Trial · NCT01757405
Recombinant Factor VIIa BI (rFVIIa BI) Treatment of Acute Bleeding Episodes Per an On-demand Regimen
NCT01757405, Phase 3, Completed, Baxalta now part of Shire; results first posted 2016-10-25
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Recombinant Factor VIIa BI (rFVIIa BI) Treatment of Acute Bleeding Episodes Per an On-demand Regimen. Trials, record NCT01757405. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01757405
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Recombinant Factor VIIa BI (rFVIIa BI) Treatment of Acute Bleeding Episodes Per an On-demand Regimen
- NCT number
- NCT01757405
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 40 participants, actual
- Lead sponsor
- Baxalta now part of Shire
- Conditions
- Hemophilia A, Hemophilia B
- Interventions
- Recombinant Factor VIIa BI (rFVIIa BI), Recombinant Factor VIIa BI (rFVIIa BI)
- First posted
- 2012-12-28
- Last updated
- 2021-05-11
- Other registries' IDs
- eudract:2011-006294-26
- Results first posted
- 2016-10-25
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Bleeding Episode With "Treatment Success" | within 12 hours of first dose | No additional hemostatic product required within 12 hours of first dose other than the prescribed dosing regimen. |
| Secondary | Treatment Response for Each Bleeding Episode | within 24 hours of infusion | Participants rated the treatment of each bleeding episode. If treatment occurred under direct supervision of treating physician, the physician rated the response. Ratings based on a 4 point scale; EXCELLENT - full relief of pain and cessation of objective signs of bleeding (swelling, tenderness, decrease in range of motion \[for muscle bleeds\]) within 9 hours of treatment initiation. No additional infusion required to control bleeding, other than prescribed dosing regimen. GOOD - Substantial relief of pain and/or cessation of objective signs of bleeding within 9 hours of treatment initiation. No additional infusion required to control bleeding, other than prescribed dosing regimen. MODERATE - slight relief of pain and slight improvement of signs of bleeding within 9 hours of treatment initiation. Requires additional infusion beyond treatment regimen. NONE - No improvement or condition worsens. SUCCESSFUL = EXCELLENT or GOOD. |
| Secondary | Percentage of Clinical Responders (Sustained Bleeding Control) for All Acute Bleeding Episodes | 24 hours post infusion | Clinical responders defined as sustained bleeding control, (no additional hemostatic medication including rFVIIa BI required between 12 and 24 hours after first infusion of the successfully treated bleeding episode). |
| Secondary | Safety and Tolerability of Treatment Regimens by Clinical Assessment of Percentage of Participants With Adverse Events (AEs) | 6 months (throughout study period) | Safety was determined by the number of AEs (both serious AEs \[SAEs\] and non-serious AEs \[nsAE\]). Tolerability was determined by the number of AEs related to rFVIIa BI (both SAEs and nsAEs) as determined by causality assessment of the AEs by the investigator. An AE was deemed Related if the investigator judged the AE to be "possibly related" or "probably related" to rFVIIa BI. The percentage of participants with AEs were presented by seriousness (SAE, nsAE), severity (Mild, Moderate or Severe) and causality (Related or Not Related to rFVIIa BI). |
| Secondary | Safety and Tolerability of Treatment Regimens by Clinical Assessment of Adverse Events (AEs) | 6 months (throughout study period) | Safety was determined by the number of AEs (both serious AEs \[SAEs\] and non-serious AEs \[nsAE\]). Tolerability was determined by the number of AEs related to rFVIIa BI (both SAEs and nsAEs) as determined by causality assessment of the AEs by the investigator. An AE was deemed Related if the investigator judges the AE to be "possibly related" or "probably related" to rFVIIa BI. The percentage of AEs were presented by seriousness (SAE, nsAE), severity (Mild, Moderate or Severe) and causality (Related or Not Related \[to rFVIIa BI\]). |
| Secondary | Percentage of Participants With Inhibitor Development to FVII | 6 months (throughout study period) | Development of rFVII inhibitors or FVIIa binding antibodies during the study. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Bleeding Episode With Treatment Success | within 12 hours of first dose | Full Analysis Dataset | percent of bleeding episodes | NUMBER |
| SECONDARY | Treatment Response for Each Bleeding Episode | within 24 hours of infusion | Full Analysis Dataset | percent of bleeding episodes | NUMBER |
| SECONDARY | Percentage of Clinical Responders (Sustained Bleeding Control) for All Acute Bleeding Episodes | 24 hours post infusion | Full Analysis Dataset | percent of bleeding episodes | NUMBER |
| SECONDARY | Safety and Tolerability of Treatment Regimens by Clinical Assessment of Percentage of Participants With Adverse Events (AEs) | 6 months (throughout study period) | Safety Analysis Dataset | percent of participants with AEs | NUMBER |
