Phase 2 Study to Assess Safety, Tolerability and Efficacy of Once Weekly SC Pemziviptadil (PB1046) in Subjects With Symptomatic PAH (VIP)
Primary Purpose
Pulmonary Arterial Hypertension
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Pemziviptadil (PB1046)
Sponsored by
About this trial
This is an interventional treatment trial for Pulmonary Arterial Hypertension
Eligibility Criteria
Inclusion Criteria:
- Male and female subjects with PAH, ≥18 and ≤ 79 years of age, who are symptomatic and have reduced exercise capacity due primarily to their PAH diagnosis and have been assessed by a qualified individual (i.e. physician, physician assistant, nurse practitioner) to be in NYHA/WHO functional class II or III;
- Willing and able to sign a written informed consent prior to all study-related procedures;
- Subjects with PAH belonging to one of the following subgroups of the Nice Clinical Classification of Pulmonary Hypertension Group 1: a. Idiopathic, b. Heritable, c. Drug or toxin-induced, d. Associated with connective tissue disease, HIV infection, portal hypertension, congenital heart disease (pulmonary-to-systemic shunt;
- Two 6MWD test results > 50 m and < 550 m prior to randomization with results +/- 10% of each other. Note: Up to four tests may be conducted between Screening and Randomization for eligibility purposes;
- Hemodynamic assessment of PAH demonstrating elevated mPAP and PVR as indicated below during the Screening Period: a. mean pulmonary artery pressure (mPAP) of ≥ 25 mmHg; and, b. pulmonary vascular resistance (PVR) ≥ 400 dyne•sec/cm5; and, c. pulmonary capillary wedge pressure (PCWP) or left ventricular end diastolic pressure (LVEDP) of ≤ 12 mmHg if PVR ≥ 400 and < 500 dynes•sec/cm5; or PCWP/LVEDP ≤ 15 mmHg if PVR ≥ 500 dynes•sec/cm5;
- Body mass index ≥ 18 kg/m2 and ≤ 40 kg/m2 at screening;
- Meet the following criteria determined by pulmonary function tests completed no more than 24 weeks prior to screening: a. Forced expiratory volume in one second (FEV1) ≥ 55% of predicted normal, b. FEV1: FVC (forced vital capacity) ratio ≥ 0.60;
- Agrees to use a medically acceptable method of contraception (both male and female patients) throughout the entire study period and continuing for 30 days after their last dose of study drug;
- Stable background medical regimen of up to 3 oral PAH therapies for at least 30 days prior to Screening and having been on PAH therapy for at least 3 months;
- If a subject has historical diagnosis (prior to screening visit) of being positive for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV), must be clinically stable and if on therapy, must be on stable therapy for HIV or HCV for at least 3 months; Willing and able to understand and follow instructions; return to the study unit for specified study visits; and able to participate in the study for the entire period.
