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    Summary
    EudraCT Number:2011-004724-35
    Sponsor's Protocol Code Number:VX-950HPC3006
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-10-24
    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 ConcernedGermany - BfArM
    A.2EudraCT number2011-004724-35
    A.3Full title of the trial
    Open-Label, Phase 3b Study To Determine Efficacy and Safety of Telaprevir, Pegylated-Interferon-alfa-2a and Ribavirin in Hepatitis C Genotype 1 Infected, Stable Liver Transplant Subjects
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    An efficacy and safety study of Telaprevir in patients with genotype 1 Hepatitis C infection after liver transplantation
    A.4.1Sponsor's protocol code numberVX-950HPC3006
    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 SponsorJanssen-Cilag International NV
    B.1.3.4CountryBelgium
    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 supportJanssen-Cilag International NV
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationJanssen-Cilag International NV - Clinical Registry Group
    B.5.2Functional name of contact pointJanssen Biologics BV
    B.5.3 Address:
    B.5.3.1Street AddressArchimedesweg 29
    B.5.3.2Town/ cityLeiden
    B.5.3.3Post code2333CM
    B.5.3.4CountryNetherlands
    B.5.4Telephone number+31071524 21 66
    B.5.5Fax number+31071524 21 10
    B.5.6E-mailClinicalTrialsEU@its.jnj.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 INCIVO
    D.2.1.1.2Name of the Marketing Authorisation holderJanssen Cilag International NV
    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.3.1Product nameINCIVO
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    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 INNTelaprevir
    D.3.9.1CAS number 402957-28-2
    D.3.9.3Other descriptive nameTELAPREVIR
    D.3.9.4EV Substance CodeSUB31651
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number375
    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) 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 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.IMP: 2
    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 Pegasys
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration Limited, UK
    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.3.1Product namePegasys
    D.3.4Pharmaceutical form Solution for injection in pre-filled syringe
    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 INNPEGINTERFERON ALFA-2A
    D.3.9.1CAS number 198153-51-4
    D.3.9.4EV Substance CodeSUB16452MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number360
    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 No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    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.IMP: 3
    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 Copegus
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Pharma AG
    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 nameCopegus
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    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 INNRIBAVIRIN
    D.3.9.1CAS number 36791-04-5
    D.3.9.4EV Substance CodeSUB10297MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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) 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 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
    Chronic hepatitis C infection
    E.1.1.1Medical condition in easily understood language
    Chronic hepatitis C infection
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.0
    E.1.2Level LLT
    E.1.2Classification code 10019752
    E.1.2Term Hepatitis C virus (HCV)
    E.1.2System Organ Class 100000004848
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    to determine the efficacy of telaprevir administered as 750 mg every 8 hours (q8h) in combination with pegylated interferon (Peg-IFN)-alfa-2a and ribavirin (RBV) in genotype 1 chronic HCV infected liver transplant patients as measured by sustained virologic response (SVR12planned). SVR12planned is defined as
    having an undetectable HCV ribonucleic acid (RNA) level 12 weeks after the last planned dose of study medication.
    E.2.2Secondary objectives of the trial
    - to compare the SVR rate from this study to a historical control SVR rate derived from the literature in subjects treated with Peg-IFN and RBV;
    - to evaluate HCV RNA levels and responses over time, on treatment and during follow-up;
    - to evaluate changes in liver graft biopsy histology comparing the last pre-treatment biopsy to the 24-week post-treatment biopsy;
    - to evaluate safety and tolerability of telaprevir in combination with Peg-IFN-alfa-2a, RBV, and tacrolimus (TAC) or cyclosporin A (CsA);
    - to evaluate the pharmacokinetics (PK) of telaprevir and concentrations of TAC or CsA;
    - to evaluate dose titration requirements for TAC and CsA;
    - to evaluate the incidence of liver graft rejection;
    - to evaluate relapse rates and virologic failure rates;
    - to evaluate changes from baseline in the amino acid sequence of HCV NS3-4A protease.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. 18 to 70 years old.
    2. First time liver transplant recipient
    3. One of the following based on clinical history or by documented HCV RNA and treatment history:
    a) Treatment-naïve subject
    OR
    - Relapser:
    - Partial responder: ;
    - Null responder:.
    4. > 6 months to 10 years post-liver transplant.
    5. Subject must be on a stable TAC or CsA containing immunosuppressive regimen, combination with MMF is allowed
    6. Subject must agree to have a liver graft biopsy: >1 year of liver transplantation within 6 months prior to screening, 6-12 months of transplantation within 3 months,
    7. The last pre-treatment liver graft biopsy report must reveal fibrosis stage (Metavir) F0-F3.
    8. Subject is judged to be in moderately good health
    9. If heterosexually active, a female subject of childbearing potential and a non- vasectomized male subject who has a female partner of childbearing potential must agree to the use of 2 effective methods of contraception from screening onwards until 6 months (female subject) or 7 months (male subject) after the last dose of RBV. Male subjects must also agree not to donate sperm during the study and for 7 months after the last intake of RBV.
