Your session is about to expire
← Back to Search
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 belowSelect...
My male partner has had a vasectomy confirmed to prevent sperm production.
Select...
I have WHIMS and have had a severe infection.
Select...
I use a diaphragm or cervical cap with spermicide for birth control.
Select...
I am between 18 and 75 years old.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have not had a severe infection in my medical history.
Select...
I have a serious heart rhythm problem or defect.
Select...
My kidneys are failing, needing dialysis or my creatinine clearance is below 15 mL/min.
Select...
I am under 18 years old.
Select...
I am not willing to undergo the tests or procedures required by this study.
Select...
I do not have signs of an infection right now.
Select...
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
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
3,335 Previous Clinical Trials
5,382,784 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- My male partner has had a vasectomy confirmed to prevent sperm production.You have a condition called neutropenia, where your body doesn't produce enough infection-fighting cells, and the doctor doesn't think this medication will help you.I have a serious heart rhythm problem or defect.My kidneys are failing, needing dialysis or my creatinine clearance is below 15 mL/min.I am willing to give samples of my blood and DNA for research.I am willing to stop taking certain medications for my white blood cell count for the study.I use condoms as a form of contraception.I have not had a severe infection in my medical history.I am under 18 years old.I am not willing to undergo the tests or procedures required by this study.I do not have signs of an infection right now.I have WHIMS and have had a severe infection.I use a diaphragm or cervical cap with spermicide for birth control.I have never been diagnosed with WHIMS.You have an intrauterine device (IUD) inserted in your uterus.I am between 18 and 75 years old.I am using an FDA-approved birth control method.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment Arm
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.