Exclusion Criteria:
- Concomitant medical disorder, condition, or history, that in the opinion of the Investigator would impair the subject's ability to participate in or complete the requirements of the study;
- Concomitant medical disorder that is expected to limit the subject's life-expectancy to ≤ 1 year;
- Pregnant or lactating female subjects;
- First positive result from serology testing at visit 1 (screening labs) for HIV, HBsAg, or HCV prior to randomization;
- Participation in another investigational drug study within 30 days prior to screening or participating in a non-medication study which, in the opinion of the Investigator, would interfere with the study compliance or outcome assessments;
- Use of chronic subcutaneous prostanoid/prostacyclin therapy for PAH within 30 days prior to screening, including prostacyclin receptor agonists;
- More than mild mitral or aortic valve disease, left ventricular ejection fraction < 50%, or left ventricular regional wall motion abnormality suggestive of active coronary artery disease on documented 2D-echocardiography occurring within 12 months of Screening;
- Sustained systolic blood pressure (SBP) < 95 mmHg and/or diastolic blood pressure (DBP) < 50 mmHg (confirmed by a duplicate seated reading) on at least 3 consecutive readings (self-monitored or office) at screening and prior to dosing, or overt symptomatic hypotension;
- Sustained resting heart rate >110 beats per minute (BPM) (confirmed by duplicate assessments of office vital signs or consecutive ECG assessments) on at least 3 consecutive readings at screening and prior to dosing;
- Clinically significant renal dysfunction at the Screening Visit as measured by the estimated glomerular filtration rate (eGFR)
- Significant liver dysfunction as measured by any one of the following at screening: a. alanine aminotransferase (ALT) >3.0 times upper limit of normal (ULN) or; b. aspartate aminotransferase (AST) >3.0 times ULN or; c. serum bilirubin ≥ 1.6 mg/dL;
- Known history of substance abuse within the past 1 year that in the opinion of the Investigator would impair the subject's ability to participate in or complete the requirements of the study;
- Any major surgical procedure within 90 days prior to screening or planned surgical procedure during the study period;
- Any in-patient hospitalization (defined as greater than 23 hours) within 30 days of subject screening;
- Enrollment within the past 3 months prior to screening or plans to enroll during the study into a cardiopulmonary rehabilitation program;
- Other medical or psychiatric condition which, in the opinion of the Investigator, would place the subject at increased risk or would preclude obtaining voluntary consent or would confound the objectives of study;
- Known hypersensitivity to study drug or any of the excipients of the drug formulation;
- More than two of the following: a. BMI > 35; b. Current atrial fibrillation; c. Current Diabetes Mellitus; d. Current hypertension; e. History of clinically significant coronary artery disease in prior 3 years.
Sites / Locations
- IMC - Diagnostic & Medical Clinic, LLC
- Banner University Medical Center
- University of California, San Diego (UCSD)
- University of Southern California, Keck School of Medicine
- VA Greater Los Angeles Healthcare System
- University of California-Davis
- University of Colorado Denver
- University of Florida
- The University Miami Health Hospital
- AdventHealth Orlando
- The Emory Clinic
- University of Chicago
- University of Iowa Hospitals & Clinics, Dept of Internal Medicine
- University of Kansas Medical Center
- Tufts University
- Brigham and Women's Hospital
- Washington University School of Medicine
- NYU Langone Health
- University of Rochester Medical Center
- The Linder Center for Resarch and Education at The Christ Hospital
- University of Cincinnati
- INTEGRIS Baptist Medical Center
- Allegheny General Hospital
- UPMC Presbyterian Hospital
- UT Southwestern Medical Center
- Memorial Hermann Hospital CRU affiliated with University of Texas Health Science Center at Houston - McGovern Medical School
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
High Dose Group
Low Dose Group
Arm Description
Maximally tolerated dose Drug: Pemziviptadil (PB1046), Once Weekly Subcutaneous Injection
Minimally effective dose Drug: Pemziviptadil (PB1046), Once Weekly Subcutaneous Injection
Outcomes
Primary Outcome Measures
Incidence and severity of AEs
Incidence of Clinical Laboratory Abnormalities
Changes in Diastolic Blood Pressure
Changes in Systolic Blood Pressure
Changes in Oral Body Temperature
Changes in Respiratory Rate
Changes in Heart Rate
12-Lead ECG - Incidence of clinically significant findings
Immunogenicity
Change in baseline in pulmonary vascular resistance (PVR)
Secondary Outcome Measures
Change from baseline in 6MWD
Change from baseline in NT-proBNP
Change from baseline in cardiac index (CI)
Change from baseline in mean pulmonary artery pressure (mPAP)
Change from baseline in mean right atrial pressure (mRAP)
Change from baseline in wedge pressure
Change from baseline in mixed venous oxygen saturation (SvO2)
Change from baseline in pulmonary artery compliance
Full Information
NCT ID
NCT03556020
First Posted
June 1, 2018
Last Updated
August 18, 2022
Sponsor
PhaseBio Pharmaceuticals Inc.
