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    Summary
    EudraCT Number:2005-000837-39
    Sponsor's Protocol Code Number:CCD01
    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:2007-01-02
    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 number2005-000837-39
    A.3Full title of the trial
    Open, randomized, prospective, controlled, multicentre study to evaluate the efficacy and safety of multiple intraportal applications of liver cell suspension in patients with acute liver failure not eligible for orthotopic liver transplantation
    A.4.1Sponsor's protocol code numberCCD01
    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 SponsorCytonet GmbH & Co. KG
    B.1.3.4CountryGermany
    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 No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEMEA/OD/037/05
    D.3 Description of the IMP
    D.3.1Product nameHuman heterologous liver cells (for infusion)
    D.3.2Product code HHLivC
    D.3.4Pharmaceutical form Intravenous infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product Yes
    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) No
    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
    Acute Liver Failure

    Subgroups of patients with indications falling under ICD classification codes:K70.4, K71, K72, K75, K76, K77
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10049844
    E.1.2Term Acute liver failure
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The main objective of the trial is to investigate the efficacy and safety of multiple applications of liver cell suspension in patients with ALF.

    The primary variable is the survival rate at 8 weeks after randomization.
    E.2.2Secondary objectives of the trial
    Efficacy:
    • Survival rate at 6 months after randomization
    • Hepatic encephalopathy score
    • Karnofsky -Index at week 2, 4 and 8
    • Laboratory parameters I: INR, AFP, albumin, bilirubin, liver enzymes (GOT,
    GPT, GLDH, GGT, AP)
    • Laboratory parameter IA: Factor V
    • Pharmacoeconomic evaluation (duration of initial hospitalization, number
    and duration of hospitalizations after initial admission, total days at ICU,
    concomitant medical interventions including blood substitution therapy)
    • Assessment of Quality of Life (QoL)

    Safety:
    • All adverse events and serious adverse events
    • Infection events
    • Laboratory parameter IB: blood levels of immunosuppression
    • Laboratory parameters II: CRP, lactate, creatinine, haematology
    (haemoglobin, hematocrit, erythrocytes, leucocytes including differential
    count, platelets)
    • Vital signs
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Age 18 years and above
    • Written informed consent before enrolment
    • Patient suffering from ALF manifested as
    - Hepatic encephalopathy grade  I (grade ≥ III for patients with ALF
    due to acetaminophen poisoning)
    - INR ≥ 2.3* OR INR ≥ 1.5 together with MELD Score ≥ 25*
    - GOT, GPT and GLDH increased by at least 3 times UNL in absence of
    signs of chronic liver disease ( = no fibrosis or cirrhosis)
    • Patient not eligible for orthotopic liver transplantation
    • Onset of first symptom(s) of liver failure less than 12 weeks ago
    • No anticoagulative therapy within the last 72 hours before the two
    consecutive measurements mentioned (*)
    • No clinically significant brain oedema
    • No manifest sepsis
    • No haemodynamic instability
    • No massive bleeding
    • No multiorgan failure (lung, kidney, heart affected)
    *determined in two consecutive measurements after a 8-12 hours time span (14 hours must not be exceeded)
    E.4Principal exclusion criteria
    • Acute liver insufficiency in presence of symptomatic chronic liver disease
    (fibrosis or cirrhosis of the liver)
    • Acute liver failure in case of transplant primary non-function
    • Acute liver failure due to Budd-Chiari-Syndrome or veno-occlusive disease
    • Thrombosis of portal vein or persisting impairment of anterograde portal
    blood flow
    • Allergic disposition for antibiotics used during manufacturing of liver cell
    transplants
    • Encephalopathy other than hepatic
    • Massive ascites (> 3 l)
    • Malignancies (except basaliomes) except there is
    • no evidence of disease within the last 2 years
    • or all of the following:
    - stable condition after tumor therapy (i.e. tumor in remission and life
    expectancy is > 6 months)
    - liver failure is not due to malignant disease and/or to therapy thereof
    - no manifestation of malignant disease within the liver (to be excluded
    by CT)
    • Clinically manifest acquired immunodeficiency syndrome (AIDS)
    • Allergy to contrast medium
    • Contraindication to immunosuppressive therapy (e.g. severe acute
    bacterial, viral or fungal infection, intolerability to immune suppression)
    • Treatment with extracorporeal liver assist devices (e.g. MARS,
    Prometheus, HepatAssist)
    • Pregnancy or lactation
    • Participation in another clinical trial within the last 30 days
    E.5 End points
    E.5.1Primary end point(s)
    Survival rate at 8 weeks after randomization
    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 Yes
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Quality of Life
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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 Yes
    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 Yes
    E.8.1.7.1Other trial design description
    control group: without catheterization, without cell application, without immunosuppression
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    control group: without catheterization, without cell application, without immunosuppression
    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 Yes
    E.8.5.1Number of sites anticipated in the EEA21
    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 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
    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 months6
    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 Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2007-01-02. Yes
    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 Yes
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    hepatic encephalopathy, coma possible
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 90
    F.4.2.2In the whole clinical trial 90
    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)
    After the end of the study, no particular treatment or aftercare of the patients is intended. The patients are being treated during and after the study with the best medical care available, and will be treated according to their individual needs after the end of their study participation.
    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 Decision2007-07-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-08-15
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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