Mavorixafor
DrugMavorixafor will be administered per schedule specified in the arm description.
Other names: X4P-001
NCT Number: NCT06056297
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.
Interested in participating?
Request Info12 year and older
All sexes
Interventional
Phase 3
Hospital El Cruce, Buenos Aires, Argentina
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".
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Key Inclusion Criteria:
AND for all potential participants:
Key Exclusion Criteria:
Note: Other protocol-defined inclusion and exclusion criteria may apply.
Mavorixafor will be administered per schedule specified in the arm description.
Other names: X4P-001
Placebo will be administered per schedule specified in the arm description.
Time frame: Up to 52 Weeks
Time frame: Up to 52 weeks
Positive ANC response: Increase of ANC >500 cells/microliter (µL) from baseline.
Time frame: Up to 52 Weeks
Time frame: Up to 52 Weeks
Time frame: Up to 52 Weeks
Time frame: Up to 52 Weeks
Time frame: Baseline, Week 52
Contact information is provided by the study sponsor or research team.
X4 Pharmaceuticals
Industry
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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