Phase 3 N=41 Prevention

Wilate in Subjects With Von Willebrand Disease Who Undergo Surgery

Prevent Bleeding in Major Surgery

Bottom Line

View on ClinicalTrials.gov: NCT01365546 ↗

Enrolled (actual)

Serious AEs

4.9%

Results posted

Mar 2015

Primary outcome: 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. — 9; 20; 29 participants

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: human VWF/FVIII concentrate (Biological)
Age: Pediatric, Adult, Older Adult · 6+ yrs
Sex: All
Sponsor: Octapharma
Primary completion: Feb 2014

Outcome Measures

Outcome	Result	p-value
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.	9; 20; 29	—
SECONDARY Assessment of Intra-operative Hemostatic Efficacy	27	—
SECONDARY Post-operative Efficacy Assessment	27	—

Summary

Proportion of surgeries in which the primary endpoint (overall assessment) is classified as success.

Eligibility Criteria

Inclusion Criteria

Diagnosed with congenital VWD (von Willebrand Disease)
Require therapy with a VWF (von Willebrand Factor) product to treat any major surgical procedure

Exclusion Criteria

Known coagulation disorder other than VWD
Known history of, or suspected VWF or FVIII inhibitors
Subjects with hepatic liver disease
Known or suspected hypersensitivity or previous evidence of severe side effects to wilate or other VWF/FVIII concentrates
Pregnant women in the first 20 weeks of gestation

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01365546). 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.