Long-Term, Open Label Extension Study of Pemziviptadil (PB1046) in PAH Subjects Following Completion of Study PB1046-PT-CL-0004
Public ClinicalTrials.gov record NCT03795428. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Long-Term, Open Label Extension Study of Pemziviptadil (PB1046) Subcutaneous Injections in Pulmonary Arterial Hypertension Subjects Following Completion of Study PB1046-PT-CL-0004
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT03795428
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 25 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 79 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 10, 2019 (Actual)
- Primary completion
- Jan 11, 2022 (Actual)
- Completion
- Jan 11, 2022 (Actual)
- Last update posted
- Feb 22, 2022
2019 – 2022
United States locations
- U.S. sites
- 16
- U.S. states
- 11
- U.S. cities
- 13
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of California San Diego | La Jolla | California | 92037 | — |
| University of California - Davis | Sacramento | California | 95817 | — |
| University of Miami - Pulmonary Research Center | Miami | Florida | 33125 | — |
| Emory University, The Emory Clinic | Atlanta | Georgia | 30322 | — |
| University of Iowa Hospitals and Clinics | Iowa City | Iowa | 52242 | — |
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | — |
| Tufts Medical Center | Boston | Massachusetts | 02111 | — |
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | — |
| NYU Langone Health | New York | New York | 10016 | — |
| University of Rochester Medical Center | Rochester | New York | 14642 | — |
| The Lindner Center for Research and Education at The Christ Hospital | Cincinnati | Ohio | 45219 | — |
| University of Cincinnati | Cincinnati | Ohio | 45267 | — |
| INTEGRIS Baptist Medical Center | Oklahoma City | Oklahoma | 73112 | — |
| Allegheny General Hospital | Pittsburgh | Pennsylvania | 15212 | — |
| UPMC Presbyterian | Pittsburgh | Pennsylvania | 15213 | — |
| University of Texas Southwestern Medical Center | Dallas | Texas | 75390 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03795428, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Feb 22, 2022 · Synced Oct 24, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03795428 live on ClinicalTrials.gov.