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    The EU Clinical Trials Register currently displays   44334   clinical trials with a EudraCT protocol, of which   7366   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:2009-013652-69
    Sponsor's Protocol Code Number:AI447-016
    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:2010-07-26
    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 number2009-013652-69
    A.3Full title of the trial
    A Phase 2a/2b study of BMS-650032 in Combination With Peginterferon Alfa-2a (Pegasys) and Ribavirin (Copegus) in Treatment-Naive Subjects with Genotypes 1 and 4 Chronic Hepatitis C Infection. Revised Protocol 01, incorporating Protocol Amendment 03 (v1.0, dated 15-Feb-2010).
    A.3.2Name or abbreviated title of the trial where available
    ND
    A.4.1Sponsor's protocol code numberAI447-016
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberND
    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 SponsorBristol-Myers Squibb International Corporation
    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 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.3.2Product code BMS-650032-01
    D.3.4Pharmaceutical form Film-coated tablet
    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.3.9.2Current sponsor codeBMS-650032-01
    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) 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.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 Registration Limited
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 Information not present in EudraCT
    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.3.10.2Concentration 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) 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 Yes
    D.3.11.13.1Other medicinal product typeProteina ricombinanate
    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 Laboratories
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 Film-coated tablet
    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 INNRibavirin
    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) 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 placeboFilm-coated tablet
    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 Virus Infection (Genotypes 1 and 4) in Treatment-Naive Subjects.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10008912
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Both Stage 1 and Stage 2 primary objectives will be based on their respective Week 12 analysis of safety and antiviral activity data. In addition, a co-primary objective of Stage 2 will be based on follow-up anti-viral activity data (SVR). The Week 12 analysis in Stage 1 supports dose selection decisions for Stage 2 while the analyses in Stage 2 will support the overall HCV program (add-on to SOC and combination anti-viral studies) and inform decisions on both dose (Week 12 analysis) and duration (SVR analysis).
    E.2.2Secondary objectives of the trial
    - To assess the proportion of HCV genotype 1 subjects with rapid virologic response (RVR), defined as undetectable HCV RNA at Week 4; - To assess the proportion of HCV genotype 1 subjects with early virologic response (EVR), defined as ≥ 2 log10 decrease in HCV RNA from baseline at Week 12 (or undetectable HCV RNA for subjects with baseline HCV RNA < 1200 IU/mL); - To assess the proportion of HCV genotype 1 subjects with 12-week sustained virologic response (SVR12), defined as undetectable HCV RNA at follow-up Week 12; - To describe resistant variants associated with virologic failure.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Signed Written Informed Consent a) Freely given informed consent must be obtained from subjects prior to clinical trial participation, including informed consent for any screening procedures conducted to establish subject eligibility for the study. 2) Target Population a) Subjects chronically infected with HCV genotype 1 as documented by: positive for anti-HCV antibody, HCV RNA, or a positive HCV genotype test at least 6 months prior to screening, and positive for HCV RNA and anti-HCV anti-body at the time of screening (Stages 1 and 2); b) Subjects chronically infected with HCV genotype 4 as documented by: positive for anti-HCV antibody, HCV RNA, or a positive HCV genotype test at least 6 months prior to screening, and positive for HCV RNA and anti-HCV anti-body at the time of screening (Stage 2 only); c) HCV RNA viral load of ≥ 100,000 IU/mL at screening; d) Results of a biopsy obtained ≤ 24 months prior to randomization showing no evidence of cirrhosis for subjects that do not have a diagnosis of cirrhosis (Stages 1 and 2); (Note: Genotype 1 subjects with compensated cirrhosis, regardless of time since biopsy, may be included in Stage 2); e) Body Mass Index (BMI) of 18 to 35 kg/m�, inclusive. BMI = weight (kg)/[height (m)]� at screening 3) Age and Sex a) Men and women, ages 18 to 70; b) Women of childbearing potential (WOCBP), unless non-heterosexual active or who have vasectomized male partners, and sexually active men (unless vasectomized) with female partners who are WOCBP must use two separate forms of contraception, one of which must be an effective barrier method (eg, condom with spermicide), from screening throughout the duration of the study and for 24 weeks after the last dose of ribavirin. In addition, WOCBP must agree to the pregnancy testing schedule specified in this protocol. Oral contraceptive pills (OCPs) may be used in this study, but cannot be considered one of the two effective forms of contraception required because drug interaction studies verifying the effectiveness of OCPs when used with