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    The EU Clinical Trials Register currently displays   43865   clinical trials with a EudraCT protocol, of which   7286   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:2005-005506-23
    Sponsor's Protocol Code Number:NV18209
    National Competent Authority:Portugal - INFARMED
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2006-04-24
    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 ConcernedPortugal - INFARMED
    A.2EudraCT number2005-005506-23
    A.3Full title of the trial
    A Randomized, Multicenter, Double Blinded, Phase IV Study Comparing the Safety and Efficacy of Pegasys 180 µg plus Copegus 1000 or 1200 mg to the Currently Approved Combination of Pegasys 180 µg plus Copegus 800 mg in Interferon-naïve Patients with Chronic Hepatitis C Genotype 1 virus infection coinfected with human immunodeficiency virus (HIV-1).
    A.4.1Sponsor's protocol code numberNV18209
    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 SponsorF. Hoffmann-La Roche Ltd
    B.1.3.4CountrySwitzerland
    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 Information not present in EudraCT
    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.3.2Product code RO 25-8310
    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.3.11 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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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 Information not present in EudraCT
    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.3.2Product code RO 20-9963
    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.3.11 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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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
    Patients with chronic hepatitis C (CHC) genotype 1 virus coinfected with human immunodeficiency virus type 1 (HIV-1)
    MedDRA Classification
    E.1.3Condition being studied is a rare disease Information not present in EudraCT
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Primary Efficacy
    • To compare the efficacy of treatment with Copegus (ribavirin (RBV)) 1000 or 1200 mg in combination with Pegasys (peginterferon alfa-2a (PEG-IFN alfa-2a)) 180 µg to the approved regimen of Copegus 800 mg in combination with Pegasys 180 µg in patients with chronic hepatitis C genotype 1 virus coinfected with HIV-1 treated for 48 weeks and followed for 24 weeks after treatment end (sustained virologic response, SVR)

    Primary Safety
    • To compare the safety of treatment with Copegus 1000 or 1200 mg in combination with Pegasys 180 µg to the approved regimen of Copegus 800 mg in combination with Pegasys 180 µg in patients with chronic hepatitis C genotype 1 virus coinfected with HIV-1 treated for 48 weeks and followed for 24 weeks after treatment end
    E.2.2Secondary objectives of the trial
    Secondary Safety
    • To evaluate the safety profile of both regimens in patients of non-Hispanic African American descent.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    • Male and female patients >= 18 years of age
    • Serological evidence of CHC infection by an anti-HCV antibody test (current or historical)
    • Detectable plasma HCV-RNA (>600 IU/mL)
    • Evidence of HCV genotype 1 infection by molecular assay
    • Chronic liver disease consistent with CHC infection on a biopsy obtained within the past 18 months as judged by a central pathologist. Up to 20% of patients with cirrhosis or incomplete cirrhosis will be allowed to enter the trial
    • Child Pugh total score at screening must be equal to 5 for a patient with cirrhosis or bridging fibrosis/transition to cirrhosis to be enrolled into NV18209. The only exception would be an elevation in Child Pugh total score (of >= 6) secondary to total bilirubin as a consequence of a concomitant medication (e.g. atazanavir and indinavir) or a clinical condition (e.g. Gilbert's syndrome) that may cause hyperbilirubinemia. An elevation in Child Pugh total score (of >= 6) secondary to albumin, INR, ascites or hepatic encephalopathy will not be acceptable
    • Patients with cirrhosis or incomplete cirrhosis must have an abdominal ultrasound, CT scan, or MRI scan without evidence of hepatocellular carcinoma (within 2 months of randomization) and a serum alpha-fetoprotein (AFP) <100 ng/mL
    • Serological evidence of HIV-1 infection by HIV-1 antibody or detection of HIV-1 RNA
    • Clinically stable status of HIV-1 infection in the opinion of the investigator, ie, patients who are not expected to progress during the study
    • Patients with a CD4+ count >= 100 cells/µL
    • Patients with HIV disease who are receiving stable antiretroviral therapy (ART) or for whom antiretroviral therapy is not required.
    • Negative urine or blood pregnancy test result (for women of childbearing potential) documented within the 24-hour period prior to the first dose of study drug.
    Additionally, all males with female partners of childbearing potential and sexually active females of childbearing potential must be using two forms of effective contraception (combined) during treatment and during the 6 months after treatment end.
    • Willingness to give written informed consent and willingness to participate in and comply with the study requirements
    E.4Principal exclusion criteria
    • History of having received alpha IFNs, PEG-IFN, ribavirin (RBV), viramidine, levovirin or investigational HCV protease or polymerase inhibitors at any previous time. Any history of systemic antiviral therapy, with established or perceived activity against HCV, =< 3 months prior to the first dose of study medication
    • Infection with any HCV genotype other than genotype 1 or infection with a mixed genotype or with a genotype that can not be established as genotype 1, i.e. ndeterminant genotype
    • History or other evidence of decompensated liver disease or a Child-Pugh score >5.
