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NCT02401061 · ClinicalTrials.gov registry record · Phase 1
PRTX-100-202 Open-Label, Dose Escalation Study in Adult Patients With ITP
A Phase 1 study, sponsored by Protalex.
- Terminated
- Registry status
- Phase 1
- Development phase
- 13
- Enrollment target
NCT02401061 is a Phase 1 study that was terminated before completion, run by Protalex. The registered enrollment target is 13 participants.
The verdict
NCT02401061, a Phase 1 study, was terminated before completion, sponsored by Protalex.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 13 participants
- Enrollment target
Study Summary
Pre-clinical and clinical evaluations show that PRTX- 100 has biological activity that may lead to improved platelet levels where these are decreased due to immunological pathologies and that PRTX-100 has an acceptable safety profile. In vivo treatment with PRTX-100 has been shown to raise platelet counts in a mouse model of immune thrombocytopenia (ITP). The primary objective of the study is to assess the efficacy of PRTX-100 in terms of platelet response in patients with chronic/persistent ITP. Funding Source - FDA OOPD (1R01FD005750-01A1)
Interventions
- DRUG PRTX-100
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2015-09 |
| Est. Completion | 2019-06-04 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02401061
The ClinicalTrials.gov registry entry for NCT02401061 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 13 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Protalex, which has 4 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which PRTX-100 is the first listed.
NCT02401061 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02401061 about?
NCT02401061 is a clinical study titled "PRTX-100-202 Open-Label, Dose Escalation Study in Adult Patients With ITP". Pre-clinical and clinical evaluations show that PRTX- 100 has biological activity that may lead to improved platelet levels where these are decreased due to immunological pathologies and that PRTX-100 has an acceptable safety profile. In vivo treatment with PRTX-100 has been shown to raise platelet ...
What is the current status of trial NCT02401061?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 13 participants. The study started on 2015-09. Estimated completion is 2019-06-04.
What interventions are being tested in trial NCT02401061?
The interventions under investigation include: PRTX-100 (DRUG).
Who is sponsoring clinical trial NCT02401061?
This trial is sponsored by Protalex, which has 4 total clinical trials registered on ClinicalTrials.gov.
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