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   35475   clinical trials with a EudraCT protocol, of which   5824   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:2011-005740-95
    Sponsor's Protocol Code Number:M13-389
    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:2012-09-21
    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 number2011-005740-95
    A.3Full title of the trial
    A Randomized, Open-Label, Multicenter Study to Evaluate the Safety and Antiviral Activity of the Combination of ABT-450 with Ritonavir (ABT- 450/r), ABT-267, and ABT-333 With and Without Ribavirin in Treatment- Experienced Subjects with Genotype 1 Chronic Hepatitis C Virus (HCV) Infection (PEARL-II).
    Sperimentazione multicentrica randomizzata, in aperto per la valutazione della sicurezza ed attivita' antivirale della combinazione di ABT-450 con Ritonavir (ABT-450/r), ABT-267, e ABT-333 con e senza Ribavirina in soggetti che hanno ricevuto un trattamento pregresso per infezione cronica da virus dell'epatite C di genotipo 1 (HCV) (PEARL-II).
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to evaluate the safety and effect of three experimental drugs ABT-450, ABT-267, and ABT-333 in people with HCV. ''Experimental'' means that they have not been approved by any regulatory agency for sale to the public.
    Sperimentazione per valutare la sicurezza e l’effetto di tre farmaci sperimentali ABT-450, ABT-267, e ABT-333 in soggetti con HCV. “Sperimentale” significa che non sono stati approvati da alcuna agenzia regolatoria per la vendita al pubblico.
    A.4.1Sponsor's protocol code numberM13-389
    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 SponsorABBOTT GMBH & Co. KG
    B.1.3.4CountryGermany
    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 supportAbbott Laboratories
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAbbott Laboratories
    B.5.2Functional name of contact pointEU Clinical Trials Helpdesk
    B.5.3 Address:
    B.5.3.1Street AddressAbbott House, Vanwall Business Park
    B.5.3.2Town/ cityMaidenhead, Berkshire
    B.5.3.3Post codeSL6 4XE
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+44 1628 77 4695
    B.5.5Fax number+44 1628 64 4330
    B.5.6E-maileuclinicaltrials@abbott.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 nameNA
    D.3.2Product code ABT-450
    D.3.4Pharmaceutical form 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.3.9.2Current sponsor codeABT-450
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 nameNA
    D.3.2Product code ABT-333
    D.3.4Pharmaceutical form 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.3.9.2Current sponsor codeABT-333
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number400
    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 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 nameNA
    D.3.2Product code ABT-267
    D.3.4Pharmaceutical form 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.3.9.2Current sponsor codeABT-267
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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 Yes
    D.2.1.1.1Trade name Copegus 200 mg film-coated tablet
    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 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.3.9.1CAS number 36791-04-5
    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: 5
    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 Norvir 100 mg soft capsules
    D.2.1.1.2Name of the Marketing Authorisation holderAbbott Laboratories Limited
    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.3.4Pharmaceutical form Capsule, soft
    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 INNRITONAVIR
    D.3.9.1CAS number 155213-67-5
    D.3.9.4EV Substance CodeSUB10342MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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
    Chronic Hepatitis C Infection.
    Infezione Cronica da Virus dell’Epatite C.
    E.1.1.1Medical condition in easily understood language
    Hepatitis C.
    Epatite C.
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 15.0
    E.1.2Level LLT
    E.1.2Classification code 10008912
    E.1.2Term Chronic 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 of this study are to evaluate the safety of both arms and to compare the efficacy (the percentage of subjects achieving a 12-week sustained virologic response, SVR12, {HCV RNA < LLOQ 12 weeks following therapy}) with 3 DAAs with and without RBV.
    Gli obiettivi primari di questa sperimentazione sono quelli di valutare la sicurezza in entrambi i bracci di trattamento e di confrontare l'efficacia (percentuale di soggetti che ottengono una risposta virologica sostenuta dopo 12 settimane, SVR12, [HCV RNA &lt; LLOQ 12 settimane dopo la fine della terapia]) con 3 agenti antivirali ad azione diretta (DAA) con e senza Ribavirina (RBV).
