Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44334   clinical trials with a EudraCT protocol, of which   7366   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2015-003510-25
    Sponsor's Protocol Code Number:2014-PT029
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-10-01
    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 ConcernedGermany - PEI
    A.2EudraCT number2015-003510-25
    A.3Full title of the trial
    A Phase I-II Study of the Safety and Efficacy of a True Human Antibody, 514G3, in Subjects Hospitalized with Bacteremia Due to Staphylococcus Aureus
    Eine Phase-I-II-Studie über die Sicherheit und Wirksamkeit eines rein humanen Antikörpers, 514G3, bei Patienten, die infolge einer Staphylococcus aureus-Bakteriämie hospitalisiert wurden
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Not available
    A.4.1Sponsor's protocol code number2014-PT029
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02357966
    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 SponsorXBiotech USA, 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 supportXBiotech USA, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationXBiotech USA, Inc.
    B.5.2Functional name of contact pointClinical Trial Information
    B.5.3 Address:
    B.5.3.1Street Address8201 E Riverside Drive, Building 4, Suite 100
    B.5.3.2Town/ cityAustin
    B.5.3.3Post code78744
    B.5.3.4CountryUnited States
    B.5.4Telephone number15123862900
    B.5.6E-mailinfo@xbiotech.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 namerecombinant human IgG3 monoclonal antibody specific for SpA
    D.3.2Product code 514G3
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    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 No
    D.3.11.9Recombinant medicinal product Yes
    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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 Yes
    D.2.1.1.1Trade name Staphylex
    D.2.1.1.2Name of the Marketing Authorisation holderActavis Group PTC ehf
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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.3.4Pharmaceutical form Powder for solution for injection/infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 No
    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 placeboConcentrate for solution 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
    Staphylococcus aereus Bacteremia
    E.1.1.1Medical condition in easily understood language
    Bacterial Infection due to Staphylococcus aereus
    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 19.1
    E.1.2Level LLT
    E.1.2Classification code 10058887
    E.1.2Term Staphylococcus aureus bacteremia
    E.1.2System Organ Class 100000004862
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Phase I: Determination of Maximum tolerated dose
    Phase II: Safety and Tolerability
    E.2.2Secondary objectives of the trial
    Efficacy of 514G3 in subjects hospitalized with bacteremia, Pharmacokinetics of 514G3
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    No waivers/exemptions will be granted for protocol inclusion/exclusion criteria.

    Subjects are included in the study if they meet all of the following criteria:
    1. One or more blood cultures positive for staphylococcus aureus within 2 days of randomization. Note that the 2-day clock begins when the culture is determined to be positive for staphylococcus aureus, and not when the culture was drawn.
    2. Age ≥18, male or female subjects.
    3. Adequate renal function, defined by serum creatinine ≤ 2 times the upper limit of normal (ULN). However, subjects with chronic renal insufficiency that are receiving dialysis are eligible even with a serum creatinine >2 times the upper limit of normal.
    4. Adequate hepatic function defined as:
     Total bilirubin ≤ 3 times the ULN.
     Alanine aminotransferase (ALT) ≤ 10 times the ULN.
    5. Adequate bone marrow function as defined as:
     Absolute neutrophil count (neutrophil and bands) of  1,500/mm3 ( 1.5 x 109/L)
     Platelet count  100,000/mm3
    6. For women of childbearing potential (WOCBP), a negative serum pregnancy test result at Screening.
    7. Signed and dated institutional review board (IRB)/ Ethics Committee (EC)-approved informed consent before any protocol-specific screening procedures are performed. If the subject is unable to sign, the LAR may sign as their representative.
