Trial · NCT02460458
Type 3 Von Willebrand International Registries Inhibitor Prospective Study
NCT02460458, Completed, Fondazione Angelo Bianchi Bonomi; results first posted 2016-04-19
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Type 3 Von Willebrand International Registries Inhibitor Prospective Study. Trials, record NCT02460458. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02460458
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Type 3 Von Willebrand International Registries Inhibitor Prospective Study
- NCT number
- NCT02460458
- Status
- Completed
- Enrollment
- 265 participants, actual
- Lead sponsor
- Fondazione Angelo Bianchi Bonomi
- Conditions
- Type 3 Von Willebrand's Disease
- Interventions
- Von Willebrand Factor
- First posted
- 2015-06-02
- Last updated
- 2024-12-27
- Results first posted
- 2016-04-19
- Limitations and caveats
- Lack of data due to issues with samples. Some samples were not collected properly or properly stored, resulting impossible to be analyzed.
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Centralized Factor VIII (FVIII) Procoagulant Activity (FVIII:C) Laboratory Test for Type 3 Von Willebrand's Disease (VWD3) Diagnosis | 12 months (confirmatory phase) | Measurement of the Factor VIII (FVIII) Procoagulant Activity (FVIII:C) in the blood through one-stage clotting test. Only patients with FVIII:C less or equal to 5 IU/dL were considered for the analysis. |
| Primary | Centralized Von Willebrand Factor Antigen (VWF:Ag) Laboratory Test for Type 3 Von Willebrand's Disease (VWD3) Diagnosis | 12 months (confirmatory phase) | Measurement of the amount of Von Willebrand Factor (VWF) protein in the blood through Von Willebrand Factor Antigen (VWF:Ag) test. Only patients with VWF:Ag less or equal to 5 IU/dL were considered for the analysis. |
| Primary | Centralized Factor VIII (FVIII) Amidolytic Activity (FVIII:Am) Laboratory Test for Type 3 Von Willebrand's Disease (VWD3) Diagnosis | 12 months (confirmatory phase) | Measurement of Factor VIII (FVIII) Amidolytic Activity (FVIII:Am) in the blood through chromogenic test. Only patients with FVIII:Am less or equal to 5 IU/dL were considered for the analysis. |
| Primary | Centralized Factor VIII (FVIII) Antigen (FVIII:Ag) Laboratory Test for Type 3 Von Willebrand's Disease (VWD3) Diagnosis | 12 months (confirmatory phase) | Measurement of the amount of Factor VIII (FVIII) protein in the blood through FVIII:Ag test. Only patients with FVIII:Ag less or equal to 5 IU/dL were considered for the analysis. |
| Primary | Centralized Von Willebrand Factor (VWF) Multimer Analysis for Type 3 Von Willebrand's Disease (VWD3) Diagnosis | 12 months (confirmatory phase) | Multimer analysis of Von Willebrand Factor (VWF) was carried out by electrophoresis of blood samples collected by investigational sites. The number of patients belonging of each multimer profile group (1 - Homozygotes / 2 - Only Protomers / 3 - 2-4 Bands) was calculated. The qualitative evaluation of VWF multimers is part of the diagnostic process of VWD3. |
| Primary | Centralized Von Willebrand Factor (VWF) Propeptide Laboratory Test for Type 3 Von Willebrand's Disease (VWD3) Diagnosis | 12 months (confirmatory phase) | Measurement of Von Willebrand Factor (VWF) Propeptide levels in the blood through VWF Propeptide test. This test has been performed according to the most recent methods and the results are important to characterize the molecular aspects of VWD patients. |
| Primary | Centralized Molecular Type 3 Von Willebrand's Disease (VWD3) Diagnosis Through DNA Analysis | 12 months (confirmatory phase) | Evaluation of the presence of Von Willebrand Factor (VWF) gene defects (confirmation or screening for the first time). |
| Primary | Record of Bleeding Episodes | 24 months (first prospective phase) + 24 months (second prospective phase) | Record of all bleedings occurred during the prospective phase of the study. |
| Primary | Adverse Events | 24 months (first prospective phase) + 24 months (second prospective phase) | Record of all adverse events occurred during the prospective phase of the study. |
