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NCT01380327 · ClinicalTrials.gov registry record · Phase 1
Biomarkers of Cockroach Sublingual Immunotherapy 2
A Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 99
- Enrollment target
NCT01380327: Completed Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT01380327 is a Phase 1 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 99 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (65% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01380327, a Phase 1 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 99 participants
- Enrollment target
Study Summary
This trial is a follow-up study of the ICAC-12 Phase I/II trial (NCT00829985), and is designed to study biomarkers of the immune response to allergen immunotherapy and the safety of this therapy in a pediatric population.
Primary Outcome
Outcome is the ratio of geometric means for baseline versus post-baseline German cockroach-specific serum IgE. This result is an indicator of immune modulation over time, however its clinical significance is unclear.
Interventions
- OTHER Placebo
- BIOLOGICAL Cockroach Sublingual Immunotherapy (SLIT) - Low Dose
- BIOLOGICAL Cockroach Sublingual Immunotherapy (SLIT) - High Dose
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 99 participants |
| Start Date | 2011-05 |
| Est. Completion | 2012-06 |
| Phase | Phase 1 |
What the finished NCT01380327 record still lists
NCT01380327 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 99 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (65% higher).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01380327 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01380327 about?
NCT01380327 is a clinical study titled "Biomarkers of Cockroach Sublingual Immunotherapy 2". This trial is a follow-up study of the ICAC-12 Phase I/II trial (NCT00829985), and is designed to study biomarkers of the immune response to allergen immunotherapy and the safety of this therapy in a pediatric population.
What is the current status of trial NCT01380327?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 99 participants. The study started on 2011-05. Estimated completion is 2012-06.
What interventions are being tested in trial NCT01380327?
The interventions under investigation include: Placebo (OTHER), Cockroach Sublingual Immunotherapy (SLIT) - Low Dose (BIOLOGICAL), Cockroach Sublingual Immunotherapy (SLIT) - High Dose (BIOLOGICAL).
Who is sponsoring clinical trial NCT01380327?
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 NCT01380327's enrollment target sits among peer trials
99 590th of 2000 higher than 1,409 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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