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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01365546
Other study ID # Wil-24
Secondary ID
Status Completed
Phase Phase 3
First received May 27, 2011
Last updated March 5, 2015
Start date June 2011
Est. completion date April 2014

Study information

Verified date March 2015
Source Octapharma
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug AdministrationIndia: Drugs Controller General of IndiaSouth Africa: Medicines Control CouncilItaly: National Monitoring Centre for Clinical Trials - Ministry of HealthPoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsRomania: Ministry of Public HealthTurkey: Ministry of HealthBulgaria: Ministry of Health
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date April 2014
Est. primary completion date February 2014
Accepts healthy volunteers No
Gender Both
Age group 6 Years and older
Eligibility 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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Biological:
human VWF/FVIII concentrate
intravenous infusion. Dose based on subject's individual invivo-recovery

Locations

Country Name City State
Bulgaria SHAT Joan Pavel Sofia
India Sahyadri Specialty Hospital Pune
India Christian Medical College Vellore Tamil Nadu
Italy Azienda Ospedaliero Universitaria Careggi Florence
Italy Granda Ospedale Maggiore Policlinico Milano
Italy ULSS6 Vicenza Ematologia Vicenza
Oman Sultan Quaboos University Hospital Muscat
Poland Instytut Hematologii i Transfuzjologii Warsaw
Romania Fundeni Clinical Institute Bucharest
Romania Louis Turcanu Childrens Emergency Hospital Timisoara
South Africa Hemophilia Comprehensive Care Center Johannesburg
Turkey Ege University Izmir
United States UNC-CH Comprehensive Hemophilia Center Chapel Hill North Carolina
United States Indiana Hemophilia and Thrombosis Center Indianapolis Indiana
United States Blood Center of Wisconsin Milwaukee Wisconsin

Sponsors (1)

Lead Sponsor Collaborator
Octapharma

Countries where clinical trial is conducted

United States,  Bulgaria,  India,  Italy,  Oman,  Poland,  Romania,  South Africa,  Turkey, 

Outcome

Type Measure Description Time frame Safety issue
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). 30 Days No
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. 1 Day No
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 up to 30 days No