Ignite Creation Date:
2025-12-26 @ 10:36 AM
Ignite Modification Date:
2025-12-29 @ 2:15 PM
Study NCT ID:
NCT03245528
Status:
APPROVED_FOR_MARKETING
Last Update Posted:
2018-03-08
First Post:
2017-08-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Expanded Access for LJPC-501
Sponsor:
La Jolla Pharmaceutical Company
Organization:
Study Overview
Official Title:
Expanded Access for LJPC-501
Status:
APPROVED_FOR_MARKETING
Status Verified Date:
2018-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary objective of the study is to provide access to LJPC-501 for distributive shock patients who remain hypotensive despite receiving fluid and vasopressor therapy.
Detailed Description:
Primary Objective
The primary objective of the study is to provide access to LJPC-501 for distributive shock patients who remain hypotensive despite receiving fluid and vasopressor therapy.
Secondary Objective
The secondary objective of the study is to assess the safety of LJPC-501.
The primary objective of the study is to provide access to LJPC-501 for distributive shock patients who remain hypotensive despite receiving fluid and vasopressor therapy.
Secondary Objective
The secondary objective of the study is to assess the safety of LJPC-501.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: