Trial · NCT02283268
Recombinant Von Willebrand Factor in Subjects With Severe Von Willebrand Disease Undergoing Surgery
NCT02283268, Phase 3, Completed, Baxalta now part of Shire; results first posted 2017-08-31
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Recombinant Von Willebrand Factor in Subjects With Severe Von Willebrand Disease Undergoing Surgery. Trials, record NCT02283268. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02283268
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Recombinant Von Willebrand Factor in Subjects With Severe Von Willebrand Disease Undergoing Surgery
- NCT number
- NCT02283268
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 24 participants, actual
- Lead sponsor
- Baxalta now part of Shire
- Conditions
- Von Willebrand Disease
- Interventions
- Recombinant von Willebrand Factor (rVWF)
- First posted
- 2014-11-05
- Last updated
- 2021-05-19
- Other registries' IDs
- eudract:2014-003575-38
- Results first posted
- 2017-08-31
Source ClinicalTrials.gov
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Hemostatic Efficacy as Assessed by the Investigator (Hemophilia Physician) | 24 hours after last peri-operative infusion or at completion of Day 14 (± 2 days) visit, whichever occurs earlier | Hemostatic efficacy will be rated on a scale of excellent - good - moderate - none. Excellent: Intra-, and postoperative hemostasis achieved with rVWF with our without ADVATE was as good or better than that expected for the type of surgical procedure performed in a hemostatically normal subject. Good: Intra-, and postoperative hemostasis achieved with rVWF with or without ADVATE was probably as good as that expected for the type of surgical procedure performed in a hemostatically normal subject. Moderate: Intra-, and postoperative hemostasis with rVWF with or without ADVATE was clearly less than optimal for the type of procedure performed but was maintained without the need to change the rVWF concentrate. None: Participant experienced uncontrolled bleeding that was the result of inadequate therapeutic response despite proper dosing, necessitating a change of rVWF concentrate. |
| Secondary | Intraoperative Actual Versus Predicted Blood Loss as Assessed by the Operating Surgeon | Day 0 (at completion of surgery) | The predicted blood loss will be estimated preoperatively by the operating surgeon based on a hemostatically normal individual of the same sex, age, stature and co-morbidities as the participant. The actual blood loss will be assessed consisting of the estimated blood loss, including into swabs, towels and suction during the procedure, per the anesthesiologist's record. |
| Secondary | Intraoperative Actual Blood Loss Relative to Predicted Blood Loss | Day 0 (at completion of surgery) | Actual blood loss relative to predicted blood loss will be calculated as \[Actual Blood loss (mL)\] divided by \[Predicted Blood Loss (mL) multiplied by 100. |
| Secondary | Intraoperative Actual Versus Predicted Blood Loss Score as Assessed by the Operating Surgeon | Day 0 (at completion of surgery) | Hemostatic efficacy will be rated on a scale of excellent - good - moderate - none. Excellent: Intraoperative blood loss was less than or equal to the maximum blood loss expected for the type of procedure performed in a hemostatically normal subject (≤ 100%). Good: Intraoperative blood loss was up to 50% more than the maximum expected blood loss for the type of procedure performed in a hemostatically normal subject (101-150%) Moderate: Intraoperative blood loss was more than 50% of the maximum expected blood loss for the type of procedure performed in a hemostatically normal subject (\>150%). None: Uncontrolled hemorrhage that was the result of inadequate therapeutic response despite proper dosing, necessitating a change of clotting factor replacement regimen. |
| Secondary | Intraoperative Hemostatic Efficacy Score as Assessed by the Operating Surgeon | Day 0 (at completion of surgery) | Hemostatic efficacy will be rated on a scale of excellent - good - moderate - none. Excellent: Intraoperative hemostasis achieved with rVWF with our without ADVATE was as good or better than that expected for the type of surgical procedure performed in a hemostatically normal subject. Good: Intraoperative hemostasis achieved with rVWF with or without ADVATE was probably as good as that expected for the type of surgical procedure performed in a hemostatically normal subject. Moderate: Intraoperative hemostasis with rVWF with or without ADVATE was clearly less than optimal for the type of procedure performed but was maintained without the need to change the rVWF concentrate. None: Participant experienced uncontrolled bleeding that was the result of inadequate therapeutic response despite proper dosing, necessitating a change of rVWF concentrate. |
