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NCT02231879 · ClinicalTrials.gov registry record · Phase 2
Plerixafor Versus G-CSF in the Treatment of People With WHIM Syndrome
A Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 2
- Development phase
- 20
- Enrollment target
NCT02231879: Completed Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT02231879 is a Phase 2 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 20 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02231879, a Phase 2 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 20 participants
- Enrollment target
Study Summary
Background: \- WHIMS (Warts, Hypogammaglobulinemia, Infections, and Myelokathexis Syndrome) is a rare disease. It can cause cancers, infections, and warts. Researchers want to see if a drug called plerixafor can treat WHIMS. Objective: \- To compare plerixafor versus granulocyte colony stimulating factor (G-CSF) for preventing infections in people with WHIMS. Eligibility: \- People ages 10-75 with WHIMS who have a CXCR4 gene mutation. Design: * Participants will be screened with a medical history, physical exam, and blood and urine tests. They may have heart and spleen tests and body scans. They may have samples of skin or warts taken. Researchers may take photographs of warts. * Participants will start twice daily self-injections of G-CSF. Their doctors will decide the dosage. * Initial Period (4-12 weeks) * Participants will: * continue the injections and their usual antibiotics and/or immunoglobulin * have blood drawn * keep a daily health diary * Participants will visit the clinic for 2 days without injections. * Adjustment Period 1 (8 weeks): * Participants will: * continue twice daily injections from home * continue the daily health diary * have blood tests every 2 weeks. * Treatment Year 1: * Participants will * receive either plerixafor or G-CSF injections twice daily * continue the health diary * have blood tests every 2 months * visit the clinic about every 4 months * At the end of year 1, participants will visit the clinic for an evaluation. They will switch to the other study drug. They will have an 8-week adjustment and 1-year treatment period. * At the end of year 2, participants will visit the clinic to complete their injections and go back to their previous G-CSF regimen. Participants will continue their daily health diary and have blood tests for 5-6 months.
Primary Outcome
The primary outcome is a Total Infection Severity Score (TISS). Each infection during the 12 month period of treatment on each drug was scored for severity on a scale of 1-10 with higher scores representing more severe infections and then these scores were summed (weighted based on time at risk) to create a total infection severity score (TISS) in each period for each participant (range 0 to infinity). Drug failures during a period were pre-defined to count as more extreme than any TISS score. T
Interventions
- DRUG G-CSF
- DRUG Plerixafor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2014-10-14 |
| Est. Completion | 2021-02-24 |
| Phase | Phase 2 |
What the finished NCT02231879 record still lists
NCT02231879 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 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (85% lower).
The record links to 0 conditions, and to 2 interventions - of which G-CSF is the first listed.
NCT02231879 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02231879 about?
NCT02231879 is a clinical study titled "Plerixafor Versus G-CSF in the Treatment of People With WHIM Syndrome". Background: \- WHIMS (Warts, Hypogammaglobulinemia, Infections, and Myelokathexis Syndrome) is a rare disease. It can cause cancers, infections, and warts. Researchers want to see if a drug called plerixafor can treat WHIMS. Objective: \- To compare plerixafor versus granulocyte colony stimulatin...
What is the current status of trial NCT02231879?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 20 participants. The study started on 2014-10-14. Estimated completion is 2021-02-24.
What interventions are being tested in trial NCT02231879?
The interventions under investigation include: G-CSF (DRUG), Plerixafor (DRUG).
Who is sponsoring clinical trial NCT02231879?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02231879's enrollment target sits among peer trials
20 1805th of 2000 higher than 107 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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