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NCT00967785 · ClinicalTrials.gov registry record · Phase 1
A Phase I Study of Mozobil in the Treatment of Patients With WHIMS
A Phase 1 study of Infections and Neutropenia, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Recruiting
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT00967785: Recruiting Phase 1 study of Infections and Neutropenia, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT00967785 is a Phase 1 study of Infections and Neutropenia that is actively recruiting participants, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 20 participants, below the 3,406-participant average among 26 other Infections trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00967785, a Phase 1 study of Infections and Neutropenia, is actively recruiting participants, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
Study Summary
Background: * WHIMS (Warts, Hypogammaglobulinemia, Infections, and Myelokathexis Syndrome) is caused by various genetic changes that increase the activity of the chemokine receptor, CXCR4. Excessive function of this receptor causes mature neutrophils (part of the white blood cells) to be retained within the bone marrow rather than being released to the blood and is one of the causes of severe inherited neutropenia (low white blood counts). In neutropenia, the body is less able to fight off infection. Patients with WHIMS usually are at risk for skin, soft tissue, sinus, and lung infections, which can result in loss of hearing, teeth, and lung function. * Current treatment for WHIMS consists of regular injections of a white blood cell growth stimulating medication called granulocyte colony stimulating factor (G-CSF), and supplemental immunoglobulin (antibody). These therapies are expensive, nonspecific, have significant side effects and toxicities, and do not fully correct all problems, especially warts and cancers related to human papillomavirus (HPV). * A drug called Mozobil has been approved for use in combination with G-CSF to increase the number of stem cells that can be collected prior to bone marrow transplantation. Mozobil may offer a specific and well-tolerated new treatment for WHIMS and other syndromes characterized by neutropenia. Objectives: * To evaluate whether Mozobil is safe and effective to treat neutropenia (low white blood cell count) in patients with WHIMS. * To determine an appropriate treatment dose of Mozobil, within currently approved dosage levels. Eligibility: \- Individuals between 18 and 75 years of age who have been diagnosed with WHIMS and have a history of severe infections. Design: * Potential participants will undergo a screening with a medical history, physical examination, questionnaire, heart and lung function scans, and blood and urine samples. Tests will also be done for hepatitis B and C virus, and human immunodeficiency
Primary Outcome
No incident of grade 3/4 toxicities.
Conditions Studied
Interventions
- DRUG Mozobil (TM)
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2010-01-06 |
| Est. Completion | 2026-12-31 |
| Phase | Phase 1 |
What NCT00967785 shows while recruiting
NCT00967785 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 3,406-participant average among 26 other Infections trials with a reported enrollment target (99% lower).
The record links to 5 conditions, with Infections appearing as the primary indexed condition, and to 1 intervention - of which Mozobil (TM) is the first listed.
NCT00967785 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT00967785 about?
NCT00967785 is a clinical study titled "A Phase I Study of Mozobil in the Treatment of Patients With WHIMS". Background: * WHIMS (Warts, Hypogammaglobulinemia, Infections, and Myelokathexis Syndrome) is caused by various genetic changes that increase the activity of the chemokine receptor, CXCR4. Excessive function of this receptor causes mature neutrophils (part of the white blood cells) to be retained w...
What is the current status of trial NCT00967785?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2010-01-06. Estimated completion is 2026-12-31.
What conditions does trial NCT00967785 study?
This clinical trial studies the following conditions: Infections, Neutropenia, Warts, Leukopenia, Myelokathexis.
What interventions are being tested in trial NCT00967785?
The interventions under investigation include: Mozobil (TM) (DRUG).
Who is sponsoring clinical trial NCT00967785?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00967785 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Infections
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00967785's enrollment target sits among peer trials
20 24th of 26 higher than 3 of 26 other Infections trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Infections trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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