Trial record 7 of 8 for:
Open Studies | "von Willebrand Diseases"
Wilate in Subjects With Von Willebrand Disease Who Undergo Surgery (WONDERS)
This study is currently recruiting participants.
Verified February 2013 by Octapharma
Sponsor:
Octapharma
Information provided by (Responsible Party):
Octapharma
ClinicalTrials.gov Identifier:
NCT01365546
First received: May 27, 2011
Last updated: February 22, 2013
Last verified: February 2013
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Purpose
Proportion of surgeries in which the primary endpoint (overall assessment) is classified as success.
| Condition | Intervention | Phase |
|---|---|---|
|
Prevent Bleeding in Major Surgery |
Biological: human VWF/FVIII concentrate |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Prospective, Open-Label, Multi-Center, Phase III CLinical Study to Investigate the Efficacy and Safety of Human Factor VWF/FVIII Concentrate (Wilate) in Subjects With Inherited Von Willebrand Disease Who Undergo Surgical Procedures |
Resource links provided by NLM:
Further study details as provided by Octapharma:
Primary Outcome Measures:
- 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. [ Time Frame: 30 Days ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Assessment of intra-operative hemostatic efficacy [ Time Frame: 30 Days ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 41 |
| Study Start Date: | June 2011 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: human VWF/FVIII concentrate |
Biological: human VWF/FVIII concentrate
intravenous infusion. Dose based on subject's individual invivo-recovery
|
Eligibility| Ages Eligible for Study: | 6 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01365546
Contacts
| Contact: Sylvia Werner, MS | sylvia.werner@octapharma.com |
Locations
| United States, District of Columbia | |
| Georgetown University | Recruiting |
| Washington, District of Columbia, United States, 20057 | |
| United States, Michigan | |
| Henry Ford Health System | Recruiting |
| Detroit, Michigan, United States, 48202 | |
| United States, New York | |
| Mary M Gooley Hemophilia Center | Recruiting |
| Rochester, New York, United States, 14621 | |
| United States, Texas | |
| Gulph States Hemophilia and Thrombophilia Center | Recruiting |
| Houston, Texas, United States, 77030 | |
| India | |
| Christian Medical College | Recruiting |
| Vellore, Tamil Nadu, India, 632004 | |
| Sahyadri Specialty Hospital | Recruiting |
| Pune, India, 411004 | |
| Italy | |
| Granda Ospedale Maggiore Policlinico | Recruiting |
| Milano, Italy, 20122 | |
| ULSS6 Vicenza Ematologia | Recruiting |
| Vicenza, Italy, 36100 | |
| Poland | |
| Uniweryteckie Centrum Kliniczne | Recruiting |
| Gdansk, Poland, 80-952 | |
| South Africa | |
| Hemophilia Comprehensive Care Center | Recruiting |
| Johannesburg, South Africa, 2193 | |
Sponsors and Collaborators
Octapharma
More Information
No publications provided
| Responsible Party: | Octapharma |
| ClinicalTrials.gov Identifier: | NCT01365546 History of Changes |
| Other Study ID Numbers: | Wil-24 |
| Study First Received: | May 27, 2011 |
| Last Updated: | February 22, 2013 |
| Health Authority: | United States: Food and Drug Administration India: DCGI South Africa: MCC Italy: MoH Poland: MoH |
Additional relevant MeSH terms:
|
Hemorrhage Von Willebrand Diseases Pathologic Processes Blood Coagulation Disorders, Inherited Blood Coagulation Disorders |
Hematologic Diseases Coagulation Protein Disorders Blood Platelet Disorders Hemorrhagic Disorders Genetic Diseases, Inborn |
ClinicalTrials.gov processed this record on May 22, 2013