Trial · NCT00703911
Observational Registry of NovoSeven® Used as On-demand Treatment of Bleeds in Patients With Haemophilia A and B With Inhibitors
NCT00703911, Completed, Novo Nordisk A/S; results first posted 2011-12-19
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Observational Registry of NovoSeven® Used as On-demand Treatment of Bleeds in Patients With Haemophilia A and B With Inhibitors. Trials, record NCT00703911. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00703911
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Observational Registry of NovoSeven® Used as On-demand Treatment of Bleeds in Patients With Haemophilia A and B With Inhibitors
- NCT number
- NCT00703911
- Status
- Completed
- Enrollment
- 102 participants, actual
- Lead sponsor
- Novo Nordisk A/S
- Conditions
- Congenital Bleeding Disorder, Haemophilia A With Inhibitors, Haemophilia B With Inhibitors
- Interventions
- eptacog alfa (activated)
- First posted
- 2008-06-24
- Last updated
- 2017-01-11
- Results first posted
- 2011-12-19
Source ClinicalTrials.gov
Registered outcomes25
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Bleed Treatments Resulting in Effective Bleed Resolution (All Bleed Episodes) | within 9 hours of first injection | The percentage of bleed treatments successfully resulting in bleed resolution. Analysis only considers the patient's opinion of effectiveness at 9 hours, with a rating of "Effective" considered as successful treatment. |
| Primary | Percentage of Bleed Treatments Resulting in Effective Bleed Resolution (Spontaneous Bleed Episodes) | within 9 hours of first injection | The percentage of bleed treatments successfully resulting in bleed resolution. Analysis only considers the patient's opinion of effectiveness at 9 hours, with a rating of "Effective" considered as successful treatment. |
| Primary | Percentage of Bleed Treatments Resulting in Effective Pain Relief (All Bleed Episodes) | within 9 hours of first injection | The percentage of participants with effective pain relief. Pain relief was a subjective assessment made by the patient during treatment of a bleed episode. |
| Primary | Percentage of Bleed Treatments Resulting in Effective Pain Relief (Spontaneous Bleed Episodes) | within 9 hours of first injection | The percentage of participants with effective pain relief. Pain relief was a subjective assessment made by the patient during treatment of a bleed episode. |
| Secondary | Percentage of Bleed Treatments Resulting in Effective Haemostasis (Cessation of Bleeds) by Time Point (All Bleed Episodes) | 1 hour, 3 hours and 6 hours, respectively, after first injection | Effective haemostasis at 3 different time points for all bleeds. Patient reported outcomes are reported over 1 hour, 3 hours and 6 hours. |
| Secondary | Percentage of Bleed Treatments Resulting in Effective Haemostasis (Cessation of Bleeds) by Time Point (Spontaneous Bleed Episodes) | 1 hour, 3 hours and 6 hours, respectively, after first injection | Effective haemostasis at 3 different time points for all bleeds. Patient reported outcomes are reported over 1 hour, 3 hours and 6 hours. |
| Secondary | Percentage of Bleed Treatments Resulting in Effective Pain Relief by Time Point (All Bleed Episodes) | 1 hour, 3 hours and 6 hours, respectively, after first injection | Effective pain relief at 3 different time points for all bleeds. Patient reported outcomes are reported over 1 hour, 3 hours and 6 hours. |
| Secondary | Percentage of Bleed Treatments Resulting in Effective Pain Relief by Time Point (Spontaneous Bleed Episodes) | 1 hour, 3 hours and 6 hours, respectively, after first injection | Effective pain relief at 3 different time points for spontaneous bleeds. Patient reported outcomes are reported over 1 hour, 3 hours and 6 hours. |
| Secondary | Total Number of Injections (All Bleed Episodes) | individual bleed episode | The median number of injections required to treat individual bleed episodes. |
| Secondary | Total Number of Injections (Spontaneous Bleed Episodes) | individual bleed episode | The median number of injections required to treat individual bleed episodes. |
1 to 10 of 25Source ClinicalTrials.gov
See all 25 registered outcomesOutcomes25
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Bleed Treatments Resulting in Effective Bleed Resolution (All Bleed Episodes) | within 9 hours of first injection | Analysis set is all bleed episodes, regardless of bleed type or initial dose level | percentage of bleed episodes | NUMBER |
| PRIMARY | Percentage of Bleed Treatments Resulting in Effective Bleed Resolution (Spontaneous Bleed Episodes) | within 9 hours of first injection | Analysis set is spontaneous bleed episodes treated with any initial dose | percentage of bleed episodes | NUMBER |
| PRIMARY | Percentage of Bleed Treatments Resulting in Effective Pain Relief (All Bleed Episodes) | within 9 hours of first injection | Analysis set is all bleed episodes, regardless of bleed type or initial dose level | percentage of bleed episodes | NUMBER |
