N/A
N=120
Surveillance of Safety and Efficacy of Wilate in Patients With Von Willebrand Disease
Von Willebrand Disease
Bottom Line
View on ClinicalTrials.gov: NCT01602419 ↗Enrolled (actual)
120
Serious AEs
0.0%
Results posted
Dec 2019
Primary outcome: Primary: Incidence of Adverse Drug Reactions (ADRs) (%) — 8; 1; 1; 3 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Patients using Wilate as standard of care (Other)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Octapharma
- Primary completion
- Apr 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Adverse Drug Reactions (ADRs) (%) |
8; 1; 1; 3; 2; 2 | — |
| PRIMARY Tolerability Assessment of Wilate Infusions by Reason for Administration |
5393; 654; 42; 127; 38; 97 | — |
| SECONDARY Patient and Investigator Efficacy Analysis Assessment of the Treatment of Bleeding Episodes (BEs) |
100; 94; 119; 69; 23; 14 | — |
| SECONDARY Efficacy Analysis for the Prevention of Breakthrough Bleeds During Prophylaxis |
15; 12; 1; 2; 0; 1 | — |
| SECONDARY Efficacy Analysis of Surgical Prophylaxis |
47; 40; 3; 6; 1; 0 | — |
| SECONDARY Overall Efficacy Assessment by Patient and Physician at the End of the Treatment Period |
67; 71; 10; 15; 1; 0 | — |
Summary
This is an observational study, hence there is no study hypothesis
Eligibility Criteria
Inclusion Criteria
- Patients with a diagnosis of von Willebrand Disease who have been prescribed Wilate
Data sourced from ClinicalTrials.gov (NCT01602419). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.