<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03013426</url>
  </required_header>
  <id_info>
    <org_study_id>PRO16110118</org_study_id>
    <nct_id>NCT03013426</nct_id>
  </id_info>
  <brief_title>A Phase Ib Study of NVX-508 in Sickle Cell Disease</brief_title>
  <official_title>A Phase Ib, Dose-finding and Pharmacodynamic Study of NVX-508 in Sickle Cell Disease Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Amma Owusu-Ansah, MD</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>NuvOx LLC</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Noguchi Memorial Institute for Medical Research</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Pittsburgh</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This Phase 1b study in adults with sickle cell disease (SCD) in steady-state (non-acutely&#xD;
      ill) aims to evaluate safety and toxicity of NVX-508 in a multi-dosing paradigm as well as to&#xD;
      determine the maximum tolerated dose (MTD) in this population. The information gained from&#xD;
      this study will be used in making decisions about the appropriate dose(s) and dosing schedule&#xD;
      in future multicenter studies of the efficacy of NVX-508 in the treatment of vaso-occlusive&#xD;
      episodes (VOE).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Sickle cell disease (SCD) is a genetic disorder of hemoglobin that affects millions of&#xD;
      individuals worldwide, with sub-Saharan Africa bearing the greatest burden of disease. The&#xD;
      leading causes of hospitalization and death in individuals with sickle cell disease are&#xD;
      painful VOE (associated with tissue injury from reduced oxygen supply) and &quot;acute chest&#xD;
      syndrome&quot; respectively. Acute chest syndrome (ACS) is a form of acute lung injury unique to&#xD;
      SCD that arises de novo or during the course of painful VOE.&#xD;
&#xD;
      A safe, reliable therapeutic deployed early in the course of painful VOE (with or without&#xD;
      ACS) that restores oxygen supply to tissues, could potentially attenuate tissue injury,&#xD;
      resolve pain and improve patient outcomes.&#xD;
&#xD;
      NVX-508 is a liquid fluorocarbon which transports oxygen. Stoichiometrically, NVX-508 has 200&#xD;
      times the oxygen carrying capacity of human hemoglobin.Oxygen is taken up by NVX-508 as it&#xD;
      circulates through the alveolar capillary bed in the lungs and is released in blood and&#xD;
      tissues with low oxygen content. Consequently, if it were administered intravenously (IV) and&#xD;
      passed through the lungs of patients, it would take up oxygen, increasing the oxygen&#xD;
      concentration in blood in a dose-dependent manner and release it to tissues with low oxygen.&#xD;
&#xD;
      The active component of NVX-508 was originally developed as an ultrasound contrast agent. It&#xD;
      has been tested as such in over 2200 patients to whom it was safely administered as a bolus&#xD;
      IV injection.The pharmacokinetics of NVX-508 in humans exhibits a biphasic decline after an&#xD;
      iv bolus dose; a rapid initial decline followed by a slow terminal phase. The terminal phase&#xD;
      t1/2 (half- life) ranges from 81-99.5 min for doses of 0.15-0.35 ml/kg. NVX-508 is not&#xD;
      metabolized in humans, it is removed from the body unchanged in the breath (expired air) .&#xD;
&#xD;
      The rationale for studying NVX-508 for SCD is based on data from preclinical studies in the&#xD;
      mouse model of ACS. NVX-508 when used as rescue therapy in the mouse model, restored oxygen&#xD;
      saturation to baseline in mice experiencing hypoxemia, with 100% survival. NVX-508 reduced&#xD;
      pulmonary vascular congestion in SCD mice experiencing ACS.&#xD;
&#xD;
      Hypothesis: Intravenous delivery of 4 doses of NVX-508 of up to 0.17 ml/kg per dose, infused&#xD;
      over 30 minutes will be well tolerated.&#xD;
&#xD;
      Experimental design: Dose-ranging study in adults with diagnosis of SCD (SS, SC, S-Beta +&#xD;
