Pulmonary Arterial HypertensionPhase 2VIPNCT03556020
Phase 2 Study to Assess Safety, Tolerability and Efficacy of Once Weekly SC Pemziviptadil (PB1046) in Subjects With Symptomatic PAH
A Phase 2 study testing Pemziviptadil (PB1046) in people with Pulmonary Arterial Hypertension, run by PhaseBio Pharmaceuticals Inc. at 26 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Pulmonary Arterial Hypertension
- What is being tested?
- Pemziviptadil (PB1046)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 26 sitesUnited States
- Study dates
- 15 Jul 2018to 7 Jan 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
26 sites in 1 country.
26 sites in 1 country
United States26 sites
The Emory Clinic
Atlanta, Georgia, 30322
University of Colorado Denver
Aurora, Colorado, 80045
Tufts University
Boston, Massachusetts, 02111
Brigham and Women's Hospital
Boston, Massachusetts, 02115
University of Chicago
Chicago, Illinois, 60637
The Linder Center for Resarch and Education at The Christ Hospital
Cincinnati, Ohio, 45219
University of Cincinnati
Cincinnati, Ohio, 45219
UT Southwestern Medical Center
Dallas, Texas, 75390
University of Florida
Gainesville, Florida, 32610
Memorial Hermann Hospital CRU affiliated with University of Texas Health Science Center at Houston - McGovern Medical School
Houston, Texas, 77030
University of Iowa Hospitals & Clinics, Dept of Internal Medicine
Iowa City, Iowa, 52242
University of Kansas Medical Center
Kansas City, Kansas, 66160
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
The University Miami Health Hospital
Miami, Florida, 66160
IMC - Diagnostic & Medical Clinic, LLC
Mobile, Alabama, 36604
NYU Langone Health
New York, New York, 10016
INTEGRIS Baptist Medical Center
Oklahoma City, Oklahoma, 73112
AdventHealth Orlando
Orlando, Florida, 32803
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212
UPMC Presbyterian Hospital
Pittsburgh, Pennsylvania, 15213
University of Rochester Medical Center
Rochester, New York, 14642
University of California-Davis
Sacramento, California, 95817
Washington University School of Medicine
St Louis, Missouri, 63110
Banner University Medical Center
Tucson, Arizona, 85724
About this study
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)
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.
Read the 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.
- Conditions
- Pulmonary Arterial Hypertension
- Being tested
- Pemziviptadil (PB1046)
- Medical subject headings
- Pulmonary Arterial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pemziviptadil (PB1046)Drug
Pemziviptadil (PB1046), Once Weekly Subcutaneous Injection
| Study group | Role | What they receive |
|---|---|---|
| High Dose Group | Experimental | Maximally tolerated dose Drug: Pemziviptadil (PB1046), Once Weekly Subcutaneous Injection Receives: Drug: Pemziviptadil (PB1046) |
| Low Dose Group | Experimental | Minimally effective dose Drug: Pemziviptadil (PB1046), Once Weekly Subcutaneous Injection Receives: Drug: Pemziviptadil (PB1046) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of AEs
Measured: 172 days - Starting up to 30 days prior to first dose and completing 28 days after last dose.
Incidence of Clinical Laboratory Abnormalities
Measured: 172 days - Starting up to 30 days prior to first dose and completing 28 days after last dose.
Changes in Diastolic Blood Pressure
Measured: 172 days - Starting up to 30 days prior to first dose and completing 28 days after last dose.
Changes in Systolic Blood Pressure
Measured: 172 days - Starting up to 30 days prior to first dose and completing 28 days after last dose.
Changes in Oral Body Temperature
Measured: 172 days - Starting up to 30 days prior to first dose and completing 28 days after last dose.
Changes in Respiratory Rate
Measured: 172 days - Starting up to 30 days prior to first dose and completing 28 days after last dose.
Changes in Heart Rate
Measured: 172 days - Starting up to 30 days prior to first dose and completing 28 days after last dose.
