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Studying the efficacy, safety, and tolerability of mavorixafor in participants with chronic neutropenia experiencing recurrent serious infections

G-CSF

The purpose of this study is to demonstrate how well the study treatment works and evaluate the safety, and how well you can tolerate any unwanted side effects caused by the study treatment, mavorixafor, in combination with any background therapy being received.

Mavorixafor, has been shown in other clinical studies to increase a patient’s white blood cells, including their neutrophils.  Increasing neutrophils in a participant's blood is expected to help their body fight infection. An increase in neutrophils in the blood may not cause any symptoms and can only be observed with blood tests. Mavorixafor, is an investigative drug that has not yet been approved by the regulatory authorities in Canada for the indication in this study.

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Conditions de participation

  • Sexe:

    Any

  • Âges admissibles:

    18 and up

Critères de participation

Inclusion Criteria:
Adults with a Diagnosis of congenital or acquired primary autoimmune and idiopathic chronic neutropenic disorder ≥ 6 months prior to the screening visit.
History of recurrent and/or serious infection in the past 12 months.
Can be on active background therapy including G-CSF.
Willing to use effective birth control methods. Can not currently be pregnant
Exclusion Criteria:
A diagnosis of neutropenia that is secondary to another disease.
An active COVID-19 infection
Active malignancy (except treated basal cell or squamous cell skin cancer, localized prostate cancer, carcinoma in situ of the cervix, or in situ ductal or lobular carcinoma of the breast)
Major surgery within the past 6 weeks
Received the study medication or one like it previously
Positive HIV, HCV or HBV with active viruses
Abnormal ECG and must have qualifying lab values (done at screening visit)
Currently taking another investigational drug. Unable or unwilling to swallow pills.

Lieu de l'étude

University of Alberta
University of Alberta
Edmonton, Alberta
Canada

Contactez l'équipe d'étude

Étude parrainée par
University of Alberta
Participants recherchés
Plus d'informations
ID de l'étude: Pro00148962