Phase 2 Study to Assess Safety, Tolerability and Efficacy of Once Weekly SC Pemziviptadil (PB1046) in Subjects With Symptomatic PAH
Public ClinicalTrials.gov record NCT03556020. 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 Randomized, Double-Blind, Parallel Group, Phase 2 Study to Assess the Safety, Tolerability, and Efficacy of Once Weekly Subcutaneous (SC) Injections of a Sustained-Release Vasoactive Intestinal Peptide (VIP) Analogue, Pemziviptadil (PB1046), in Adult Subjects With Symptomatic Pulmonary Arterial Hypertension (PAH)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT03556020
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 35 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
- Jul 15, 2018 (Actual)
- Primary completion
- Jan 7, 2022 (Actual)
- Completion
- Jan 7, 2022 (Actual)
- Last update posted
- Aug 23, 2022
2018 – 2022
United States locations
- U.S. sites
- 26
- U.S. states
- 16
- U.S. cities
- 22
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| IMC - Diagnostic & Medical Clinic, LLC | Mobile | Alabama | 36604 | — |
| Banner University Medical Center | Tucson | Arizona | 85724 | — |
| University of California, San Diego (UCSD) | La Jolla | California | 92037 | — |
| University of Southern California, Keck School of Medicine | Los Angeles | California | 90033 | — |
| VA Greater Los Angeles Healthcare System | Los Angeles | California | 90073 | — |
| University of California-Davis | Sacramento | California | 95817 | — |
| University of Colorado Denver | Aurora | Colorado | 80045 | — |
| University of Florida | Gainesville | Florida | 32610 | — |
| The University Miami Health Hospital | Miami | Florida | 66160 | — |
| AdventHealth Orlando | Orlando | Florida | 32803 | — |
| The Emory Clinic | Atlanta | Georgia | 30322 | — |
| University of Chicago | Chicago | Illinois | 60637 | — |
| University of Iowa Hospitals & Clinics, Dept of Internal Medicine | Iowa City | Iowa | 52242 | — |
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | — |
| Tufts University | Boston | Massachusetts | 02111 | — |
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | — |
| Washington University School of Medicine | St Louis | Missouri | 63110 | — |
| NYU Langone Health | New York | New York | 10016 | — |
| University of Rochester Medical Center | Rochester | New York | 14642 | — |
| The Linder Center for Resarch and Education at The Christ Hospital | Cincinnati | Ohio | 45219 | — |
| University of Cincinnati | Cincinnati | Ohio | 45219 | — |
| INTEGRIS Baptist Medical Center | Oklahoma City | Oklahoma | 73112 | — |
| Allegheny General Hospital | Pittsburgh | Pennsylvania | 15212 | — |
| UPMC Presbyterian Hospital | Pittsburgh | Pennsylvania | 15213 | — |
| UT Southwestern Medical Center | Dallas | Texas | 75390 | — |
| Memorial Hermann Hospital CRU affiliated with University of Texas Health Science Center at Houston - McGovern Medical School | Houston | Texas | 77030 | — |
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 NCT03556020, 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 Aug 23, 2022 · Synced Oct 23, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03556020 live on ClinicalTrials.gov.