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Efficacy and Safety Study of Mavorixafor in Participants With Warts, Hypogammaglobulinemia, Infections, and Myelokathexis (WHIM) Syndrome

Primary Purpose

WHIM Syndrome

Status

Active

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Mavorixafor

Placebo

About this trial

This is an interventional treatment trial for WHIM Syndrome

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria for the Randomized Placebo-Controlled Period :

Have signed the current approved informed consent form. Participants under 18 years of age (in the Netherlands and other applicable regions, participants under 16 years of age) will sign an approved informed assent form and must also have a signed parental/legal guardian consent.
Have a genotype-confirmed mutation of chemokine (C-X-C motif) receptor 4 (CXCR4) consistent with WHIM phenotype.
Agree to use a highly effective form of contraception.
Be willing and able to comply with the protocol.
Have confirmed ANC ≤400 cells/µL during screening, obtained while participant has no clinical evidence of infection.

Inclusion Criteria for the Open-Label Period:

Completed the Randomized Period; or
Granted Early Release from the Randomized Period.

Exclusion Criteria:

Has known systemic hypersensitivity to the mavorixafor drug substance, its inactive ingredients, or the placebo.
Is pregnant or breastfeeding.
Has any medical or personal condition, which in the opinion of the Investigator may potentially compromise the safety or compliance of the participant or may preclude the participant's successful completion of the clinical study.

Sites / Locations

University of California San Diego Health/Rady Children's Hospital
California Dermatology Institute
University of Iowa
Johns Hopkins University Medical Center
University of Texas Southwestern Medical Center
University of Washington Medical Center
Wesley Hospital
Children's Health Queensland Hospital
Medical University of Vienna - Medizinische Universität Wien
Aarhus University Hospital
CHU de Lyon, Institut d'Hematologie et d'Oncologie Pediatrique
CHU Paris Est, Hôpital d'Enfants Armand-Trousseau
Hopital Necker-Enfants Malades
University of Debrecen, Affiliated Department of Infectology
HaEmek Medical Center
Università degli Studi di Brescia, Scienze Cliniche e Sperimentali
Seoul National University Hospital, Children's Hospital
Emma Children's Hospital Academic Medical Center (AMC)
Dmitry Rogachev National Research Center of Pediatric Hematology, Oncology and Immunology
Academician I.P. Pavlov First Saint Petersburg State Medical University
Hospital Sant Joan de Deu Barcelona
Hospital Universitario Virgen del Rocío
Cukurova University Faculty of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Mavorixafor

Placebo

Arm Description

Participants (adults and adolescents [12 to 17 years of age weighing >50 kilograms [kg]) will receive mavorixafor 400 milligrams (mg) once daily (QD) orally for 52 weeks in the Randomized Placebo-Controlled Period. Adolescents weighing ≤50 kg will receive mavorixafor 200 mg QD. Participants who complete the Randomized Placebo-Controlled Period or are granted Early Release due to recurrent or significant infections, as adjudicated by a blinded, independent adjudication committee (AC), will be offered the opportunity to enroll in the Open-Label Period and receive treatment with mavorixafor 400 mg once daily orally until commercial availability or study termination by the Sponsor.

Participants will receive placebo matching to mavorixafor QD orally for 52 weeks in the Randomized Placebo-Controlled Period. Participants who complete the Randomized Placebo-Controlled Period or are granted Early Release due to recurrent or significant infections, as adjudicated by a blinded, independent AC, will be offered the opportunity to enroll in the Open-Label Period and receive treatment with mavorixafor 400 mg once daily orally until commercial availability or study termination by the Sponsor.

Outcomes

Primary Outcome Measures

Randomized Placebo-Controlled Period: Time (in Hours) Above Threshold-Absolute Neutrophil Count (TAT-ANC in hours) of ≥ 500 Cells/Microliter (µL) over a 24-hour period

Open-Label Period: Percentage of Participants With Adverse Events (AEs)

Secondary Outcome Measures

Randomized Placebo-Controlled Period: Time (in Hours) Above Threshold-Absolute Lymphocyte Count (TAT-ALC) of ≥ 1000 Cells/µL over a 24-hour period

Randomized Placebo-Controlled Period: Composite Clinical Efficacy for Mavorixafor based on total infection score and total wart change score

Randomized Placebo-Controlled Period: Change From Baseline in Total Warts Score at Week 52

