Ignite Creation Date:
2024-05-06 @ 3:10 AM
Last Modification Date:
2024-10-26 @ 11:29 AM
Study NCT ID:
NCT02222714
Status:
COMPLETED
Last Update Posted:
2018-11-08
First Post:
2014-08-18
Brief Title:
Safety Evaluation of 3K3A-APC in Ischemic Stroke
Sponsor:
ZZ Biotech LLC
Organization:
ZZ Biotech LLC
Study Overview
Official Title:
A Multi-center Phase 2 Study Using a Continual Reassessment Method to Determine the Safety and Tolerability of 3K3A-APC in Combination With tPA Mechanical Thrombectomy or Both in Moderate to Severe Acute Ischemic Stroke
Status:
COMPLETED
Status Verified Date:
2018-10
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:
RHAPSODY
Brief Summary:
The purpose of this study was to evaluate the safety pharmacokinetics PK and preliminary efficacy of multiple ascending intravenous doses of 3K3A-APC a Recombinant Variant of Human activated protein C APC in in the treatment of acute ischemic stroke following treatment with recombinant tissue plasminogen activator tPA mechanical thrombectomy or both
Detailed Description:
This was a multicenter prospective randomized controlled double-blinded Phase 2 study intended to evaluate the safety PK and preliminary efficacy of 3K3A-APC following treatment with tPA mechanical thrombectomy or both in subjects with moderate to severe acute ischemic stroke
Approximately 115 subjects were to be randomized which included the planned 88 subjects in groups of 4 subjects to either 3K3A-APC or placebo in a 31 ratio and the additional placebo subjects who were enrolled during safety review pauses This study used a modified version of the continual reassessment method CRM in order to establish a maximum tolerated dose MTD
Eligible subjects received 3K3A-APC or placebo every 12 hours for up to 5 doses approximately 3 days or until discharge from the hospital whichever occurred first Subjects were monitored for safety evaluations through Day 7 or discharge if earlier and were expected to be seen on Day 7 14 30 and 90 for safety and outcome evaluations
Approximately 115 subjects were to be randomized which included the planned 88 subjects in groups of 4 subjects to either 3K3A-APC or placebo in a 31 ratio and the additional placebo subjects who were enrolled during safety review pauses This study used a modified version of the continual reassessment method CRM in order to establish a maximum tolerated dose MTD
Eligible subjects received 3K3A-APC or placebo every 12 hours for up to 5 doses approximately 3 days or until discharge from the hospital whichever occurred first Subjects were monitored for safety evaluations through Day 7 or discharge if earlier and were expected to be seen on Day 7 14 30 and 90 for safety and outcome evaluations
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 |
|---|---|---|---|
| U01NS077179-01 | NIH | None | httpsreporternihgovquickSearchU01NS077179-01 |
| 1U01NS088312-01 | NIH | None | None |
| U01NS077352 | NIH | None | None |