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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: Completed Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
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, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.
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 |
What the finished NCT00001476 record still lists
NCT00001476 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (77% lower).
The record links to 0 conditions, and to 2 interventions - of which Gene Therapy Method for CGD is the first listed.
NCT00001476 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00001476's enrollment target sits among peer trials
14 1844th of 2000 higher than 154 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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