Randomized Placebo-Controlled Period: Total Infection Score for Mavorixafor

Randomized Placebo-Controlled Period: Time to Early Release

Randomized Placebo-Controlled Period: TAT-ALC of ≥ 1000 Cells/µL in Participants With Lymphopenia

Randomized Placebo-Controlled Period: Total Infection Score for Participants With Non-Immunoglobulin (non-Ig) Use (Percentage of Participants With Infections)

Randomized Placebo-Controlled Period: Change in Total Wart Score at Baseline, Based on Clinical Global Impression of Change (CGI-C)

Randomized Placebo-Controlled Period: Composite Clinical Efficacy (Total Infection Score and Total Wart Change Score) for Participants With Non-Ig Use

Composite clinical efficacy will be calculated using the total infection score and total wart change score for participants with warts at baseline or non-Ig use. It will be analyzed by a blinded, independent AC.

Randomized Placebo-Controlled Period: Change in Total Wart Score at Baseline (CGI-C), Based on Local Dermatologist Review

Randomized Placebo-Controlled Period: Participant Global Impression of Change (PGI-C)

Randomized Placebo-Controlled Period: Participant Global Impression of Severity (PGI-S)

Randomized Placebo-Controlled Period: Vaccine Titer Levels at Week 52 in Participants Vaccinated at Week 13, With Tetanus, Diphtheria, and Pertussis (Tdap) Including Pertussis Toxin, and Tetanus

Randomized Placebo-Controlled Period: Vaccine Titer Levels at Week 52 for Human Papillomavirus (HPV) 16 and HPV 18 in Participants Receiving Vaccinations With HPV 9-Valent Vaccine, Recombinant (Gardasil®9)

Randomized Placebo-Controlled Period: Change From Baseline in Clinical Global Impression of Severity (CGI-S), Based on Local Dermatologist Review

Randomized Placebo-Controlled Period: Number of Participants with Infections

Randomized Placebo-Controlled Period: Infection-Free Time

Randomized Placebo-Controlled Period: Number of Days Lost From Work/School

Randomized Placebo-Controlled Period: Quality of Life as Measured by 36-Item Short Form Survey Score

Randomized Placebo-Controlled Period: Quality of Life as Measured by EuroQoL-5 Dimension-5 Level (EQ-5D-5L) Score

Randomized Placebo-Controlled Period: Quality of Life as Measured by Life Quality Index (LQI) Score

Randomized Placebo-Controlled Period: Quality of Life as Measured by Dermatology LQI Score

Randomized Placebo-Controlled Period: Quality of Life as Measured by Pediatric Quality of Life Inventory (PedsQL) Score

Randomized Placebo-Controlled Period: Change From Baseline in Anogenital (AG) Warts Based on Dermatologist CGI-C Assessment

Randomized Placebo-Controlled Period: Change From Baseline in Anogenital (AG) Warts Based on AG Wart Severity Assessment

Randomized Placebo-Controlled Period: Number of Events Requiring Rescue Treatment Due to Infection

Randomized Placebo-Controlled Period: Number of Participants With Incidence and Duration of Hospitalizations Due to Infection

Randomized Placebo-Controlled Period: Number of Participants With Incidence of Newly Developed Warts

Randomized Placebo-Controlled Period: Area Under the Curve for ANC (AUCANC) Using Trapezoidal Method

Randomized Placebo-Controlled Period: Percentage of Neutrophil Responders

Randomized Placebo-Controlled Period: Mavorixafor Treatment Group: AUCANC

Randomized Placebo-Controlled Period: Area Under the Curve for ALC (AUCALC)

Randomized Placebo-Controlled Period: Percentage of Lymphocyte Responders

Randomized Placebo-Controlled Period: Change From Baseline in Total ALC, Absolute Monocyte Count (AMC), ANC, and White Blood Cell (WBC) at Week 52

Absolute and Fold Change From Baseline in Absolute T, B and Natural Killer Lymphocyte at Week 52

Randomized Placebo-Controlled Period: Number of Participants With AEs

Randomized Placebo-Controlled Period: Pharmacokinetics (PK), Maximum Observed Plasma Concentration (Cmax) of Mavorixafor

Randomized Placebo-Controlled Period: PK, Time to Reach Cmax (Tmax) of Mavorixafor

Randomized Placebo-Controlled Period: PK, Half-Life of (T1/2) of Mavorixafor

Randomized Placebo-Controlled Period: PK, Area Under the Curve (AUC) of Mavorixafor

