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
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | May 27, 2011 | ||||
| Last Updated Date | February 22, 2013 | ||||
| Start Date ICMJE | June 2011 | ||||
| Estimated Primary Completion Date | December 2013 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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 ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01365546 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Assessment of intra-operative hemostatic efficacy [ Time Frame: 30 Days ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Wilate in Subjects With Von Willebrand Disease Who Undergo Surgery | ||||
| Official Title ICMJE | 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 | ||||
| Brief Summary | Proportion of surgeries in which the primary endpoint (overall assessment) is classified as success. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 3 | ||||
| Study Design ICMJE | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention |
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| Condition ICMJE | Prevent Bleeding in Major Surgery | ||||
| Intervention ICMJE | Biological: human VWF/FVIII concentrate
intravenous infusion. Dose based on subject's individual invivo-recovery |
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| Study Arm (s) | Experimental: human VWF/FVIII concentrate
Intervention: Biological: human VWF/FVIII concentrate |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 41 | ||||
| Estimated Completion Date | December 2013 | ||||
| Estimated Primary Completion Date | December 2013 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 6 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States, India, Italy, Poland, South Africa | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01365546 | ||||
| Other Study ID Numbers ICMJE | Wil-24 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Octapharma | ||||
| Study Sponsor ICMJE | Octapharma | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE | Not Provided | ||||
| Information Provided By | Octapharma | ||||
| Verification Date | February 2013 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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