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NCT03232580 · ClinicalTrials.gov registry record · Phase 2
99mTc-rhAnnexin V-128 in Diagnosis of Spondyloarthritis
A Phase 2 study, sponsored by Advanced Accelerator Applications.
- Terminated
- Registry status
- Phase 2
- Development phase
- 5
- Enrollment target
NCT03232580 is a Phase 2 study that was terminated before completion, run by Advanced Accelerator Applications. The registered enrollment target is 5 participants.
The verdict
NCT03232580, a Phase 2 study, was terminated before completion, sponsored by Advanced Accelerator Applications.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 5 participants
- Enrollment target
Study Summary
This single center, open-label, proof of concept (PoC) Phase II study aimed to assess the investigational imaging agent 99mTc-rhAnnexin V-128 in detecting spondyloarthritis (SpA) lesions. Overall, it was planned to recruit 20 adults with suspected or confirmed SpA. First, 5 patients were enrolled into a "proof of concept" phase, to assess the imaging potential of 99mTc-rhAnnexin V-128 in terms of imaging quality, disease-lesion radiotracer uptake and medical relevance. Based on these results the Data Monitoring Committee (DMC) was to decide whether to terminate the study or whether to continue and enroll the next 15 planned patients.
Interventions
- DRUG rhAnnexin V-128
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2017-09-18 |
| Est. Completion | 2018-11-12 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03232580
The ClinicalTrials.gov registry entry for NCT03232580 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 5 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Advanced Accelerator Applications, which has 8 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which rhAnnexin V-128 is the first listed.
NCT03232580 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03232580 about?
NCT03232580 is a clinical study titled "99mTc-rhAnnexin V-128 in Diagnosis of Spondyloarthritis". This single center, open-label, proof of concept (PoC) Phase II study aimed to assess the investigational imaging agent 99mTc-rhAnnexin V-128 in detecting spondyloarthritis (SpA) lesions. Overall, it was planned to recruit 20 adults with suspected or confirmed SpA. First, 5 patients were enrolled i...
What is the current status of trial NCT03232580?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 5 participants. The study started on 2017-09-18. Estimated completion is 2018-11-12.
What interventions are being tested in trial NCT03232580?
The interventions under investigation include: rhAnnexin V-128 (DRUG).
Who is sponsoring clinical trial NCT03232580?
This trial is sponsored by Advanced Accelerator Applications, which has 8 total clinical trials registered on ClinicalTrials.gov.
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