Ignite Creation Date:
2024-05-06 @ 8:17 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06322394
Status:
RECRUITING
Last Update Posted:
2024-03-21
First Post:
2024-03-12
Brief Title:
BXOS110 Injection in the Treatment of Acute Ischaemic Stroke
Sponsor:
Biocells Beijing Biotech CoLtd
Organization:
Biocells Beijing Biotech CoLtd
Study Overview
Official Title:
A Multicentre Randomised Double-blind Placebo-parallel Controlled Phase II Clinical Trial Evaluating the Efficacy and Safety of BXOS110 Injection in the Treatment of Acute Ischaemic Stroke Within 3 Hours of Onset
Status:
RECRUITING
Status Verified Date:
2024-03
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:
None
Brief Summary:
The purpose of this study was to evaluate the effectiveness of early administration of BXOS110 for injection in reducing overall disability in patients with acute ischaemic stroke
Detailed Description:
This trial was conducted in a multicentre randomised double-blind placebo-parallel controlled design with a total of three groups of 100 subjects in each of the three planned groups namely the BXOS110 high-dose group 30 mgkg with a maximum dose of up to 300 mg the BXOS110 low-dose group 20 mgkg with a maximum dose of up to 200 mg and the placebo-control group with the aim of exploring the efficacy and safety of BXOS110 at different doses of BXOS110 efficacy and safety of BXOS110
The trial was divided into a screeningbaseline period a treatment period and a follow-up period In the screeningbaseline phase patients signed an informed consent form within 3 hours of stroke onset to enter the trial and after completing the screening and procedures related to the trial subjects who met the enrolment requirements were randomly assigned to the BXOS110 high-dose group the BXOS110 low-dose group or a placebo-controlled group in a ratio of 1 1 1 During the treatment phase subjects were randomly grouped into groups to start the intravenous treatment and evaluations were carried out immediately after the administration of BXOS110 immediately after administration during the Follow-up Period subjects were evaluated for effectiveness and safety on Day 2 Day 3 Day 10 or at discharge whichever occurred earlier Day 30 and Day 90 after administration
The trial was divided into a screeningbaseline period a treatment period and a follow-up period In the screeningbaseline phase patients signed an informed consent form within 3 hours of stroke onset to enter the trial and after completing the screening and procedures related to the trial subjects who met the enrolment requirements were randomly assigned to the BXOS110 high-dose group the BXOS110 low-dose group or a placebo-controlled group in a ratio of 1 1 1 During the treatment phase subjects were randomly grouped into groups to start the intravenous treatment and evaluations were carried out immediately after the administration of BXOS110 immediately after administration during the Follow-up Period subjects were evaluated for effectiveness and safety on Day 2 Day 3 Day 10 or at discharge whichever occurred earlier Day 30 and Day 90 after administration
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