| SECONDARY | Safety and Tolerability of Treatment Regimens by Clinical Assessment of Adverse Events (AEs) | 6 months (throughout study period) | Safety Analysis Dataset | percent of AEs | NUMBER |
| SECONDARY | Percentage of Participants With Inhibitor Development to FVII | 6 months (throughout study period) | Safety Analysis Dataset | percent of participants | NUMBER |
Source ClinicalTrials.gov
Results by group38
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Bleeding Episode With Treatment Success | Arm 1: up to 3 x 90 Micrograms/kg rFVIIa BI | 96.19 | 95% Confidence Interval 93.31 to 97.86 | percent of bleeding episodes | |
| Percentage of Bleeding Episode With Treatment Success | Arm 2: 1 x 270 Micrograms/kg rFVIIa BI | 79.30 | 95% Confidence Interval 73.92 to 83.81 | percent of bleeding episodes | |
| Treatment Response for Each Bleeding Episode | Arm 1: up to 3 x 90 Micrograms/kg rFVIIa BI | Successful | 87.89 | 95% Confidence Interval 83.62 to 91.16 | percent of bleeding episodes |
| Treatment Response for Each Bleeding Episode | Arm 2: 1 x 270 Micrograms/kg rFVIIa BI | Successful | 79.30 | 95% Confidence Interval 73.92 to 83.81 | percent of bleeding episodes |
| Treatment Response for Each Bleeding Episode | Arm 1: up to 3 x 90 Micrograms/kg rFVIIa BI | Excellent | 34.60 | 95% Confidence Interval 29.35 to 40.26 | percent of bleeding episodes |
| Treatment Response for Each Bleeding Episode | Arm 2: 1 x 270 Micrograms/kg rFVIIa BI | Excellent | 36.72 | 95% Confidence Interval 31.05 to 42.78 | percent of bleeding episodes |
| Treatment Response for Each Bleeding Episode | Arm 1: up to 3 x 90 Micrograms/kg rFVIIa BI | Good | 53.29 | 95% Confidence Interval 47.53 to 58.96 | percent of bleeding episodes |
| Treatment Response for Each Bleeding Episode | Arm 2: 1 x 270 Micrograms/kg rFVIIa BI | Good | 42.58 | 95% Confidence Interval 36.67 to 48.70 | percent of bleeding episodes |
| Treatment Response for Each Bleeding Episode | Arm 1: up to 3 x 90 Micrograms/kg rFVIIa BI | Moderate | 9.69 | 95% Confidence Interval 6.79 to 13.65 | percent of bleeding episodes |
| Treatment Response for Each Bleeding Episode | Arm 2: 1 x 270 Micrograms/kg rFVIIa BI | Moderate | 18.36 | 95% Confidence Interval 14.10 to 23.56 | percent of bleeding episodes |
1 to 10 of 38Source ClinicalTrials.gov
See all 38 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm 1: up to 3 x 90 Micrograms/kg rFVIIa BI | 18 | |
| Overall Study | STARTED | Arm 2: 1 x 270 Micrograms/kg rFVIIa BI | 20 | |
| Overall Study | COMPLETED | Arm 1: up to 3 x 90 Micrograms/kg rFVIIa BI | 17 | |
| Overall Study | COMPLETED | Arm 2: 1 x 270 Micrograms/kg rFVIIa BI | 18 | |
| Overall Study | NOT COMPLETED | Arm 1: up to 3 x 90 Micrograms/kg rFVIIa BI | 1 | |
| Overall Study | NOT COMPLETED | Arm 2: 1 x 270 Micrograms/kg rFVIIa BI | 2 |
Source ClinicalTrials.gov
Adverse events34
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 | Laceration | Injury, poisoning and procedural complications | Arm 1: up to 3 x 90 Micrograms/kg rFVIIa BI | 1 | 18 | 1 |
| other | Laceration | Injury, poisoning and procedural complications | Arm 2: 1 x 270 Micrograms/kg rFVIIa BI | 0 | 20 | 0 |
| other | Hepatic Enzyme Increased | Investigations | Arm 1: up to 3 x 90 Micrograms/kg rFVIIa BI | 1 | 18 | 1 |
| other | Hepatic Enzyme Increased | Investigations | Arm 2: 1 x 270 Micrograms/kg rFVIIa BI | 0 | 20 | 0 |
| other | Nasal Congestion | Respiratory, thoracic and mediastinal disorders | Arm 1: up to 3 x 90 Micrograms/kg rFVIIa BI | 1 | 18 | 1 |
| other | Nasal Congestion | Respiratory, thoracic and mediastinal disorders | Arm 2: 1 x 270 Micrograms/kg rFVIIa BI | 0 | 20 | 0 |
| other | Oropharyngeal Pain | Respiratory, thoracic and mediastinal disorders | Arm 1: up to 3 x 90 Micrograms/kg rFVIIa BI | 1 | 18 | 2 |
| other | Oropharyngeal Pain | Respiratory, thoracic and mediastinal disorders | Arm 2: 1 x 270 Micrograms/kg rFVIIa BI | 0 | 20 | 0 |
| other | Drug Hypersensitivity | Immune system disorders | Arm 1: up to 3 x 90 Micrograms/kg rFVIIa BI | 1 | 18 | 1 |
| other | Drug Hypersensitivity | Immune system disorders | Arm 2: 1 x 270 Micrograms/kg rFVIIa BI | 0 | 20 | 0 |
1 to 10 of 34Source ClinicalTrials.gov
See all 34 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm 1: up to 3 x 90 Micrograms/kg rFVIIa BI | ||
| Total, all-cause mortality | Arm 2: 1 x 270 Micrograms/kg rFVIIa BI | ||
| Total, other adverse events | Arm 1: up to 3 x 90 Micrograms/kg rFVIIa BI | 4 | 18 |
| Total, other adverse events | Arm 2: 1 x 270 Micrograms/kg rFVIIa BI | 2 | 20 |
| Total, serious adverse events | Arm 1: up to 3 x 90 Micrograms/kg rFVIIa BI | 2 | 18 |
| Total, serious adverse events | Arm 2: 1 x 270 Micrograms/kg rFVIIa BI | 2 | 20 |
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Arm 1: up to 3 x 90 Micrograms/kg rFVIIa BI vs Arm 2: 1 x 270 Micrograms/kg rFVIIa BI: serious adverse events |
Source 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.
GET https://conductscience.org/api/trials/v1/NCT01757405
GET https://conductscience.org/api/trials/v1/NCT01757405/results?page=2