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    The EU Clinical Trials Register currently displays   43936   clinical trials with a EudraCT protocol, of which   7310   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2010-021113-23
    Sponsor's Protocol Code Number:TMC435HPC3007
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-01-24
    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 ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2010-021113-23
    A.3Full title of the trial
    A Phase III, randomized, double-blind, placebo-controlled study to investigate the efficacy, safety and tolerability of TMC435 vs. placebo as part of a treatment regimen including peginterferon alfa-2a and ribavirin in hepatitis C, genotype 1 infected subjects who relapsed after previous interferon-based therapy
    A.3.2Name or abbreviated title of the trial where available
    Promise
    A.4.1Sponsor's protocol code numberTMC435HPC3007
    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 SponsorTibotec Pharmaceuticals
    B.1.3.4CountryIreland
    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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameTMC435
    D.3.2Product code TMC435 (R494617 or JNJ-38733214-AAA, G007
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNnot assigned yet
    D.3.9.1CAS number 92360-59-5
    D.3.9.2Current sponsor codeTMC435
    D.3.9.3Other descriptive nameR494617 or JNJ-38733214-AAA
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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) 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) 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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule, hard
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Hepatitis C Virus (HCV)
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 15.0
    E.1.2Level LLT
    E.1.2Classification code 10019752
    E.1.2Term Hepatitis C virus (HCV)
    E.1.2System Organ Class 10022891 - Investigations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To demonstrate the superiority of TMC435 versus placebo as part of a treatment regimen including peginterferon alfa-2a (PegIFN╬▒-2a) and ribavirin (RBV), with respect to the proportion of subjects with sustained virologic response (SVR) 24 weeks after the planned end of treatment (SVR24).
    E.2.2Secondary objectives of the trial
    - Secondary Objectives: Reference is made to section 2 (Objectives) on page(s) 27 and 28 of the Clinical Trial Protocol
    - Exploratory Objectives: Reference is made to section 2 (Objectives) on page(s) 27 and 28 of the Clinical Trial Protocol
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female subject aged 18 years or above.
    2. Subject must have a liver biopsy within 3 years prior to the screening visit (or between the screening and baseline visit) with histology consistent with chronic HCV infection:
    a. If only inflammation is present, there should be laboratory evidence of chronic hepatitis C infection, i.e., presence of anti-HCV antibody or HCV RNA for at least 6 months prior to Day 1;
    b. If cirrhosis (Metavir score F4) has been demonstrated on a previous liver biopsy,
    the 3-year time window does not apply and there is no need for a new biopsy.
    c. A biopsy is not required for subjects with bleeding disorders.
    3. Subjects with bridging fibrosis (Metavir score F3) or cirrhosis (Metavir score F4) must have an ultrasound taken within 6 months prior to the screening visit (or between the screening and baseline visit) with no findings suspicious for hepatocellular carcinoma.
    4. Genotype 1 HCV infection (confirmed at screening).
    5. Plasma HCV RNA of > 10,000 IU/mL at screening.
    Note: retesting of HCV RNA to assess eligibility will be allowed once, using an unscheduled visit during the screening period.
    6. Subjects must have received (Peg)IFN-based therapy for at least 24 weeks with documented undetectable HCV RNA at the last measurement on treatment, and a subsequent detectable HCV RNA level within 1 year after the last medication intake.
    7. Female subjects of childbearing potential or male subjects with a female partner of
    childbearing potential must agree to use 2 forms of effective contraceptive methods (one of the methods needs to be a barrier method, e.g., condom or diaphragm) from at least 2 weeks prior to Day 1 (baseline) until at least 6 months after the last dose of PegIFN alfa-2a/RBV (or longer if dictated by local regulations), or not be heterosexually active, or vasectomized (male subjects) or have a vasectomized partner (female subjects), or be a female (subject or partner of male subject) of nonchildbearing potential (i.e., postmenopausal for at least 2 years or surgically sterile) (for further details, refer to Section 4.4, Prohibitions and Restrictions).
    8. Subjects must be willing and able to comply with the protocol requirements.
    9. Subjects must have voluntarily signed an ICF indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.
    Note: To participate in the optional pharmacogenomic component in this study (exploratory host genotyping), subjects must have voluntarily signed a separate ICF for this component. Refusal to give consent for this component does not exclude a subject from participation in the clinical study.
