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NCT00001476 · ClinicalTrials.gov registry record · Phase 1
Gene Therapy for Chronic Granulomatous Diseases - Long-term Follow-up
A Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 14
- Enrollment target
NCT00001476 is a Phase 1 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 14 participants.
The verdict
NCT00001476, a Phase 1 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 14 participants
- Enrollment target
Study Summary
This protocol will follow patients who participated in NIAID's study Gene Therapy Approach for Chronic Granulomatous Diseases (95-I-0134). No further gene therapy treatments will be given under this protocol. However, because gene therapy is a new technology and involves a permanent change in the genetic code of some cells, patients who have had this treatment require long-term health monitoring. Participants will be asked to provide updated address and telephone information and the names of two contact persons, such as siblings or friends. Patients will be seen about once a year at the NIH Clinical Center to provide an update on their health status and donate a small blood sample (about 2 teaspoons), which will be frozen and stored. If a patient acquires a serious illness, such as cancer, his or her stored blood will be tested; another of blood or tissue sample may also be requested for further study. If a patient develops a medical problem that is thought possibly to be related to gene therapy, the illness will be investigated. The annual follow-up visits will continue indefinitely or until the patient declines to continue participation. Participants may also agree to store some of their blood future research on chronic granulomatous diseases and other medical conditions. Stored samples may be labeled with a code, such as a number, that only the study team can link with the patient. Any identifying information about the patient will be kept confidential as is permitted by law.
Interventions
- DRUG Gene Therapy Method for CGD
- DEVICE Isolex 300i Magnetic Cell Selector
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 1995-06-01 |
| Est. Completion | 2010-12-13 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00001476
The ClinicalTrials.gov registry entry for NCT00001476 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 14 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 Gene Therapy Method for CGD is the first listed.
NCT00001476 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00001476 about?
NCT00001476 is a clinical study titled "Gene Therapy for Chronic Granulomatous Diseases - Long-term Follow-up". This protocol will follow patients who participated in NIAID's study Gene Therapy Approach for Chronic Granulomatous Diseases (95-I-0134). No further gene therapy treatments will be given under this protocol. However, because gene therapy is a new technology and involves a permanent change in the ge...
What is the current status of trial NCT00001476?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 14 participants. The study started on 1995-06-01. Estimated completion is 2010-12-13.
What interventions are being tested in trial NCT00001476?
The interventions under investigation include: Gene Therapy Method for CGD (DRUG), Isolex 300i Magnetic Cell Selector (DEVICE).
Who is sponsoring clinical trial NCT00001476?
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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