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    Summary
    EudraCT Number:2008-000504-92
    Sponsor's Protocol Code Number:APX-PHP-07-008
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2008-11-12
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedAustria - BASG
    A.2EudraCT number2008-000504-92
    A.3Full title of the trial
    PHP for the Treatment of Excess Nitric Oxide in Distributive Shock (PHOENIX)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    PHP for the Treatment of Excess Nitric Oxide in Distributive Shock (PHOENIX)
    A.3.2Name or abbreviated title of the trial where available
    PHOENIX
    A.4.1Sponsor's protocol code numberAPX-PHP-07-008
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorApex Bioscience, Inc.
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportApex Bioscience, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationApex Bioscience, Inc.
    B.5.2Functional name of contact pointJoseph deAngelo
    B.5.3 Address:
    B.5.3.1Street Address109 Connor Drive, Suite 2102
    B.5.3.2Town/ cityChapel Hill
    B.5.3.3Post codeNC 27514
    B.5.3.4CountryUnited States
    B.5.4Telephone number001919405 4002
    B.5.5Fax number001919405 4010
    B.5.6E-mailjdeangelo@apexbioscience.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product namePyridoxalated hemoglobin polyoxyethylene conjugate
    D.3.2Product code PHP
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 900535-06-0
    D.3.9.2Current sponsor codePHP
    D.3.9.3Other descriptive namepPPHb
    D.3.10 Strength
    D.3.10.1Concentration unit mg/kg/h milligram(s)/kilogram/hour
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product Yes
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Catecholamine-resistant distributive shock
    E.1.1.1Medical condition in easily understood language
    Catecholamine-resistant distributive shock
    E.1.1.2Therapeutic area Diseases [C] - Bacterial Infections and Mycoses [C01]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level PT
    E.1.2Classification code 10040070
    E.1.2Term Septic shock
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    · To compare the effectiveness of continuous infusion PHP plus conventional vasopressor therapy to that of placebo (normal saline) plus conventional vasopressor therapy in patients with catecholamine-resistant distributive shock. Efficacy will be demonstrated by PHP significantly reducing 28-day all-cause mortality.

    · To compare over 28 days the safety and tolerability of continuous infusion PHP plus conventional vasopressor therapy to the safety and tolerability of placebo plus conventional vasopressor therapy by evaluating mortality, morbidity measured by indicators of organ failure, and the frequency and duration of adverse effects.
    E.2.2Secondary objectives of the trial
    None
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    SIRS Inclusion Criteria
    Patients with SIRS as characterized by two or more of the following conditions (worst values in a 24 hour period):
    a) Either respiratory rate ≥ 20 breaths/minute, or partial pressure of arterial carbon dioxide (PaCO2) ≤ 32 torr, or mechanical ventilation
    b) Heart rate ≥ 90 beats/minute
    c) Either hyperthermia ≥ 38°C, or hypothermia ≤ 36°C
    d) Either white blood cell (WBC) ≥ 12,000 cells/mm3, ≤ 4,000 cells/mm3, or ≥ 10% immature (band) forms

    Shock Inclusion Criteria
    Patients with adequate fluid resuscitation (see guidelines in Section IV.G.) and requiring a norepinephrine dose of ≥0.3 mcg/kg/min for at least one hour to maintain a MAP ≥ 65 mmHg but ≤ 80 mmHg within the first 24 hours of the initiation of norepinephrine treatment.
    E.4Principal exclusion criteria
    Exclusion Criteria
    · Patients who lack documented Informed Consent signed by the patient or his/her legally authorized representative
    · Patients that are pregnant
    · Patients less than 18 years old
    · Patients with suspicion of or active treatment for coronary artery disease within 60 days of enrollment defined as any of the following:
    - Acute myocardial infarction with an abnormal ECG indicative for myocardial
    infarction or abnormal regional wall motion (echocardiography)
    - Unstable angina with abnormal regional wall motion (echocardiography)
    and/or EF < 35%
    -Coronary revascularization (angioplasty, stenting, coronary bypass graft) if
    EF < 35 %
    - Patients who have received a stent within the last 12 months
    · Patients with suspicion of or active treatment for malignant arrhythmia within 60 days of enrollment defined as any of the following:
    - Ventricular Tachycardia
    - Ventricular Fibrillation
    - Appropriate defibrillator firing in patient with AICD
    Note: A pacemaker is not an exclusion criterion.
    · Patients with suspicion of or active treatment for congestive heart failure within 60 days of enrollment defined as any of the following:
    -Ejection fraction < 35% and LV end-diastolic dimension > 6.0 cm demonstrated by echocardiography or MUGA
    -Hospitalization primarily for congestive heart failure
    -NYHA Class IV congestive heart failure
    · Patients with suspicion of or active treatment for aortic valve heart disease within 60 days of enrollment defined as any of the following:
    - Aortic valve stenosis with area < 1.0 cm2
    - Severe aortic insufficiency
    - After aortic valve replacement if EF < 35%
    (If there is no history of coronary artery disease, malignant arrhythmia, congestive heart failure, or aortic valve heart disease, the patient may be enrolled without further cardiac evaluation. If history is ambiguous, an echocardiogram may be performed to exclude suspected diagnosis (e.g. to assess ejection fraction or aortic valve performance). Patients successfully treated for any of the above conditions earlier than 60 days before enrollment, who are asymptomatic and in stable clinical condition, may be enrolled (e.g. CABG 1 year before with no ongoing angina). This rule is not applied in patients with stents.
    Prior to randomization, the cardiac status of the subject, from the perspective of study eligibility, must be documented in the medical or research record, and be supported by the baseline medical history.
    · Patients with stage 3 or 4 solid tumors (TMN classification, group staging), hematologic malignancies with high tumor burden, CNS cancer (WHO stage 3 and 4)unless significant tumor mass was removed near occurence of shock.
    · Patients with dead bowel likely to result in death. After surgical removal of dead bowel the patient can be enrolled.
    · Patients receiving/scheduled to receive another investigational drug or have received an investigational drug in the previous 30 days
    · Patients with known hypersensitivity to blood products
    · Patients with hypovolemic shock from bleeding or other volume loss
    . Patients with anaphylactic shock
    · Patients who are likely to die within days for diseases or conditions other than catecholamine-dependent shock (e.g. multiple organ failure that is irreversible as distinct from multiple organ dysfunction that may resolve)
    · Patients with Glasgow Coma Score ≤ 7 at the time of admission and prior to the administration of confounding medications such as narcotics, sedatives or neuromuscular blockers
    · Patients that experienced trauma within the past 48 hours
    · Patients that experienced burns within the past 48 hours
    ·

    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint will be 28 day all-cause mortality
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 28
    E.5.2Secondary end point(s)
    - All-cause mortality at days 3, 7, 14, and 21;
    - Survival time;
    - Survivor days in the ICU censored at 28 days;
    - Survivors' hospital length of stay censored at 28 days;
    - Time on mechanical ventilation,
    - Time on pressors.
    - All-cause mortality at days 60 and 90
    E.5.2.1Timepoint(s) of evaluation of this end point
    3,7,14, 21, 28, 60 and 90 days
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA90
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    End of the trial will be the 90 day follow up contact with the patient (last visit).
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months8
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 270
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 184
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2008-11-12. Yes
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation Yes
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Due to the distributive shock subjects may be incapable of giving informed consent personally. Following the ERB approved institutional pratice at each study site provisions will be made to obtain consent from the subject's legal representative.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 454
    F.4.2.2In the whole clinical trial 454
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Standard medical treatment for the patient's condition
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2009-02-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-02-11
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2011-07-26
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