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    Summary
    EudraCT Number:2007-004720-20
    Sponsor's Protocol Code Number:VX07-950-108
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-07-22
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2007-004720-20
    A.3Full title of the trial
    A Phase 3 Study of 2 Dose Regimens of Telaprevir in Combination with Peginterferon Alfa-2a (Pegasys) and Ribavirin (Copegus) in Treatment-Naive Subjects with Genotype 1 Chronic Hepatitis C.
    Studio di fase 3 con 2 regimi di dosaggio di Telaprevir in combinazione con Peginterferone Alfa-2a (Pegasys) e Ribavirina (Copegus) in soggetti naive con epatite C cronica 1 genotipo 1
    A.4.1Sponsor's protocol code numberVX07-950-108
    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 SponsorVERTEX PHARMACEUTICALS INCOPORATED
    B.1.3.4CountryUnited States
    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 nameVX-950 (telaprevir, TVR)
    D.3.2Product code VX-950
    D.3.4Pharmaceutical form 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.3.9.2Current sponsor codeVX-950
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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 RoleComparator
    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 SpA
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 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 INNPeginterferon alfa-2a
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.3Concentration number180
    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 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: 3
    D.1.2 and D.1.3IMP RoleComparator
    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 SpA
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 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.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    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
    Chronic Hepatitis C, Genotype 1
    Epatite C Cronica, Genotipo 1
    E.1.1.2Therapeutic area Diseases [C] - Digestive System Diseases [C06]
    MedDRA Classification
    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 efficacy of telaprevir in combination with peginterferon alfa-2a (Peg-IFN-alfa-2a) and ribavirin (RBV) in treatment-naive subjects with genotype 1 chronic hepatitis C.
    Dimostrare l'efficacia del telaprevir in combinazione con peginterferone alfa-2a (Peg-IFN-alfa-2a) e ribavirina (RBV) in soggetti naive affetti da epatite C cronica genotipo 1
    E.2.2Secondary objectives of the trial
    To evaluate the safety of telaprevir in combination with Peg-IFN-alfa-2a and RBV in treatment-naive subjects with genotype 1 chronic hepatitis C.
    Valutare la sicurezza del telaprevir in combinazione con Peg-IFN-alfa-2a e RBV in soggetti naive affetti da epatite C cronica genotipo 1.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Male and female subjects, 18 to 70 years of age inclusive. - Genotype 1, chronic hepatitis C with detectable HCV RNA. Genotype will be confirmed at screening. Chronic disease is defined as one of the following: <Diagnosis of HCV >6 months before the screening period, or <History of a remote risk factor, or <Abnormal alanine aminotransferase (ALT) levels for >6 months before the screening period (Note, elevated ALT is not an inclusion criterion if one of the otehr criteria for chronic hepatitis C was met) - Aside from hepatitis C, judged to be in good health on the basis of medical history and physical examination (including vital signs and screening ECG), with any chronic medical conditions under stable medical control. - Seronegative for Hepatitis B surface antigen and Human Immunodeficiency Virus (HIV) 1 and 2. - Parameters for Absolute neutrophil count, platelet count, hemoglobin, uric acid and other hematology and clinical chemistry results within ranges specified in Section 9 of the protocol. - Documentation of a liver biopsy within 1 year (+/- 3 months) before the screening visit or agree to have a biopsy performed during screening. The biopsy must show evidence of hepatitis (demonstrated by inflammation and/or fibrosis). If a biopsy more than 1 year prior to screening has already demonstrated histological cirrhosis, the biopsy does not need to be repeated if this biopsy report can be provided. - Female and Male subjects and female partners of male subjects must consent to following contraception instructions detailed Protocol section 9. - Willing to refrain from the concomitant use of any medications, substances, or foods noted in section 10.11 of the Protocol. - Able to read and understand, and willingness to sign the informed consent and abide by study restrictions.
    Male and female subjects, 18 to 70 years of age inclusive. - Genotype 1, chronic hepatitis C with detectable HCV RNA. Genotype will be confirmed at screening. Chronic disease is defined as one of the following: &lt;Diagnosis of HCV &gt;6 months before the screening period, or &lt;History of a remote risk factor, or &lt;Abnormal alanine aminotransferase (ALT) levels for &gt;6 months before the screening period (Note, elevated ALT is not an inclusion criterion if one of the otehr criteria for chronic hepatitis C was met) - Aside from hepatitis C, judged to be in good health on the basis of medical history and physical examination (including vital signs and screening ECG), with any chronic medical conditions under stable medical control. - Seronegative for Hepatitis B surface antigen and Human Immunodeficiency Virus (HIV) 1 and 2. - Parameters for Absolute neutrophil count, platelet count, hemoglobin, uric acid and other hematology and clinical chemistry results within ranges specified in Section 9 of the protocol. - Documentation of a liver biopsy within 1 year (+/- 3 months) before the screening visit or agree to have a biopsy performed during screening. The biopsy must show evidence of hepatitis (demonstrated by inflammation and/or fibrosis). If a biopsy more than 1 year prior to screening has already demonstrated histological cirrhosis, the biopsy does not need to be repeated if this biopsy report can be provided. - Female and Male subjects and female partners of male subjects must consent to following contraception instructions detailed Protocol section 9. - Willing to refrain from the concomitant use of any medications, substances, or foods noted in section 10.11 of the Protocol. - Able to read and understand, and willingness to sign the informed consent and abide by study restrictions.
