- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02216279
Phase-II Study of the Use of PulmoBind for Molecular Imaging of Pulmonary Hypertension (PB-02)
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Quebec
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Montreal, Quebec, Canada, H1T 1C8
- Montreal Heart Institute
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Montreal, Quebec, Canada
- Sir Mortimer B.Davis Jewish General Hospital
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Quebec city, Quebec, Canada
- Institut Universitaire De Cardiologie Et De Pneumologie De Québec
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
HEALTHY VOLUNTEERS:
Inclusion Criteria:
- Male of female participants greater than 18 years of age,
- Female participants must be post-menopausal (defined as two year after last menstrual cycle) or surgically sterilized or use 1 form of contraception with a urine negative pregnancy test (commercial brand: first response kit) within 2 hours of study drug injection,
Baseline measurements must be within limits of normal or judged non-clinically significant by the investigator:
- Blood pressure systolic 90 mmHg to 140 mmHg,and diastolic 50 mmHg to 90 mmHg;
- Heart rate: 50 to 100 beats per minute;
- Oral temperature: less than 37.6C;
- Respiratory rate: 12 to 20 breaths per minute;
- Lung function testing within 6 months;
- Electrocardiogram in the past three years;
- Chest X-Ray in the past three years;
- Electrocardiogram.
Exclusion Criteria:
- Any known chronic or acute medical condition with or without the need for chronic pharmacologic therapy or any condition that may interfere with normal biodistribution of PulmoBind. This includes but is not restricted to: lung parenchymal or lung vascular diseases such as chronic obstructive pulmonary disease, bronchitis, lung cancer, pleural effusion, emphysema, asthma, pulmonary fibrosis, occupational lung disease,pulmonary hypertension (primary or secondary), systemic hypertension, diabetes, cancer, kidney disease, liver disease, heart failure or previous myocardial infarction, coronary artery disease, peripheral vascular disease or inflammatory disease,
- Participants requiring chronic administration of any substance for a medical condition,
- Active smoking or history of smoking within 6 months,
- Alcoholism or known substance abuse,
- Psychotic,addictive or other disorder limiting the ability to provide informed consent or to comply with study requirements,
- Unable to tolerate study procedures (e.g. venipuncture, movement restrictions during imaging),
- Previous nuclear medicine study within one week (to avoid cross-contamination).
PULMONARY HYPERTENSION PARTICIPANTS:
Inclusion Criteria:
- Male of female participants greater than 18 years of age and upper age 70,
- Female participants must be post-menopausal (defined as two year after last menstrual cycle) or surgically sterilized or use 1 form of contraception with a urine negative pregnancy test (commercial brand: first response kit) within 2 hours of study drug injection,
Diagnosis of pulmonary hypertension (PH) according to the Dana Point PH classification of the following types:
- Type I: idiopathic, heritable or scleroderma spectrum of disease,
- Type IV: unoperated chronic thromboembolic PH.
- Participants with chronic thromboembolic pulmonary hypertension (CTEPH) must have a previous positive V/Q scan and multiple chronic/organised occlusive thrombi/emboli in the pulmonary arteries (main, lobar, segmental, subsegmental) on CT angiogram or conventional pulmonary angiography,
Documented hemodynamic diagnosis of significant PH by right heart catheterization - performed at any time prior to Screening showing:
- Resting mean pulmonary arterial pressure (mPAP) > 25 mmHg and
- Resting pulmonary vascular resistance (PVR) > 240 dyn/s.cm5 and
- Resting capillary wedge pressure (PCWP) or left ventricular end diastolic pressure (LVDEP) ≤ 15 mmHg (if available),
- New York Heart Association (NYHA) functional class II-III,
- Six minutes walking distance test of ≥ 250 meters, and ≤ 450 meters within 6 months,
- Echocardiogram documented in the participants medical history (including an agitated saline study),
- Computed tomography of the chest documented in the participants medical history.
