Trial · NCT02932618
A Study of Recombinant Von Willebrand Factor (rVWF) With or Without ADVATE in Children With Severe Von Willebrand Disease (VWD)
NCT02932618, Phase 3, Completed, Baxalta now part of Shire
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study of Recombinant Von Willebrand Factor (rVWF) With or Without ADVATE in Children With Severe Von Willebrand Disease (VWD). Trials, record NCT02932618. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02932618
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Recombinant Von Willebrand Factor (rVWF) With or Without ADVATE in Children With Severe Von Willebrand Disease (VWD)
- NCT number
- NCT02932618
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 47 participants, actual
- Lead sponsor
- Baxalta now part of Shire
- Conditions
- Von Willebrand Disease
- Interventions
- Vonicog alfa, Antihemophilic Factor (Recombinant)
- First posted
- 2016-10-13
- Last updated
- 2026-05-15
- Other registries' IDs
- eudract:2016-001477-33
Source ClinicalTrials.gov
Registered outcomes26
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Hemostatic Efficacy | Within 24 hours after the last infusion of study drug following the onset of the bleeding episode (if/when the severity and/or duration of the bleeding requires the infusion of the study drug) | Treatment success for vonicog alfa-treated nonsurgical bleeding episodes (using a 4-point scale: Excellent, Good, Moderate, None). |
| Secondary | Number of Treated Nonsurgical Bleeding Episodes With an Efficacy Rating of 'Excellent' or 'Good' | Throughout the study duration of approximately 8.5 years | If/when the severity and/or duration of the bleeding requires the infusion of the study drug. |
| Secondary | Number of Infusions per Bleeding Episode | Throughout the study duration of approximately 8.5 years | |
| Secondary | Number of Vonicog Alfa Units per Bleeding Episode | Throughout the study duration of approximately 8.5 years | |
| Secondary | Number of ADVATE Units (if needed) per Bleeding Episode | Throughout the study duration of approximately 8.5 years | |
| Secondary | Elective or Emergency Surgery: Assessment of Hemostatic Efficacy - Immediately After Surgery | Immediately after surgery | Assessed by the operating surgeon, based on a 4-point ordinal scale: Excellent, Good, Moderate, None. |
| Secondary | Elective or Emergency Surgery: Overall Assessment of Hemostatic Efficacy 24 Hours After the Last Perioperative Infusion of rVWF | 24 hours after last perioperative rVWF infusion | Assessed by the Investigator (hematologist) on a 4-point ordinal scale: Excellent, Good, Moderate, None. |
| Secondary | Elective or Emergency surgery: Overall Assessment of Hemostatic Efficacy Day 7 Post-operative | Post-operative Day 7 | Assessed by the Investigator (hematologist) on a 4-point ordinal scale: Excellent, Good, Moderate, None. |
| Secondary | Elective or Emergency surgery: Overall Assessment of Hemostatic Efficacy Day 14 Post-operative | Post-operative Day 14 | Assessed by the Investigator (hematologist) on a 4-point ordinal scale: Excellent, Good, Moderate, None. |
| Secondary | Incidence and Severity of Adverse Events (AEs) | Throughout the study period of approximately 8.5 years |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
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 totals0
The totals the trial posted for each group.
None in this release.
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/NCT02932618
GET https://conductscience.org/api/trials/v1/NCT02932618/registered?page=2