| Primary | Type of Von Willebrand Factor / Factor VIII (VWF/FVIII)-Containing Concentrates in Use | 24 months (first prospective phase) + 24 months (second prospective phase) | Record of any Von Willebrand Factor / Factor VIII (VWF/FVIII)-containing concentrates used and currently in use, including the current schedule type of treatment. |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Centralized Factor VIII (FVIII) Procoagulant Activity (FVIII:C) Laboratory Test for Type 3 Von Willebrand's Disease (VWD3) Diagnosis | 12 months (confirmatory phase) | Factor VIII (FVIII) Procoagulant Activity (FVIII:C) was centrally obtained from samples collected from investigational sites. | IU/dL | MEAN |
| PRIMARY | Centralized Von Willebrand Factor Antigen (VWF:Ag) Laboratory Test for Type 3 Von Willebrand's Disease (VWD3) Diagnosis | 12 months (confirmatory phase) | Von Willebrand Factor (VWF) protein blood levels were centrally obtained from samples collected from investigational sites. | IU/dL | MEAN |
| PRIMARY | Centralized Factor VIII (FVIII) Amidolytic Activity (FVIII:Am) Laboratory Test for Type 3 Von Willebrand's Disease (VWD3) Diagnosis | 12 months (confirmatory phase) | Factor VIII (FVIII) Amidolytic Activity (FVIII:Am) in the blood was centrally obtained from samples collected from investigational sites. | IU/dL | MEAN |
| PRIMARY | Centralized Factor VIII (FVIII) Antigen (FVIII:Ag) Laboratory Test for Type 3 Von Willebrand's Disease (VWD3) Diagnosis | 12 months (confirmatory phase) | Factor VIII (FVIII) protein blood levels were centrally obtained from samples collected from investigational sites. | IU/dL | MEAN |
| PRIMARY | Centralized Von Willebrand Factor (VWF) Multimer Analysis for Type 3 Von Willebrand's Disease (VWD3) Diagnosis | 12 months (confirmatory phase) | Von Willebrand Factor (VWF) multimer profiles of patients were centrally obtained from samples collected from investigational sites. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Centralized Von Willebrand Factor (VWF) Propeptide Laboratory Test for Type 3 Von Willebrand's Disease (VWD3) Diagnosis | 12 months (confirmatory phase) | Von Willebrand Factor (VWF) Propeptide blood levels were centrally obtained from samples collected from investigational sites. | IU/dL | MEAN |
| PRIMARY | Centralized Molecular Type 3 Von Willebrand's Disease (VWD3) Diagnosis Through DNA Analysis | 12 months (confirmatory phase) | Samples were not available for 34 patients out of 265 | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Record of Bleeding Episodes | 24 months (first prospective phase) + 24 months (second prospective phase) | Patients that have competed both prospective phases. | bleeding episodes | NUMBER |
| PRIMARY | Adverse Events | 24 months (first prospective phase) + 24 months (second prospective phase) | Patients that have competed both prospective phases. | AE | NUMBER |
| PRIMARY | Type of Von Willebrand Factor / Factor VIII (VWF/FVIII)-Containing Concentrates in Use | 24 months (first prospective phase) + 24 months (second prospective phase) | Patients that have competed both prospective phases. | participants | NUMBER |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 outcomesResults by group24
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Centralized Factor VIII (FVIII) Procoagulant Activity (FVIII:C) Laboratory Test for Type 3 Von Willebrand's Disease (VWD3) Diagnosis | Type 3 Von Willebrand's Disease (VWD3) | 2.42 | Standard Deviation 0.88 | IU/dL | |
| Centralized Von Willebrand Factor Antigen (VWF:Ag) Laboratory Test for Type 3 Von Willebrand's Disease (VWD3) Diagnosis | Type 3 Von Willebrand's Disease (VWD3) | 1.01 | Standard Deviation 1.03 | IU/dL | |
| Centralized Factor VIII (FVIII) Amidolytic Activity (FVIII:Am) Laboratory Test for Type 3 Von Willebrand's Disease (VWD3) Diagnosis | Type 3 Von Willebrand's Disease (VWD3) | 1.54 | Standard Deviation 0.91 | IU/dL | |