Open-Label Period: Percentage of Neutrophil Responders

Open-Label Period: Percentage of Lymphocyte Responders

Open-Label Period: Absolute and Fold Change From Baseline in Total ALC, AMC, ANC, and WBC at Week 52

Open-Label Period: Vaccine Titer Levels During the First Year of Open-Label Period, in Participants Vaccinated With Tdap During the Study Including Pertusis Toxin and Tetanus

Open-Label Period: Vaccine Titer Levels During the First Year of the Open-Label Period for HPV 16 and HPV 18 in Participants Receiving Vaccinations With HPV 9-Valent Vaccine, Recombinant (Gardasil®9) During the Study

Open-Label Period: Change From Baseline in Cutaneous Warts at Week 52, Based on Central Review of CGI-C

Open-Label Period: Change From Baseline in Cutaneous Warts, Based on Central Review of CGI-S

Open-Label Period: Change From Baseline in Cutaneous Warts, Based on Local Dermatologist CGI-C

Open-Label Period: Change From Baseline in Cutaneous Warts, Based on Local Dermatologist CGI-S

Open-Label Period: Change Over Time in PGI-C

Open-Label Period: Change Over Time in PGI-S

Open-Label Period: Total Infection Score (Percentage of Participants With Infections)

Full Information

NCT ID

NCT03995108

First Posted

June 19, 2019

Last Updated

October 3, 2023

Sponsor

X4 Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT03995108

Brief Title

Efficacy and Safety Study of Mavorixafor in Participants With Warts, Hypogammaglobulinemia, Infections, and Myelokathexis (WHIM) Syndrome

Official Title

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Mavorixafor in Patients With WHIM Syndrome With Open-Label Extension

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

October 24, 2019 (Actual)

Primary Completion Date

October 10, 2022 (Actual)

Study Completion Date

December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

X4 Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This study has a double-blind, Randomized Placebo-Controlled Period and an Open-Label Period. The primary objective of the Randomized Placebo-Controlled Period is to demonstrate the efficacy of mavorixafor in participants with WHIM syndrome as assessed by increasing levels of circulating neutrophils compared with placebo, and relative to a clinically meaningful threshold. The primary objective of the Open-Label Period is to evaluate the safety and tolerability of mavorixafor in participants with WHIM syndrome. Participants are allowed to continue treatment in the Open-Label Period, if regionally applicable, until mavorixafor becomes commercially available, or until the study is terminated by the Sponsor.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

WHIM Syndrome

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

31 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Mavorixafor

Arm Type

Experimental

Arm Description

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Mavorixafor

Other Intervention Name(s)

AMD11070, X4P-001

Intervention Description

Mavorixafor provided as 100 mg capsules.

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo matching to mavorixafor capsules

Primary Outcome Measure Information:

Title

Randomized Placebo-Controlled Period: Time (in Hours) Above Threshold-Absolute Neutrophil Count (TAT-ANC in hours) of ≥ 500 Cells/Microliter (µL) over a 24-hour period

Time Frame

Time 0 (pre-dose, up to 15 minutes prior), 30, 60, and 90 min (each ± 5 min) and 2, 3, 4, 8, 12, 16, and 24 hours (each ± 15 min) post-dose at Baseline, Weeks 13, 26, 39, and 52

Title

Open-Label Period: Percentage of Participants With Adverse Events (AEs)

Time Frame

From Day 1 (end of randomized period) up to end of study (30 days post-treatment in open-label period [Week 56 of open-label period])

Secondary Outcome Measure Information:

Title

Randomized Placebo-Controlled Period: Time (in Hours) Above Threshold-Absolute Lymphocyte Count (TAT-ALC) of ≥ 1000 Cells/µL over a 24-hour period

Time Frame

Time 0 (pre-dose, up to 15 minutes prior), 30, 60, and 90 minutes (each ± 5 minutes) and 2, 3, 4, 8, 12, 16, and 24 hours (each ± 15 minutes) post-dose at Baseline, Weeks 13, 26, 39, and 52

Title

Randomized Placebo-Controlled Period: Composite Clinical Efficacy for Mavorixafor based on total infection score and total wart change score

Time Frame

Baseline up to Week 52

Title

Randomized Placebo-Controlled Period: Change From Baseline in Total Warts Score at Week 52

Time Frame

Baseline, Week 52

Title

Randomized Placebo-Controlled Period: Total Infection Score for Mavorixafor

Time Frame

Baseline up to Week 52

Title

Randomized Placebo-Controlled Period: Time to Early Release

Time Frame

Baseline up to Week 52

Title

Randomized Placebo-Controlled Period: TAT-ALC of ≥ 1000 Cells/µL in Participants With Lymphopenia

