- 2009-02-10
- Last updated
- 2017-03-17
- Other registries' IDs
- eudract:2008-003960-20
- Results first posted
- 2014-09-04
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The Incidence Rate of FVIII Inhibitors (Greater Than or Equal to 0.6 Bethesda Units (BU)) | The adverse events were collected throughout the trial, corresponding to an average of 188 days per subject. | The incidence rate of FVIII inhibitors was calculated by including all patients with inhibitors in the nominator and including all patients with a minimum 50 exposure plus any patients with less than 50 exposures but with inhibitors in denominator. |
| Secondary | Frequency of Adverse Events (AEs) | The adverse events were collected throughout the trial, corresponding to an average of 188 days per subject | Adverse event was defined as events occurring after administration of trial product. Severe AEs: considerable interference with subject's daily activities, unacceptable. Moderate AEs: Marked symptoms, moderate interference with the patient's daily activities. Mild AEs: No or transient symptoms, no interference with the patient's daily activities. Serious AEs: AE that at any dose results in any of the following: death, a life-threatening experience, in-subject hospitalization/prolongation of existing hospitalization, persistent/significant disability/incapacity/congenital anomaly/birth defect. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | The Incidence Rate of FVIII Inhibitors (Greater Than or Equal to 0.6 Bethesda Units (BU)) | The adverse events were collected throughout the trial, corresponding to an average of 188 days per subject. | The safety analysis set includes all 150 subjects who received at least one dose of the investigational product. The analysis of the primary endpoint included all subjects with at least 50 exposure days and/or with inhibitors. A total of 148 subjects had 50 exposure days (EDs). | N with Inhibitors / N with ≥50 EDs | NUMBER |
| SECONDARY | Frequency of Adverse Events (AEs) | The adverse events were collected throughout the trial, corresponding to an average of 188 days per subject | Safety analysis set includes all subjects who received at least one dose of the investigational product. | events | NUMBER |
Source ClinicalTrials.gov
Results by group19
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| The Incidence Rate of FVIII Inhibitors (Greater Than or Equal to 0.6 Bethesda Units (BU)) | All Subjects Treated With Turoctocog Alfa | 0 | N with Inhibitors / N with ≥50 EDs | ||
| Frequency of Adverse Events (AEs) | Total (Part A + Part B) | All AEs | 222 | events | |
| Frequency of Adverse Events (AEs) | Part C | All AEs | 3 | events | |
| Frequency of Adverse Events (AEs) | All Subjects Treated With Turoctocog Alfa | All AEs | 225 | events | |
| Frequency of Adverse Events (AEs) | Total (Part A + Part B) | Severe AEs | 8 | events | |
| Frequency of Adverse Events (AEs) | Part C | Severe AEs | 0 | events | |
| Frequency of Adverse Events (AEs) | All Subjects Treated With Turoctocog Alfa | Severe AEs | 8 | events | |
| Frequency of Adverse Events (AEs) | Total (Part A + Part B) | Moderate AEs | 51 | events | |
| Frequency of Adverse Events (AEs) | Part C | Moderate AEs | 1 | events | |
| Frequency of Adverse Events (AEs) | All Subjects Treated With Turoctocog Alfa | Moderate AEs | 52 | events |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | All Subjects Treated With Turoctocog Alfa | 150 | |
| Overall Study | COMPLETED | All Subjects Treated With Turoctocog Alfa | 146 | |
| Overall Study | NOT COMPLETED | All Subjects Treated With Turoctocog Alfa | 4 |
Source ClinicalTrials.gov
Adverse events11
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 | Nasopharyngitis | Infections and infestations | All Subjects Treated With Turoctocog Alfa | 12 | 150 | 13 |
| other | Incorrect dose administered | Injury, poisoning and procedural complications | All Subjects Treated With Turoctocog Alfa | 15 | 150 | 19 |
| other | Headache | Nervous system disorders | All Subjects Treated With Turoctocog Alfa | 14 | 150 | 18 |
| serious | Sinus tachycardia | Cardiac disorders | All Subjects Treated With Turoctocog Alfa | 1 | 150 | 1 |
| serious | Melaena | Gastrointestinal disorders | All Subjects Treated With Turoctocog Alfa | 2 | 150 | 2 |
| serious | Upper gastrointestinal haemorrhage | Gastrointestinal disorders | All Subjects Treated With Turoctocog Alfa | 1 | 150 | 1 |
| serious | Fall | Injury, poisoning and procedural complications | All Subjects Treated With Turoctocog Alfa | 1 | 150 | 1 |
| serious | Road traffic accident | Injury, poisoning and procedural complications | All Subjects Treated With Turoctocog Alfa | 1 | 150 | 1 |
| serious | Hepatic enzyme increased | Investigations | All Subjects Treated With Turoctocog Alfa | 1 | 150 | 1 |
| serious | Insomnia | Psychiatric disorders | All Subjects Treated With Turoctocog Alfa | 1 | 150 | 1 |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | All Subjects Treated With Turoctocog Alfa | ||
| Total, other adverse events | All Subjects Treated With Turoctocog Alfa | 36 | 150 |
| Total, serious adverse events | All Subjects Treated With Turoctocog Alfa | 7 | 150 |
Source ClinicalTrials.gov
Papers4
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/NCT00840086
GET https://conductscience.org/api/trials/v1/NCT00840086/registered