    8. Expected survival unrelated to the staphylococcal bacteremia of at least 2 months.
    9. If the patient has a central venous catheter in place at the time of qualifying blood culture, and the bacteremia is thought to be secondary to the catheter, the subject and his/her primary health care provider must agree to having the catheter removed within 5 days of randomization
    E.4Principal exclusion criteria
    Subjects with ANY of the following will be excluded from the study:
    1. Polymicrobial bacteremia.
    2. Known or suspected complicated bacteremia:
    a. Meningitis
    b. Brain abscess
    c. Epidural abscess
    d. Intracranial hemorrhage due to mycotic aneurysm
    e. Definite Left Sided Endocarditis as defined by modified Duke criteria (Right-sided endocarditis is allowed):
    f. Visceral abscess (Liver,Spleen, Kidney)
    g. Staphylococcal Pneumonia (any one criteria below)
    i. Pulmonary infiltrate consistent with pneumonia
    ii. S aureus recovered from pleural fluid or bronchoalveolar lavage
    iii. Clinical evidence of pneumonia (increased FiO2, elevated respiratory rate, cough, purulent sputum)
    h. Pyomyositis
    i. Septic arthritis
    j. Septic thrombophlebitis
    3. Need for emergent valve surgery at the time of screening, and/or the presence of decompensated heart failure or cardiogenic shock.
    4. History of HIV Infection with a nadir CD4+ count of <200 cells/mm3 upon the most recent measurement
    5. Subjects with history of hypersensitivity to compounds of similar chemical or biologic composition to 514G3 or any component of its formulations.
    6. Women who are pregnant or breastfeeding.
    7. Non-removable intravascular foreign material in-situ when the qualifying blood culture was performed (eg cardiac pacemaker, defibrillator, prosthetic heart valve). Extravascular prostheses (prosthetic joints, surgical mesh, orthopedic pins/plates) are allowed as long as there is no evidence of infection at the site at the time of enrollment.
    8. Presence of septic shock during or prior to screening. Septic shock is defined as sepsis-induced hypotension persisting despite adequate fluid resuscitation
    9. Investigational agent in past 30 days
    E.5 End points
    E.5.1Primary end point(s)
    Primary Endpoint of Phase I:
    • MTD will be determined as the dose level at which no subjects experience a single probably or definitely related Grade 4 AE, and no more than one subject experiences a probably or definitely related Grade 3 AE
    Primary Endpoint of Phase II:
    • Safety and tolerability of 514G will be assessed by AE’s, serious adverse events including abnormalities of lab parameters
    E.5.1.1Timepoint(s) of evaluation of this end point
    MTD = Day 14 after treatment
    For safety assessments: Subjects will be followed for 30 days of hospitalization
    E.5.2Secondary end point(s)
    Pharmacokinetics will be determined by analyzing AUC, tmax, Cmax and t1/2 for 514G3

    Efficacy of 514G3 will be determined by:
    • Time to clearance of bacteremia
    • Time to resolution of fever
    • Fever resolution rate at 72 hours of dosing
    • Length of hospitalization
    • Difference in Serious Adverse Events (SAEs) between arms
    • Difference in opsonophagocytosis activity between arms (pharmacodynamics)
    E.5.2.1Timepoint(s) of evaluation of this end point
    PK: Determination of serum half-life of 514G3 every day until day 14 and then every 2 days up to 2 consecutives days with negative results (see primary endpoint) or Day 28 (maximum)
    Time to clearance of bacterimia: Time to sterile culture expressed in interval in days from the first dose of study drug until 2 consecutive days of negative blood cultures (Max day 28)
    Duration of fever (time frame = 28 days)
    Lenght of hopsitalization (time frame = 28 days)
    Difference in Serious Adverse Events (SAEs) between arms (time frame = 28 days)
    Difference in opsonophagocytosis activity between arms (pharmacodynamics) (time frame = 28 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 Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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) Yes
    E.7.1.1First administration to humans Yes
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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) Yes
    E.8.2.2Placebo Yes
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Standard IV antibiotic therapy
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Korea, Democratic People's Republic of
    United States
    E.8.7Trial has a data monitoring committee No
    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
    Last patient, last visit
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    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: 52
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 52
    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 No
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Only in exceptional situations, in which a potential trial subject cannot consent personnally due to their underlying disease (bacteremia) a Legally Authorized Representative (LAR) may consent to trial participation on their behalf.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state8
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 8
    F.4.2.2In the whole clinical trial 52
    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)
    If patient requires further medication, standard therapy is applicable
    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 Decision2016-01-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-12-11
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-03-27
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Fri May 02 18:39:17 CEST 2025 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA