Ignite Creation Date:
2024-05-06 @ 7:33 PM
Last Modification Date:
2024-10-26 @ 3:09 PM
Study NCT ID:
NCT06056297
Status:
RECRUITING
Last Update Posted:
2024-07-03
First Post:
2023-09-20
Brief Title:
A Study of Mavorixafor in Participants With Congenital and Acquired Primary Autoimmune and Idiopathic Chronic Neutropenic Disorders Who Are Experiencing Recurrent andor Serious Infections
Sponsor:
X4 Pharmaceuticals
Organization:
X4 Pharmaceuticals
Study Overview
Official Title:
A Phase 3 Randomized Double-blind Placebo-controlled Multicenter Study of Mavorixafor in Participants With Congenital and Acquired Primary Autoimmune and Idiopathic Chronic Neutropenic Disorders Who Are Experiencing Recurrent andor Serious Infections
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:
None
Brief Summary:
The purpose of this study is to demonstrate the efficacy and evaluate the safety and tolerability of mavorixafor in participants with congenital or acquired primary autoimmune and idiopathic chronic neutropenic disorders who are experiencing recurrent andor serious infections as assessed by demonstrating its clinical benefit and increasing levels of circulating neutrophils
Detailed Description:
All participants will continue their pre-study background therapy defined as the participants current treatment regimen Options include but are not limited to granulocyte-colony stimulating factor G-CSF immunoglobulin replacement therapy prophylactic antibiotics or watchful waiting
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