Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43857   clinical trials with a EudraCT protocol, of which   7284   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).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2005-002202-28
    Sponsor's Protocol Code Number:KF(02)263999
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2005-06-14
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2005-002202-28
    A.3Full title of the trial
    Hepatitis C virusdynamik og immunaktivering hos HCV/HIV-koinficerede patienter under behandling med pegyleret interferon a-2a og ribavirin
    A.3.2Name or abbreviated title of the trial where available
    DICO-D
    A.4.1Sponsor's protocol code numberKF(02)263999
    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 SponsorRigshospitalet
    B.1.3.4CountryDenmark
    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 Information not present in EudraCT
    D.2.1.1.1Trade name Pegasys
    D.2.1.1.2Name of the Marketing Authorisation holderRoche A/S
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    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 IMP
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    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 Yes
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.11Herbal medicinal product Information not present in EudraCT
    D.3.11.12Homeopathic medicinal product Information not present in EudraCT
    D.3.11.13Another type of medicinal product Information not present in EudraCT
    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.2.1.1.1Trade name Copegus
    D.2.1.1.2Name of the Marketing Authorisation holderRoche A/S
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    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 IMP
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.11Herbal medicinal product Information not present in EudraCT
    D.3.11.12Homeopathic medicinal product Information not present in EudraCT
    D.3.11.13Another type of medicinal product Information not present in EudraCT
    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
    HIV-infection and concomittant HCV-infection
    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
    Inestigationg various immunological and viral kinetic parameters during Pegays/Copegus treatment of HCV-infection in patients co-infected with HIV
    E.2.2Secondary objectives of the trial
    Investigations of liver fibrosis parameters, inflammation parameters and depression
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    Inklusionskriterier

    · Mænd og kvinder ³ 18 år med serologisk og genteknologisk verificeret HCV- og HIV-infektion
    · Patienterne skal have en positiv HCV-RNA PCR med kvantificerbar HCV-RNA ifølge Roche AMPLICOR HCV MONITOR Test version 2.0 eller Cobas TaqMan Real-time PCR
    · Patienterne skal have en kompenseret leversygdom (Child-Pugh grad A)
    · Patienterne kan inkluderes uafhængig af ALAT værdi
    · Patienterne må ikke tidligere have været behandlet med interferon eller ribavirin
    · Patienter, der modtager antiretroviral behandling skal have en stabil HIV infektion med umålelige niveauer af HIV-RNA ifølge Roche AMPLICOR HIV-1 MONITOR Test version 1.5 eller Cobas TaqMan Realtime PCR ved screening og baseline
    · Patienter, der modtager antiretroviral behandling må ikke have haft ændringer i HIV-behandlingen inden for 6 uger før påbegyndelse af HCV-behandling, og den skal forventes at ville forblive uændret i mindst de første 8 uger af forsøget
    · Patienter, der endnu ikke er behandlet for deres HIV infektion, skal have stabil HIV infektion efter investigators mening, dvs. patienter som ikke forventes at progrediere klinisk under forsøget
    · CD4-tallet må ikke være lavere end 300/mL eller CD4-procenten må ikke være mindre end 12% inden for screeningsperioden for både HAART-naïve patienter og patienter, der modtager HAART
    · Patienten må ikke have tegn på opportunistisk infektion eller andre kliniske tegn på immundefekt
    · Negativ graviditetstest baseret på blod- eller urinprøve (for kvinder i den fødedygtige alder) skal være dokumenteret inden for 24-timer før første dosis forsøgsmedicin
    · Alle frugtbare mænd og kvinder, der modtager ribavirin, skal anvende effektiv prævention under behandlingen og i 6 måneder efter endt behandling
    E.4Principal exclusion criteria
    Eksklusionskriterier

