Ignite Creation Date:
2024-05-05 @ 5:19 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00434473
Status:
COMPLETED
Last Update Posted:
2014-03-04
First Post:
2007-02-09
Brief Title:
IMPACTS Trial Investigation of the Modulation of Phospholipase in Acute Chest Syndrome
Sponsor:
Anthera Pharmaceuticals
Organization:
Anthera Pharmaceuticals
Study Overview
Official Title:
IMPACTS Trial Investigation of the Modulation of Phospholipase in Acute Chest Syndrome Dose Escalation Study Varespladib Infusion A-001 for the Prevention of Acute Chest Syndrome in At-Risk Patients With Sickle Cell Disease and Vaso-occlusive Crisis
Status:
COMPLETED
Status Verified Date:
2014-01
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 study will be conducted at 15-20 US centers in a randomized placebo-controlled double-blind fashion Enrollees will be hospitalized sickle cell disease SCD patients at-risk for acute chest syndrome ACS based on the presence of vaso-occlusive crisis VOC fever T 380C and serum sPLA2 concentration 50 ngmL
Detailed Description:
This is a double-blind randomized parallel group placebo-controlled dose escalation study 2 cohorts in patients with sickle cell disease SCD and vaso-occlusive crisis VOC who are at-risk for development of acute chest syndrome ACS based on the combination of VOC fever T 380ºC and a serum sPLA2 concentration 50 ngmL
The first group of patients will be randomized 21 to receive low dose A-001 or placebo as a 48-hour continuous infusion Pharmacokinetic and clinical data from this group will undergo review by the Independent Data Monitoring Committee IDMC If there is no significant toxicity associated with A-001 then an additional group of patients will be enrolled and randomized 21 to high dose A-001 versus placebo as a 48-hour continuous infusion
The first group of patients will be randomized 21 to receive low dose A-001 or placebo as a 48-hour continuous infusion Pharmacokinetic and clinical data from this group will undergo review by the Independent Data Monitoring Committee IDMC If there is no significant toxicity associated with A-001 then an additional group of patients will be enrolled and randomized 21 to high dose A-001 versus placebo as a 48-hour continuous infusion
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None