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NCT03795428 · ClinicalTrials.gov registry record · Phase 2
Long-Term, Open Label Extension Study of Pemziviptadil (PB1046) in PAH Subjects Following Completion of Study PB1046-PT-CL-0004
A Phase 2 study, sponsored by PhaseBio Pharmaceuticals.
- Terminated
- Registry status
- Phase 2
- Development phase
- 25
- Enrollment target
NCT03795428: Clinical Trial Phase 2 study, sponsored by PhaseBio Pharmaceuticals.
NCT03795428 is a Phase 2 study that was terminated before completion, run by PhaseBio Pharmaceuticals. The registered enrollment target is 25 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (81% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03795428, a Phase 2 study, was terminated before completion, sponsored by PhaseBio Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 25 participants
- Enrollment target
Study Summary
This is a multi-center, Phase 2 Long-Term, Open Label Extension (OLE) Study to assess the safety and tolerability of pemziviptadil (PB1046) at an optimally titrated dose. This is a Long-Term, Open label Extension (OLE) Study for subjects with (PAH), having participated in double-blind Study PB1046-PT-CL-0004. The study will include adult subjects previously diagnosed with symptomatic PAH, who are receiving background clinician-directed therapy for PAH. During this period, subjects will continue to be followed for safety and tolerability, as well as for periodic efficacy, quality of life data and immunogenicity. The study will continue per the schedule of events until such time when pemziviptadil (PB1046) is able to be self-administered, becomes commercially available to the subjects in a particular country or region, or the sponsor terminates the study due to lack of efficacy, safety or other reasons.
Interventions
- DRUG Pemziviptadil (PB1046) Injection
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2019-04-10 |
| Est. Completion | 2022-01-11 |
| Phase | Phase 2 |
Why NCT03795428 stopped before completion
NCT03795428 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (81% lower).
The record links to 0 conditions, and to 1 intervention - of which Pemziviptadil (PB1046) Injection is the first listed.
NCT03795428 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03795428 about?
NCT03795428 is a clinical study titled "Long-Term, Open Label Extension Study of Pemziviptadil (PB1046) in PAH Subjects Following Completion of Study PB1046-PT-CL-0004". This is a multi-center, Phase 2 Long-Term, Open Label Extension (OLE) Study to assess the safety and tolerability of pemziviptadil (PB1046) at an optimally titrated dose. This is a Long-Term, Open label Extension (OLE) Study for subjects with (PAH), having participated in double-blind Study PB1046-P...
What is the current status of trial NCT03795428?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 25 participants. The study started on 2019-04-10. Estimated completion is 2022-01-11.
What interventions are being tested in trial NCT03795428?
The interventions under investigation include: Pemziviptadil (PB1046) Injection (DRUG).
Who is sponsoring clinical trial NCT03795428?
This trial is sponsored by PhaseBio Pharmaceuticals, which has 13 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03795428's enrollment target sits among peer trials
25 1719th of 2000 higher than 245 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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