    · Gravide eller ammende kvinder
    · Gravide kvinders mandlige partnere
    · Tidligere behandling med IFN eller ribavirin
    · Behandling med ikke-registreret anti-HIV-behandling
    · Positiv test ved eller inden screening for anti-HAV IgM, HBsAg, HbeAg eller anti-HBc IgM
    · Tidligere eller andre tegn på medicinsk tilstand forbundet med kronisk leversygdom, bortset fra HCV (f.eks. hæmochromatosis, autoimmun hepatitis, alkoholisk leversygdom, toksineksponering)
    · Tidligere eller tegn på dekompenseret leversygdom og/eller Child-Pugh score >5 (ascites, koagulationsdefekt, hyperbilirubinæmi, hepatisk encephalopati eller hypoalbuminæmi og en Child-Pugh score >6 er tilstande, der er konsistente med dekompenseret leversygdom)
    · Tidligere eller andre tegn på blødning fra åreknuder i spiserøret eller andre tilstande konsistente med dekompenseret leversygdom
    · Aktiv HIV-relateret opportunistisk infektion og/eller malignitet, der kræver akut systemisk behandling
    · Absolut neutrofiltal <1500 celler/mm3
    · Hæmoglobin <6,7 mM hos kvinder eller 7,3 mM hos mænd eller hos enhver patient, for hvem anæmi ville være et medicinsk problem
    · Hæmoglobinopati (f.eks. thalassæmi) eller enhver anden årsag til eller tendens til hæmolyse
    · Trombocyttal <70.000 celler/mm3
    · Serumkreatinin >1,5 gange øvre normale grænse ved screening
    · Tidligere alvorlig psykiatrisk lidelse, især depression
    · Pågående intravenøst stofmisbrug
    · Tidligere alvorlig anfaldslidelse eller nuværende indtagelse af krampestillende midler
    · Tidligere immunologisk medieret sygdom (fx. inflammatorisk tarmsygdom, ITP, lupus erytematosus, autoimmun hæmolytisk anæmi, sclerodermi, alvorlig psoriasis, reumatoid arthritis)
    · Tidligere eller andre tegn på kronisk lungesygdom forbundet med funktionel svækkelse
    · Tidligere alvorlig hjertesygdom, som kan forværres af akut anæmi
    · Tidligere thyroidealidelse, der kontrolleres dårligt af receptpligtig medicin. Patienter med kliniske tegn på igangværende thyroidealidelse ekskluderes.
    · Tidligere eller andre tegn på alvorlig sygdom, malignitet eller andre tilstande, som efter investigators mening ville gøre patienten uegnet til deltagelse i forsøget
    · Tidligere systematisk anti-neoplastisk eller immunomodulatorisk behandling <6 måneder inden første dosis af forsøgsmedicin eller forventningen om, at en sådan behandling vil blive nødvendig på et tidspunkt under forsøget
    · Samtidig medicinering med rifampicin/rifabutin, pyrazinamid, isoniazid, gancyclovir, talidomid og oxymetholon
    · Tegn på overdreven alkoholindtagelse og/eller medicin- eller stofmisbrug inden for 6 måneder før første dosis, som efter investigators bedømmelse ville betyde, at patienten blev upålidelig med hensyn til opfyldelse af betingelserne i protokollen
    · Anvendelse af det antiretrovirale middel didanosin (Videx)
    · Anvendelse af det antiretrovirale middel stavudin (Zerit) skal ske med forsigtighed.
    E.5 End points
    E.5.1Primary end point(s)
    Primære variable

    · Viral kinetik vurderet som plasma HCV-RNA-niveauer målt med Roche AMPLICOR™ HCV Test, version 2.0 eller Cobas TaqMan Real-time PCR inden påbegyndelse af HCV-behandling (baseline), og 1, 2, 7, 14, 28, 56 og 84 (uge 12) dage efter baseline.

    · CD4-/CD8-tal ved baseline og efter 4, 12, 24, 36, 48 og 72 uger

    · Procentdel af patienter med et enkelt, sidste, upåviseligt HCV-RNA PCR målt 24 uger efter endt HCV-behandling
    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 Information not present in EudraCT
    E.6.5Efficacy Information not present in EudraCT
    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 Information not present in EudraCT
    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) Information not present in EudraCT
    E.7.1.1First administration to humans Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Information not present in EudraCT
    E.7.3Therapeutic confirmatory (Phase III) Information not present in EudraCT
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Information not present in EudraCT
    E.8.1.1Randomised Information not present in EudraCT
    E.8.1.2Open Yes
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Uncontrolled
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    No comparator
    E.8.3 The trial involves single site in the Member State concerned Information not present in EudraCT
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    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 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
    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 months
    E.8.9.1In the Member State concerned days
    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 Information not present in EudraCT
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Information not present in EudraCT
    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 2005-06-14. 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 state20
    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 Decision2005-07-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-04-27
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2008-05-01
    For support, Contact us.
    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.

    European Medicines Agency © 1995-Tue Apr 23 21:03:52 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA