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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
No Placebo-Only Group

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 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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Active Control
Group I: Treatment ArmActive Control1 Intervention
neutropenia and infections

Find a Location

Who is running the clinical trial?

National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor
3,322 Previous Clinical Trials
5,364,718 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
~1 spots leftby Dec 2025
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