12-Lead ECG - Incidence of clinically significant findings
Measured: 172 days - Starting up to 30 days prior to first dose and completing 28 days after last dose.
Immunogenicity
Measured: 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.
Change in baseline in pulmonary vascular resistance (PVR)
Measured: 142 days - Pre-dose (up to 30 days prior to first dose) and post-dose 16.
Secondary outcomes (8)
Change from baseline in 6MWD
Measured: 142 days - Pre-dose (up to 30 days prior to first dose) and one week post-dose 16.
Change from baseline in NT-proBNP
Measured: 142 days - Pre-dose (up to 30 days prior to first dose) and one week post-dose 16.
Change from baseline in cardiac index (CI)
Measured: 142 days - Pre-dose (up to 30 days prior to first dose) and one week post-dose 16.
Change from baseline in mean pulmonary artery pressure (mPAP)
Measured: 142 days - Pre-dose (up to 30 days prior to first dose) and one week post-dose 16.
Change from baseline in mean right atrial pressure (mRAP)
Measured: 142 days - Pre-dose (up to 30 days prior to first dose) and one week post-dose 16.
Change from baseline in wedge pressure
Measured: 142 days - Pre-dose (up to 30 days prior to first dose) and one week post-dose 16.
Change from baseline in mixed venous oxygen saturation (SvO2)
Measured: 142 days - Pre-dose (up to 30 days prior to first dose) and one week post-dose 16.
Change from baseline in pulmonary artery compliance
Measured: 142 days - Pre-dose (up to 30 days prior to first dose) and one week post-dose 16.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2018
- Study start15 Jul 2018
- Primary completion7 Jan 2022
- Study completion7 Jan 2022
Why it stopped: Terminated: Study drug resupply delayed (Covid-19)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Arterial HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- PhaseBio Pharmaceuticals Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03556020
- Sponsor's protocol ID
- PB1046-PT-CL-0004
- Acronym
- VIP
- Status last verified
- Aug 2022
- First submitted
- 1 Jun 2018
- Last updated
- 23 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT03556020
- Acronym / sponsor ID
- VIP / PB1046-PT-CL-0004
- Conditions
- Pulmonary Arterial Hypertension
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Terminated: Study drug resupply delayed (Covid-19)
- Enrolment
- 35 participants (actual)
- Lead sponsor
- PhaseBio Pharmaceuticals Inc.Industry (pharma, biotech, devices)
- Study start
- 15 Jul 2018 (actual)
- Primary completion
- 7 Jan 2022 (actual)
- Study completion
- 7 Jan 2022 (actual)
- First posted
- 14 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High Dose Group | Experimental | Drug: Pemziviptadil (PB1046)Maximally tolerated dose Drug: Pemziviptadil (PB1046), Once Weekly Subcutaneous Injection |
| Low Dose Group | Experimental | Drug: Pemziviptadil (PB1046)Minimally effective dose Drug: Pemziviptadil (PB1046), Once Weekly Subcutaneous Injection |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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;
Key exclusion criteria (18 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pemziviptadil (PB1046)Pemziviptadil (PB1046), Once Weekly Subcutaneous Injection | Drug | High Dose Group, Low Dose Group |
Primary outcome
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.
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.
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.
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.
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.
Changes in Respiratory Rate
Time frame: 172 days - Starting up to 30 days prior to first dose and completing 28 days after last dose.
Changes in Heart Rate
Time frame: 172 days - Starting up to 30 days prior to first dose and completing 28 days after last dose.
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.
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.
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.
8 secondary outcomes
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.
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.
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.
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.
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.
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.
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.
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.
Results and safety
The study was stopped early (reason given: Terminated: Study drug resupply delayed (Covid-19)). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
26 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pemziviptadil (PB1046) in people with Pulmonary Arterial Hypertension, run by PhaseBio Pharmaceuticals Inc. at 26 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 23 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Terminated: Study drug resupply delayed (Covid-19)). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2022.