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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up duration of treatment, up to 7 years
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.
Select...
I use a diaphragm or cervical cap with spermicide for birth control.
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I am between 18 and 75 years old.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Increase ANC
Safety
Secondary outcome measures
Increase Leucocytes
reduced HPV lesions

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
3,270 Previous Clinical Trials
5,485,217 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this scientific experiment currently accept elderly participants?

"The trial stipulates that the minimum permissible age for enrollment is 18 and the uppermost limit of age set by the inclusion criteria is 75."

Answered by AI

Is enrollment for this clinical experiment still available?

"Clinicialtrials.gov cites that this medical trial is actively pursuing patients, having been posted on the 6th of January 2010 and receiving its last update on the 17th of September 2022."

Answered by AI

What is the upper limit of participants for this trial?

"Affirmative, the information on clinicaltrials.gov suggests that this trial is presently recruiting patients. It was first posted 6th January 2010 and most recently updated 17th September 2022 - with a requirement to recruit 20 participants from two different sites."

Answered by AI

Under what criteria may individuals enroll in this research program?

"This investigation necessitates the enrollment of 20 leukopenia sufferers aged between 18 and 75. To be eligible, they must use an FDA-approved contraceptive technique such as oral contraception or a condom with spermicide, have access to personal care physicians and not be pregnant or lactating."

Answered by AI

What distinct investigations have been carried out regarding Treatment Arm?

"Currently, 18 studies are being conducted to assess the efficacy of Treatment Arm. None of these active trials have progressed to Phase 3 yet. Most investigations into this treatment take place in Seattle, Washington but 54 other sites across the globe are also researching Treatment Arm."

Answered by AI
~0 spots leftby Apr 2024