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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: Clinical Trial Phase 1 study, sponsored by Protalex.
NCT02401061 is a Phase 1 study that was terminated before completion, run by Protalex. The registered enrollment target is 13 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (78% lower). According to ClinicalTrials.gov, the official US trial registry.
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)
Primary Outcome
The primary efficacy endpoint is platelet response defined as a platelet count ≥ 30,000/μL and at least a doubling of baseline platelet count (determined on Day 1 prior to PRTX-100 administration) in patients with a baseline platelet count \< 30,000/μL. In patients receiving permitted treatments for ITP with a baseline platelet count ≥ 30,000/μL and \< 50,000/μL, an increase in platelet count to ≥ 50,000/μL and at least a doubling of baseline platelet count or an increase to \> 100,000/μL be con
Interventions
- DRUG PRTX-100
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2015-09 |
| Est. Completion | 2019-06-04 |
| Phase | Phase 1 |
Why NCT02401061 stopped before completion
NCT02401061 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 13 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (78% lower).
The record links to 0 conditions, and to 1 intervention - of which PRTX-100 is the first listed.
NCT02401061 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02401061's enrollment target sits among peer trials
13 1847th of 2000 higher than 149 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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