| Secondary | Daily Intra- and Postoperative Weight-adjusted Dose of rVWF With or Without ADVATE | Daily, from day of surgery through postoperative Day 14 (± 2 days) | |
| Secondary | Occurrence of Adverse Events | From first infusion of investigational product through study completion (ie, 14 (± 2) days post surgery) | Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) will be evaluated. |
| Secondary | Occurrence of Thrombotic Events | From first infusion of investigational product through study completion (ie, 14 (± 2) days post surgery) | Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) will be evaluated for thrombotic events. |
| Secondary | Occurrence of Severe Allergic Reactions (eg, Anaphylaxis) | From first infusion of investigational product through study completion (ie, 14 (± 2) days post surgery) | Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) will be evaluated for severe allergic reactions. |
| Secondary | Number of Participants Who Developed Inhibitory and Total Binding Antibodies to Von Willebrand Factor (VWF) and Inhibitory Antibodies to Factor VIII (FVIII) | Testing occurred throughout the study at screening, prior PK infusion, pre-surgery, post surgery in case of excessive bleeding or unexplained bleeding, at postoperative day 7 and at study completion visit (ie. 14 (± 2) days post surgery). | Participants were treated with recombinant van Willebrand Factor (rVWF) with or without ADVATE. |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 registered outcomesOutcomes18
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Hemostatic Efficacy as Assessed by the Investigator (Hemophilia Physician) | 24 hours after last peri-operative infusion or at completion of Day 14 (± 2 days) visit, whichever occurs earlier | Number of participants with major, minor and oral surgery and number of participant with Von Willebrand Type 1, 2A, 2B, 2M and 3 do sum up to the overall number of participants analyzed. The full analysis data set, including all participants who received investigational product and have at least 1 hemostatic assessment, was used for analysis. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Intraoperative Actual Versus Predicted Blood Loss as Assessed by the Operating Surgeon | Day 0 (at completion of surgery) | For predicted blood loss the number of participants analyzed is 14 as for one participant (included in the major surgery reporting group) the predicted blood loss was not collected. The full analysis data set, including all participants who received investigational product and have at least 1 hemostatic assessment, was used for analysis. | mL | MEAN |
| SECONDARY | Intraoperative Actual Blood Loss Relative to Predicted Blood Loss | Day 0 (at completion of surgery) | Number of participants analyzed is 11, as for 3 participants the actual and the predicted blood loss was zero and for 1 participant the predicted blood loss was not collected. Therefore 'actual blood loss relative to predicted blood loss' could not be calculated. The full analysis data set was used for the analysis of this outcome measure. | Percent | MEAN |
| SECONDARY | Intraoperative Actual Versus Predicted Blood Loss Score as Assessed by the Operating Surgeon | Day 0 (at completion of surgery) | Number of participants with major, minor and oral surgery and number of participant with Von Willebrand Type 1, 2A, 2B, 2M and 3 do sum up to the overall number of participants analyzed. The full analysis data set, including all participants who received investigational product and have at least 1 hemostatic assessment, was used for analysis. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Intraoperative Hemostatic Efficacy Score as Assessed by the Operating Surgeon | Day 0 (at completion of surgery) | Number of participants with major, minor and oral surgery and number of participant with Von Willebrand Type 1, 2A, 2B, 2M and 3 do sum up to the overall number of participants analyzed. The full analysis data set, including all participants who received investigational product and have at least 1 hemostatic assessment, was used for analysis. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Daily Intra- and Postoperative Weight-adjusted Dose of rVWF With or Without ADVATE | Daily, from day of surgery through postoperative Day 14 (± 2 days) | Number of participants analyzed is different for the time points according to individual treatment. The full analysis data set, including all participants who received investigational product and have at least 1 hemostatic assessment, was used for analysis. | IU/kg | MEDIAN |
| SECONDARY | Occurrence of Adverse Events | From first infusion of investigational product through study completion (ie, 14 (± 2) days post surgery) | The safety analysis data set, including all participants who received any amount of investigational product, was used for analysis of this outcome measure. | Adverse Events | NUMBER |
