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Chemokine Receptor Antagonist

Mozobil for Neutropenia

Phase 1 & 2

Recruiting

Led By David H McDermott, M.D.

Research Sponsored by National Institute of Allergy and Infectious Diseases (NIAID)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

- Male partner has previously undergone a vasectomy for which there is documentation of aspermatogenic sterility

Clinical diagnosis of WHIMS and documented severe infection

Must not have

Absence of a documented history of severe infection

History of serious cardiac arrhythmia or cardiac defects that make such more likely

Timeline

Screening 3 weeks

Treatment Varies

Follow Up duration of treatment, up to 7 years

Awards & highlights

Summary

This trial is testing whether a drug called Mozobil is safe and effective to treat neutropenia in patients with WHIMS.

Who is the study for?

Adults aged 18-75 with WHIMS, a condition causing low white blood cells and severe infections. Participants must not be pregnant or breastfeeding, agree to use two forms of contraception, stop certain medications before the study, have a personal physician, and provide samples for research.

What is being tested?

The trial is testing Mozobil's safety and effectiveness in treating neutropenia in WHIMS patients. It includes a Dose Escalation study to find the right dose over 5 days and a Chronic Dosing study for long-term treatment up to 60 months.

What are the potential side effects?

While specific side effects are not listed here, participants will be closely monitored for any adverse reactions during the trial as they receive increasing doses of Mozobil.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My male partner has had a vasectomy confirmed to prevent sperm production.

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I have WHIMS and have had a severe infection.

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I use a diaphragm or cervical cap with spermicide for birth control.

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I am between 18 and 75 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have not had a severe infection in my medical history.

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I have a serious heart rhythm problem or defect.

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My kidneys are failing, needing dialysis or my creatinine clearance is below 15 mL/min.

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I am under 18 years old.

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I am not willing to undergo the tests or procedures required by this study.

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I do not have signs of an infection right now.

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I have never been diagnosed with WHIMS.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ duration of treatment, up to 7 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~duration of treatment, up to 7 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and duration of treatment, up to 7 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Increase ANC

Safety

Secondary study objectives

Increase Leucocytes

reduced HPV lesions

Trial Design

1Treatment groups

Active Control

Group I: Treatment ArmActive Control1 Intervention

neutropenia and infections

0 / 11Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor

3,302 Previous Clinical Trials

5,501,422 Total Patients Enrolled

7 Trials studying Neutropenia

5,020 Patients Enrolled for Neutropenia

David H McDermott, M.D.Principal InvestigatorNational Institute of Allergy and Infectious Diseases (NIAID)

3 Previous Clinical Trials

1,918 Total Patients Enrolled

2 Trials studying Neutropenia

30 Patients Enrolled for Neutropenia

Media Library

Mozobil (Chemokine Receptor Antagonist) Clinical Trial Eligibility Overview. Trial Name: NCT00967785 — Phase 1 & 2

Neutropenia Research Study Groups: Treatment Arm

Neutropenia Clinical Trial 2023: Mozobil Highlights & Side Effects. Trial Name: NCT00967785 — Phase 1 & 2

Mozobil (Chemokine Receptor Antagonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00967785 — Phase 1 & 2

~2 spots leftby Dec 2025

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