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    The EU Clinical Trials Register currently displays   35474   clinical trials with a EudraCT protocol, of which   5826   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2008-004760-39
    Sponsor's Protocol Code Number:P05685
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-03-16
    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 ConcernedFrance - ANSM
    A.2EudraCT number2008-004760-39
    A.3Full title of the trial
    A phase 3 safety and efficacy study of boceprevir in combination with peginterferon alfa-2a and ribavirin in subjects with chronic hepatitis C genotype 1 who failed prior treatment with peginterferon/ribavirin
    A.4.1Sponsor's protocol code numberP05685
    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 SponsorSchering Plough Research Institute, A Division of Schering Corporation
    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 nameBoceprevir
    D.3.2Product code SCH 503034
    D.3.4Pharmaceutical form Capsule*
    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 INNBoceprevir
    D.3.9.2Current sponsor codeSCH 503034
    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 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
    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 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.3.9.3Other descriptive namePegasys
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    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) 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: 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 Rebetol
    D.2.1.1.2Name of the Marketing Authorisation holderSchering-Plough Europe
    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 nameRebetol
    D.3.2Product code SCH 18908
    D.3.4Pharmaceutical form Capsule*
    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.3.9.2Current sponsor codeSCH 18908
    D.3.9.3Other descriptive nameRebetol
    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 placeboCapsule*
    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
    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.1.2Term Chronic hepatitis C
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level PT
    E.1.2Classification code 10019744
    E.1.2Term Hepatitis C
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level SOC
    E.1.2Classification code 10021881
    E.1.2Term Infections and infestations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level SOC
    E.1.2Classification code 10019805
    E.1.2Term Hepatobiliary disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this study is to compare the efficacy of boceprevir 800 mg three times a day (TID) orally (PO) in combination with peginterferon alfa-2a (PEG2a) 180 mcg weekly (QW) subcutaneously (SC) plus ribavirin (1000 mg/day to 1200 mg/day) PO to the same PEG2a/ribavirin regimen without boceprevir for 48 weeks in adult subjects with chronic hepatitis C (CHC) genotype 1 with demonstrated interferon responsiveness who failed prior treatment with peginterferon/ribavirin.
    E.2.2Secondary objectives of the trial
    • To evaluate the safety of boceprevir when used in combination with PEG2a/Ribavirin
    • To define predictors of sustained virologic response (SVR), such as epidemiologic factors, disease characteristics, and on-treatment response.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. For inclusion in the study, subjects must have a qualifying regimen defined as PEG2a/ribavirin or peginterferon alfa-2b (PEG2b)/ribavirin for a minimum of 12 weeks. If a subject has received more than one such regimen, the most recent regimen is considered the qualifying regimen
    Note: Maintenance therapy, following failure of qualifying therapy, with any interferon alfa is acceptable; however, the subject must have discontinued the maintenance therapy at least 1 month prior to the Screening Visit
    2. During the qualifying regimen, subjects must have either:
    a. A documented undetectable HCV-RNA within 30 days of EOT and a subsequent detectable HCV-RNA during follow-up OR
    b. A documented decline in HCV-RNA by >/= 2 log10 by TW 12.