Time Frame

Baseline

Title

Randomized Placebo-Controlled Period: Total Infection Score for Participants With Non-Immunoglobulin (non-Ig) Use (Percentage of Participants With Infections)

Time Frame

Baseline up to Week 52

Title

Randomized Placebo-Controlled Period: Change in Total Wart Score at Baseline, Based on Clinical Global Impression of Change (CGI-C)

Time Frame

Baseline

Title

Randomized Placebo-Controlled Period: Composite Clinical Efficacy (Total Infection Score and Total Wart Change Score) for Participants With Non-Ig Use

Description

Time Frame

Baseline up to Week 52

Title

Randomized Placebo-Controlled Period: Change in Total Wart Score at Baseline (CGI-C), Based on Local Dermatologist Review

Time Frame

Baseline

Title

Randomized Placebo-Controlled Period: Participant Global Impression of Change (PGI-C)

Time Frame

Baseline up to Week 52

Title

Randomized Placebo-Controlled Period: Participant Global Impression of Severity (PGI-S)

Time Frame

Baseline up to Week 52

Title

Randomized Placebo-Controlled Period: Vaccine Titer Levels at Week 52 in Participants Vaccinated at Week 13, With Tetanus, Diphtheria, and Pertussis (Tdap) Including Pertussis Toxin, and Tetanus

Time Frame

Week 52

Title

Time Frame

Week 52

Title

Randomized Placebo-Controlled Period: Change From Baseline in Clinical Global Impression of Severity (CGI-S), Based on Local Dermatologist Review

Time Frame

Baseline up to Week 52

Title

Randomized Placebo-Controlled Period: Number of Participants with Infections

Time Frame

Baseline up to Week 52

Title

Randomized Placebo-Controlled Period: Infection-Free Time

Time Frame

Baseline up to Week 52

Title

Randomized Placebo-Controlled Period: Number of Days Lost From Work/School

Time Frame

Baseline up to Week 52

Title

Randomized Placebo-Controlled Period: Quality of Life as Measured by 36-Item Short Form Survey Score

Time Frame

Baseline up to Week 52

Title

Randomized Placebo-Controlled Period: Quality of Life as Measured by EuroQoL-5 Dimension-5 Level (EQ-5D-5L) Score

Time Frame

Baseline up to Week 52

Title

Randomized Placebo-Controlled Period: Quality of Life as Measured by Life Quality Index (LQI) Score

Time Frame

Baseline up to Week 52

Title

Randomized Placebo-Controlled Period: Quality of Life as Measured by Dermatology LQI Score

Time Frame

Baseline up to Week 52

Title

Randomized Placebo-Controlled Period: Quality of Life as Measured by Pediatric Quality of Life Inventory (PedsQL) Score

Time Frame

Baseline up to Week 52

Title

Randomized Placebo-Controlled Period: Change From Baseline in Anogenital (AG) Warts Based on Dermatologist CGI-C Assessment

Time Frame

Baseline to Week 52

Title

Randomized Placebo-Controlled Period: Change From Baseline in Anogenital (AG) Warts Based on AG Wart Severity Assessment

Time Frame

Baseline to Week 52

Title

Randomized Placebo-Controlled Period: Number of Events Requiring Rescue Treatment Due to Infection

Time Frame

Baseline to Week 52

Title

Randomized Placebo-Controlled Period: Number of Participants With Incidence and Duration of Hospitalizations Due to Infection

Time Frame

Baseline to Week 52

Title

Randomized Placebo-Controlled Period: Number of Participants With Incidence of Newly Developed Warts

Time Frame

Baseline to Week 52

Title

Randomized Placebo-Controlled Period: Area Under the Curve for ANC (AUCANC) Using Trapezoidal Method

Time Frame

Time 0 (pre-dose, up to 15 minutes prior), 30, 60, and 90 minutes (each ± 5 minutes) and 2, 3, 4, 8, 12, 16, and 24 hours (each ± 15 minutes) post-dose at Baseline, Weeks 13, 26, 39, and 52

Title

Randomized Placebo-Controlled Period: Percentage of Neutrophil Responders

Time Frame

Baseline up to Week 52

Title

Randomized Placebo-Controlled Period: Mavorixafor Treatment Group: AUCANC

Time Frame

Time 0 (pre-dose, up to 15 minutes prior), 30, 60, and 90 minutes (each ± 5 minutes) and 2, 3, 4, 8, 12, 16, and 24 hours (each ± 15 minutes) post-dose at Baseline, Weeks 13, 26, 39, and 52

