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NCT03556020 · ClinicalTrials.gov registry record · Phase 2
Phase 2 Study to Assess Safety, Tolerability and Efficacy of Once Weekly SC Pemziviptadil (PB1046) in Subjects With Symptomatic PAH
A Phase 2 study, sponsored by PhaseBio Pharmaceuticals.
- Terminated
- Registry status
- Phase 2
- Development phase
- 35
- Enrollment target
NCT03556020: Clinical Trial Phase 2 study, sponsored by PhaseBio Pharmaceuticals.
NCT03556020 is a Phase 2 study that was terminated before completion, run by PhaseBio Pharmaceuticals. The registered enrollment target is 35 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (74% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03556020, a Phase 2 study, was terminated before completion, sponsored by PhaseBio Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 35 participants
- Enrollment target
Study Summary
This is a multi-center, randomized, double-blind, controlled, Phase 2 study to assess the safety, tolerability, and efficacy of pemziviptadil (PB1046) at the optimally titrated dose after 16 weeks of treatment. Subjects will be randomized in a 2:1 ratio to one of two parallel dose groups: a) high-dose group where PB1046 will be up-titrated from a 0.2 mg/kg minimally effective starting dose to a target high dose level of at least 1.2 mg/kg or higher to a maximally tolerated dose (MTD), or b) a low-dose group that will start at 0.2 mg/kg and remain at this minimally effective dose (MED) level with sham up-titration. The total treatment period will be comprised of 2 phases: 1) an initial 10 week dose titration phase in which weekly doses of PB1046 will be titrated (or sham titrated) up to a target dose level of at least 1.2 mg/kg or higher to the MTD, and 2) a maintenance of treatment phase that begins when subjects reach week 11 and continues for 6 weeks during which no further up-titration should occur.
Interventions
- DRUG Pemziviptadil (PB1046)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2018-07-15 |
| Est. Completion | 2022-01-07 |
| Phase | Phase 2 |
Why NCT03556020 stopped before completion
NCT03556020 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 35 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (74% lower).
The record links to 0 conditions, and to 1 intervention - of which Pemziviptadil (PB1046) is the first listed.
NCT03556020 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03556020 about?
NCT03556020 is a clinical study titled "Phase 2 Study to Assess Safety, Tolerability and Efficacy of Once Weekly SC Pemziviptadil (PB1046) in Subjects With Symptomatic PAH". This is a multi-center, randomized, double-blind, controlled, Phase 2 study to assess the safety, tolerability, and efficacy of pemziviptadil (PB1046) at the optimally titrated dose after 16 weeks of treatment. Subjects will be randomized in a 2:1 ratio to one of two parallel dose groups: a) high-do...
What is the current status of trial NCT03556020?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 35 participants. The study started on 2018-07-15. Estimated completion is 2022-01-07.
What interventions are being tested in trial NCT03556020?
The interventions under investigation include: Pemziviptadil (PB1046) (DRUG).
Who is sponsoring clinical trial NCT03556020?
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 NCT03556020's enrollment target sits among peer trials
35 1524th of 2000 higher than 462 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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