Ignite Creation Date:
2024-05-06 @ 5:56 PM
Last Modification Date:
2024-10-26 @ 2:38 PM
Study NCT ID:
NCT05484154
Status:
WITHDRAWN
Last Update Posted:
2023-07-12
First Post:
2022-07-29
Brief Title:
Efficacy and Safety Evaluation of 3K3A-APC in Ischemic Stroke
Sponsor:
ZZ Biotech LLC
Organization:
ZZ Biotech LLC
Study Overview
Official Title:
A Phase 3 Study to Evaluate the Efficacy and Safety of 3K3A-APC in Combination with Tissue Plasminogen Activator Mechanical Thrombectomy or Both in Subjects with Moderate to Severe Acute Ischemic Stroke
Status:
WITHDRAWN
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
NIH funding suspension
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RHAPSODY-2
Brief Summary:
The purpose of this study is to evaluate the efficacy and safety of intravenous doses of 3K3A-APC a recombinant variant of human activated protein C APC in the treatment of acute ischemic stroke following treatment with thrombolysis mechanical thrombectomy or both
Detailed Description:
This multicenter randomized placebo-controlled double-blind Phase 3 study is being performed in coordination with StrokeNet to evaluate efficacy and safety of 3K3A-APC following administration of thrombolysis mechanical thrombectomy or both in subjects with moderate to severe acute ischemic stroke
The study will be conducted in two phases During a lead-in dose-finding phase a maximum of 360 subjects will be randomized to 3K3A-APC or placebo using a Bayesian adaptive approach Randomized subjects will receive 3K3A-APC or placebo every 12 hours for up to 5 doses approximately 3 days or until discharge from the hospital whichever occurs first The lead-in phase will transition to one selected 3K3A APC dose-and recruitment will continue-when a single dose proves superior to all other doses and safe
The definitive phase will continue with the selected dose of 3K3A-APC from the lead-in phase Randomization will be stratified on 4 variables Lead-in patients who received the dose selected for the definitive phase will be included in the final data analysis
The study will be conducted in two phases During a lead-in dose-finding phase a maximum of 360 subjects will be randomized to 3K3A-APC or placebo using a Bayesian adaptive approach Randomized subjects will receive 3K3A-APC or placebo every 12 hours for up to 5 doses approximately 3 days or until discharge from the hospital whichever occurs first The lead-in phase will transition to one selected 3K3A APC dose-and recruitment will continue-when a single dose proves superior to all other doses and safe
The definitive phase will continue with the selected dose of 3K3A-APC from the lead-in phase Randomization will be stratified on 4 variables Lead-in patients who received the dose selected for the definitive phase will be included in the final data analysis
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| UG3NS119199 | NIH | None | httpsreporternihgovquickSearchUG3NS119199 |