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 are conducted in the European Union (EU) and the European Economic Area (EEA);
  • clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development.
  • Learn   more about the EU Clinical Trials Register   including the source of the information and the legal basis.


    The EU Clinical Trials Register currently displays   36821   clinical trials with a EudraCT protocol, of which   6079   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).
     
    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:2013-002726-23
    Sponsor's Protocol Code Number:TMC435HPC3016
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-10-24
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2013-002726-23
    A.3Full title of the trial
    Phase 2, Open-Label Study to Investigate the Pharmacokinetics, Efficacy, Safety, and Tolerability of the Combination of Simeprevir (TMC435), Daclatasvir (BMS-790052) and Ribavirin (RBV) in Patients with Recurrent Chronic Hepatitis C Genotype 1b Infection after Orthotopic Liver Transplantation
    Studio in aperto di fase 2 per studiare la farmacocinetica, l'efficacia, la sicurezza e la tollerabilità dell'associazione di simeprevir (TMC435), daclatasvir (BMS-790052) e ribavirina (RBV) in pazienti con infezione cronica ricorrente da epatite C di genotipo 1b dopo un trapianto di fegato ortotopico
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study of Pharmacokinetics, Efficacy, Safety, Tolerability, of the Combination of Simeprevir (TMC435), Daclatasvir (BMS-790052), and Ribavirin (RBV) in Patients with Recurrent Chronic Hepatitis C Genotype 1b Infection after Orthotopic Liver Transplantation
    Studio per studiare la farmacocinetica, l'efficacia, la sicurezza e la tollerabilità dell'associazione di simeprevir (TMC435), daclatasvir (BMS-790052) e ribavirina (RBV) in pazienti con infezione cronica ricorrente da epatite C di genotipo 1b dopo un trapianto di fegato ortotopico
    A.4.1Sponsor's protocol code numberTMC435HPC3016
    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 SponsorJanssen R&D, Ireland
    B.1.3.4CountryBelgium
    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 supportJanssen R&D, Ireland
    B.4.2CountryIreland
    B.4.1Name of organisation providing supportJANSSEN CILAG SPA
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationJanssen-Cilag International NV- Clinical Registry Group
    B.5.2Functional name of contact pointJanssen Biologics BV
    B.5.3 Address:
    B.5.3.1Street AddressArchimedesweg 29
    B.5.3.2Town/ cityLeiden
    B.5.3.3Post code2333CM
    B.5.3.4CountryNetherlands
    B.5.4Telephone number+31 715242166
    B.5.5Fax number+31 715242110
    B.5.6E-mailClinicalTrialsEU@its.jnj.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 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 nameJNJ-38733214-AAA - capsule, hard (G028) - 150mg
    D.3.2Product code TMC435 (or R494617)
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    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 INNSimeprevir
    D.3.9.2Current sponsor codeTMC435
    D.3.9.3Other descriptive nameJNJ-38733214-AAA
    D.3.9.4EV Substance CodeSUB26723
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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.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 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 nameDaclatasvir
    D.3.2Product code BMS-790052 / DCV
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    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 INNdaclatasvir
    D.3.9.2Current sponsor codeBMS-790052
    D.3.9.3Other descriptive nameDACLATASVIR
    D.3.9.4EV Substance CodeSUB34092
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number60
    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.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 Copegus 200 mg film-coated tablets
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Products Limited
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 200 mg film-coated tablets
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    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.3.9.3Other descriptive nameRIBAVIRIN
    D.3.9.4EV Substance CodeSUB10297MIG
    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) 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.IMP: 4
    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 nameJNJ-38733214-AAA - capsule, hard (G019) - 150mg
    D.3.2Product code TMC435 (or R494617)
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    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 INNSimeprevir
    D.3.9.2Current sponsor codeTMC435
    D.3.9.3Other descriptive nameJNJ-38733214-AAA
    D.3.9.4EV Substance CodeSUB26723
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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 C Virus (HCV) genotype-1b Infection
    Infezione da epatite C di genotipo 1b
    E.1.1.1Medical condition in easily understood language
    Hepatitis C Virus (HCV) genotype-1 Infection
    Infezione da epatite C di genotipo 1b
    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.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objectives are:
    - To evaluate the effect of steady-state simeprevir and daclatasvir on the steady-state pharmacokinetics of cyclosporine and tacrolimus when administered as a regimen containing simeprevir (150 mg qd), daclatasvir (60 mg qd) and RBV (1000 to 1200 mg per day) in post-OLT subjects with recurrent HCV genotype 1b infection
    - To evaluate the efficacy of a 24-week treatment regimen containing simeprevir, daclatasvir, and RBV with respect to the proportion of HCV genotype 1b infected post-OLT subjects achieving sustained virologic response 12 weeks after EOT (SVR12)
    Gli obiettivi primari sono i seguenti:
    - Valutare l'effetto di simeprevir e daclatasvir allo steady-state sulla farmacocinetica allo steady-state di ciclosporina e tacrolimus quando si somministra un regime contenente simeprevir (150 mg una volta al giorno), daclatasvir (60 mg una volta al giorno) e RBV (1000-1200 mg al giorno) in soggetti che hanno subito un trapianto di fegato ortotopico con infezione ricorrente da HCV di genotipo 1b.
    - Valutare l'efficacia di un regime di trattamento di 24 settimane contenente simeprevir, daclatasvir e RBV rispetto alla percentuale di soggetti con trapianto di fegato ortotopico e infezione da HCV di genotipo 1b che ottengono una risposta virologica duratura 12 settimane dopo la fine del trattamento (SVR12).
    E.2.2Secondary objectives of the trial
    The secondary objectives are:
    - To evaluate the pharmacokinetic profile of simeprevir and daclatasvir during a 24-week treatment regimen containing simeprevir, daclatasvir and RBV in post-OLT subjects with recurrent HCV genotype 1b infection
    - To determine the need for dose adjustment of cyclosporine and tacrolimus during a 24-week treatment regimen containing simeprevir, daclatasvir and RBV in post-OLT subjects with recurrent HCV genotype 1b infection
    - To evaluate the efficacy of a 24-week treatment regimen containing simeprevir, daclatasvir, and RBV with respect to the proportion of HCV genotype 1b infected post-OLT subjects achieving sustained virologic response 4 and 24 weeks after EOT (SVR4 and SVR24, respectively)
    - To evaluate safety and tolerability of a 24-week treatment regimen containing simeprevir, daclatasvir and RBV in post-OLT subjects with recurrent HCV genotype 1b infection
    Gli obiettivi secondari sono i seguenti:
    Valutare il profilo farmacocinetico di simeprevir e daclatasvir durante un regime di trattamento di 24 settimane contenente simeprevir, daclatasvir e RBV in soggetti con trapianto di fegato ortotopico e infezione ricorrente da HCV di genotipo 1b.
    Stabilire la necessità di un aggiustamento della dose di ciclosporina e tacrolimus durante un regime di trattamento di 24 settimane contenente simeprevir, daclatasvir e RBV in soggetti con trapianto di fegato ortotopico e infezione ricorrente da HCV di genotipo 1b.
