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    Summary
    EudraCT Number:2014-000461-43
    Sponsor's Protocol Code Number:GV29216
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-10-30
    Trial results View 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 ConcernedHungary - National Institute of Pharmacy
    A.2EudraCT number2014-000461-43
    A.3Full title of the trial
    A PHASE 2 RANDOMIZED, DOUBLE-BLIND PLACEBO CONTROLLED TRIAL OF MHAA4549A, A MONOCLONAL ANTIBODY IN COMBINATION WITH OSELTAMIVIR VERSUS OSELTAMIVIR FOR TREATMENT OF SEVERE INFLUENZA A INFECTION
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study comparing MHAA4549A in combination with oseltamivir versus placebo in combination with oseltamivir for the treatment of severe influenza A infection
    A.4.1Sponsor's protocol code numberGV29216
    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 SponsorGenentech 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 supportGENENTECH, Inc. c/o F.Hoffmann-La Roche Ltd
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGENENTECH, Inc. c/o F.Hoffmann-La Roche Ltd
    B.5.2Functional name of contact pointTrial Information Support Line-TISL
    B.5.3 Address:
    B.5.3.1Street AddressGrenzacherstrasse 124
    B.5.3.2Town/ cityBasel
    B.5.3.3Post code4070
    B.5.3.4CountrySwitzerland
    B.5.6E-mailglobal.rochegenentechtrials@roche.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 nameMHAA4549A
    D.3.2Product code MHAA4549A/RO6876802
    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.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNn.a.
    D.3.9.1CAS number n.a.
    D.3.9.2Current sponsor codeMHAA4549A/RO6876802
    D.3.9.3Other descriptive name[anti-Influenza A, 39.29]
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    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 Yes
    D.3.11.13.1Other medicinal product typeRecombinant human monoclonal immunoglobulin G1 (IgG1) antibody
    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 Tamiflu
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration Limited
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNOSELTAMIVIR PHOSPHATE
    D.3.9.1CAS number 204255-11-8
    D.3.9.3Other descriptive nameOSELTAMIVIR PHOSPHATE
    D.3.9.4EV Substance CodeSUB12544MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number75
    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 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
    Treatment of Influenza
    E.1.1.1Medical condition in easily understood language
    Flu treatment
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level LLT
    E.1.2Classification code 10022002
    E.1.2Term Influenza A virus infection
    E.1.2System Organ Class 100000004862
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level LLT
    E.1.2Classification code 10022001
    E.1.2Term Influenza (epidemic)
    E.1.2System Organ Class 100000004862
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level LLT
    E.1.2Classification code 10016790
    E.1.2Term Flu
    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
    to determine the time to normalization of respiratory function of patients dosed with MHAA4549A in combination with oseltamivir compared to patients dosed with placebo and oseltamivir.
    E.2.2Secondary objectives of the trial
    • To measure clinical failure after 24 hours post-infusion of study drug
    • To determine the time to clinical resolution of vital signs
    • To measure mortality in patients
    • To determine changes in the extent and duration of viral shedding in upper respiratory samples
    • To measure the duration of hospital and/or intensive care unit stay
    • To measure antibiotic usage for respiratory infections
    • To measure the frequency and severity of secondary complications of influenza
    • To measure duration of positive pressure ventilation
    • To measure readmission rates
    • To characterize the PK profile of MHAA4549A in serum
    • To identify any potential viral resistance to MHAA4549A in influenza A isolates from upper respiratory samples and from tracheal aspirate samples
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    DNA REPOSITORY SUBSTUDY IN ASSOCIATION WITH MHAA4549A STUDY GV29216, dated 11th March 2015, version 3.0

    The primary objective of this study is to perform exploratory analyses to generate hypotheses identifying genes associated with treatment response, toxicity, or disease risk
    E.3Principal inclusion criteria
    • Men or women ≥ 18 years of age
    • Diagnosis of influenza A where a Sponsor-approved influenza test is used as an aid in diagnosis. A Sponsor-approved influenza test includes:
    Influenza antigen test or Influenza PCR test
    • Requirement for oxygen supplementation to maintain SpO2 >92% or PPV within 24 hours of hospital admission
    • Negative urine or serum pregnancy test for women of childbearing potential
    E.4Principal exclusion criteria
    • Pregnant or lactating, or intending to become pregnant during the study