      thalassemia, S-Beta0 thalassemia, and SS/S-Hemoglobin D (SD)or S in combination with another&#xD;
      variant hemoglobin) , who are in steady state (no painful episode, hospitalization or blood&#xD;
      transfusion in the preceding 4 weeks) will be recruited from a single institution (Ghana&#xD;
      Institute of Clinical Genetics, Korle-Bu, Accra, Ghana) to participate in the study.&#xD;
&#xD;
      The study has a 3 + 3 design. The first cohort of 3 subjects enrolled in the study shall be&#xD;
      administered one dose (0.05 mL/kg) of NVX-508, the next cohort of 3 will be treated using two&#xD;
      doses of NVX-508 at 0.05 mL/kg and subsequent cohort will be assigned to four doses of&#xD;
      NVX-508. Higher doses of 0.1ml/kg and 0.17ml/kg will be administered Intra-patient dose&#xD;
      escalation will not be allowed. Each dose shall be administered as slow IV push over 5-10&#xD;
      minutes with the next dose administered no less than 90 minutes after cessation of the prior&#xD;
      infusion, but not more than 120 minutes later.&#xD;
&#xD;
      Within each cohort, when the first subject is treated, there will be a 72 hour observation&#xD;
      interval before the next two subjects are treated at the same dose.&#xD;
&#xD;
      Study Procedures&#xD;
&#xD;
      A maximum of 24 adults with sickle cell disease aged 18 years and above will be recruited&#xD;
      into the study.&#xD;
&#xD;
      Screening - After giving informed consent, potential study participants will undergo&#xD;
      screening which comprises a standardized history and physical examination, lab tests (blood&#xD;
      counts, serum chemistries) and electrocardiogram( EKG). Eligible participants will return&#xD;
      within a week to be enrolled in the study.&#xD;
&#xD;
      Intervention - Study participants will go to a designated staffed phase I center for&#xD;
      administration of the study drug. They will have baseline evaluations (arterial blood gas&#xD;
      evaluation, hemoglobin and EKG) done prior to administration of the study drug. They will&#xD;
      receive 1, 2 or 4 doses of the study drug depending They will be continuously monitored by&#xD;
      medical research staff and the principal investigator prior to, during and in the 4 hour&#xD;
      observation period post intervention, with physical examination, labs ( complete blood&#xD;
      counts, serum chemistries, coagulation profile and blood samples drawn for blood gas&#xD;
      evaluation and EKGs.&#xD;
&#xD;
      Subjects will be discharged from the clinical trials facility after the 4 hour observation&#xD;
      period if they have had no adverse events requiring further clinical management. There will&#xD;
      be a one week post-intervention observation period for dose-limiting toxicity for each&#xD;
      subject, at the end of which they will have a follow up visit.&#xD;
&#xD;
      Follow up - 1 week after administration of NVX-508, subjects will have a follow-up visit at&#xD;
      the clinical trial facility which includes history, physical exam and labs. If there are no&#xD;
      adverse events or problems requiring continued clinical care and monitoring, subjects will&#xD;
      exit the study once the lab and clinical data from the visit have been completely reviewed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    NuvOx Pharma suspended the clinical program related to this study.&#xD;
  </why_stopped>
  <start_date type="Anticipated">July 2018</start_date>
  <completion_date type="Anticipated">December 2018</completion_date>
  <primary_completion_date type="Anticipated">December 2018</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Maximum tolerated dose of NVX-508</measure>
    <time_frame>1 year</time_frame>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Sickle Cell Disease</condition>
  <arm_group>