    Coagulopathy, hyperbilirubinemia, hepatic encephalopathy, hypoalbuminemia, ascites, and bleeding from esophageal varices or other conditions consistent with decompensated liver disease
    • Positive test result at screening for anti-HAV IgM Ab, HBsAg, anti-HBc IgM Ab
    • History or other evidence of a medical condition associated with chronic liver disease other than HCV
    • Evidence of an active or suspected cancer or a history of malignancy where the risk of recurrence is >= 20% within 2 years. Patients with liver cirrhosis with a lesion suspicious for hepatic malignancy on the screening imaging study will be eligible only if the likelihood of carcinoma is =<10% following an appropriate evaluation
    • Active HIV-related opportunistic infection and/or malignancy requiring acute systemic therapy
    • Within 6 weeks of starting the study screening period, the use of colony stimulating factors , such as granulocyte colony stimulating factor (GCSF) or erythropoietin to elevate hematology parameters. (These factors may be used after treatment has commenced)
    • Absolute neutrophil count (ANC) <1500 cells/mm3, except for African-Americans whose ANC should not be <1200 cells/mm3
    • Platelet count <70,000 cells/mm3
    • Hemoglobin <11 g/dL in females or <12 g/dL in males or any patient with a aseline
    increased risk for anemia (eg, thalassemia, sickle cell anemia, spherocytosis, history
    of GI bleeding) or for whom anemia would be medically problematic.
    • Serum creatinine level >1.5 times the upper limit of normal at screening
    • History of severe psychiatric disease including psychosis and or depression, a suicide attempt, hospitalization for psychiatric disease, or a period of disability as a result of psychiatric disease
    • History of uncontrolled severe seizure disorder
    • History of immunologically mediated disease (eg, inflammatory bowel disease, idiopathic thrombocytopenic purpura, lupus erythematosus, autoimmune hemolytic anemia, scleroderma, severe psoriasis (defined as affecting > 10% of the body, where the palm of one hand equals 1%, or if the hands and feet are affected), rheumatoid arthritis requiring more than intermittent nonsteroidal anti-inflammatory medications for management
    • History or other evidence of chronic pulmonary disease associated with functional limitation
    • History of significant cardiac disease that could be worsened by acute anemia (eg, NYHA Functional Class III or IV, myocardial infarction within 6 months, ventricular tachyarrhythmias requiring ongoing treatment, unstable angina or other significant cardiovascular diseases). In addition, patients with documented or presumed coronary artery disease or cerebrovascular disease should not be enrolled if, in the judgment of the investigator, an acute decrease in hemoglobin by up to 4 g/dL (as may be seen with RBV therapy) would not be well-tolerated
    • Poorly controlled thyroid dysfunction
    • History or other evidence of severe retinopathy (eg, CMV retinitis, macular degeneration) or clinically relevant opthalmological disorder due to diabetes mellitus or hypertension
    • History of major organ transplantation with an existing functional graft
    • History or other evidence of severe illness, malignancy or any other conditions which would make the patient, in the opinion of the investigator, unsuitable for the study
    • History of any systemic antineoplastic or immunomodulatory treatment (including supraphysiological doses of steroids and radiation) =<6 months prior to the first dose of study drug or the expectation that such treatment will be needed at any time during the study
    • Any investigational drug =< 6 weeks prior to the first dose of study drug or during the study. Patients enrolled in this study cannot be enrolled in another study for either diagnostic or treatment purposes.
    • Patients who are expected to need systemic antiviral therapy with established or perceived activity against HCV at any time during their participation in the study are also excluded
    • Excessive alcohol consumption and/or drug or substance use that, in the judgment of the investigator, would result in the patient being unreliable in fulfilling the conditions of the protocol
    • Women who are pregnant or breast-feeding
    • Male partners of women who are pregnant
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy variable is sustained virological response, as defined by the percentage of patients with undetectable HCV RNA at 24 weeks after completion of the 48 week treatment period (ie, a single last HCV RNA < 20 IU/mL measured >= study day 477 ( >= week 68).
    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 Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic Information not present in EudraCT
    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) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 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.8.5The trial involves multiple Member States Yes
    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 Information not present in EudraCT
    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
    the last visit of the last subject
    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 months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months6
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    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 Information not present in EudraCT
    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 2006-04-24. Yes
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 state23
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 70
    F.4.2.2In the whole clinical trial 400
    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)
    normal treatment
    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 Decision2006-07-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-08-04
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2009-04-07
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