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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 is a Phase 2 study that was terminated before completion, run by PhaseBio Pharmaceuticals. The registered enrollment target is 35 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03556020
The ClinicalTrials.gov registry entry for NCT03556020 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 35 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) is the first listed.
NCT03556020 reports 0 study locations.
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.
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