Title

Randomized Placebo-Controlled Period: Area Under the Curve for ALC (AUCALC)

Time Frame

Time 0 (pre-dose, up to 15 minutes prior), 30, 60, and 90 minutes (each ± 5 minutes) and 2, 3, 4, 8, 12, 16, and 24 hours (each ± 15 minutes) post-dose at Baseline, Weeks 13, 26, 39, and 52

Title

Randomized Placebo-Controlled Period: Percentage of Lymphocyte Responders

Time Frame

Baseline up to Week 52

Title

Randomized Placebo-Controlled Period: Change From Baseline in Total ALC, Absolute Monocyte Count (AMC), ANC, and White Blood Cell (WBC) at Week 52

Time Frame

Baseline, Week 52

Title

Absolute and Fold Change From Baseline in Absolute T, B and Natural Killer Lymphocyte at Week 52

Time Frame

Baseline, Week 52

Title

Randomized Placebo-Controlled Period: Number of Participants With AEs

Time Frame

Baseline up to Week 52

Title

Randomized Placebo-Controlled Period: Pharmacokinetics (PK), Maximum Observed Plasma Concentration (Cmax) of Mavorixafor

Time Frame

Time 0 (pre-dose, up to 15 minutes prior), 30, 60, and 90 minutes (each ± 5 minutes) and 2, 3, 4, 8, 12, 16, and 24 hours (each ± 15 minutes) post-dose at Weeks 13, 26, 39, and 52; and 4 hours post-dose at Baseline

Title

Randomized Placebo-Controlled Period: PK, Time to Reach Cmax (Tmax) of Mavorixafor

Time Frame

Time 0 (pre-dose, up to 15 minutes prior), 30, 60, and 90 min (each ± 5 minutes) and 2, 3, 4, 8, 12, 16, and 24 hours (each ± 15 minutes) post-dose at Weeks 13, 26, 39, and 52; and 4 hours post-dose at Baseline

Title

Randomized Placebo-Controlled Period: PK, Half-Life of (T1/2) of Mavorixafor

Time Frame

Title

Randomized Placebo-Controlled Period: PK, Area Under the Curve (AUC) of Mavorixafor

Time Frame

Title

Open-Label Period: Percentage of Neutrophil Responders

Time Frame

Baseline up to Week 52 of open-label period

Title

Open-Label Period: Percentage of Lymphocyte Responders

Time Frame

Baseline up to Week 52 of open-label period

Title

Open-Label Period: Absolute and Fold Change From Baseline in Total ALC, AMC, ANC, and WBC at Week 52

Time Frame

Baseline up to Week 52 of open-label period

Title

Open-Label Period: Vaccine Titer Levels During the First Year of Open-Label Period, in Participants Vaccinated With Tdap During the Study Including Pertusis Toxin and Tetanus

Time Frame

Year 1 of open-label period

Title

Time Frame

Year 1 of open-label period

Title

Open-Label Period: Change From Baseline in Cutaneous Warts at Week 52, Based on Central Review of CGI-C

Time Frame

Baseline, Week 52 of open-label period

Title

Open-Label Period: Change From Baseline in Cutaneous Warts, Based on Central Review of CGI-S

Time Frame

Baseline, Week 52 of open-label period

Title

Open-Label Period: Change From Baseline in Cutaneous Warts, Based on Local Dermatologist CGI-C

Time Frame

Baseline, Week 52 of open-label period

Title

Open-Label Period: Change From Baseline in Cutaneous Warts, Based on Local Dermatologist CGI-S

Time Frame

Baseline, Week 52 of open-label period

Title

Open-Label Period: Change Over Time in PGI-C

Time Frame

Baseline up to Week 52 of open-label period

Title

Open-Label Period: Change Over Time in PGI-S

Time Frame

Baseline up to Week 52 of open-label period

Title

Open-Label Period: Total Infection Score (Percentage of Participants With Infections)

