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NCT01489956 · ClinicalTrials.gov registry record · Early Phase 1
A Study to Determine the Immunogenicity and Oral Tolerance to Keyhole Limpet Hemocyanin (KLH)
A Early Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Terminated
- Registry status
- Early Phase 1
- Development phase
- 19
- Enrollment target
NCT01489956: Clinical Trial Early Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT01489956 is a Early Phase 1 study that was terminated before completion, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 19 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (64% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01489956, a Early Phase 1 study, was terminated before completion, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- TERMINATED
- Registry status
- Early Phase 1
- Development phase
- 19 participants
- Enrollment target
Study Summary
The purpose of this study is to test the oral tolerance of Keyhole Limpet Hemocyanin (KLH) and to determine if Immucothel by itself is strong enough to trigger the immune response. If not, Immucothel will be tested in combination with an adjuvant to determine if an adequate immune response can be seen.
Primary Outcome
T cell stimulation index (SI) as measured by 3H-thymidine incorporation after in vitro keyhole limpet hemocyanin (KLH) stimulation of peripheral blood mononuclear cells (PBMC). An SI ≥3 on day 16 will indicate the presence of immune response. The SI is the ratio of 3H-thymidine incorporation by T cells in the presence of KLH stimulation to 3H-thymidine incorporation by T cells in the absence of stimulation. Higher values correspond with lower tolerance to KLH.
Interventions
- BIOLOGICAL Immucothel Alone (Part A)
- BIOLOGICAL Immucothel+Montanide (Part A)
- BIOLOGICAL Immucothel Alone or Immucothel+Montanide (Part B)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2011-12 |
| Est. Completion | 2013-04 |
| Phase | Early Phase 1 |
Why NCT01489956 stopped before completion
NCT01489956 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 19 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (64% lower).
The record links to 0 conditions, and to 3 interventions - of which Immucothel Alone (Part A) is the first listed.
NCT01489956 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01489956 about?
NCT01489956 is a clinical study titled "A Study to Determine the Immunogenicity and Oral Tolerance to Keyhole Limpet Hemocyanin (KLH)". The purpose of this study is to test the oral tolerance of Keyhole Limpet Hemocyanin (KLH) and to determine if Immucothel by itself is strong enough to trigger the immune response. If not, Immucothel will be tested in combination with an adjuvant to determine if an adequate immune response can be se...
What is the current status of trial NCT01489956?
This trial is currently terminated. It is a Early Phase 1 study. The enrollment target is 19 participants. The study started on 2011-12. Estimated completion is 2013-04.
What interventions are being tested in trial NCT01489956?
The interventions under investigation include: Immucothel Alone (Part A) (BIOLOGICAL), Immucothel+Montanide (Part A) (BIOLOGICAL), Immucothel Alone or Immucothel+Montanide (Part B) (BIOLOGICAL).
Who is sponsoring clinical trial NCT01489956?
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 NCT01489956's enrollment target sits among peer trials
19 1292nd of 2000 higher than 685 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early 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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