BMS-650032 have not been completed. Men (unless vasectomized) with female partners who are WOCBP must agree to inform their female partners of the protocol-specified contraception requirements and pregnancy testing recommendations during treatment and post-treatment (monthly pregnancy testing on-treatment and following discontinuation of RBV for 6 months post-treatment or the duration specified in the label used for RBV in that country), and agree to adhere to these recommendations for both the on-treatment and post-treatment follow-up period. WOCBP are defined as a non-menopausal female or a female with menopause ≤ 2 years and who has not had a hysterectomy, bilateral tubal ligation, bilateral oophorectomy or medically documented ovarian failure. Female subjects who are postmenopausal for less than two years are required to have FSH > 40 mIU/mL. If the FSH is ≤ 40 mIU/mL, the subject must agree to use two forms of contraception to participate in the study. Women are considered surgically sterile only if they have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy. Post menopause is defined as: • Amenorrhea ≥ 12 consecutive months without another cause or • For women with irregular menstrual periods and on hormone replacement therapy (HRT), a documented serum follicle stimulating hormone (FSH) level > 40 mIU/mL. See protocol
    E.4Principal exclusion criteria
    1)Sex and Reproductive Status a)WOCBP unwilling or unable to use an acceptable method to avoid pregnancy (two effective forms of contraception) for the entire study period (on treatment) and for up to 24 weeks after the last dose of investigational product or for the duration specified in the label use for RBV in that country, whichever is longer b)Women who are pregnant of breastfeeding c)Women with positive pregnancy test on enrollment or prior to investigational product administration d)Sexually active fertile men not using effective birth control if their partners are WOCBP e)Sexually active fertile men whose partners are pregnant at screening (contraindicated with RBV use) 2)Medical History and Concurrent Diseases a)Evidence of medical condition associated with chronic liver disease other than HCV b)Evidence of decompensated cirrhosis based on radiologic criteria or biopsy results and clinical criteria (in Stage 2) c)Evidence of HCC documented by ultrasound (U/S), computed tomography (CT) scan, or magnetic resonance imaging (MRI) within 12 months of randomization d)Co-infection with HBV, HIV-1 or HIV-2 at screening e)History of variceal bleeding, hepatic encephalopathy, or ascites requiring management with diuretics or paracentesis f)Current or known history of cancer (except in situ carcinoma of the cervix or adequately treated basal or squamous cell carcinoma of the skin) within 5 years prior to enrollment g)Any gastrointestinal disease or surgical procedure that may impact the absorption of study drug; h)Any other medical, psychiatric and/or social reason including active substance or alcohol abuse, as defined by DMS IV, Diagnostic Criteria for Drug and Alcohol Abuse (see Protocol Appendix 3), which in the opinion of the investigator, would make the candidate inappropriate for participation in this study i)Inability to tolerate oral medication j)Poor venous access k)Liver transplant recipients 3)Physical & Laboratory Test Findings a)ALT ≥5 x ULN b)Total bilirubin ≥2 mg/dL (or ≥ 34 μmol/L) c)INR≥ 1.7 d)Albumin ≤3.5 g/dL (35 g/L) e)Creatinine clearance (CrCl) (as estimated by Cockcroft and Gault) ≤50 mL/min f)Any ECG finding which, in the opinion of the investigator, would make the candidate inappropriate for participation in this study (ie, corrected QT value > 450 msec, second/third degree AV block, and bundle branch block) g)Positive HBs Antigen 4)Medical History or Laboratory Findings that Exclude Subject from pegIFNα or RBV Therapy The following exclusion criteria are based on guidelines or recommendations from the pegIFNα and RBV package inserts. 5)Allergies and Adverse Drug Reactions 6)Prohibited Treatments and/or Therapies 7)Other See protocol for details
    E.5 End points
    E.5.1Primary end point(s)
    - Safety, as measured by the frequency of SAEs and discontinuations due to AEs; - Antiviral activity, as determined by the proportion of HCV genotype 1 subjects with extended rapid virologic response (eRVR), defined as undetectable HCV RNA at both Weeks 4 and 12; - Antiviral activity, as determined by the proportion of HCV genotype 1 subjects with 24-week sustained virologic response (SVR24), defined undetectable HCV RNA at follow-up Week 24 (Stage 2 only).
    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 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 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 EEA28
    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 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 years3
    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 years3
    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 state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 231
    F.4.2.2In the whole clinical trial 435
    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)
    At the end of the study, the sponsor will not continue to supply study drug to subjects/investigators unless the sponsor chooses to extend the study. The investigator should ensure that the subject receives appropriate standard of care to treat the condition under study.
    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 Decision2011-02-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-07-19
    P. End of Trial
    P.End of Trial StatusCompleted
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