1. Study Identification
Unique Protocol Identification Number
NCT03556020
Brief Title
Phase 2 Study to Assess Safety, Tolerability and Efficacy of Once Weekly SC Pemziviptadil (PB1046) in Subjects With Symptomatic PAH
Acronym
VIP
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)
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Terminated
Why Stopped
Terminated: Study drug resupply delayed (Covid-19)
Study Start Date
July 15, 2018 (Actual)
Primary Completion Date
January 7, 2022 (Actual)
Study Completion Date
January 7, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
PhaseBio Pharmaceuticals Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
Detailed Description
The primary safety and tolerability objectives will be assessed by investigating the incidence and severity of adverse events (AEs) as well as changes from baseline in vital signs, laboratory parameters, ECGs and their relationship to pemziviptadil (PB1046). The primary efficacy objective will be assessed by investigating the change in PVR derived from right heart catheterization (RHC). Secondary efficacy objectives will be assessed by investigating the impact of pemziviptadil (PB1046) on change from baseline in 6 minute walk distance (6MWD) test and NT-proBNP, a prognostic biomarker for PAH, in the two groups (comparing the MTD and MED groups) at the end of the treatment period. In addition, the effect of pemziviptadil (PB1046) on other cardiopulmonary hemodynamic parameters (e.g. CI, mPAP, mRAP, wedge pressure and SvO2) as measured by RHC will be assessed. Changes in BDI, HRQoL, and NYHA/WHO (New York Heart Association/World Health Organization) FC will also be assessed.
An independent Data Safety Monitoring Board (DSMB) will periodically assess safety, efficacy and biomarker data to independently assess the overall safety profile of pemziviptadil (PB1046), to help adjudicate potential dose-limiting toxicities, and to monitor the overall benefit risk profile of pemziviptadil (PB1046) during the study. The DSMB will review the safety and tolerability data after the first 10 subjects while recruitment is ongoing.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Arterial Hypertension
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
35 (Actual)
8. Arms, Groups, and Interventions
Arm Title
High Dose Group
Arm Type
Experimental
Arm Description
Maximally tolerated dose Drug: Pemziviptadil (PB1046), Once Weekly Subcutaneous Injection
Arm Title
Low Dose Group
Arm Type
Experimental
Arm Description
Minimally effective dose Drug: Pemziviptadil (PB1046), Once Weekly Subcutaneous Injection
Intervention Type
Drug
Intervention Name(s)
Pemziviptadil (PB1046)
Intervention Description
Pemziviptadil (PB1046), Once Weekly Subcutaneous Injection
Primary Outcome Measure Information:
Title
Incidence and severity of AEs
Time Frame
172 days - Starting up to 30 days prior to first dose and completing 28 days after last dose.
Title
Incidence of Clinical Laboratory Abnormalities
Time Frame
172 days - Starting up to 30 days prior to first dose and completing 28 days after last dose.
Title
Changes in Diastolic Blood Pressure
Time Frame
172 days - Starting up to 30 days prior to first dose and completing 28 days after last dose.
Title
Changes in Systolic Blood Pressure
Time Frame
172 days - Starting up to 30 days prior to first dose and completing 28 days after last dose.
Title
Changes in Oral Body Temperature
Time Frame
172 days - Starting up to 30 days prior to first dose and completing 28 days after last dose.
Title
Changes in Respiratory Rate
Time Frame
172 days - Starting up to 30 days prior to first dose and completing 28 days after last dose.
Title
Changes in Heart Rate
Time Frame
172 days - Starting up to 30 days prior to first dose and completing 28 days after last dose.
Title
12-Lead ECG - Incidence of clinically significant findings
Time Frame
172 days - Starting up to 30 days prior to first dose and completing 28 days after last dose.
Title
Immunogenicity
Time Frame
172 days - Starting up to 30 days prior to first dose and completing 8 weeks after last dose. May be extended in the event that result does not return to baseline in time allotted.
Title
Change in baseline in pulmonary vascular resistance (PVR)
Time Frame
142 days - Pre-dose (up to 30 days prior to first dose) and post-dose 16.