    • Hypersensitivity to monoclonal antibodies or to the active substance or any excipients of MHAA4549A study drug
    • Hypersensitivity to the active substance or to any excipients of oseltamivir
    • Investigational therapy within 30 days prior to study treatment
    • Received prior therapy with any anti-influenza monoclonal antibody therapy including MHAA4549A 8 months prior to study treatment
    • Onset of influenza symptoms >5 days prior to study treatment
    • Patients who have taken more than a total of 6 doses (3 doses of peramivir) of anti-influenza therapy (e.g., oseltamivir, zanamivir, peramivir) in the period from onset of symptoms and prior to study treatment
    • Requiring home or baseline oxygenation therapy
    • Positive influenza B or influenza A+B infection within 2 weeks prior to study treatment
    • Admission >48 hours prior to study treatment
    • Any disease or condition that would, in the opinion of the investigator or Sponsor, place the subject at an unacceptable risk of injury or render the subject unable to meet the requirements of the protocol
    E.5 End points
    E.5.1Primary end point(s)
    Median time to normalization of respiratory function
    E.5.1.1Timepoint(s) of evaluation of this end point
    The time to normalization of respiratory function will be defined as the time to removal of the patient from oxygen supplementation in order to maintain an oxygen saturation >95%. The analysis of this endpoint will be conducted at the end of the study after all patients have completed all study assessments and the database has been cleaned and closed.
    E.5.2Secondary end point(s)
    • Proportion of patients with clinical failure 24 hours post-infusion of study drug
    • Median time to clinical normalization of vital signs
    • Hazard ratio for mortality at Day 14, Day 30 and Day 60.
    • Mean and median AUC of viral load
    • Mean and median peak viral load
    • Median duration of viral shedding in upper respiratory samples
    • Median duration of hospitalization
    • Median duration of ICU stay
    • Proportion of patients requiring antibiotics for respiratory indications during study
    • Proportion of patients with influenza secondary complications
    • Median duration of ventilation
    • Proportion of patients who are readmitted by Day 30 and Day 60
    E.5.2.1Timepoint(s) of evaluation of this end point
    All secondary endpoint analyses of the total study population will be conducted at the end of the study after all patients have completed all study assessments and the database has been cleaned and closed.

    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 No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Optional DNA Repository Substudy
    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) 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 Yes
    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 No
    E.8.2.4Number of treatment arms in the trial3
    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 concerned63
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA70
    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
    Argentina
    Australia
    Belgium
    Brazil
    Bulgaria
    Canada
    Chile
    Czech Republic
    France
    Germany
    Hong Kong
    Hungary
    Italy
    Korea, Republic of
    Lithuania
    Mexico
    Netherlands
    New Zealand
    Peru
    Poland
    Singapore
    South Africa
    Spain
    Sweden
    United Kingdom
    United States
    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
    If it is the last visit of the last subject, please enter “LVLS”. If it is not LVLS provide the definition: The end of the study is defined as the first day when all patients have had a study completion visit or early termination visit or have otherwise been discontinued from the study. End of study is defined by last visit of the last subject .
    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 months11
    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 months11
    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: 200
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 130
    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 Yes
    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
    Subjects with a condition which makes them incapable of giving consent personally and who need urgent care
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state19
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 136
    F.4.2.2In the whole clinical trial 330
    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)
    Genentech does not intend to provide MHAA4549A to patients after the conclusion of the study or any earlier withdrawal, as this is a single dose administration. Genentech will provide oseltamivir during this study for up to a 10-day course (either 75 mg or 150 mg oseltamivir administered twice daily).
    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 Decision2015-01-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-12-15
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-08-07
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