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The European Union Clinical Trials Register   allows you to search for protocol and results information on:
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    The EU Clinical Trials Register currently displays   43871   clinical trials with a EudraCT protocol, of which   7290   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:2007-005344-25
    Sponsor's Protocol Code Number:HCV 07-01
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2007-10-31
    Trial 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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2007-005344-25
    A.3Full title of the trial
    High-dose versus standard-dose weight-based ribavirin in combination with peginterferon alfa-2a for patients infected with hepatitis C virus genotype 1 or 4
    A.3.2Name or abbreviated title of the trial where available
    VIRID
    A.4.1Sponsor's protocol code numberHCV 07-01
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT00662220
    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 SponsorFoundation for Liver Research
    B.1.3.4CountryNetherlands
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    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 Yes
    D.2.1.1.1Trade name Copegus
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Products 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 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.3.9.1CAS number 66510-90-5
    D.3.9.2Current sponsor codevirid
    D.3.9.3Other descriptive nameribavirin
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number200 to 3000
    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 Yes
    D.3.11.13.1Other medicinal product typesynthetic nucleoside analogue
    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 NeoRecormon
    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.3.1Product nameNeoRecormon
    D.3.4Pharmaceutical form Injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNepoetin beta
    D.3.9.1CAS number 122312-54-3
    D.3.9.2Current sponsor codevirid
    D.3.9.3Other descriptive nameepoetin beta
    D.3.10 Strength
    D.3.10.1Concentration unit IU international unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30000
    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 typeRecombinant human erythropoietin
    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
    Chonic hepatitis C
    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
    · HCV-RNA negativity by qualitative assay 24 weeks after end of treatment (sustained virological response, SVR)
    E.2.2Secondary objectives of the trial
    · HCV-RNA negativity at week 4 (rapid virologic response, RVR)
    · HCV-RNA negativity at week 12 (complete early virologic response, cEVR)
    · HCV-RNA ≥ 2log10 drop at week 12, but HCV-RNA still detectable (partial early virologic response, pEVR)
    · HCV-RNA negativity at week 48 (end of treatment response, ETR)
    · Relapse rate after end of treatment response
    · Safety (serious adverse events, grade 4 NCI toxicity)
    · Tolerability of peginterferon alfa-2a and high-dose ribavirin (percentage of patients completing treatment on full or >80% of total intended dose and reasons for dose adjustments)
    · Normalization of serum ALT at the end of therapy and and at the end of follow-up
    · Health related quality of life assessment using SF-36 questionnaires
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    ancillary I: Monitoring immune responses in chronic hepatitis C virus infected patients during combined treatment with high-dose or standard-dose weight-based ribavirin and peginterferon alfa-2a. Date: September 20th, 2007, version 1. Objective: The aim of this ancillary study is to evaluate intrahepatic immune responses in chronic HCV patients treated with peg-interferon alfa-2a, and standard or high dose ribavirin. The intrahepatic immune response will be correlated to peripheral immune activity (in blood).

    ancillary II: Monitoring the effects of erythropoietin treatment in chronic hepatitis C virus infected patients during combined treatment with high-dose or standard-dose weight-based ribavirin and peginterferon alfa-2a. Date: September 20th, 2007, version 1. Objective: A common side effect of ribavirin treatment is anemia, which will -if required- be treated with erythropoietin and possible blood transfusions. The aim of this ancillary study is to examine the effects of erythropoietin treatment on the immune system by assessing immune parameters in blood before and after erythropoietin treatment (epoietin beta, NeoRecormon).

    Ancillary III: Influence of standard-dose or high-dose weight-based ribavirin and interferon on semen quality.
    Objective: Primary aim:
    To assess changes in sperm chromatin structure integrity and in seminal parameters according to the WHO criteria for semen analysis.
    Secondary aims:
    To assess if the changes in sperm due to treatment with ribavirin and peginterferon alpha are reversible.
    To investigate if possible teratogenic and embyolethal effects of ribavirin are dose-dependent.

    Ancillary IV: Monitoring ribavirin plasma concentrations and the effect on HCV viral load and mutation rate in NS5B domain in hepatitis C patients during combined treatment with peginterferon alfa-2a and high or standard dose weight-based ribavirin.
    Objective: The aim of this ancillary study is to assess the ribavirin plasma concentration and the effect on HCV load and to determine whether high dose ribavirin leads to a higher number of mutations in the HCV NS5B region during combination treatment with peginterferon and standard or high dose ribavirin.
    E.3Principal inclusion criteria
    • Hepatitis C genotype 1 or 4
    • High viral load (>400,000 IU/ml)
    • Indication for antiviral treatment or patient’s desire for antiviral treatment
    • Hepatitis C treatment naïve
    • Liver biopsy within 3 years of the date of the screening visit or when liver
    biopsy is contraindicated e.g. in patients with clotting diseases e.g hemophilia and von Willebrand disease or when a patient refuses to undergo a new liver biopsy in case the liver biopsy is older than 3 years, substitution by fibroscan is allowed.
    • Age 18-70 years
    E.4Principal exclusion criteria
    • Signs of progressive liver disease, beyond generally accepted criteria for HCV antiviral therapy:
     serum bilirubin >35 μmol/l, or albumin <36 g/l or prothrombin time >4 sec prolonged or platelets <90x109/l (if normal values are different at the local laboratory, upper and lower limits of the local laboratory should be used)
     decompensated cirrhosis (Child-Pugh Grade B or C)
    • Hepatic imaging (ultrasound, CT or MRI) with the evidence of hepatocellular carcinoma (hepatic imaging should be performed within 3 months prior to screening for cirrhotic patients and within 6 months prior to screening for non-cirrhotic patients)
    • Thrombocytosis, defined as platelet count > 500.000/mm³
    • History or evidence of risk of thrombosis
    • Poorly controlled hypertension
    • Other acquired or inherited causes of liver disease that could explain liver disease activity (if an indicator is present at screening, additional examinations should be done to confirm or rule out the diagnoses):
     Alcoholic liver disease (indicator: MCV>100)
     Obesity induced liver disease (indicators: steatosis proven by biopsy or ultrasound in association with a body mass index >30)
     Drug related liver disease (indicator: positive history of hepatic toxic drug intake with a causal relation)
     Auto-immune hepatitis (indicators: IgG >30g/l, anti smooth-muscle or antinuclear antibodies titer 1:40)
     Hemochromatosis (indicator: ferritin >1000 μg/l)
     Wilson’s disease (indicator: ceruloplasmin (<0.2 g/l)
     Alpha-1 antitrypsin deficiency (indicator alpha-1 antitrypsin <0.8 g/L)
    • Co-infection with hepatitis B virus or human immunodeficiency virus (HIV)
    • Any cardiovascular dysfunction (e.g. decompensatio cordis, myocard infarction, present or history of arrythmia)
    • Other significant medical illness that might interfere with this study: significant pulmonary or renal dysfunction, malignancy other than skin basocellular carcinoma in previous 5 years, immunodeficiency syndromes (e.g.: steroid therapy, organ transplants other than cornea and hair transplant)
    • Contra-indications for peginterferon and/or ribavirin:
     Severe psychiatric disorder, such as major psychoses, suicidal ideation, suicidal attempt and/or manifest depression. Severe depression would include the following: (a) subjects who have been hospitalized for depression, (b) subjects who have received electroconvulsive therapy for depression, or (c) subjects whose depression has resulted in a prolonged absence of work and/or significant disruption of daily functions. Subjects with a history of mild depression may be considered for entry into the protocol provided that a pretreatment assessment of the subject’s mental status supports that the subject is clinically stable and that there is ongoing evaluation of the patient’s mental status during the study
     Visual symptoms related to retinal abnormalities
     Pregnancy, breast-feeding or inadequate contraception
     Thalassemia, spherocytosis
    • Females who are pregnant or intending to become pregnant or male partners of females who are pregnant or intending to become pregnant
    • Absolute neutrophil count (ANC) <1.40x109/l
    • Hemoglobin (Hb) <7.5 mmol/l (female) or <8.1 mmol/l (male)
    • Creatinine clearance below 50 ml/min (Cockroft/Gault) at screening
    • Substance abuse, such as I.V. drugs or alcohol (indicator: >28 drinks/week). If the subject has a history of substance abuse, to be considered for inclusion into the protocol, the subject must have abstained from using the abused substance for at least 1 year
    • Treatment with investigational antiviral drugs e.g. protease/polymerase inhibitors within 6 months before start of therapy
    • Any other condition which in the opinion of the investigator would make the patient unsuitable for enrollment, or could interfere with the patient participating in and completing the study

    E.5 End points
    E.5.1Primary end point(s)
    · HCV-RNA negativity by qualitative assay 24 weeks after end of treatment (sustained virological response, SVR)
    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 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) 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 Yes
    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 Yes
    E.8.2.3.1Comparator description
    standard dose ribavirin
    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 concerned20
    E.8.5The trial involves multiple Member States No
    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 Information not present in EudraCT
    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
    provided in protocol
    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 months2
    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 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 state170
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 170
    F.4.2.2In the whole clinical trial 170
    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)
    not different from expected 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 Decision2007-12-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-03-19
    P. End of Trial
    P.End of Trial StatusCompleted
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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