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    Summary
    EudraCT Number:2010-023498-20
    Sponsor's Protocol Code Number:P07614
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2011-09-08
    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 ConcernedUK - MHRA
    A.2EudraCT number2010-023498-20
    A.3Full title of the trial
    Assessment of the Pharmacokinetics of Boceprevir in Pediatric Subjects with Chronic Hepatitis C Genotype 1 (Phase 1b)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A single dose study of boceprevir in children and adolescents to determine the therapeutic dose.
    A.3.2Name or abbreviated title of the trial where available
    PO7614 PK of Boceprevir in CHC Paediatric Patients
    A.4.1Sponsor's protocol code numberP07614
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/154/2010
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
    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 supportMerck and Co., Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
    B.5.2Functional name of contact pointJoan R. Butterton
    B.5.3 Address:
    B.5.3.1Street Address33 Avenue Louis Pasteur
    B.5.3.2Town/ cityBoston, MA
    B.5.3.3Post code02115
    B.5.3.4CountryUnited States
    B.5.4Telephone number617 992-2313
    B.5.5Fax number617 992-2446
    B.5.6E-mailJoan_Butterton@merck.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 Victrelis
    D.2.1.1.2Name of the Marketing Authorisation holderMerck Sharp & Dohme Ltd.
    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 nameboceprevir
    D.3.2Product code SCH 503034
    D.3.4Pharmaceutical form Oral powder
    D.3.4.1Specific paediatric formulation Yes
    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 INNboceprevir
    D.3.9.1CAS number 394730-60-0
    D.3.9.2Current sponsor codeSCH 503034
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number50 to 200
    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
    Hepatitis type C (genotype I) virus infection
    E.1.1.1Medical condition in easily understood language
    Liver disease caused by hepatitis C virus 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 14.1
    E.1.2Level PT
    E.1.2Classification code 10019744
    E.1.2Term Hepatitis C
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10008912
    E.1.2Term Chronic hepatitis C
    E.1.2System Organ Class 10021881 - Infections and infestations
    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 weight based doses of boceprevir for children 3 to 17 years of age.
    E.2.2Secondary objectives of the trial
    To evaluate the safety and tolerability of a single dose of boceprevir in children 3 to 17 years of age.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subjects and/or legal guardian must provide written informed consent for the trial. 2. Subjects must be able to adhere to dose and visit schedules. 3. Subjects must have chronic Hepatitis C genotype 1 infection. 4. Pediatric subject with CHC genotype 1 who a) is treatment naive, OR b) failed previous (peg)interferon/Ribavirin treatment (e.g. null responder, partical responder, or relapser) 5. Subjects may be cirrhotic or non-cirrhotic 6. Subject who is a treatment failure must have completed at least 12 weeks of uninterrupted therapy with (peg)interferon/Ribavirin 7. Male and female subjects must be between the ages of 17 and 3 years (inclusive) and have a body mass index of between 18 and 32, inclusive. 8. Subjects must weigh between 10 kg and 90 kg at screening and baseline. 9. Vital sign measurements must be within an acceptable range. 10. Female subjects of childbearing potential, who are not surgically sterilized, must be willing to use medically accepted method(s) of contraception for 3 months prior to the screening period, during the screening and study period and for 2 months after stopping the trial medication or abstain from sexual intercourse. Nonvasectomized men must agree to use a condom with spermicide or abstain from sexual intercourse during the trial and for 3 months after stopping study medication.
    E.4Principal exclusion criteria
    A subject meeting any of the following exclusion criteria is not eligible to participate in the study. 1. Subject is coinfected with HIV or Hepatitis B virus. 2. Subject received any prior hepatitis C treatment with known hepatotoxicy including herbal remedies with known hepatotoxicity. 3. Subject received treatment with ribavirin within 90 days or any interferon-alpha within 30 days prior to screening. 4. Subject received previous treatment with a HCV protease inhibitor. 5. Subject required discontinuation of previous (peg)interferon/ribavirin therapy for an AE considered by the investigator to be related to (peg)interferon and/or ribavirin. 6. Subject is currently taking any antiviral/immunomodulatory treatment for hepatitis C. 7. The subject has used any investigational drugs within 30 days of enrolment into this study. 8. The subject is participating in a clinical trial within 30 days of enrolment or is planning to participate in another clinical trial during participation in this study. 9. Subject has evidence of decompensated liver disease. 10. The subject has a history of diabetes, hypertension or birth prior to 32 weeks gestation with clinically significant ocular examination findings or any other clinically significant preexisting medical condition that would affect participation in the study. 11. Preexisting clinically significant psychiatric conditions or personality disorders that in the opinion of the Investigator and Sponsor, affects the subject's ability to participate in the trial. 12. Substance abuse any time prior to entry into the study. 13. Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of any drug or interfer with the subject's participation and completion of the study. 14. Subject has a history of infectious disease within 4 weeks prior to drug administration that will affect participation in the study. 15. Evidence of active or suspected malignancy, or a history of malignancy, within the last 5 years (except adequately treated carcinoma in situ and basal cell carcinoma of the skin). 16. The female subject is pregnant or breastfeeding. The female subject intends to become pregnant during or 3 months after the ending of the study or the male subjects intends to father a child during or 3 months after the ending of the study. 17. The subject had a lifethreateningserious adverse event during the screening period. Key Clinical Laboratory Criteria: 1. Haematologic criteria (growth factors may not be used to achieve study entry requirements): o Haemoglobin < lower limit of normal range (LLN) o Neutrophils <1500/mm3 o Platelets <100,000/mm3 2. Serum albumin < lower limit of normal (LLN) of laboratory reference range. 3. Serum creatinine > ULN of laboratory reference range 4. Thyroidstimulating hormone (TSH) >1.2 x ULN or <0.8 x LLN of laboratory reference range with the following exceptions: o The subject may be enroled if clinically euthyroid, AND o The euthyroid function is confirmed by thyroxine/triiodothyronine (T4/T3) testing
    E.5 End points
    E.5.1Primary end point(s)
    Measurement of common pharmacokinetic parameters, including AUCĪ±, Cmax, Tmax, CL/F, Vd/F, from children aged 17 - 3 years (inclusive) after receiving a single weight base dose of boceprevir.
    E.5.1.1Timepoint(s) of evaluation of this end point
    N/A
    E.5.2Secondary end point(s)
    N/A
    E.5.2.1Timepoint(s) of evaluation of this end point
    N/A
    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 No
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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) Yes
    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) No
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA3
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Poland
    Russian Federation
    United Kingdom
    United States
    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
    Last subject last visit
    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 days16
    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 days16
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 48
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 32
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 16
    F.1.2Adults (18-64 years) No
    F.1.2.1Number of subjects for this age range: 0
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 0
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Pediatric patients between ages 3 and 17
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state6
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 12
    F.4.2.2In the whole clinical trial 48
    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)
    This is a Phase Ib pharmacokinetic study. It is not expected to have any treatment benefits for the trial participants. Following completion of this study, the PK data from this trial will be used to estimate the dose levels of Boceprevir for use in further SCH 503034 paediatric studies. The intention is for subjects who have participated in study PO7614 and meet the eligibility requirements will be offered the opportunity to enroll in a phase II study PO8034 which will include a full treatment
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Medicines for Children Research Network
    G.4.3.4Network Country United Kingdom
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2011-08-31
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-11-14
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2014-01-21
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