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    Summary
    EudraCT Number:2011-004394-90
    Sponsor's Protocol Code Number:IM1
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-12-12
    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 number2011-004394-90
    A.3Full title of the trial
    Keyhole Limpet Hemocyanin in Chronic Hepatitis C and Compensated Cirrhosis - IM1
    Keyhole Limpet Hemocyanin bei chronischer Hepatitis C und kompensierter Leberzirrhose
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A prospective trial to investigate the safety and efficacy of keyhole limpet hemocyanin (KLH) in patients with chronic hepatitis C infection and liver cirrhosis, who are unable to perform standard therapy due to contraindications.
    Studie zur Untersuchung der Wirksamkeit von Keyhole Limpet
    Haemocyanin (=KLH, Blutfarbstoff einer Schneckenart) bei Patienten mit
    chronischer Hepatitis C (=Leberentzündung auf Grund einer
    Virusinfektion) und Leberzirrhose (Form der Lebererkrankung), welche
    für eine Standardtherapie aufgrund des Vorliegens von Gegenanzeigen
    gegen Peginterferon / Ribavirin (=Medikamente zur Behandlung der
    Hepatitis C) nicht geeignet sind.
    A.3.2Name or abbreviated title of the trial where available
    KLH in CHC – IM1
    KLH bei CHC – IM1
    A.4.1Sponsor's protocol code numberIM1
    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 SponsorMedizinische Universität Graz, Universitätsklinik für Innere Medizin, Abteilung für Gastroenterologie und Hepatologie
    B.1.3.4CountryAustria
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportMedical University Graz
    B.4.2CountryAustria
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMedical University of Graz
    B.5.2Functional name of contact pointDepartment of Internal Medicine
    B.5.3 Address:
    B.5.3.1Street AddressAuenbruggerplatz 15
    B.5.3.2Town/ cityGraz
    B.5.3.3Post code8036
    B.5.3.4CountryAustria
    B.5.4Telephone number0043316385 16122
    B.5.5Fax number0043316385 13927
    B.5.6E-mailgastroenterologie@klinikum-graz.at
    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 Immucothel 1 mg - Trockensubstanz mit Lösungsmittel
    D.2.1.1.2Name of the Marketing Authorisation holderbiosyn Arzneimittel GmbH
    D.2.1.2Country which granted the Marketing AuthorisationAustria
    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 nameImmucothel 1 mg
    D.3.4Pharmaceutical form Concentrate and solvent for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNImmunocyanin
    D.3.9.3Other descriptive nameKeyhole Limpet Haemocyanin
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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) Yes
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Patients with CHC and liver cirrhosis who are not applicable to standard therapy due to the presence of a contraindication.
    Patienten mit CHC und kompensierter Leberzirrhose, bei welchen eine Standardtherapie kontraindiziert ist.
    E.1.1.1Medical condition in easily understood language
    Patients with CHC and liver cirrhosis who are not applicable to standard therapy (Peginterferon and Ribavirin) due to the presence of a medical circumstance.
    Patienten mit chronischer Hepatitis C und kompensierter Leberzirrhose, bei welchen eine Standardtherapie (Peginterferon and Ribavirin) nicht möglich ist.
    E.1.1.2Therapeutic area Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level PT
    E.1.2Classification code 10019744
    E.1.2Term Hepatitis C
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level PT
    E.1.2Classification code 10019759
    E.1.2Term Hepatitis chronic persistent
    E.1.2System Organ Class 10019805 - Hepatobiliary disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To confirm the safety and efficacy of keyhole limpet hemocyanin (KLH) to achieve sustained virological response in patients with chronic hepatitis C and compensated liver cirrhosis.
    Es ist das Ziel der vorliegenden klinischen Untersuchung, bei Patienten mit CHC und dadurch hervorgerufener fortgeschrittener Lebererkrankung im Sinne einer Leberzirrhose die Wirksamkeit und Sicherheit von KLH in Bezug auf die Replikation des Hepatitis C Virus (Erreichen eines Sustained Virological Response, SVR)zu zeigen.
    E.2.2Secondary objectives of the trial
    To confirm the safety and efficacy of keyhole limpet hemocyanin to achieve biochemical response and decrease of viral load in patients with chronic hepatitis C and compensated liver cirrhosis.
    Es ist das Ziel der vorliegenden klinischen Untersuchung, bei Patienten mit CHC und dadurch hervorgerufener fortgeschrittener Lebererkrankung im Sinne einer Leberzirrhose die Wirksamkeit und Sicherheit von KLH in Bezug auf die Replikation des Hepatitis C Virus (Senkung der Viruslast) und der biochemischen Remission zu zeigen.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - CHC of any Genotype
    - compensated liver cirrhosis (Child Pugh A or Child Pugh B, 7 points)
    - presence of at least one contraindication against standard therapy (Peginterferon alpha 2a/b and Ribavirin)

    Contraindications are:
    - hypersensitivity against Peginterferon alpha 2a/b and Ribavirin
    - severe heart disease
    - liver cirrhosis of Child Pugh ≥6
    - hemoglobinopathias
    - platelet count Thrombozytenzahl < 90000/mm 3
    - neutrophil count absolute < 1500/mm 3
    - psychosis, depression
    - CHC jeden Genotyps
    - Kompensierte Leberzirrhose (Child Pugh A sowie Child Pugh B, 7 Punkte) und fehlende Dekompensationszeichen (Ascites aktuell oder unter Behandlung, Z.n. Ösophagusvarizenblutung in den letzten 6 Monaten, Hepatische Encephalopathie > Grad 1, Hepatorenales Syndrom)
    - mindestens eine Kontraindikation gegen die Kombinationstherapie mit Peginterferon alpha 2a/b und Ribavirin

    Als derartige Kontraindikationen gelten (Auszug aus den Fachinformationen von Pegasys ®, PegIntron ®, Copegus ® und Rebetol ®):

    • Überempfindlichkeit gegen Ribavirin oder Peginterferon
    • Vorbestehende schwere Herzkrankheit, einschließlich instabiler oder nicht beherrschter Herzerkrankung in den letzten 6 Monaten.
    • Leberzirrhose mit Child Pugh Score ≥6
    • Hämoglobinopathien (z.B. Thalassämie, Sichelzellenanämie).
    • Thrombozytenzahl < 90000/mm 3
    • absolute Neutrophilenzahl < 1500/mm 3
    • Vorbestehende Psychose, Depression
    E.4Principal exclusion criteria
    1) hypersensitivity against KLH
    2) immunosuppression (therapy with steroids, Azathioprin, Mycophenolat, TNF alpha blockers, calcineurin inhibitors, IL2 blockers)
    3) hepatocellular carcinoma
    4) coinfektion with hepatitis B and / or HIV
    5) pregnancy
    6) cardiovascular event (stroke, myocardial infarction) during the last 6 months
    7) uncontrolled diabetes (HbA1c > 10)
    8) chronic renal insufficiency (GFR < 50 ml/min) or chronic hemodialysis
    1) Bekannte Überempfindlichkeit gegenüber KLH
    2) Immunsuppression (Aktuelle Therapie mit Cortison, Azathioprin, Mycophenolat, TNF alpha Blockern, Calcineurininhibitoren, IL2 Blockern)
    3) Hepatozelluläres Karzinom
    4) Koinfektion mit Hepatitis B und/oder HIV
    5) Schwangerschaft
    6) Cardiovaskuläres Ereignis (Insult, Herzinfarkt) in den letzten 6 Monaten
    7) Unkontrollierte diabetische Stoffwechsellage (HbA1c > 10)
    8) Chronische Niereninsuffizienz (GFR < 50 ml/min) oder Dialysepflichtigkeit
    E.5 End points
    E.5.1Primary end point(s)
    HCV RNA at week 24
    Viruslast Hepatitis C zur Woche 24
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 24
    Woche 24
    E.5.2Secondary end point(s)
    HCV RNA at week 1
    HCV RNA at week 2
    HCV RNA at week 4
    HCV RNA at week 8
    HCV RNA at week 12
    HCV RNA at week 18
    HCV RNA at week 32
    ALT at weeks 1,2,4,8,12,18,32
    Viruslast Hepatitis C zur Woche 1
    Viruslast Hepatitis C zur Woche 2
    Viruslast Hepatitis C zur Woche 4
    Viruslast Hepatitis C zur Woche 8
    Viruslast Hepatitis C zur Woche 12
    Viruslast Hepatitis C zur Woche 18
    Viruslast Hepatitis C zur Woche 32
    ALT zu allen Zeitpunkten
    E.5.2.1Timepoint(s) of evaluation of this end point
    Weeks 1,2,4,8,12,18,32
    Wochen 1,2,4,8,12,18,32
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open No
    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 No
    E.8.2.3Other No
    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.8.4.1Number of sites anticipated in Member State concerned1
    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 No
    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
    LVLS
    LVLS
    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 months0
    E.8.9.1In the Member State concerned 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: 15
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 15
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state45
    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 therapy in the referring institution.
    Routinebehandlung an der zuweisenden Abteilung (Univ Klinik für Innere Medizin, Abteilung für Gastroenterologie / Hepatologie oder LKH Hörgas, Abteilung für Innere Medizin)
    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 Decision2012-01-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-12-12
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-11-12
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