Time Frame

Baseline up to Week 52 of open-label period

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria for the Randomized Placebo-Controlled Period : Have signed the current approved informed consent form. Participants under 18 years of age (in the Netherlands and other applicable regions, participants under 16 years of age) will sign an approved informed assent form and must also have a signed parental/legal guardian consent. Have a genotype-confirmed mutation of chemokine (C-X-C motif) receptor 4 (CXCR4) consistent with WHIM phenotype. Agree to use a highly effective form of contraception. Be willing and able to comply with the protocol. Have confirmed ANC ≤400 cells/µL during screening, obtained while participant has no clinical evidence of infection. Inclusion Criteria for the Open-Label Period: Completed the Randomized Period; or Granted Early Release from the Randomized Period. Exclusion Criteria: Has known systemic hypersensitivity to the mavorixafor drug substance, its inactive ingredients, or the placebo. Is pregnant or breastfeeding. Has any medical or personal condition, which in the opinion of the Investigator may potentially compromise the safety or compliance of the participant or may preclude the participant's successful completion of the clinical study.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Chief Medical Officer

Organizational Affiliation

X4 Pharmaceuticals

Official's Role

Study Director

Facility Information:

Facility Name

University of California San Diego Health/Rady Children's Hospital

City

San Diego

State/Province

California

ZIP/Postal Code

92123

Country

United States

Facility Name

California Dermatology Institute

City

Thousand Oaks

State/Province

California

ZIP/Postal Code

91320

Country

United States

Facility Name

University of Iowa

City

Iowa City

State/Province

Iowa

ZIP/Postal Code

52242

Country

United States

Facility Name

Johns Hopkins University Medical Center

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21224

Country

United States

Facility Name

University of Texas Southwestern Medical Center

City

Dallas

State/Province

Texas

ZIP/Postal Code

75390-9020

Country

United States

Facility Name

University of Washington Medical Center

City

Seattle

State/Province

Washington

ZIP/Postal Code

98195

Country

United States

Facility Name

Wesley Hospital

City

Auchenflower

State/Province

Queensland

ZIP/Postal Code

4006

Country

Australia

Facility Name

Children's Health Queensland Hospital

City

South Brisbane

State/Province

Queensland

ZIP/Postal Code

4101

Country

Australia

Facility Name

Medical University of Vienna - Medizinische Universität Wien

City

Wien

ZIP/Postal Code

1090

Country

Austria

Facility Name

Aarhus University Hospital

City

Aarhus

ZIP/Postal Code

8000

Country

Denmark

Facility Name

CHU de Lyon, Institut d'Hematologie et d'Oncologie Pediatrique

City

Lyon

State/Province

Rhne

ZIP/Postal Code

69008

Country

France

Facility Name

CHU Paris Est, Hôpital d'Enfants Armand-Trousseau

City

Paris Cedex 12

ZIP/Postal Code

75571

Country

France

Facility Name

Hopital Necker-Enfants Malades

City

Paris

ZIP/Postal Code

75743

Country

France

Facility Name

University of Debrecen, Affiliated Department of Infectology

City

Debrecen

State/Province

Hajdu-Bihar

ZIP/Postal Code

H-4031

Country

Hungary

Facility Name

HaEmek Medical Center

City

Afula

ZIP/Postal Code

1834111

Country

Israel

Facility Name

Università degli Studi di Brescia, Scienze Cliniche e Sperimentali

City

Brescia

State/Province

Piazza Del Mercato

ZIP/Postal Code

25123

Country

Italy

Facility Name

Seoul National University Hospital, Children's Hospital

City

Seoul

ZIP/Postal Code

03080

Country

Korea, Republic of

Facility Name

Emma Children's Hospital Academic Medical Center (AMC)

City

Amsterdam

ZIP/Postal Code

1105 AZ

Country

Netherlands

Facility Name

Dmitry Rogachev National Research Center of Pediatric Hematology, Oncology and Immunology

City

Moscow

ZIP/Postal Code

117997

Country

Russian Federation

Facility Name

Academician I.P. Pavlov First Saint Petersburg State Medical University

City

Saint Pertersburg

ZIP/Postal Code

197022

Country

Russian Federation

Facility Name

Hospital Sant Joan de Deu Barcelona

City

Barcelona

State/Province

Esplugues De Llobregat

ZIP/Postal Code

8950

Country

Spain

Facility Name

Hospital Universitario Virgen del Rocío

City

Seville

State/Province

Sevilla

ZIP/Postal Code

41013

Country

Spain

Facility Name

Cukurova University Faculty of Medicine

City

Sarıcam

State/Province

Adana

ZIP/Postal Code

1330

Country

Turkey

12. IPD Sharing Statement

Learn more about this trial

Efficacy and Safety Study of Mavorixafor in Participants With Warts, Hypogammaglobulinemia, Infections, and Myelokathexis (WHIM) Syndrome

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