    <arm_group_label>NVX-508</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Administration of 1, 2 or 4 doses of NVX-508 at three dose levels; 0.05ml/kg. 0.1ml/kg and 0.17ml/kg in a 3 + 3 design.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>NVX-508</intervention_name>
    <description>Administration of NVX-508 emulsion intravenously</description>
    <arm_group_label>NVX-508</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Clinical diagnosis of SCD without acute VOE and/or ACS.&#xD;
&#xD;
          -  Age 18 years and older&#xD;
&#xD;
          -  Adequate hematologic, renal and hepatic function, defined by:&#xD;
&#xD;
               1. Absolute neutrophil count (ANC) ≥ 1.5 x109/L&#xD;
&#xD;
               2. Platelet count ≥ 100 x 109/L,&#xD;
&#xD;
               3. Hemoglobin ≥ 60 g/L&#xD;
&#xD;
               4. International normalized ratio (INR) &lt; 1.5 x upper limit of normal (ULN)&#xD;
&#xD;
               5. Activated partial thromboplastin time (APTT) &lt; 1.5 x ULN&#xD;
&#xD;
               6. Plasma creatinine &lt; 1.5 x ULN&#xD;
&#xD;
               7. Total bilirubin &lt; 2.5 x ULN (in the presence of Gilbert's syndrome or indirect&#xD;
                  hyperbilirubinemia caused by hemolysis)&#xD;
&#xD;
               8. Aspartate transaminase (AST) &lt; 2.5 x ULN&#xD;
&#xD;
               9. Alanine transaminase (ALT) &lt; 2.5 x ULN&#xD;
&#xD;
          -  Ability of the prospective subject to understand and willingness to sign written&#xD;
             informed consent document&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who have received any other investigational agent within 4 weeks before&#xD;
             enrollment.&#xD;
&#xD;
          -  Patients who have had a VOE/ACS in the previous 4 weeks before enrollment.&#xD;
&#xD;
          -  Stroke or transient ischemic attack within 6 months before enrollment.&#xD;
&#xD;
          -  Myocardial infarction within 6 months before enrollment, unstable angina, New York&#xD;
             Heart Association class II or greater congestive heart failure, or uncontrolled&#xD;
             hypertension (systolic BP &gt; 160 mmHg and/or diastolic BP &gt; 100 mmHg).&#xD;
&#xD;
          -  Congenital long QT syndrome, or corrected QT interval ( QTc) &gt; 450 milliseconds (msec)&#xD;
             in males and &gt; 470 mSec in females on EKG.&#xD;
&#xD;
          -  Uncontrolled arrhythmia or any history of clinically significant arrhythmia in the&#xD;
             past 6 months&#xD;
&#xD;
          -  Clinically-significant chronic obstructive pulmonary disease or asthma that is not&#xD;
             controlled by medication.&#xD;
&#xD;
          -  A history of other malignancies, except adequately treated non-melanoma skin cancer,&#xD;
             curatively treated in-situ cancer or other solid tumors curatively treated with no&#xD;
             evidence of disease for ≥ 2 years.&#xD;
&#xD;
          -  Current anticoagulant or antiplatelet therapy, except for prophylactic doses of low&#xD;
             molecular weight heparins or low-dose aspirin.&#xD;
&#xD;
          -  History of allergic reactions attributed to compounds of similar chemical composition&#xD;
             to NVX- 508.&#xD;
&#xD;
          -  Women who are pregnant or breastfeeding.&#xD;
&#xD;
          -  Inability to comply with study procedures.&#xD;
&#xD;
          -  History or evidence of any other clinically-significant condition that, in the opinion&#xD;
             of the investigator, would pose a risk to subject safety or interfere with study&#xD;
             procedures, evaluation or completion.&#xD;
&#xD;
          -  Patients with active VOE or ACS or other significant current acute complication of&#xD;
             SCD.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Amma T Owusu-Ansah, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Pittsburgh</affiliation>
  </overall_official>
  <reference>
    <citation>Modell B, Darlison M. Global epidemiology of haemoglobin disorders and derived service indicators. Bull World Health Organ. 2008 Jun;86(6):480-7. doi: 10.2471/blt.06.036673.</citation>
