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    Summary
    EudraCT Number:2013-004503-39
    Sponsor's Protocol Code Number:IG1104
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2014-10-08
    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 number2013-004503-39
    A.3Full title of the trial
    A multicenter, prospective, randomized, placebo-controlled, double-blind, parallel-group clinical trial to assess the efficacy and safety of Immune Globulin Intravenous (Human) Flebogamma® 5% DIF in patients with Post-Polio Syndrome
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to evaluate the safety and efficacy of Flebogamma 5% DIF in patients with Post-Polio Syndorme
    A.4.1Sponsor's protocol code numberIG1104
    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 SponsorInstituto Grifols, S.A.
    B.1.3.4CountrySpain
    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 supportInstituto Grifols, S.A.
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationInstituto Grifols, S.A.
    B.5.2Functional name of contact pointBioScience Clinial and PhV
    B.5.3 Address:
    B.5.3.1Street AddressAv. Generalitat 152
    B.5.3.2Town/ citySant Cugat del Vallès (Barcelona)
    B.5.3.3Post code08174
    B.5.3.4CountrySpain
    B.5.4Telephone number34935712200
    B.5.5Fax number34935712482
    B.5.6E-mailIGregulatory.affairs@grifols.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 Yes
    D.2.1.1.1Trade name Flebogamma DIF 50 mg/ml - 200 ml
    D.2.1.1.2Name of the Marketing Authorisation holderInstituto Grifols, S.A.
    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 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 INNHuman normal immunoglobulin (IVIg)
    D.3.9.3Other descriptive nameHUMAN NORMAL IMMUNOGLOBULIN (IV)
    D.3.9.4EV Substance CodeSUB12041MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 Yes
    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
    Patients with Post-polio syndrome
    E.1.1.1Medical condition in easily understood language
    Therapy for subjects suffering post-poliomyelitis syndorme
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level PT
    E.1.2Classification code 10036239
    E.1.2Term Post polio syndrome
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level SOC
    E.1.2Classification code 10029205
    E.1.2Term Nervous system disorders
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the safety and efficacy of Flebogamma 5% DIF in patients with post-polio syndrome
    E.2.2Secondary objectives of the trial
    To evaluate clinical effect of Flebogamma 5%DIF in PPS subjects by:
    - assessing pain , as measured by VAS of pain, compared to that of placebo
    - evaluating health-related quality of life (HRQoL), as measured by SF-36 PCS, compared to that of placebo
    - endurance, as measured by 6MWD, compared to that of placebo.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Clinical trial subject inclusion criteria:
    1. Male or female aged 18 to 75 years.
    2. Subjects who understand and voluntarily signed and dated the Clinical Trial Written Informed Consent Form for his/her clinical trial participation.
    3. Subjects with BMI less than 35 kg/m2.
    4. Subjects who meet the clinical criteria for diagnosis of PPS as set by the March-of-Dimes.
    5. Subjects who are ambulatory or are able to walk with a cane or other aids or use a wheelchair (but they are not wheelchair-bound)
    6. Subjects who have at least two newly weakened muscle groups due to PPS (as defined by medical history), with at least one of them in a lower extremity, and having a mMRC scale score of 3 or greater at the MMT performed by the independent assessor at the SV.
    7. Female subjects of child-bearing potential must have a negative test for pregnancy (human chorionic gonadotropin [HCG]-based assay).
    8. Female subjects of child-bearing potential and their sexual partners have agreed to practice contraception using a method of proven reliability (i.e., hormonal methods; barrier methods; intrauterine devices methods) to prevent a pregnancy during the course of the clinical trial.
    9. Subjects must be willing to comply with all aspects of the clinical trial protocol, including blood sampling and long-term storage of extra samples for the entire duration of the study.
    10. Subjects who are able to walk a 2MWD of at least 50 meters at the Screening Visit (SV) and EV/IV1.
    11. Subjects who are able to walk a consistent baseline 2MWD, that is, the difference in 2MWD between the SV and EV/IV1 is not more than 10%.
    E.4Principal exclusion criteria
    Clinical trial subject exclusion criteria:
    1. Subjects who have received human normal immune globulin treatment given by intravenous, subcutaneous or intramuscular route within the last 3 years.
    2. Subjects who are not ambulatory (wheelchair-bound individuals).
    3. Subjects with poor venous access.
    4. Subjects with intractable pain requiring narcotics or other psychotropic drugs.
    5. Subjects with a history of anaphylactic reactions or severe reactions to any blood-derived product.
    6. Subjects with a history of intolerance to any component of the investigational products, such as sorbitol.
    7. Subjects who are receiving corticosteroids, except for those who are taking them for asthma.
    8. Subjects with a documented diagnosis of hyperviscosity or hypercoagulable state or thrombotic complications to polyclonal IVIG therapy in the past.
    9. Subjects with a history of recent (within the last year) myocardial infarction, stroke, or uncontrolled hypertension.
    10. Subjects who suffer from congestive heart failure, embolism, or ECG changes indicative of unstable angina or atrial fibrillation.
    11. Subjects with a history of chronic alcoholism or illicit drug abuse (addiction) in the preceding 12 months prior to the SV.
    12. Subjects with active psychiatric illness that interferes with compliance or communication with health care personnel.
    13. Subjects with depression with scores >30 as assessed by the CESD validated scale.
    14. Females who are pregnant or are nursing an infant child.
    15. Subjects with any medical condition which makes clinical trial participation unadvisable or which is likely to interfere with the evaluation of the study treatment and/or the satisfactory conduct of the clinical trial according to the Investigator's judgment.
    16. Subjects currently receiving, or have received within 3 months prior to the Screening Visit, any investigational medicinal product or device.
    17. Subjects who are unlikely to adhere the protocol requirements, or are likely to be uncooperative, or unable to provide a storage serum/plasma sample prior to the first investigational drug infusion.
    18. Subjects with a known selective IgA deficiency and serum antibodies anti-IgA.
    19. Subjects with renal impairment (i.e., serum creatinine exceeds more than 1.5 time the upper limit of normal [ULN] for the expected normal range for the testing laboratory).
    20. Subjects with AST or ALT levels exceeding more than 2.5 times the ULN for the expected normal range for the testing laboratory.
    21. Subjects with hemoglobin levels <10 g/dL, platelets levels <100,000/mm3, white blood cells count <3.0 k/μL and ESR >50 mm/h or twice above normal.
    22. Subjects with known seropositive to HCV, HIV-1 and/or HIV-2.
    23. Subjects with a history of intolerance to fructose.
    E.5 End points
    E.5.1Primary end point(s)
    To test whether monthly infusions (every four weeks) of
    intravenous Flebogamma® 5% DIF in a 1 year treatment period
    in PPS subjects are superior to placebo by assessing physical
    performance, as measured by 2MWD (2-minutes walk distance)
    For Stage 1, to select the optimal dose of IVIG as compared to
    the placebo.
    For Stage 2, to establish superiority of the selected dose of IVIG
    as compared to placebo by combining both Stage 1 and Stage 2
    data.
    E.5.1.1Timepoint(s) of evaluation of this end point
    1 year treatment
    E.5.2Secondary end point(s)
    Efficacy endpoints:
    - Pain (Visual Analogue Scale [VAS] of pain) from baseline
    to the end of the treatment period.
    - HRQoL (Medical Outcomes Study 36-Item Short Form
    Health Survey [SF-36] Physical Component Summary
    [PCS]) from baseline to the end of the treatment period.
    - Endurance (Six Minutes Walk Distance [6MWD]) from
    baseline to the end of the treatment period.

    Safety endpoints will include Adverse Events (AEs), vital signs during infusions,
    physical assessments and blood tests for clinical safety.
    E.5.2.1Timepoint(s) of evaluation of this end point
    One year treatment.
    And for the one year treatments and a half year without treatment (to assess the sustainability effect).
    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 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) Yes
    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 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 Yes
    E.8.1.7.1Other trial design description
    It is a study trial with two stages design
    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 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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA15
    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
    Canada
    United States
    Denmark
    France
    Hungary
    Ireland
    Poland
    Sweden
    Netherlands
    Spain
    Czechia
    Germany
    Italy
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years8
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years8
    E.8.9.2In all countries concerned by the trial months6
    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.1.2.1Number of subjects for this age range: 70
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 140
    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 state60
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 150
    F.4.2.2In the whole clinical trial 210
    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)
    None
    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 Decision2014-10-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-01-16
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2022-07-18
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