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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 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.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02231879
The ClinicalTrials.gov registry entry for NCT02231879 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which G-CSF is the first listed.
NCT02231879 reports 0 study locations.
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.
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