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NCT01147042 · ClinicalTrials.gov registry record · Phase 4
Biochemical Response to Interferon-Gamma in Subjects With Specific Gene Mutation in Chronic Granulomatous Disease
A Phase 4 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Terminated
- Registry status
- Phase 4
- Development phase
- 2
- Enrollment target
NCT01147042 is a Phase 4 study that was terminated before completion, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 2 participants.
The verdict
NCT01147042, a Phase 4 study, was terminated before completion, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 2 participants
- Enrollment target
Study Summary
Background: \- Chronic granulomatous disease (CGD) is an immunodeficiency disease in which white blood cells are unable to kill certain bacteria and fungi. People with CGD are more likely to develop recurrent life-threatening infections. Certain changes or mutations in genes contribute to the severity of CGD, and also appear to affect the success of treatment with interferon-gamma, a substance that is used to improve the immune system s ability to fight infection. Researchers are interested in studying changes in the immune system caused by interferon-gamma treatment of CGD in individuals with different mutations that cause CGD. Objectives: \- To compare changes in the immune system caused by interferon-gamma treatment for CGD in individuals with different mutations that cause CGD. Eligibility: \- Individuals of any age who have been diagnosed with CGD and have specific types of mutations that cause CGD (to be determined after testing). Design: * Participants will be screened with a medical history, physical examination, and blood and urine tests. Participants must weigh more than 11 kilograms (\~24 pounds) to participate in the study. * Participants will receive injections of interferon-gamma once weekly for 4 weeks, twice weekly for 4 weeks, and then three times weekly for 4 weeks (a total of 24 injections). * Blood will be drawn periodically during treatment and for 8 weeks after the treatment, for a total of 21 weeks on the study. Participants will regularly provide information on their symptoms and responses to treatment to the study researchers.
Interventions
- DRUG IFN-gamma
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2010-05-18 |
| Est. Completion | 2014-11-14 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01147042
The ClinicalTrials.gov registry entry for NCT01147042 describes a study currently listed as terminated, categorized as Phase 4. The registered enrollment target is 2 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 1 intervention - of which IFN-gamma is the first listed.
NCT01147042 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01147042 about?
NCT01147042 is a clinical study titled "Biochemical Response to Interferon-Gamma in Subjects With Specific Gene Mutation in Chronic Granulomatous Disease". Background: \- Chronic granulomatous disease (CGD) is an immunodeficiency disease in which white blood cells are unable to kill certain bacteria and fungi. People with CGD are more likely to develop recurrent life-threatening infections. Certain changes or mutations in genes contribute to the sever...
What is the current status of trial NCT01147042?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 2 participants. The study started on 2010-05-18. Estimated completion is 2014-11-14.
What interventions are being tested in trial NCT01147042?
The interventions under investigation include: IFN-gamma (DRUG).
Who is sponsoring clinical trial NCT01147042?
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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