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Proportion of surgeries in which the primary endpoint (overall assessment) is classified as success.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| human VWF/FVIII concentrate | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| human VWF/FVIII concentrate | Biological | intravenous infusion. Dose based on subject's individual invivo-recovery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Hemostatic Efficacy (Success or Failure) of Wilate, Based on the Intra-operative Assessment of the Surgeon and the Post-operative Assessment by the Investigator Using a 4-point Ordinal Efficacy Scale. | Efficacy of Wilate in surgical procedures was assessed intra-operatively by the surgeon and post-operatively by the investigator. The IDMC additionally conducted an independent adjudication of all hemostatic efficacy results ('secondary adjudication') and adjudicated the surgeons'/investigators' assessments of the intra- and post-operative assessments where there were discrepancies between the two assessments ('primary adjudication'). It was specified in the SAP that the study will be terminated early and success claimed if the two-sided 98.75% confidence interval (CI) for the overall success rate excludes and is greater than 0.60 (equivalent to 25 or more successes out of the 30 procedures). | 30 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of Intra-operative Hemostatic Efficacy | The efficacy of Wilate during surgical procedures was assessed by a 4-point ordinal efficacy scale by the surgeon at the end of the surgical procedure and took the predicted versus actual blood loss and transfusion requirements into consideration. Outcome measure 1 takes the results of outcome measure 2 and 3 into consideration and is an overall assessment covering intra- and post-operative efficacy. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana Hemophilia and Thrombosis Center | Indianapolis | Indiana | 46260 | United States | ||
| UNC-CH Comprehensive Hemophilia Center |
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| ID | Title | Description |
|---|---|---|
| FG000 | Human VWF/FVIII Concentrate | human VWF/FVIII concentrate: intravenous infusion. Dose based on subject's individual invivo-recovery |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Human VWF/FVIII Concentrate | human VWF/FVIII concentrate: intravenous infusion. Dose based on subject's individual invivo-recovery |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Overall Hemostatic Efficacy (Success or Failure) of Wilate, Based on the Intra-operative Assessment of the Surgeon and the Post-operative Assessment by the Investigator Using a 4-point Ordinal Efficacy Scale. | Efficacy of Wilate in surgical procedures was assessed intra-operatively by the surgeon and post-operatively by the investigator. The IDMC additionally conducted an independent adjudication of all hemostatic efficacy results ('secondary adjudication') and adjudicated the surgeons'/investigators' assessments of the intra- and post-operative assessments where there were discrepancies between the two assessments ('primary adjudication'). It was specified in the SAP that the study will be terminated early and success claimed if the two-sided 98.75% confidence interval (CI) for the overall success rate excludes and is greater than 0.60 (equivalent to 25 or more successes out of the 30 procedures). | Posted | Number | 95% Confidence Interval | participants | 30 Days |
|
Adverse events were collected for each patient over a period of 1 to approximately 6 month from signing the informed consent to study completion.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Human VWF/FVIII Concentrate | human VWF/FVIII concentrate: intravenous infusion. Dose based on subject's individual invivo-recovery |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vaginal Hemorrhage | Reproductive system and breast disorders | MedDRA (12.0) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Procedural Pain | Injury, poisoning and procedural complications | MedDRA (12.0) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Operations | Octapharma | 4152609577 | sylvia.werner@octapharma.com |
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| 1 Day |
| Post-operative Efficacy Assessment | Post-operative efficacy was assessed by the investigator, covering the time period from the end of the procedure up to 24 hours following the last infusion of study medication. This assessment took the post-operative bleeding and oozing into consideration | up to 30 days |
| Chapel Hill |
| North Carolina |
| 27599 |
| United States |
| Blood Center of Wisconsin | Milwaukee | Wisconsin | 53201 | United States |
| SHAT Joan Pavel | Sofia | 1233 | Bulgaria |
| Sahyadri Specialty Hospital | Pune | Pune | 411004 | India |
| Christian Medical College | Vellore | Tamil Nadu | 632004 | India |
| Azienda Ospedaliero Universitaria Careggi | Florence | 50133 | Italy |
| Granda Ospedale Maggiore Policlinico | Milan | 20122 | Italy |
| ULSS6 Vicenza Ematologia | Vicenza | 36100 | Italy |
| Sultan Quaboos University Hospital | Muscat | PC123 | Oman |
| Instytut Hematologii i Transfuzjologii | Warsaw | 0.-776 | Poland |
| Fundeni Clinical Institute | Bucharest | 022328 | Romania |
| Louis Turcanu Childrens Emergency Hospital | Timișoara | 300011 | Romania |
| Hemophilia Comprehensive Care Center | Johannesburg | 2193 | South Africa |
| Ege University | Izmir | 35100 | Turkey (Türkiye) |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
human VWF/FVIII concentrate: intravenous infusion. Dose based on subject's individual invivo-recovery
| OG001 | Major Surgery |
| OG002 | All Surgeries |
|
|
| Secondary | Assessment of Intra-operative Hemostatic Efficacy | The efficacy of Wilate during surgical procedures was assessed by a 4-point ordinal efficacy scale by the surgeon at the end of the surgical procedure and took the predicted versus actual blood loss and transfusion requirements into consideration. Outcome measure 1 takes the results of outcome measure 2 and 3 into consideration and is an overall assessment covering intra- and post-operative efficacy. | Posted | Number | participants | 1 Day |
|
|
|
| Secondary | Post-operative Efficacy Assessment | Post-operative efficacy was assessed by the investigator, covering the time period from the end of the procedure up to 24 hours following the last infusion of study medication. This assessment took the post-operative bleeding and oozing into consideration | Posted | Number | participants | up to 30 days |
|
|
|
| 2 |
| 41 |
| 29 |
| 41 |
| Gastritis erosive | Gastrointestinal disorders | MedDRA (14.0) | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (14.0) | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Pain | General disorders | MedDRA (14.0) | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (14.0) | Non-systematic Assessment |
|
| Hemoglobin decreased | Investigations | MedDRA (14.0) | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA (14.0) | Non-systematic Assessment |
|
Octapharma agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Octapharma supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial. Octapharma also reserves the right to review data prior to publishing and provide comments/changes within a certain time period.