    E.4Principal exclusion criteria
    1. Evidence of hepatic decompensation (history or current evidence of ascites, bleeding varices or hepatic encephalopathy)
    2. Any liver disease of non-HCV etiology. This includes acute hepatitis A, drug- or alcoholrelated liver disease, autoimmune hepatitis, hemochromatosis, Wilson's disease, alpha-1 antitrypsin deficiency, primary biliary cirrhosis, or any other non-HCV liver disease considered clinically significant by the investigator.
    3. Infection/co-infection with nongenotype 1 HCV.
    4. Co-infection with HIV type 1 or type 2 (HIV-1 or HIV-2) (positive HIV-1 or HIV-2
    antibodies test at screening).
    5. Co-infection with hepatitis B virus (hepatitis B surface antigen [HBsAg] positive).
    6. Previous discontinuation of (Peg-)IFN or RBV for an adverse event that in the opinion of the investigator would likely be treatment limiting during re-exposure to PegIFNalfa-2a or RBV.
    7. Known allergy or hypersensitivity to TMC435, PegIFNalfa-2a, RBV, or any of the other
    components of the formulation.
    8. Medical conditions which are contraindications for PegIFNalfa-2a or RBV therapy:
    a. Major uncontrolled depressive illness;
    b. Organ transplant (other than cornea or hair transplant or skin graft);
    c. Severe concurrent medical disease such as severe hypertension, significant coronary heart disease, poorly controlled diabetes, untreated thyroid disease, chronic obstructive pulmonary disease, severe infections (bacterial, viral, fungal, including acute tuberculosis), or hemoglobinopathies (thalassemia major or sickle-cell anemia);
    d. Autoimmune hepatitis or other autoimmune conditions known to be exacerbated by PegIFN and RBV. Any other clinically significant disease that in the opinion of the investigator would be exacerbated by the known effects of PegIFN and RBV.
    10. History of malignancy within 5 years of the screening visit (exceptions: squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy that in the opinion of the investigator is considered cured with minimal risk of recurrence).
    11. Subject with any of the following laboratory abnormalities:
    a. Platelet count < 90,000/mm3;
    b. Absolute neutrophil count < 1500 cells/mm3 (blacks: < 1200 cells/mm3);
    c. Hemoglobin < 12 g/dL for women and < 13 g/dL for men;
    d. Creatinine > 1.5 mg/dL;
    e. ALT and/or AST > 10 x upper limit of laboratory normal range (ULN);
    f. Total serum bilirubin > 1.5 x ULN;
    g. Alpha-fetoprotein (AFP) > 50 ng/mL in subjects with cirrhosis (Metavir score F4).
    Subjects without cirrhosis and AFP > 50 ng/mL must have an ultrasound between the
    screening and baseline visit with no findings suspicious for hepatocellular carcinoma.
    Note: retesting of abnormal laboratory values that lead to exclusion will be allowed once using an unscheduled visit during the screening period to assess eligibility.
    12. Any other active clinically significant disease or clinically significant findings during
    screening of medical history, physical examination, laboratory testing or ECG recording that, in the investigator?s opinion, would compromise the subject?s safety or could interfere with the subject participating in and completing the study.
    Note: retesting of results that lead to exclusion will be allowed once using an unscheduled visit during the screening period to assess eligibility.
    13. Current or past abuse of alcohol and/or recreational or narcotic drugs, which in the opinion of the investigator would compromise the subject?s safety and/or compliance with the study procedures.
    14. Pregnant, planning on becoming pregnant, or breastfeeding female subject or male subject whose partner is pregnant or planning on becoming pregnant.
    15. Subject who has received an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 30 days of screening.
    16. Use of disallowed concomitant therapy.
    17. Previous treatment with any HCV therapy other than IFN and RBV, including any directacting anti-HCV agents (e.g., NS5B polymerase, NS3/4A protease or NS5A inhibitor, or cyclophilin inhibitors).
    E.5 End points
    E.5.1Primary end point(s)
    See section 11.2.1 of the Protocol (pages 73 and 74)
    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 Yes
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    tolerability
    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) 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 No
    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.8.3 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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA48
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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 years2
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    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 state60
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 201
    F.4.2.2In the whole clinical trial 375
    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 Decision2011-03-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-02-28
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-02-04
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