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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 and/or Serious Infections
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 and/or serious infections as assessed by demonstrating its clinical benefit and increasing levels of circulating neutrophils.
All participants will continue their pre-study background therapy, defined as the participant's current treatment regimen. Options include, but are not limited to, granulocyte-colony stimulating factor (G-CSF), immunoglobulin replacement therapy, prophylactic antibiotics, or "watchful waiting".
Age
12 - No limit years
Sex
ALL
Healthy Volunteers
No
Phoenix Children's Hospital
Phoenix, Arizona, United States
UC Irvine
Irvine, California, United States
Orso Health
La Jolla, California, United States
University of California, Los Angeles-UCLA
Los Angeles, California, United States
Orso Health
Torrance, California, United States
University of Southern Florida
St. Petersburg, Florida, United States
Children's Healthcare of Atlanta (CHOA)
Atlanta, Georgia, United States
University of Iowa
Iowa City, Iowa, United States
University of Michigan
Ann Arbor, Michigan, United States
Washington University
St Louis, Missouri, United States
Start Date
June 6, 2024
Primary Completion Date
September 1, 2027
Completion Date
November 1, 2027
Last Updated
March 2, 2026
176
ESTIMATED participants
Mavorixafor
DRUG
Placebo
DRUG
Lead Sponsor
X4 Pharmaceuticals
NCT06999954
NCT06788691
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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