    E.4Principal exclusion criteria
    Previous treatment with any approved or investigational drug or drug regimen for the treatment of hepatitis C. - Any contraindications to Peg-IFN-alfa-2a or RBV therapy. - Decompensated liver disease. - Any other cause of significant liver disease in addition to hepatitis C, which may include, but is not limited to, hepatitis B, drug or alcohol-related cirrhosis, autoimmune hepatitis, hemochromatosis, Wilson's disease, nonalcoholic steatohepatitis (NASH), or primary biliary cirrhosis. - Diagnosed or suspected hepatocellular carcinoma. - Use of prohibited medications identified in Section 10.11 within 14 days before day 1. - A history of any illness that, in the opinion of the investigator, might confound the results of the study or pose an additional risk in administering study drug to the subjects. This may include but is not limited to a history of relevant drug or food allergies, history of cardiovascular or central nervous system disease, history or presence of clinically significant illness, or history of mental illness that may affect compliance with study requirements. - History of organ transplant, with the exception of corneal transplants and skin grafts which are permissible. - History of hemophilia. - History of acute or chronic pancreatitis. - Alcohol abuse or excessive use (in the opinion of the investigator, as judged by medical history) in the last 12 months. - Active drug abuse in the last 12 months. - Participation in any investigational drug study within 90 days before drug administration, or participation in more than 2 drug studies in the last 12 months (exclusive of the current study), or participation in any concurrent study. - Hypersensitivity to tartrazine (yellow dye #5). - Women who are pregnant, planning to become pregnant, or breastfeeding, and male partners of women who are pregnant or planning to become pregnant.
    Previous treatment with any approved or investigational drug or drug regimen for the treatment of hepatitis C. - Any contraindications to Peg-IFN-alfa-2a or RBV therapy. - Decompensated liver disease. - Any other cause of significant liver disease in addition to hepatitis C, which may include, but is not limited to, hepatitis B, drug or alcohol-related cirrhosis, autoimmune hepatitis, hemochromatosis, Wilson's disease, nonalcoholic steatohepatitis (NASH), or primary biliary cirrhosis. - Diagnosed or suspected hepatocellular carcinoma. - Use of prohibited medications identified in Section 10.11 within 14 days before day 1. - A history of any illness that, in the opinion of the investigator, might confound the results of the study or pose an additional risk in administering study drug to the subjects. This may include but is not limited to a history of relevant drug or food allergies, history of cardiovascular or central nervous system disease, history or presence of clinically significant illness, or history of mental illness that may affect compliance with study requirements. - History of organ transplant, with the exception of corneal transplants and skin grafts which are permissible. - History of hemophilia. - History of acute or chronic pancreatitis. - Alcohol abuse or excessive use (in the opinion of the investigator, as judged by medical history) in the last 12 months. - Active drug abuse in the last 12 months. - Participation in any investigational drug study within 90 days before drug administration, or participation in more than 2 drug studies in the last 12 months (exclusive of the current study), or participation in any concurrent study. - Hypersensitivity to tartrazine (yellow dye #5). - Women who are pregnant, planning to become pregnant, or breastfeeding, and male partners of women who are pregnant or planning to become pregnant.
    E.5 End points
    E.5.1Primary end point(s)
    Primary endpoint: Proportion of subjects achieving sustained viral response (SVR), demonstrated by achieving undetectable hepatitis C virus (HCV) RNA 24 weeks after last planned dose of study treatment. Key secondary endpoint: Proportion of subjects who have undetectable HCV RNA at Week 72 (i.e., 24 weeks after the last planned dose for subjects receiving 48 weeks of study treatment, and 48 weeks after the last planned dose for subjects receiving 24 weeks of study treatment). Other secondary endpoints: - Proportion of subjects achieving RVR, demonstrated by achieving undetectable HCV RNA 4 weeks after starting study treatment. - Proportion of subjects who have early viral response (EVR, defined as >/= 2-log10 decrease in HCV RNA at Week 12 compared to baseline). - Proportion of subjects who have undetectable HCV RNA at the end of treatment (EOT). - Proportion of subjects who have undetectable HCV RNA 12 weeks after last planned dose of study treatment. - Proportion of subjects who complete treatment with undetectable HCV RNA, and subsequently relapse between EOT and SVR assessment. - Biochemical response including transaminase levels and noninvasive markers of fibrosis. - Total Fatigue Score from the Fatigue Severity Scale (FSS). - Adverse events, physical examination findings, and clinical laboratory, vital sign, and electrocardiogram (ECG) assessments Tertiary Endpoints: - Amino acid sequence of the HCV NS3 protease domain - Pharmacokinetics and pharmacokinetic-pharmacodynamic relationships of telaprevir, VRT-127394, Peg-IFN-alfa-2a, and RBV - Patient reported outcomes including EQ-5D and assessment of work productivity.
    Percentuale di soggetti che raggiungono una risposta virale sostenuta (SVR, sustained viral response), dimostrata dal raggiungimento dell'HCV RNA non rilevabile 24 settimane dopo l'ultima dose di trattamento prevista nello studio.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy No
    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 Yes
    E.6.13.1Other scope of the trial description
    HCV sequencing, gene expression profiling, HLA and CYP gene sequencing, plasma proteomics
    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 Yes
    E.8.1.7.1Other trial design description
    All groups double-blinded to week 12. Group A unblinded after Week 24 if HCV RNA is detectable
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA30
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months30
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months30
    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.1.1Number of subjects for this age range: 0
    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) No
    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 state90
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 350
    F.4.2.2In the whole clinical trial 1050
    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)
    There is a safety follow-up visit 14 days after last dose, & antiviral follow-up visits as provided in the protocol.
    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 Decision2008-09-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-07-14
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2010-08-25
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