    Valutare l'efficacia di un regime di trattamento di 24 settimane contenente simeprevir, daclatasvir e RBV rispetto alla percentuale di soggetti con trapianto di fegato ortotopico e infezione da HCV di genotipo 1b che ottengono una risposta virologica duratura 4 e 24 settimane dopo la fine del trattamento (rispettivamente SVR4 e SVR24).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Liver transplant between 6 months and 10 years prior to the screening visit
    -Hepatitis C virus (HCV) genotype 1 subtype b infection
    - Screening HCV ribose nucleic acid level greater than 10,000 IU per milliliter
    - HCV treatment-naïve participants must not have received post-OLT treatment with any approved or investigational drug for the treatment of HCV
    - Receiving stable immunosuppressant therapy (ie, no change in dose in the last month) with cyclosporine or tacrolimus for more than 3 months prior to the screening visit
    - Trapianto di fegato avvenuto tra 6 mesi e 10 anni prima della visita di screening
    - Infezione da virus dell’epatite C (HCV) di genotipo 1 sottotipo b
    - Concentrazione di acido ribonucleico dell’HCV maggiore di 10.000 IU per millilitro allo screening
    - Partecipanti naive al trattamento per l’HCV che non siano stati trattati dopo il trapianto di fegato ortotopico con qualsiasi farmaco approvato o sperimentale per l’HCV
    - Assunzione di una terapia immunosoppressiva stabile (ossia senza variazioni della dose nell'ultimo mese) con ciclosporina o tacrolimus da oltre 3 mesi prima della visita di screening

    E.4Principal exclusion criteria
    - Evidence of acute or chronic hepatic decompensation after the liver transplantation (including ascites, bleeding varices or hepatic encephalopathy)
    - Any liver disease of non-HCV etiology, including current evidence of graft rejection except the presence of liver steatosis
    - Any other clinically significant disease that in the opinion of the investigator would be exacerbated by the known effects of ribavarin
    - Coinfection with HCV of another genotype than genotype 1b, HIV type 1 or 2 (positive HIV-1 or HIV-2 antibodies test at screening), and hepatitis B virus (hepatitis B surface antigen positive)
    - Multi-organ transplant that included heart, lung, pancreas, or kidney
    - Evidenza di scompenso epatico acuto o cronico dopo il trapianto di fegato (compresi ascite, sanguinamento di varici o encefalopatia epatica)
    - Qualsiasi epatopatia di eziologia diversa dall’HCV, inclusa attuale evidenza di rigetto dell’organo trapiantato, ad eccezione della presenza di steatosi epatica
    - Qualsiasi altra malattia clinicamente significativa che, secondo lo sperimentatore, verrebbe esacerbata dagli effetti noti della ribavirina
    - Coinfezione da HCV di un genotipo diverso dal genotipo 1b, da virus dell’HIV di tipo 1 o 2 (test degli anticorpi HIV-1 o HIV-2 positivo allo screening) o da virus dell’epatite B (antigene di superficie dell’epatite B positivo)
    - Trapianto multiorgano comprendente cuore, polmone, pancreas o rene
    E.5 End points
    E.5.1Primary end point(s)
    1 - Number of participants with a sustained virologic response (SVR)12 Weeks after the end of treatment
    2 - Maximum Observed Plasma Concentration (Cmax) of cyclosporine and tacrolimus
    3 - Area Under the Plasma Concentration-Time Curve From Time Zero to Time at Last Observed Quantifiable Concentration (AUC[last]) of cyclosporine and tacrolimus
    1 - Numero di partecipanti con risposta virologica duratura (SVR) 12 settimane dopo la fine del trattamento
    2- Massima concentrazione plasmatica osservata (Cmax) di ciclosporina e tacrolimus
    3- Area sotto la curva concentrazione plasmatica-tempo dal tempo zero al tempo all’ultima concentrazione quantificabile osservata (AUC[last]) di ciclosporina e tacrolimus
    E.5.1.1Timepoint(s) of evaluation of this end point
    1 - Week 36
    2 - Baseline, Week 2, 4, 8, 12
    3 - Baseline, Week 2, 4, 8, 12
    1- Settimana 36
    2- Basale, Settimana 2, 4, 8, 12
    3- Basale, Settimana 2, 4, 8, 12
    E.5.2Secondary end point(s)
    1 - Maximum Observed Plasma Concentration (Cmax) of simprenavir and daclatasvir
    2 - Time to Reach Maximum Observed Plasma Concentration (Tmax) of simprenavir and daclatasvir
    3 - Predose (trough) concentration (C0h) of simprenavir and daclatasvir
    4 - Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of simprenavir and daclatasvir
    5 - Number of participants with dose adjustment of cyclosporine and tacrolimus during treament with
    regimen simeprevir, daclatasvir and RBV
    6 - Number of patients with a sustained virological response SVR4 after the end of treatment
    7 - Number of participants with a sustained virologic response SVR24 after the end of treatment