Exclusion Criteria:
- Participants with impaired renal function defined as estimated creatinine clearance ≤ 30 ml/min (eGFR with modification of diet in renal disease (MDRD) calculator formula),
Significant liver impairment:
- Aspartate alanine transferase ( ALT) and/or Aspartate transaminase (AST) ≥ 3 x upper limit of normal (ULN)
- Bilirubin ≥ 1.5x ULN ( > 35% direct bilirubin)
- Unstable pulmonary arterial hypertension defined as recent syncope or World Health Organization (WHO) functional class IV,
- Participants with CTEPH not on anticoagulant therapy,
- Echocardiographic restrictive lung disease (total lung capacity < 70% of predicted) or obstructive (FEC1/Forced Vital Capacity < 70%),
- Systemic blood pressure < 90 mmHG systolic or less than 50 mmHG diastolic,
- Patient foramen ovale with significant right to left shunting with hypoxia (room air saturation < 88%),
- Active smoking within six months,
- More than minimal pulmonary fibrosis on high resolution computed tomography of the chest,
- The subject's clinical condition is such that they are not expected to remain clinically stable for the duration of the study,
- Active coronary artery disease or stable coronary artery disease that has required an intervention or any change of therapy within 6 months,
- Alcoholism or known substance abuse,
- Psychotic,addictive or other disorder limiting the ability to provide informed consent or to comply with study requirements,
- Participants who have participated in a clinical study involving another investigational drug or devise within four weeks before screening,
- Female participants who are pregnant or breastfeeding,
- Previous nuclear medicine study within one week,
- Unable to tolerate study procedures (e.g. venipuncture, movement restrictions during imaging).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Pulmonary Hypertension Patients
PulmoBind is a peptide derived from human adrenomedullin (hAM1-52), labelled with 99mTc (imaging isotope used in clinical medicine).
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PulmoBind is a peptide derived from human adrenomedullin (hAM1-52), labelled with 99mTc (imaging isotope used in clinical medicine).
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Active Comparator: Control Non-Smoking Participants
PulmoBind is a peptide derived from human adrenomedullin (hAM1-52), labelled with 99mTc (imaging isotope used in clinical medicine).
|
PulmoBind is a peptide derived from human adrenomedullin (hAM1-52), labelled with 99mTc (imaging isotope used in clinical medicine).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To determine the absence of allergic reaction after repeated exposures to PulmoBind in healthy participants
Time Frame: Static lung uptake 10 minutes duration post injection
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Static lung uptake 10 minutes duration post injection
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To determine the safety of PulmoBind in participants diagnosed with pulmonary hypertension.
Time Frame: Static lung uptake 10 minutes duration post injection
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Static lung uptake 10 minutes duration post injection
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To determine the capacity of PulmoBind lung scan for the detection of abnormal pulmonary circulation associated with pulmonary hypertension.
Time Frame: Status lung uptake 10 minutes duration post injection
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This is an efficacy outcome
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Status lung uptake 10 minutes duration post injection
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To determine the intra-subject variability for quantification of PulmoBind lung uptake in control participants
Time Frame: Status lung uptake 10 minutes duration post injection
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Status lung uptake 10 minutes duration post injection
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Determine the capacity of PulmoBind lung scan to diagnose pulmonary perfusion defects in participants with chronic thromboembolic pulmonary hypertension.
Time Frame: Status lung uptake 10 minutes duration post injection
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Status lung uptake 10 minutes duration post injection
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To correlate lung PulmoBind scan results with parameters of the severity of pulmonary hypertension: 6 minutes walking distance, New York Heart Association functional class, pulmonary artery pressure measured by echo, pulmonary artery pressure measured by
Time Frame: Status lung uptake 10 minutes duration post injection
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Status lung uptake 10 minutes duration post injection
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jocelyn Dupuis, MD, Montreal Heart Institute
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PulmoBind II safety Trial
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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