Secondary Outcome Measure Information:
Title
Change from baseline in 6MWD
Time Frame
142 days - Pre-dose (up to 30 days prior to first dose) and one week post-dose 16.
Title
Change from baseline in NT-proBNP
Time Frame
142 days - Pre-dose (up to 30 days prior to first dose) and one week post-dose 16.
Title
Change from baseline in cardiac index (CI)
Time Frame
142 days - Pre-dose (up to 30 days prior to first dose) and one week post-dose 16.
Title
Change from baseline in mean pulmonary artery pressure (mPAP)
Time Frame
142 days - Pre-dose (up to 30 days prior to first dose) and one week post-dose 16.
Title
Change from baseline in mean right atrial pressure (mRAP)
Time Frame
142 days - Pre-dose (up to 30 days prior to first dose) and one week post-dose 16.
Title
Change from baseline in wedge pressure
Time Frame
142 days - Pre-dose (up to 30 days prior to first dose) and one week post-dose 16.
Title
Change from baseline in mixed venous oxygen saturation (SvO2)
Time Frame
142 days - Pre-dose (up to 30 days prior to first dose) and one week post-dose 16.
Title
Change from baseline in pulmonary artery compliance
Time Frame
142 days - Pre-dose (up to 30 days prior to first dose) and one week post-dose 16.
Other Pre-specified Outcome Measures:
Title
Change from baseline in Borg Dyspnea Index (BDI) at the end of treatment
Time Frame
142 days - Pre-dose (up to 30 days prior to first dose) and one week post-dose 16.
Title
Change from baseline in emPHasis-10 (HRQoL) score at the end of treatment
Time Frame
142 days - Pre-dose (up to 30 days prior to first dose) and one week post-dose 16.
Title
Change in NYHA/WHO Functional Class (FC) at the end of treatment
Time Frame
142 days - Pre-dose (up to 30 days prior to first dose) and one week post-dose 16.
Title
Incidence of clinical worsening over 16 weeks as defined by any one of the following (See description):
Description
All-cause mortality, Hospitalization due to worsening of PAH, Initiation of parenteral prostacyclin, Worsening of PAH either by >15% decrease in 6MWD or new or worsening right heart failure (RHF), or worsening of symptoms requiring escalation of PAH therapy
Time Frame
142 days - Pre-dose (up to 30 days prior to first dose) and post-dose 16.
Title
Time to clinical worsening with data censored at the end of treatment
Time Frame
142 days - Pre-dose (up to 30 days prior to first dose) and post-dose 16.
Title
Change from baseline in other PAH biomarkers at the end of treatment
Time Frame
142 days - Pre-dose (up to 30 days prior to first dose) and post-dose 16.
Title
Multi-dose pharmacokinetic (PK) profile of individually dose-titrated pemziviptadil (PB1046) administered once-weekly for 16 weeks - Cmax
Time Frame
Pre-dose (Dose 1), day 28 pre-dose, day 70 pre-dose, day 77 pre-dose, day 84 pre-dose, day 91 pre-dose, day 98 pre-dose, day 105 pre-dose, 1 and 3 hours post-dose, day 106, day 107, day 108, day 110 and day 112.
Title
Multi-dose pharmacokinetic (PK) profile of individually dose-titrated PB1046 administered once-weekly for 16 weeks - Tmax
Time Frame
Pre-dose (Dose 1), day 28 pre-dose, day 70 pre-dose, day 77 pre-dose, day 84 pre-dose, day 91 pre-dose, day 98 pre-dose, day 105 pre-dose, 1 and 3 hours post-dose, day 106, day 107, day 108, day 110 and day 112.
Title
Multi-dose pharmacokinetic (PK) profile of individually dose-titrated pemziviptadil (PB1046) administered once-weekly for 16 weeks - Ctrough
Time Frame
Pre-dose (Dose 1), day 28 pre-dose, day 70 pre-dose, day 77 pre-dose, day 84 pre-dose, day 91 pre-dose, day 98 pre-dose, day 105 pre-dose, 1 and 3 hours post-dose, day 106, day 107, day 108, day 110 and day 112.