    Note: For subjects who did not participate in Schering-Plough Research Institute (SPRI) protocols, qualifying virology reports and documentation of qualifying previous treatment regimen must be completely de-identified and faxed to the sponsor's project physician for confirmation that the subject qualifies for this study
    3. Subject must have previously documented CHC genotype 1 infection. Subjects with other or mixed genotypes are not eligible. The HCV-RNA result obtained from the central laboratory at the Screening Visit must confirm genotype 1 infection and be equal or greater than 10,000 IU/mL
    4. Subject must have a liver biopsy with histology consistent with CHC and no other etiology. Copies of the pathology report and slides are required for the subject to be included in the study. The study site must be able to access the pathology report and histology slides prior to subject randomization. Two unstained slides are preferred; however, one slide stained with hematoxylin plus eosin (H & E) plus one slide stained with Masson’s trichrome will be accepted (slides should be reviewed by the investigator to confirm adequacy). The central pathologist’s reading will be used for analysis purposes
    a. No cirrhosis: Biopsy must be within 3 years of the Screening Visit
    b. Cirrhosis: Any historic liver biopsy demonstrating cirrhosis will be accepted regardless of length of time since biopsy
    c. Subjects whose timing of liver biopsy does not meet this criterion for subject eligibility may have a liver biopsy performed between Screening and Day 1, if their Screening Visit confirms that the subject meets the other study inclusion criteria
    5. Subjects with bridging fibrosis or cirrhosis must have an ultrasound within 6 months of the Screening Visit (or between Screening and Day 1) with no findings suspicious for hepatocellular carcinoma (HCC)
    6. Subjects participating in SPRI maintenance protocols P02570 or P02569 must have completed the study (ie, finished last contact) to be eligible for this protocol
    7. Subject must be 18 years of age
    8. Subject must weigh between 40 kg and 125 kg
    9. Subject and subject’s partner(s) must each agree to use acceptable methods of contraception for at least 2 weeks prior to Day 1 and continue until at least 6 months after last dose of study drug, or longer if dictated by local regulations
    10. Subjects must be willing to give written informed consent
    E.4Principal exclusion criteria
    1. Subjects known to be coinfected w/HIV or HBV
    2. Subjects requiring discontinuation of previous interferon or ribavirin regimen for an AE considered to be possibly/probably related to ribavirin &/or interferon
    3. Treatment w/ribavirin w/in 90 days & any interferon alfa w/in 1 month of Screening
    4. Treatment for hepatitis C w/any investigational drug. Prior treatment with herbal remedies w/known hepatotoxicity
    5. Treatment w/any investigational drug w/in 30 days of the randomization
    6. Participation in any other clinical trial w/in 30 days of randomization
    7. Evidence of decompensated liver disease including history or presence of clinical ascites, bleeding varices, or hepatic encephalopathy
    8. Diabetic &/or hypertensive subjects w/clinically significant ocular findings
    9. Pre-existing psychiatric condition(s), including but not limited to:
    a. Current moderate or severe depression (mild depression may be enrolled)
    b. History of depression associated with: Hospitalization; Electroconvulsive therapy; prolonged absence from work &/or significant disruption of daily functions
    c. Suicidal or homicidal ideation &/or attempt
    d. History of severe psychiatric disorders
    e. Past/current use of lithium
    f. Past/current use of antipsychotic drugs
    10. Clinical diagnosis of substance abuse of the following drugs w/in the following timeframes:
    a. Alcohol, intravenous drugs, inhalational (not including marijuana), psychotropics, narcotics, cocain, prescription or over-the-counter drugs: w/in 1 year of the Screening Visit, OR
    b. Multi-drug abuse w/in 3 years of Screening Visit OR
    c. Subjects receiving opiate agonist substitution therapy w/in 1 year of Screening (except for subjects monitored in an opioid substitution maintenance program) OR
    d. Historic marijuana use is deemed excessive by a physician, or is interfering with the subject's life
    11. Any known pre-existing medical condition that could interfere w/the participation in & completion of study, including but not limited to:
    a. Central nervous system trauma
    b. Current or history of seizure disorder unless >10 years ago, a single isolated event, no anti-seizure medications prescribed, & a normal neurological examination documented in study files w/in 6 months of Day 1
    c. History of stroke/transient ischemic attack
    d. Immunologically mediated disease
