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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 is a Phase 2 study that was terminated before completion, run by PhaseBio Pharmaceuticals. The registered enrollment target is 25 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03795428
The ClinicalTrials.gov registry entry for NCT03795428 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 25 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is PhaseBio Pharmaceuticals, which has 13 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Pemziviptadil (PB1046) Injection is the first listed.
NCT03795428 reports 0 study locations.
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.
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