Title
Multi-dose pharmacokinetic (PK) profile of individually dose-titrated pemziviptadil (PB1046) administered once-weekly for 16 weeks - Area Under Curve(0-t) [AUC(0-t)]
Time Frame
Pre-dose (Dose 1), day 28 pre-dose, day 70 pre-dose, day 77 pre-dose, day 84 pre-dose, day 91 pre-dose, day 98 pre-dose, day 105 pre-dose, 1 and 3 hours post-dose, day 106, day 107, day 108, day 110 and day 112.
Title
Multi-dose pharmacokinetic (PK) profile of individually dose-titrated pemziviptadil (PB1046) administered once-weekly for 16 weeks - AUC(0-tmax)
Time Frame
Pre-dose (Dose 1), day 28 pre-dose, day 70 pre-dose, day 77 pre-dose, day 84 pre-dose, day 91 pre-dose, day 98 pre-dose, day 105 pre-dose, 1 and 3 hours post-dose, day 106, day 107, day 108, day 110 and day 112.
Title
Multi-dose pharmacokinetic (PK) profile of individually dose-titrated pemziviptadil (PB1046) administered once-weekly for 16 weeks - AUC(tmax-t)
Time Frame
Pre-dose (Dose 1), day 28 pre-dose, day 70 pre-dose, day 77 pre-dose, day 84 pre-dose, day 91 pre-dose, day 98 pre-dose, day 105 pre-dose, 1 and 3 hours post-dose, day 106, day 107, day 108, day 110 and day 112.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male and female subjects with PAH, ≥18 and ≤ 79 years of age, who are symptomatic and have reduced exercise capacity due primarily to their PAH diagnosis and have been assessed by a qualified individual (i.e. physician, physician assistant, nurse practitioner) to be in NYHA/WHO functional class II or III;
Willing and able to sign a written informed consent prior to all study-related procedures;
Subjects with PAH belonging to one of the following subgroups of the Nice Clinical Classification of Pulmonary Hypertension Group 1: a. Idiopathic, b. Heritable, c. Drug or toxin-induced, d. Associated with connective tissue disease, HIV infection, portal hypertension, congenital heart disease (pulmonary-to-systemic shunt;
Two 6MWD test results > 50 m and < 550 m prior to randomization with results +/- 10% of each other. Note: Up to four tests may be conducted between Screening and Randomization for eligibility purposes;
Hemodynamic assessment of PAH demonstrating elevated mPAP and PVR as indicated below during the Screening Period: a. mean pulmonary artery pressure (mPAP) of ≥ 25 mmHg; and, b. pulmonary vascular resistance (PVR) ≥ 400 dyne•sec/cm5; and, c. pulmonary capillary wedge pressure (PCWP) or left ventricular end diastolic pressure (LVEDP) of ≤ 12 mmHg if PVR ≥ 400 and < 500 dynes•sec/cm5; or PCWP/LVEDP ≤ 15 mmHg if PVR ≥ 500 dynes•sec/cm5;
Body mass index ≥ 18 kg/m2 and ≤ 40 kg/m2 at screening;
Meet the following criteria determined by pulmonary function tests completed no more than 24 weeks prior to screening: a. Forced expiratory volume in one second (FEV1) ≥ 55% of predicted normal, b. FEV1: FVC (forced vital capacity) ratio ≥ 0.60;
Agrees to use a medically acceptable method of contraception (both male and female patients) throughout the entire study period and continuing for 30 days after their last dose of study drug;
Stable background medical regimen of up to 3 oral PAH therapies for at least 30 days prior to Screening and having been on PAH therapy for at least 3 months;
If a subject has historical diagnosis (prior to screening visit) of being positive for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV), must be clinically stable and if on therapy, must be on stable therapy for HIV or HCV for at least 3 months; Willing and able to understand and follow instructions; return to the study unit for specified study visits; and able to participate in the study for the entire period.
