Ignite Creation Date:
2024-05-06 @ 7:58 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06205095
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-08
First Post:
2023-12-18
Brief Title:
A Pilot Crossover Trial of Prophylactic Wilate Compared to Placebo for Heavy Menstrual Bleeding in Patients With VWD
Sponsor:
Unity Health Toronto
Organization:
Unity Health Toronto
Study Overview
Official Title:
A Multi-cEnter Pilot Crossover Trial of Prophylactic Wilate coMpared to PlacebO for Heavy Menstrual Bleeding in Patients With Von WillEbRand Disease
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EMPOWER
Brief Summary:
The EMPOWER trial is a pilot multi-center placebo-controlled normal saline double-blind patient and outcome assessor crossover 2-year randomized trial in female outpatients with von Willebrand disease VWD and heavy menstrual bleeding to determine trial feasibility and viability and to explore assay sensitivity of the proposed efficacy clinical outcomes for a definitive randomized controlled trial
Detailed Description:
The EMPOWER trial is a pilot multi-center placebo-controlled normal saline double-blind patient and outcome assessor crossover 2-year randomized trial in female outpatients with von Willebrand disease VWD and heavy menstrual bleeding to determine trial feasibility and viability and explore assay sensitivity of the proposed efficacy clinical outcomes for a definitive randomized controlled trial
For the first treatment period patients will be randomized to receive either plasma derived von Willebrand factorFactor VIII pdVWFFVIII concentrate plus standard of care or placebo plus standard of care for VWD-associated heavy menstrual bleeding for 4 cycles crossing over to the comparator treatment during the second treatment period The first treatment period will be followed by a 1 cycle washout period when no study-based treatment will be delivered
The main purpose of the pilot will be to evaluate viability and feasibility of the trial design as well as to explore assay sensitivity to inform determination of the primary efficacy outcome for the definitive randomized trial which will evaluate the effect of prophylaxis with pdVWFFVIII concentrate compared with placebo on HMB in women with VWD A secondary objective is to conduct a preliminary assessment of the effect on clinical outcomes of 2-3 doses of prophylaxis with pdVWFFVIII concentrate when provided on the first 4 days of menstruation compared with placebo
For the first treatment period patients will be randomized to receive either plasma derived von Willebrand factorFactor VIII pdVWFFVIII concentrate plus standard of care or placebo plus standard of care for VWD-associated heavy menstrual bleeding for 4 cycles crossing over to the comparator treatment during the second treatment period The first treatment period will be followed by a 1 cycle washout period when no study-based treatment will be delivered
The main purpose of the pilot will be to evaluate viability and feasibility of the trial design as well as to explore assay sensitivity to inform determination of the primary efficacy outcome for the definitive randomized trial which will evaluate the effect of prophylaxis with pdVWFFVIII concentrate compared with placebo on HMB in women with VWD A secondary objective is to conduct a preliminary assessment of the effect on clinical outcomes of 2-3 doses of prophylaxis with pdVWFFVIII concentrate when provided on the first 4 days of menstruation compared with placebo
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None