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NCT04057040 · ClinicalTrials.gov registry record · Phase 2
Hepcidin Mimetic in Patients With Polycythemia Vera (REVIVE)
A Phase 2 study, sponsored by Protagonist Therapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 70
- Enrollment target
NCT04057040: Completed Phase 2 study, sponsored by Protagonist Therapeutics.
NCT04057040 is a Phase 2 study that has completed, run by Protagonist Therapeutics. The registered enrollment target is 70 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (47% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04057040, a Phase 2 study, has completed, sponsored by Protagonist Therapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 70 participants
- Enrollment target
Study Summary
This is a Phase 2 study with an open-label dose escalation phase followed by a blinded withdrawal phase and an open label extension. The study is designed to monitor the PTG-300 safety profile and to obtain preliminary evidence of efficacy of PTG-300 for the treatment of phlebotomy-requiring polycythemia vera.
Primary Outcome
A subject will be considered a responder during the blinded randomized withdrawal phase if hematocrit control is maintained without phlebotomy eligibility. "Phlebotomy eligibility" is defined as any one of the following criteria being met: * hematocrit ≥45% that was ≥3% higher than Week 29 pre-randomization hematocrit value, or * hematocrit \>48%, or * an increase of ≥5% in hematocrit compared to Week 29 pre-randomization hematocrit value.
Interventions
- DRUG Placebo
- DRUG PTG-300
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 70 participants |
| Start Date | 2019-10-01 |
| Est. Completion | 2024-06-17 |
| Phase | Phase 2 |
What the finished NCT04057040 record still lists
NCT04057040 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 70 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (47% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04057040 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04057040 about?
NCT04057040 is a clinical study titled "Hepcidin Mimetic in Patients With Polycythemia Vera (REVIVE)". This is a Phase 2 study with an open-label dose escalation phase followed by a blinded withdrawal phase and an open label extension. The study is designed to monitor the PTG-300 safety profile and to obtain preliminary evidence of efficacy of PTG-300 for the treatment of phlebotomy-requiring polycyt...
What is the current status of trial NCT04057040?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 70 participants. The study started on 2019-10-01. Estimated completion is 2024-06-17.
What interventions are being tested in trial NCT04057040?
The interventions under investigation include: Placebo (DRUG), PTG-300 (DRUG).
Who is sponsoring clinical trial NCT04057040?
This trial is sponsored by Protagonist Therapeutics, which has 8 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04057040's enrollment target sits among peer trials
70 937th of 2000 higher than 1,036 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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