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    Summary
    EudraCT Number:2009-015012-18
    Sponsor's Protocol Code Number:P/0035
    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:2009-11-19
    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 ConcernedGermany - PEI
    A.2EudraCT number2009-015012-18
    A.3Full title of the trial
    A prospective, randomized, open, multi-centre study to assess safety of PURETHAL Grasses given with a rush induction schedule to patients with allergic rhinoconjunctivitis.
    A.3.2Name or abbreviated title of the trial where available
    PURETHAL Grasses Rush study
    A.4.1Sponsor's protocol code numberP/0035
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorHAL Allergy BV
    B.1.3.4CountryNetherlands
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 Yes
    D.2.1.1.1Trade name PURETHAL Gräser
    D.2.1.1.2Name of the Marketing Authorisation holderHAL Allergie GmbH
    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.3.1Product namePURETHAL Gräser
    D.3.4Pharmaceutical form Suspension for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPSubcutaneous 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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Yes
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Allergic (IgE-mediated) rhinitis/rhinoconjunctivitis due to sensitization to grass pollen
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.0
    E.1.2Level LLT
    E.1.2Classification code 10001728
    E.1.2Term Allergic rhinoconjunctivitis
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.0
    E.1.2Level LLT
    E.1.2Classification code 10001726
    E.1.2Term Allergic rhinitis due to pollen
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.0
    E.1.2Level LLT
    E.1.2Classification code 10053741
    E.1.2Term Allergenic desensitization procedure
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The aim of the study is to show that reaching the maintenance dose of 0.5 ml PURETHAL Grasses following a rush initial phase of three injections (0.1, 0.3 and 0.5 ml) given in weekly intervals is as safe as a conventional initial phase of six injections (0.05, 0.1, 0.2, 0.3, 0.4 and 0.5 ml) given in weekly intervals. Within the scope of this study an initial phase is considered safe if no possible injection related systemic side effect occurred during the first 24 hours after injection or, due to large local reactions, more than 2 additional injections are needed to reach the maintenance dose.
    E.2.2Secondary objectives of the trial
    In addition local reactions and systemic reactions throughout the study will be assessed as secondary parameters. Furthermore, pharmacodynamic parameters of PURETHAL Grasses showing an effect on the immune system will be analysed by means of serum levels of allergen specific immunoglobulins (IgG and IgE).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    •Patients with rhinitis or rhinoconjunctivitis, with or without mild asthma (FEV1 > 70%) for at least 2 years related to grass pollen, eligible for SCIT.
    Confirmation of IgE-mediated allergy by means of:
    • Positive SPT to grass pollen (mean wheal diameter ≥ 3 mm (see appendix 2) and
    negative control truly negative (no reaction), or
    • Specific serum IgE-test (ssIgE >0.7 U/ml) for grass pollen, or
    • Positive provocation test for grass pollen.
    •Age ≥ 18 years.
    •Patients have given a written informed consent.
    E.4Principal exclusion criteria
    •Chronic asthma or emphysema, particularly with a FEV1 ≤ 70% of predicted value.
    •Serious immuno-pathological diseases or malignancies (including auto-immune diseases, tuberculosis, HIV).
    •Active inflammation/infection of the target organs (nose, eyes, lungs).
    •Severe atopic dermatitis in need for systemic immunosuppressive medication.
    •Symptomatic coronary heart diseases (e.g heart failure, recent myocardial infarction, unstable angina, serious arrhythmias) or severe (even under treatment) arterial hypertension.
    •Severe kidney disease.
    •Diseases with a contra-indication for the use of adrenaline.
    •Treatment with systemic or local b-blockers or immunosuppressive drugs.
    •History of life threatening anaphylactic events, including anaphylactic food allergy, insect venom anaphylaxis, exercise or drug induced anaphylaxis.
    •Any specific immunotherapy (including sublingual) during the study period or during the previous 3 years for a period longer than three months.
    •Participation in a clinical study with a new investigational drug within the last three months.
    •Pregnancy, lactation or inadequate contraceptive measures (adequate measures: oral contraceptives, IUD, condom use if used together with a spermicide and having no sexual relationship with a man).
    •Alcohol or drug abuse.
    •Lack of co-operation or severe psychological disorders.
    •Completed or ongoing long-term treatment with tranquilizer or psycho active drugs.
    •Low compliance or inability to understand instructions/study documents.
    •Completed or ongoing treatment with anti-IgE-antibody.
    •Patients being in relationship or dependence with the sponsor or investigator.
    •Allergy to any of the excipients.
    •Severe illness or any other condition, which makes the patient, in the opinion of the investigator, unsuitable for the study
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint of the study is the comparison of the proportion of patients who have successfully reached the maintenance dose between the two treatment groups (rush vs. conventional). A patient is regarded as having successfully reached the maintenance dose in case he/she did not experience an at least possibly treatment related systemic reaction > grade I within 24 hours after the injection or he/she needed not more than 2 additional injections to reach the maintenance dose of 0.5 ml.
    This means that in the rush treated group the 5th injection must contain 0.5 ml and in the conventional treated group the 8th injection must contain 0.5 ml. In all other cases the patient will be regarded as not successfully reaching the maintenance dose.
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic Yes
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    A rush-in initial phase is tested against a conventional initial phase
    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 concerned14
    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 No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    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
    When the required number of subjects receiving PURETHAL Grasses has been included in the study, recruitment will be stopped. Subjects who have already signed an informed consent may be screened further and included if another patient drops out.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months0
    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.1.1.1In 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.1.3Elderly (>=65 years) Yes
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state150
    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)
    At the end of the study patients can ask their own physician for the regular PURETHAL Grasses immunotherapy.
    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 Decision2010-01-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-02-09
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2010-08-24
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