    <PMID>18568278</PMID>
  </reference>
  <reference>
    <citation>Grosse SD, Odame I, Atrash HK, Amendah DD, Piel FB, Williams TN. Sickle cell disease in Africa: a neglected cause of early childhood mortality. Am J Prev Med. 2011 Dec;41(6 Suppl 4):S398-405. doi: 10.1016/j.amepre.2011.09.013.</citation>
    <PMID>22099364</PMID>
  </reference>
  <reference>
    <citation>Johnson JL, Dolezal MC, Kerschen A, Matsunaga TO, Unger EC. In vitro comparison of dodecafluoropentane (DDFP), perfluorodecalin (PFD), and perfluoroctylbromide (PFOB) in the facilitation of oxygen exchange. Artif Cells Blood Substit Immobil Biotechnol. 2009;37(4):156-62. doi: 10.1080/10731190903043192. Epub 2009 Jun 22.</citation>
    <PMID>19548131</PMID>
  </reference>
  <reference>
    <citation>Riess JG. Understanding the fundamentals of perfluorocarbons and perfluorocarbon emulsions relevant to in vivo oxygen delivery. Artif Cells Blood Substit Immobil Biotechnol. 2005;33(1):47-63. doi: 10.1081/bio-200046659.</citation>
    <PMID>15768565</PMID>
  </reference>
  <reference>
    <citation>Grayburn PA, Weiss JL, Hack TC, Klodas E, Raichlen JS, Vannan MA, Klein AL, Kitzman DW, Chrysant SG, Cohen JL, Abrahamson D, Foster E, Perez JE, Aurigemma GP, Panza JA, Picard MH, Byrd BF 3rd, Segar DS, Jacobson SA, Sahn DJ, DeMaria AN. Phase III multicenter trial comparing the efficacy of 2% dodecafluoropentane emulsion (EchoGen) and sonicated 5% human albumin (Albunex) as ultrasound contrast agents in patients with suboptimal echocardiograms. J Am Coll Cardiol. 1998 Jul;32(1):230-6. doi: 10.1016/s0735-1097(98)00219-8.</citation>
    <PMID>9669275</PMID>
  </reference>
  <reference>
    <citation>Correas JM, Meuter AR, Singlas E, Kessler DR, Worah D, Quay SC. Human pharmacokinetics of a perfluorocarbon ultrasound contrast agent evaluated with gas chromatography. Ultrasound Med Biol. 2001 Apr;27(4):565-70. doi: 10.1016/s0301-5629(00)00363-x.</citation>
    <PMID>11368867</PMID>
  </reference>
  <verification_date>July 2018</verification_date>
  <study_first_submitted>January 3, 2017</study_first_submitted>
  <study_first_submitted_qc>January 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 6, 2017</study_first_posted>
  <last_update_submitted>July 12, 2018</last_update_submitted>
  <last_update_submitted_qc>July 12, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">July 16, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Pittsburgh</investigator_affiliation>
    <investigator_full_name>Amma Owusu-Ansah, MD</investigator_full_name>
    <investigator_title>Assistant Professor of Medicine and Clinical Director, Center for Translational and International Hematology</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anemia, Sickle Cell</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03013426
org study id: PRO16110118
nct id: NCT03013426
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
This Phase 1b study in adults with sickle cell disease (SCD) in steady-state (non-acutely
      ill) aims to evaluate safety and toxicity of NVX-508 in a multi-dosing paradigm as well as to
      determine the maximum tolerated dose (MTD) in this population. The information gained from
      this study will be used in making decisions about the appropriate dose(s) and dosing schedule
      in future multicenter studies of the efficacy of NVX-508 in the treatment of vaso-occlusive
      episodes (VOE).
Sickle cell disease (SCD) is a genetic disorder of hemoglobin that affects millions of
      individuals worldwide, with sub-Saharan Africa bearing the greatest burden of disease. The
      leading causes of hospitalization and death in individuals with sickle cell disease are
      painful VOE (associated with tissue injury from reduced oxygen supply) and "acute chest
      syndrome" respectively. Acute chest syndrome (ACS) is a form of acute lung injury unique to
      SCD that arises de novo or during the course of painful VOE.