    8 - Number of participants with adverse events
    9 - Number of participants with Undetectable HCV RNA (less than 25 IU/milliliter undetectable) and HCV RNA less than 25 IU/milliliter detectable
    10 - Number of participants with HCV RNA level less than 100 IU/milliliter
    11 - Number of participants with ontreatment failure after treatment with regimen simeprevir, daclatasvir and
    RBV
    12 - Number of participants with viral relapse after treatment with regimen simeprevir, daclatasvir and RBV
    13 - Number of participants with HCV NS3/4A and NS5A sequences
    1 - Massima concentrazione plasmatica osservata (Cmax) di simprenavir e daclatasvir
    2- Tempo al raggiungimento della massima concentrazione plasmatica osservata (Tmax) di simprenavir e daclatasvir
    3- Concentrazione pre-dose (valle) (C0h) di simprenavir e daclatasvir
    4- Area sotto la curva dal tempo zero alla fine dell’intervallo di somministrazione (AUCtau) di simprenavir e daclatasvir
    5- Numero di partecipanti con aggiustamento della dose di ciclosporina e tacrolimus durante il trattamento con il regime simeprevir, daclatasvir e RBV
    6- Numero di pazienti con risposta virologica duratura SVR4 dopo la fine del trattamento
    7- Numero di partecipanti con risposta virologica duratura SVR24 dopo la fine del trattamento
    8- Numero di partecipanti con eventi avversi
    9- Numero di partecipanti con RNA HCV non rilevabile (meno di 25 IU/millilitro non rilevabili) e RNA HCV inferiore a 25 IU/millilitro non rilevabili
    10- Numero di partecipanti con concentrazione di RNA HCV inferiore a 100 IU/millilitro
    11- Numero di partecipanti con fallimento durante il trattamento dopo il trattamento con il regime simeprevir, daclatasvir e RBV
    12- Numero di partecipanti con recidiva virale dopo il trattamento con il regime simeprevir, daclatasvir e RBV
    13- Numero di partecipanti con sequenze dell’HCV NS3/4A e NS5A
    E.5.2.1Timepoint(s) of evaluation of this end point
    1 - Baseline, Week 2, 4, 8, 12
    2 - Baseline, Week 2, 4, 8, 12
    3 - Baseline, Week 2, 4, 8, 12
    4 - Baseline, Week 2, 4, 8, 12
    5 - Part 1: Days 10 to 14
    6 - Week 28
    7 - Week 48
    8 - Up to Week 48
    9 - Weeks 2, 4, 12 and 24
    10 - Week 4
    11 - Screening, baseline, Weeks 1, 2, 4, 8, 12, 16, 20, 24
    12 - Screening, baseline, Weeks 1, 2, 4, 8, 12, 16, 20, 24
    13 - Screening, baseline, Weeks 1, 2, 4, 8, 12, 16, 20, 24
    1 - Basale, Settimana 2, 4, 8, 12
    2- Basale, Settimana 2, 4, 8, 12
    3- Basale, Settimana 2, 4, 8, 12
    4- Basale, Settimana 2, 4, 8, 12
    5- Parte 1: Giorni da 10 a 14
    6- Settimana 28
    7- Settimana 48
    8- Fino alla Settimana 48
    9- Settimane 2, 4, 12 e 24
    10- Settimana 4
    11- Screening, basale, Settimane 1, 2, 4, 8, 12, 16, 20, 24
    12- Screening, basale, Settimane 1, 2, 4, 8, 12, 16, 20, 24
    13- Screening, basale, Settimane 1, 2, 4, 8, 12, 16, 20, 24
    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 Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    - tolerability
    - HCV NS3/4A and NS5A sequences determination
    -tollerabilità
    -determinazione sequenza HCV NS3/4A e NS5A
    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) Yes
    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 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) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    E.8.2.4Number of treatment arms in the trial1
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA11
    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 No
    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 visit of the last subject
    Ultima visita ultimo soggetto
    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 months3
    E.8.9.1In the Member State concerned days0
    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 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.1.2.1Number of subjects for this age range: 38
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 2
    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 state8
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 40
    F.4.2.2In the whole clinical trial 40
    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)
    expected normal treatment of that condition
    normale trattamento per la patologia
    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 Decision2014-02-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-11-20
    P. End of Trial
    P.End of Trial StatusCompleted
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
    European Medicines Agency © 1995-2020 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    Legal notice
    EMA HMA