Exclusion Criteria:
Concomitant medical disorder, condition, or history, that in the opinion of the Investigator would impair the subject's ability to participate in or complete the requirements of the study;
Concomitant medical disorder that is expected to limit the subject's life-expectancy to ≤ 1 year;
Pregnant or lactating female subjects;
First positive result from serology testing at visit 1 (screening labs) for HIV, HBsAg, or HCV prior to randomization;
Participation in another investigational drug study within 30 days prior to screening or participating in a non-medication study which, in the opinion of the Investigator, would interfere with the study compliance or outcome assessments;
Use of chronic subcutaneous prostanoid/prostacyclin therapy for PAH within 30 days prior to screening, including prostacyclin receptor agonists;
More than mild mitral or aortic valve disease, left ventricular ejection fraction < 50%, or left ventricular regional wall motion abnormality suggestive of active coronary artery disease on documented 2D-echocardiography occurring within 12 months of Screening;
Sustained systolic blood pressure (SBP) < 95 mmHg and/or diastolic blood pressure (DBP) < 50 mmHg (confirmed by a duplicate seated reading) on at least 3 consecutive readings (self-monitored or office) at screening and prior to dosing, or overt symptomatic hypotension;
Sustained resting heart rate >110 beats per minute (BPM) (confirmed by duplicate assessments of office vital signs or consecutive ECG assessments) on at least 3 consecutive readings at screening and prior to dosing;
Clinically significant renal dysfunction at the Screening Visit as measured by the estimated glomerular filtration rate (eGFR)
Significant liver dysfunction as measured by any one of the following at screening: a. alanine aminotransferase (ALT) >3.0 times upper limit of normal (ULN) or; b. aspartate aminotransferase (AST) >3.0 times ULN or; c. serum bilirubin ≥ 1.6 mg/dL;
Known history of substance abuse within the past 1 year that in the opinion of the Investigator would impair the subject's ability to participate in or complete the requirements of the study;
Any major surgical procedure within 90 days prior to screening or planned surgical procedure during the study period;
Any in-patient hospitalization (defined as greater than 23 hours) within 30 days of subject screening;
Enrollment within the past 3 months prior to screening or plans to enroll during the study into a cardiopulmonary rehabilitation program;
Other medical or psychiatric condition which, in the opinion of the Investigator, would place the subject at increased risk or would preclude obtaining voluntary consent or would confound the objectives of study;
Known hypersensitivity to study drug or any of the excipients of the drug formulation;
More than two of the following: a. BMI > 35; b. Current atrial fibrillation; c. Current Diabetes Mellitus; d. Current hypertension; e. History of clinically significant coronary artery disease in prior 3 years.
Facility Information:
Facility Name
IMC - Diagnostic & Medical Clinic, LLC
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36604
Country
United States
Facility Name
Banner University Medical Center
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Facility Name
University of California, San Diego (UCSD)
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
University of Southern California, Keck School of Medicine
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
VA Greater Los Angeles Healthcare System
City
Los Angeles
State/Province
California
ZIP/Postal Code
90073
Country
United States
Facility Name
University of California-Davis
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
University of Colorado Denver
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
The University Miami Health Hospital
City
Miami
State/Province
Florida
ZIP/Postal Code
66160
Country
United States
Facility Name
AdventHealth Orlando
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Facility Name
The Emory Clinic
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
University of Iowa Hospitals & Clinics, Dept of Internal Medicine
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
Tufts University
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
NYU Langone Health
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
The Linder Center for Resarch and Education at The Christ Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
University of Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
INTEGRIS Baptist Medical Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Allegheny General Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Facility Name
UPMC Presbyterian Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
UT Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
Memorial Hermann Hospital CRU affiliated with University of Texas Health Science Center at Houston - McGovern Medical School
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Phase 2 Study to Assess Safety, Tolerability and Efficacy of Once Weekly SC Pemziviptadil (PB1046) in Subjects With Symptomatic PAH
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