Ignite Creation Date:
2024-05-06 @ 8:12 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06299111
Status:
RECRUITING
Last Update Posted:
2024-03-07
First Post:
2024-03-01
Brief Title:
A Trial to Learn How Well REGN9933 and REGN7508 Work for Preventing Blood Clots and How Safe They Are in Adults Who Have a Peripherally Inserted Central Catheter PICC
Sponsor:
Regeneron Pharmaceuticals
Organization:
Regeneron Pharmaceuticals
Study Overview
Official Title:
A Master Protocol for a Phase 2 Randomized Double-Blind Placebo-Controlled Study of REGN9933 and REGN7508 Monoclonal Antibodies Against Factor XI for Prevention of Venous Thromboembolism in Patients With a Peripherally Inserted Central Catheter ROXI-CATH
Status:
RECRUITING
Status Verified Date:
2024-09
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:
ROXI-CATH
Brief Summary:
This study is researching 2 different experimental drugs called REGN9933 and REGN7508 called study drugs The study is focused on adults undergoing a placement of a catheter in the vein also called a PICC line
The aim of the study is to see how effective the study drug is at preventing venous thromboembolism VTE and other related disease after catheter placement
The study is looking at several other research questions including
What side effects may happen from taking the study drug
How much study drug is in the blood at different times
Whether the body makes antibodies against the study drug which could make the study drug less effective or could lead to side effects
The aim of the study is to see how effective the study drug is at preventing venous thromboembolism VTE and other related disease after catheter placement
The study is looking at several other research questions including
What side effects may happen from taking the study drug
How much study drug is in the blood at different times
Whether the body makes antibodies against the study drug which could make the study drug less effective or could lead to side effects
Detailed Description:
None
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2023-508603-21-00 | OTHER | EU CT Number | None |