| PRIMARY | Percentage of Bleed Treatments Resulting in Effective Pain Relief (Spontaneous Bleed Episodes) | within 9 hours of first injection | Analysis set is spontaneous bleed episodes treated with any initial dose | percentage of bleed episodes | NUMBER |
| SECONDARY | Percentage of Bleed Treatments Resulting in Effective Haemostasis (Cessation of Bleeds) by Time Point (All Bleed Episodes) | 1 hour, 3 hours and 6 hours, respectively, after first injection | Analysis set is all bleed episodes, regardless of bleed type or initial dose level | percentage of bleed episodes | NUMBER |
| SECONDARY | Percentage of Bleed Treatments Resulting in Effective Haemostasis (Cessation of Bleeds) by Time Point (Spontaneous Bleed Episodes) | 1 hour, 3 hours and 6 hours, respectively, after first injection | Analysis set is spontaneous bleed episodes treated with any initial dose | percentage of bleed episodes | NUMBER |
| SECONDARY | Percentage of Bleed Treatments Resulting in Effective Pain Relief by Time Point (All Bleed Episodes) | 1 hour, 3 hours and 6 hours, respectively, after first injection | Analysis set is all bleed episodes, regardless of bleed type or initial dose level | percentage of bleed episodes | NUMBER |
| SECONDARY | Percentage of Bleed Treatments Resulting in Effective Pain Relief by Time Point (Spontaneous Bleed Episodes) | 1 hour, 3 hours and 6 hours, respectively, after first injection | Analysis set is spontaneous bleed episodes treated with any initial dose | percentage of bleed episodes | NUMBER |
| SECONDARY | Total Number of Injections (All Bleed Episodes) | individual bleed episode | Analysis set is all bleed episodes, regardless of bleed type or initial dose level | injections | MEDIAN |
| SECONDARY | Total Number of Injections (Spontaneous Bleed Episodes) | individual bleed episode | Analysis set is spontaneous bleed episodes treated with any initial dose | injections | MEDIAN |
1 to 10 of 25Source ClinicalTrials.gov
See all 25 outcomesResults by group160
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Bleed Treatments Resulting in Effective Bleed Resolution (All Bleed Episodes) | Activated Recombinant Human Factor VII | Any initial dose, n=494 | 61.7 | percentage of bleed episodes | |
| Percentage of Bleed Treatments Resulting in Effective Bleed Resolution (All Bleed Episodes) | Activated Recombinant Human Factor VII | Low initial dose, n=156 | 67.9 | percentage of bleed episodes | |
| Percentage of Bleed Treatments Resulting in Effective Bleed Resolution (All Bleed Episodes) | Activated Recombinant Human Factor VII | Intermediate initial dose, n=127 | 62.2 | percentage of bleed episodes | |
| Percentage of Bleed Treatments Resulting in Effective Bleed Resolution (All Bleed Episodes) | Activated Recombinant Human Factor VII | High initial dose, n=211 | 56.9 | percentage of bleed episodes | |
| Percentage of Bleed Treatments Resulting in Effective Bleed Resolution (Spontaneous Bleed Episodes) | Activated Recombinant Human Factor VII | Any initial dose, n=324 | 59.0 | percentage of bleed episodes | |
| Percentage of Bleed Treatments Resulting in Effective Bleed Resolution (Spontaneous Bleed Episodes) | Activated Recombinant Human Factor VII | Low initial dose, n=92 | 62.6 | percentage of bleed episodes | |
| Percentage of Bleed Treatments Resulting in Effective Bleed Resolution (Spontaneous Bleed Episodes) | Activated Recombinant Human Factor VII | Intermediate initial dose, n=91 | 60.4 | percentage of bleed episodes | |
| Percentage of Bleed Treatments Resulting in Effective Bleed Resolution (Spontaneous Bleed Episodes) | Activated Recombinant Human Factor VII | High initial dose, n=141 | 55.7 | percentage of bleed episodes | |
| Percentage of Bleed Treatments Resulting in Effective Pain Relief (All Bleed Episodes) | Activated Recombinant Human Factor VII | Any initial dose, n=494 | 71.3 | percentage of bleed episodes | |
| Percentage of Bleed Treatments Resulting in Effective Pain Relief (All Bleed Episodes) | Activated Recombinant Human Factor VII | Low initial dose, n=156 | 82.1 | percentage of bleed episodes |
1 to 10 of 160Source ClinicalTrials.gov
See all 160 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Activated Recombinant Human Factor VII | 102 | |
| Overall Study | COMPLETED | Activated Recombinant Human Factor VII | 92 | |
| Overall Study | NOT COMPLETED | Activated Recombinant Human Factor VII | 10 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Activated Recombinant Human Factor VII | ||
| Total, other adverse events | Activated Recombinant Human Factor VII | 0 | 85 |
| Total, serious adverse events | Activated Recombinant Human Factor VII | 0 | 85 |
Source ClinicalTrials.gov
Papers0
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
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/NCT00703911
GET https://conductscience.org/api/trials/v1/NCT00703911/registered?page=2