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NCT00906243 · ClinicalTrials.gov registry record · Phase 1
RNActive®-Derived Therapeutic Vaccine
A Phase 1 study, sponsored by University of Florida.
- Terminated
- Registry status
- Phase 1
- Development phase
- 6
- Enrollment target
NCT00906243 is a Phase 1 study that was terminated before completion, run by University of Florida. The registered enrollment target is 6 participants.
The verdict
NCT00906243, a Phase 1 study, was terminated before completion, sponsored by University of Florida.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 6 participants
- Enrollment target
Study Summary
This is a Phase I/IIa open, uncontrolled, prospective study, to be conducted in an out-patient setting. The present study is one of two clinical trials of the RNActive®-derived vaccine CV9103 being conducted concurrently in the US and Europe, which represent the first clinical trials conducted for this novel vaccine. The Phase I part of the study consists of a staggered inclusion of subjects in two cohorts of 3, to confirm the safety of the intended dose (320 µg RNA per antigen), with a lower dose to be considered in case of dose-limiting toxicity (DLT) being reported in greater than or equal to 2 out of 3-6 subjects; in this way, the recommended dose (RD) for the Phase IIa part of the study will be established. In the Phase IIa part of the study, additional subjects will be included at the RD, to confirm the safety and explore the activity of that dose.
Interventions
- BIOLOGICAL CV9103
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2009-05 |
| Est. Completion | 2010-12 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00906243
The ClinicalTrials.gov registry entry for NCT00906243 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 6 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Florida, which has 1,106 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which CV9103 is the first listed.
NCT00906243 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00906243 about?
NCT00906243 is a clinical study titled "RNActive®-Derived Therapeutic Vaccine". This is a Phase I/IIa open, uncontrolled, prospective study, to be conducted in an out-patient setting. The present study is one of two clinical trials of the RNActive®-derived vaccine CV9103 being conducted concurrently in the US and Europe, which represent the first clinical trials conducted for t...
What is the current status of trial NCT00906243?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 6 participants. The study started on 2009-05. Estimated completion is 2010-12.
What interventions are being tested in trial NCT00906243?
The interventions under investigation include: CV9103 (BIOLOGICAL).
Who is sponsoring clinical trial NCT00906243?
This trial is sponsored by University of Florida, which has 1,106 total clinical trials registered on ClinicalTrials.gov.
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