    e. Chronic pulmonary disease
    f. Current or history of any clinically significant cardiac abnormalities/dysfunction including current uncontrolled hypertension or history of antianginal agents for cardiac conditions
    g. Any medical condition requiring chronic systemic administration of corticosteroids during study
    h. Active clinical gout w/in 1 year
    i. Hemoglobinopathy
    j. Myelodysplastic syndromes
    k. Coagulopathy
    l. Organ transplants other than corneal & hair
    m. Poor venous access precluding routine peripheral blood sampling
    n. Subjects w/indwelling venous catheters
    o. Subjects w/a history of gastric surgery or malabsorption disorders
    12. Evidence of active or suspected malignancy or a history of malignancy w/in the last 5 years. Subjects under evaluation for malignancy are not eligible
    13. Subjects who are pregnant, nursing or intend to become pregnant during study. Male subjects w/partners who are or intend to become pregnant during study
    14. Other conditions making the subject unsuitable for enrollment or could interfere w/the subject participating in & completing study
    15. Subjects who are part of the site personnel directly involved with study, family members of study staff, or had a life-threatening SAE during the screening period
    18. Any history of pancreatitis
    Laboratory Exclusion Criteria
    If a single value is within 10% of the exclusion criterion value & the value is considered not clinically significant by the investigator, the subject may be considered for enrollment
    1. Hematologic, biochemical & serologic criteria (growth factors may not be used to achieve entry requirements):
    a. Hemoglobin Females:<12 g/dL Males:<13 g/dL
    b. Neutrophils <1500/mm3 (blacks: <1200/mm3)
    c. Platelets <100,000/mm3
    d. Direct bilirubin >1.5xULN. Total bilirubin >1.6 mg/dL unless a history of Gilbert's disease
    2. Serum albumin < lower limit of normal (LLN)
    3. Thyroid-stimulating hormone (TSH)>1.2xULN or <0.8xLLN w/the following exception:
    a. The subject may be enrolled if clinically euthyroid, AND
    b. The euthyroid function is confirmed by T4/T3 testing
    4. Serum creatinine >ULN
    5. Serum glucose:
    a. Subjects not previously diagnosed with diabetes mellitus:
    1) >/=140 mg/dL (nonfasting) unless hemoglobin, A1c subtype (HbA1c)</=7% OR
    2). >/=100 mg/dL (fasting) unless HbA1c </=7%
    b.For subjects previously diagnosed w/diabetes mellitus: HbA1c>8.5%
    6. PT/PTT >10% above lab reference range
    7. Anti-nuclear antibodies (ANA)>1:320
    8. Alpha fetoprotein (AFP)
    a. AFP >100 ng/mL OR
    b. AFP 50-100 ng/mL requires a liver ultrasound & subjects w/findings suspicious for HCC are excluded
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is the achievement of SVR, defined as undetectable plasma HCV-RNA at FW 24. Subjects will be declared treatment failures in one of the following ways:
    • Subjects in any treatment arm with detectable HCV-RNA at Follow-up Week (FW) 24
    • Subjects in any treatment arm with detectable HCV-RNA at TW 12
    •Subjects in any treatment arm who are missing their HCV-RNA at FW 24 with detectable or missing HCV RNA at FW 12
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Information not present in EudraCT
    E.6.2Prophylaxis Information not present in EudraCT
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Information not present in EudraCT
    E.6.7Pharmacodynamic Information not present in EudraCT
    E.6.8Bioequivalence Information not present in EudraCT
    E.6.9Dose response Information not present in EudraCT
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic Information not present in EudraCT
    E.6.13Others Information not present in EudraCT
    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) Yes
    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 EEA22
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2009-03-16. Yes
    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 state100
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 60
    F.4.2.2In the whole clinical trial 198
    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)
    All subjects who receive at least one dose of study medication will be offered the opportunity to enroll in a 3-year long-term follow-up study (P05063 - EudraCT number : 2006-006529-25) after completing their participation in this study. Control Arm subjects with detectable HCV-RNA at TW12, relapsing or virologic breakthrough will be eligible to participate in PROVIDE study (P05514) and receive boceprevir in combination with PegIntron and ribavirin for up to 44 weeks
    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 Decision2009-02-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-02-04
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2010-10-19
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