    10. Subject or female partner is not pregnant, planning to become pregnant, or breastfeeding.
    11. Subject is willing and able to refrain from the concomitant use of medications as described in the section “Disallowed Medication”
    12. Subject is able to read and understand, and is willing to sign the Informed Consent Form (ICF) voluntarily.
    13. Subject should agree not to participate in other clinical studies for the duration of his/her participation in this study, except for non-interventional or observational studies.
    E.4Principal exclusion criteria
    1. Subject is infected or co-infected with non-genotype 1 HCV.
    2. Subject received treatment with a direct acting antiviral for hepatitis C.
    3. Subject received HCV treatment following liver transplantation.
    4. Subject has histological evidence of rejection on the most recent liver graft biopsy
    5. Subject has a contraindication to the administration of Peg-IFN-alfa or RBV,
    6. Subject has a pre-existing psychiatric condition that could interfere with the subject’s participation in and completion of the study,:
    7. Following transplantation, subject has history of decompensated liver disease:
    8. Subject’s liver graft biopsy used to meet study eligibility criteria and/or clinical condition shows evidence of liver disease in addition to hepatitis C,
    9. Subject has active malignant disease or history of malignant disease within the past 5 years (with the exception of treated basal cell carcinoma or hepatocellular carcinoma (HCC) cured by liver transplant).
    10. Family history of congenital QT prolongation or sudden death. History of congenital QT prolongation, drug-induced QT prolongation or Torsade de Pointes, nonsustained or sustained ventricular tachycardia, or baseline QTcF >450 msec.
    11. Subject has history of seizure disorders unrelated to calcineurin toxicity.
    12. Uncontrolled diabetes or hypertension post transplantwithin 3 months prior to the screening visit.
    13. Subject has history or other evidence of clinically significant retinopathy or ophthalmological disorder,
    14. Subject has history or other clinical evidence of chronic pulmonary disease
    15. Subject has active hemophilia or other bleeding disorder.
    16. Subject has evidence of serious or severe bacterial or fungal infection(s), including active tuberculosis.
    17. Subject has HIV or HBV co-infection.
    18. Subject has a history of acute or chronic pancreatitis post transplant with exception of gallstone or post ERCP pancreatitis.
    19. Knowledge of alcohol, barbiturate, amphetamine, recreational or narcotic drug use, current or within 2 years prior to the screening visit that in the investigator’s opinion would compromise the subject’s safety and/or compliance with study procedures.
    20. Subject has a confirmed Grade 4 laboratory abnormality as defined by the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (“DAIDS AE grading table”) or any other clinically relevant abnormalities in the opinion of the investigator. Subjects with Grade 4 elevations of gamma- glutamyltransferase (GGT) will be allowed to enter the study if there are no other clinically relevant laboratory abnormalities as judged by the investigator.
    The screening laboratory values of the following variables should meet the acceptable values defined below:
    - absolute neutrophil count (ANC) ≥ 1,000/mm3;
    - platelet count ≥ 75,000/mm3;
    - hemoglobin ≥ 11g/dL;
    - estimated creatinine clearance (Cockroft-Gault) > 60 mL/min at screening;
    - potassium and magnesium within normal range;
    - Grade ≤ 1 uric acid;
    - Thyroxin stimulating hormone (TSH) and free thyroxine (T4) within normal range, or hyperthyroid and adequately controlled with thyroid treatment, or TSH or free T4 abnormal but considered to be clinically insignificant as judged by the investigator.
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of patients achieving undetectable plasma HCV ribonucleic acid (RNA) levels.
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 weeks after the last planned dose of study drugs
    E.5.2Secondary end point(s)
    - Proportion of patients having undetectable plasma HCV ribonucleic acid (RNA levels)
    - Proportion of patients having undetectable plasma HCV ribonucleic acid (RNA levels)
    - Proportion of patients having undetectable plasma HCV ribonucleic acid (RNA levels)
    - Proportion of patients having detectable plasma HCV ribonucleic acid (RNA levels) of <25IU/mL
    - Proportion of patients having confirmed detectable HCV ribonucleic acid (RNA levels)
    - Proportion of patients having confirmed detectable HCV ribonucleic acid (RNA levels)
    - Proportion of patients having confirmed detectable HCV RNA during the follow-up period after previous HCV RNA < 25 IU/mL at
    planned end of treatment
    - Proportion of patients having an increase > 1 log in HCV RNA level from the lowest level reached, or a value of HCV RNA > 100 IU/mL in subjects whose HCV RNA has previously become < 25 IU/mL during treatment
    E.5.2.1Timepoint(s) of evaluation of this end point
    - 24 weeks after last planned dose of study drugs
    - actual end of study drugs
    - week 48 of study drugs
    - week 48 of study drugs
    - follow-up period after previous undetectable HCV RNA levels at actual end of study drugs
    - follow-up period after previous undetectable HCV RNA levels at week 48
    - follow up period after previous undetectable HCV RNA levels at week 48
    - from day 1 till week 48
    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 Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    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) Yes
    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 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 EEA23
    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
    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 days0
    E.8.9.2In all countries concerned by the trial years1
    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: 13
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 1
    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 state14
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 72
    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)
    Not applicable
    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 Decision2011-12-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-07-15
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