      A safe, reliable therapeutic deployed early in the course of painful VOE (with or without
      ACS) that restores oxygen supply to tissues, could potentially attenuate tissue injury,
      resolve pain and improve patient outcomes.

      NVX-508 is a liquid fluorocarbon which transports oxygen. Stoichiometrically, NVX-508 has 200
      times the oxygen carrying capacity of human hemoglobin.Oxygen is taken up by NVX-508 as it
      circulates through the alveolar capillary bed in the lungs and is released in blood and
      tissues with low oxygen content. Consequently, if it were administered intravenously (IV) and
      passed through the lungs of patients, it would take up oxygen, increasing the oxygen
      concentration in blood in a dose-dependent manner and release it to tissues with low oxygen.

      The active component of NVX-508 was originally developed as an ultrasound contrast agent. It
      has been tested as such in over 2200 patients to whom it was safely administered as a bolus
      IV injection.The pharmacokinetics of NVX-508 in humans exhibits a biphasic decline after an
      iv bolus dose; a rapid initial decline followed by a slow terminal phase. The terminal phase
      t1/2 (half- life) ranges from 81-99.5 min for doses of 0.15-0.35 ml/kg. NVX-508 is not
      metabolized in humans, it is removed from the body unchanged in the breath (expired air) .

      The rationale for studying NVX-508 for SCD is based on data from preclinical studies in the
      mouse model of ACS. NVX-508 when used as rescue therapy in the mouse model, restored oxygen
      saturation to baseline in mice experiencing hypoxemia, with 100% survival. NVX-508 reduced
      pulmonary vascular congestion in SCD mice experiencing ACS.

      Hypothesis: Intravenous delivery of 4 doses of NVX-508 of up to 0.17 ml/kg per dose, infused
      over 30 minutes will be well tolerated.

      Experimental design: Dose-ranging study in adults with diagnosis of SCD (SS, SC, S-Beta +
      thalassemia, S-Beta0 thalassemia, and SS/S-Hemoglobin D (SD)or S in combination with another
      variant hemoglobin) , who are in steady state (no painful episode, hospitalization or blood
      transfusion in the preceding 4 weeks) will be recruited from a single institution (Ghana
      Institute of Clinical Genetics, Korle-Bu, Accra, Ghana) to participate in the study.

      The study has a 3 + 3 design. The first cohort of 3 subjects enrolled in the study shall be
      administered one dose (0.05 mL/kg) of NVX-508, the next cohort of 3 will be treated using two
      doses of NVX-508 at 0.05 mL/kg and subsequent cohort will be assigned to four doses of
      NVX-508. Higher doses of 0.1ml/kg and 0.17ml/kg will be administered Intra-patient dose
      escalation will not be allowed. Each dose shall be administered as slow IV push over 5-10
      minutes with the next dose administered no less than 90 minutes after cessation of the prior
      infusion, but not more than 120 minutes later.

      Within each cohort, when the first subject is treated, there will be a 72 hour observation
      interval before the next two subjects are treated at the same dose.

      Study Procedures

      A maximum of 24 adults with sickle cell disease aged 18 years and above will be recruited
      into the study.

      Screening - After giving informed consent, potential study participants will undergo
      screening which comprises a standardized history and physical examination, lab tests (blood
      counts, serum chemistries) and electrocardiogram( EKG). Eligible participants will return
      within a week to be enrolled in the study.

      Intervention - Study participants will go to a designated staffed phase I center for
      administration of the study drug. They will have baseline evaluations (arterial blood gas
      evaluation, hemoglobin and EKG) done prior to administration of the study drug. They will
      receive 1, 2 or 4 doses of the study drug depending They will be continuously monitored by
      medical research staff and the principal investigator prior to, during and in the 4 hour
      observation period post intervention, with physical examination, labs ( complete blood
      counts, serum chemistries, coagulation profile and blood samples drawn for blood gas
      evaluation and EKGs.