| Centralized Factor VIII (FVIII) Antigen (FVIII:Ag) Laboratory Test for Type 3 Von Willebrand's Disease (VWD3) Diagnosis | Type 3 Von Willebrand's Disease (VWD3) | 3.63 | Standard Deviation 0.83 | IU/dL | |
| Centralized Von Willebrand Factor (VWF) Multimer Analysis for Type 3 Von Willebrand's Disease (VWD3) Diagnosis | Type 3 Von Willebrand's Disease (VWD3) | Homozygotes | 174 | Participants | |
| Centralized Von Willebrand Factor (VWF) Multimer Analysis for Type 3 Von Willebrand's Disease (VWD3) Diagnosis | Type 3 Von Willebrand's Disease (VWD3) | Only Protomers | 15 | Participants | |
| Centralized Von Willebrand Factor (VWF) Multimer Analysis for Type 3 Von Willebrand's Disease (VWD3) Diagnosis | Type 3 Von Willebrand's Disease (VWD3) | 2 - 4 Bands | 54 | Participants | |
| Centralized Von Willebrand Factor (VWF) Propeptide Laboratory Test for Type 3 Von Willebrand's Disease (VWD3) Diagnosis | Type 3 Von Willebrand's Disease (VWD3) | 6.44 | Standard Deviation 13.98 | IU/dL | |
| Centralized Molecular Type 3 Von Willebrand's Disease (VWD3) Diagnosis Through DNA Analysis | Type 3 Von Willebrand's Disease (VWD3) | Analyzed participants with confirmed VWD3 diagnosis | 219 | Participants | |
| Centralized Molecular Type 3 Von Willebrand's Disease (VWD3) Diagnosis Through DNA Analysis | Type 3 Von Willebrand's Disease (VWD3) | Analyzed participants without confirmed VWD3 diagnosis | 12 | Participants |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Retrospective Phase | STARTED | Type 3 Von Willebrand's Disease (VWD3) | 265 | |
| Retrospective Phase | COMPLETED | Type 3 Von Willebrand's Disease (VWD3) | 265 | |
| Retrospective Phase | NOT COMPLETED | Type 3 Von Willebrand's Disease (VWD3) | 0 | |
| Confirmatory Phase | STARTED | Type 3 Von Willebrand's Disease (VWD3) | 265 | |
| Confirmatory Phase | COMPLETED | Type 3 Von Willebrand's Disease (VWD3) | 210 | |
| Confirmatory Phase | NOT COMPLETED | Type 3 Von Willebrand's Disease (VWD3) | 55 | |
| First Prospective Phase | STARTED | Type 3 Von Willebrand's Disease (VWD3) | 210 | |
| First Prospective Phase | COMPLETED | Type 3 Von Willebrand's Disease (VWD3) | 126 | |
| First Prospective Phase | NOT COMPLETED | Type 3 Von Willebrand's Disease (VWD3) | 84 | |
| Confirmation of Clinical Phase Data | STARTED | Type 3 Von Willebrand's Disease (VWD3) | 126 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events43
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 | Abdomen and flank pain | General disorders | Type 3 Von Willebrand's Disease (VWD3) | 1 | 265 | 1 |
| other | Abdominal pain | General disorders | Type 3 Von Willebrand's Disease (VWD3) | 4 | 265 | 4 |
| other | Diarrhea | Gastrointestinal disorders | Type 3 Von Willebrand's Disease (VWD3) | 1 | 265 | 1 |
| other | Common cold | Respiratory, thoracic and mediastinal disorders | Type 3 Von Willebrand's Disease (VWD3) | 10 | 265 | 23 |
| other | Allergy | Immune system disorders | Type 3 Von Willebrand's Disease (VWD3) | 1 | 265 | 4 |
| other | Rhinorrea | Respiratory, thoracic and mediastinal disorders | Type 3 Von Willebrand's Disease (VWD3) | 1 | 265 | 1 |
| other | Arthrosis in right ankle | Musculoskeletal and connective tissue disorders | Type 3 Von Willebrand's Disease (VWD3) | 1 | 265 | 1 |
| other | Ankle trauma | Musculoskeletal and connective tissue disorders | Type 3 Von Willebrand's Disease (VWD3) | 1 | 265 | 1 |
| other | B12 deficiency | Metabolism and nutrition disorders | Type 3 Von Willebrand's Disease (VWD3) | 1 | 265 | 1 |
| other | Bone pain | Musculoskeletal and connective tissue disorders | Type 3 Von Willebrand's Disease (VWD3) | 1 | 265 | 1 |
1 to 10 of 43Source ClinicalTrials.gov
See all 43 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Type 3 Von Willebrand's Disease (VWD3) | 0 | 265 |
| Total, other adverse events | Type 3 Von Willebrand's Disease (VWD3) | 28 | 265 |
| Total, serious adverse events | Type 3 Von Willebrand's Disease (VWD3) | 5 | 265 |
Source ClinicalTrials.gov
Papers118
The papers the trial lists on ClinicalTrials.gov.
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/NCT02460458
GET https://conductscience.org/api/trials/v1/NCT02460458/results?page=2