| SECONDARY | Occurrence of Thrombotic Events | From first infusion of investigational product through study completion (ie, 14 (± 2) days post surgery) | The safety analysis data set, including all participants who received any amount of investigational product, was used for analysis of this outcome measure. | Adverse Events | NUMBER |
| SECONDARY | Occurrence of Severe Allergic Reactions (eg, Anaphylaxis) | From first infusion of investigational product through study completion (ie, 14 (± 2) days post surgery) | The safety analysis data set, including all participants who received any amount of investigational product, was used for analysis of this outcome measure. | Adverse Events | NUMBER |
| SECONDARY | Number of Participants Who Developed Inhibitory and Total Binding Antibodies to Von Willebrand Factor (VWF) and Inhibitory Antibodies to Factor VIII (FVIII) | Testing occurred throughout the study at screening, prior PK infusion, pre-surgery, post surgery in case of excessive bleeding or unexplained bleeding, at postoperative day 7 and at study completion visit (ie. 14 (± 2) days post surgery). | The safety analysis data set, including all participants who received any amount of investigational product, was used for analysis of this outcome measure. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 outcomesResults by group204
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Hemostatic Efficacy as Assessed by the Investigator (Hemophilia Physician) | Recombinant Von Willebrand Factor (rVWF) | Excellent | 11 | Participants | |
| Overall Hemostatic Efficacy as Assessed by the Investigator (Hemophilia Physician) | Minor Surgery | Excellent | 4 | Participants | |
| Overall Hemostatic Efficacy as Assessed by the Investigator (Hemophilia Physician) | Major Surgery | Excellent | 7 | Participants | |
| Overall Hemostatic Efficacy as Assessed by the Investigator (Hemophilia Physician) | Oral Surgery | Excellent | 0 | Participants | |
| Overall Hemostatic Efficacy as Assessed by the Investigator (Hemophilia Physician) | Von Willebrand Disease Type 1 | Excellent | 2 | Participants | |
| Overall Hemostatic Efficacy as Assessed by the Investigator (Hemophilia Physician) | Von Willebrand Disease Type 2A | Excellent | 1 | Participants | |
| Overall Hemostatic Efficacy as Assessed by the Investigator (Hemophilia Physician) | Von Willebrand Disease Type 2B | Excellent | 1 | Participants | |
| Overall Hemostatic Efficacy as Assessed by the Investigator (Hemophilia Physician) | Von Willebrand Disease Type 2M | Excellent | 0 | Participants | |
| Overall Hemostatic Efficacy as Assessed by the Investigator (Hemophilia Physician) | Von Willebrand Disease Type 3 | Excellent | 7 | Participants | |
| Overall Hemostatic Efficacy as Assessed by the Investigator (Hemophilia Physician) | Recombinant Von Willebrand Factor (rVWF) | Good | 4 | Participants |
1 to 10 of 204Source ClinicalTrials.gov
See all 204 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Recombinant Von Willebrand Factor (rVWF) | 15 | |
| Overall Study | COMPLETED | Recombinant Von Willebrand Factor (rVWF) | 14 | |
| Overall Study | NOT COMPLETED | Recombinant Von Willebrand Factor (rVWF) | 1 |
Source ClinicalTrials.gov
Adverse events12
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 | Acne | Skin and subcutaneous tissue disorders | Recombinant Von Willebrand Factor (rVWF) | 1 | 15 | 1 |
| other | Dry skin | Skin and subcutaneous tissue disorders | Recombinant Von Willebrand Factor (rVWF) | 1 | 15 | 1 |
| other | Iron deficiency anaemia | Blood and lymphatic system disorders | Recombinant Von Willebrand Factor (rVWF) | 1 | 15 | 1 |
| other | Peripheral swelling | General disorders | Recombinant Von Willebrand Factor (rVWF) | 1 | 15 | 1 |
| other | Nasopharyngitis | Infections and infestations | Recombinant Von Willebrand Factor (rVWF) | 1 | 15 | 1 |
| other | Joint swelling | Musculoskeletal and connective tissue disorders | Recombinant Von Willebrand Factor (rVWF) | 1 | 15 | 1 |
| other | Dizziness | Nervous system disorders | Recombinant Von Willebrand Factor (rVWF) | 1 | 15 | 1 |
| other | Headache | Nervous system disorders | Recombinant Von Willebrand Factor (rVWF) | 1 | 15 | 1 |
| other | Pelvic pain | Reproductive system and breast disorders | Recombinant Von Willebrand Factor (rVWF) | 1 | 15 | 1 |
| other | Deep vein thrombosis | Vascular disorders | Recombinant Von Willebrand Factor (rVWF) | 1 | 15 | 1 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Recombinant Von Willebrand Factor (rVWF) | 0 | 15 |
| Total, other adverse events | Recombinant Von Willebrand Factor (rVWF) | 6 | 15 |
| Total, serious adverse events | Recombinant Von Willebrand Factor (rVWF) | 2 | 15 |
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.
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