      Subjects will be discharged from the clinical trials facility after the 4 hour observation
      period if they have had no adverse events requiring further clinical management. There will
      be a one week post-intervention observation period for dose-limiting toxicity for each
      subject, at the end of which they will have a follow up visit.

      Follow up - 1 week after administration of NVX-508, subjects will have a follow-up visit at
      the clinical trial facility which includes history, physical exam and labs. If there are no
      adverse events or problems requiring continued clinical care and monitoring, subjects will
      exit the study once the lab and clinical data from the visit have been completely reviewed.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Maximum tolerated dose of NVX-508
time frame: 1 year
arm group label: NVX-508
arm group type: Experimental
description: Administration of 1, 2 or 4 doses of NVX-508 at three dose levels; 0.05ml/kg. 0.1ml/kg and 0.17ml/kg in a 3 + 3 design.
intervention type: Drug
intervention name: NVX-508
description: Administration of NVX-508 emulsion intravenously
arm group label: NVX-508
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Amma T Owusu-Ansah, MD
role: Principal Investigator
affiliation: University of Pittsburgh
citation: Modell B, Darlison M. Global epidemiology of haemoglobin disorders and derived service indicators. Bull World Health Organ. 2008 Jun;86(6):480-7. doi: 10.2471/blt.06.036673.
PMID: 18568278
citation: Grosse SD, Odame I, Atrash HK, Amendah DD, Piel FB, Williams TN. Sickle cell disease in Africa: a neglected cause of early childhood mortality. Am J Prev Med. 2011 Dec;41(6 Suppl 4):S398-405. doi: 10.1016/j.amepre.2011.09.013.
PMID: 22099364
citation: Johnson JL, Dolezal MC, Kerschen A, Matsunaga TO, Unger EC. In vitro comparison of dodecafluoropentane (DDFP), perfluorodecalin (PFD), and perfluoroctylbromide (PFOB) in the facilitation of oxygen exchange. Artif Cells Blood Substit Immobil Biotechnol. 2009;37(4):156-62. doi: 10.1080/10731190903043192. Epub 2009 Jun 22.
PMID: 19548131
citation: Riess JG. Understanding the fundamentals of perfluorocarbons and perfluorocarbon emulsions relevant to in vivo oxygen delivery. Artif Cells Blood Substit Immobil Biotechnol. 2005;33(1):47-63. doi: 10.1081/bio-200046659.
PMID: 15768565
citation: Grayburn PA, Weiss JL, Hack TC, Klodas E, Raichlen JS, Vannan MA, Klein AL, Kitzman DW, Chrysant SG, Cohen JL, Abrahamson D, Foster E, Perez JE, Aurigemma GP, Panza JA, Picard MH, Byrd BF 3rd, Segar DS, Jacobson SA, Sahn DJ, DeMaria AN. Phase III multicenter trial comparing the efficacy of 2% dodecafluoropentane emulsion (EchoGen) and sonicated 5% human albumin (Albunex) as ultrasound contrast agents in patients with suboptimal echocardiograms. J Am Coll Cardiol. 1998 Jul;32(1):230-6. doi: 10.1016/s0735-1097(98)00219-8.
PMID: 9669275
citation: Correas JM, Meuter AR, Singlas E, Kessler DR, Worah D, Quay SC. Human pharmacokinetics of a perfluorocarbon ultrasound contrast agent evaluated with gas chromatography. Ultrasound Med Biol. 2001 Apr;27(4):565-70. doi: 10.1016/s0301-5629(00)00363-x.
PMID: 11368867
responsible party type: Sponsor-Investigator
investigator affiliation: University of Pittsburgh
investigator full name: Amma Owusu-Ansah, MD
investigator title: Assistant Professor of Medicine and Clinical Director, Center for Translational and International Hematology
mesh term: Anemia, Sickle Cell
sharing ipd: No