    E.2.2Secondary objectives of the trial
    - To compare the percentage of subjects achieving SVR24 (HCV RNA < LLOQ 24 weeks following therapy), rapid virologic response (RVR, HCV RNA < LLOQ at Week 4), and end of treatment response (EOTR, HCV RNA < LLOQ at Week 12) following 3 DAA/RBV/12 versus 3 DAA/12. - To compare the antiviral activity (SVR12, SVR24, RVR, EOTR) of the treatment regimens within the pegIFN/RBV treatment null-responder, non-responder/partial responder and relapser populations.
    - Confrontare la percentuale di soggetti che raggiungono una SVR24 (HCV RNA &lt; LLOQ 24 settimane dopo la fine della terapia), una risposta virologica rapida (RVR, HCV RNA &lt; LLOQ alla Settimana 4 ), e una risposta alla fine del trattamento (EOTR, HCV RNA &lt; LLOQ alla settimana 12) mediante confronto fra 3 DAA/RBV/12 rispetto a 3 DAA/12. -Confrontare l'attività antivirale (SVR12, SVR24, RVR, EOTR) dei regimi di trattamento nelle diverse popolazioni, di soggetti con risposta nulla (null responders), soggetti che non hanno risposto/hanno risposto in maniera parziale (non-responder/partial responder) e soggetti che hanno recidivato (relapsers) dopo un pregresso trattamento con pegIFN/RBV.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Male or female between the age of 18 and 70 years, inclusive, at time of randomization. 2.Subject must have documentation that they meet one of the following categories: •Null-responders: received at least 12 weeks of pegIFN/RBV for the treatment of HCV and failed to achieve a 2 log10 reduction in HCV RNA at Week 12. Subjects will be considered to meet this definition if the lack of treatment response was documented following 10 to 16 weeks of treatment; •Non-responders/partial responders: received at least 20 weeks of pegIFN/RBV for the treatment of HCV and achieved ≥ 2 log10 reduction in HCV RNA at Week 12, but failed to achieve HCV RNA undetectable at the end of treatment. Subjects will be considered to meet this definition if the lack of treatment response was documented following 10 to 16 weeks of treatment; or • Relapsers: received at least 36 weeks of pegIFN/RBV for the treatment of HCV and was undetectable at the end of treatment, but HCV RNA was detectable within 24 weeks of treatment follow-up. 3.Body mass index (BMI) is ≥ 18 to < 38 kg/m2. Body mass index is calculated as weight measured in kilograms (kg) divided by the square of height measured in meters (m). 4.Chronic HCV genotype 1-infection for at least 6 months prior to study enrollment. Chronic HCV infection is defined as one of the following: •Positive for anti-HCV antibody or HCV RNA at least 6 months before Screening, and positive for HCV RNA and anti-HCV antibody at the time of Screening; or •Positive for anti-HCV antibody and HCV RNA at the time of Screening with a liver biopsy consistent with chronic HCV infection (or a liver biopsy performed prior to enrollment with evidence of chronic hepatitis C disease). 5.Subject has a plasma HCV RNA level > 10,000 International Units (IU)/mL at screening.
    1. Soggetti di ambo i sessi e di età compresa fra 18 e 70 anni (compresi) al momento dell'arruolamento. 2. Soggetti con evidenza documentata di appartenenza a una delle seguenti categorie: • Null-responders: soggetti che hanno ricevuto almeno 12 settimane di trattamento per l’ HCV con pegIFN/RBV e non hanno ottenuto una riduzione di 2 log10 nei livelli di HCV RNA alla Settimana 12. Si considererà soddisfatto questo criterio per i soggetti in cui si documenti una mancata risposta al trattamento dopo un periodo di trattamento compreso fra 10 e 16 settimane. • Non-responders/partial responders: soggetti che hanno ricevuto almeno 20 settimane di trattamento per l’HCV con pegIFN/RBV ed hanno ottenuto una riduzione ≥ 2 log10 nei livelli di HCV RNA alla Settimana 12, ma che non hanno ottenuto livelli non rilevabili di HCV RNA alla fine del trattamento. Si considererà soddisfatto questo criterio per i soggetti in cui si documenti una mancata risposta al trattamento dopo un periodo di trattamento compreso fra 10 e 16 settimane. o • Relapsers: soggetti che hanno ricevuto almeno 36 settimane di trattamento con pegIFN/RBV per l’HCV, i cui livelli di HCV RNA non erano rilevabili alla fine del trattamento ma risultavano rilevabili nel corso delle 24 settimane di follow-up dalla fine del trattamento. 3. Indice di massa corporea (BMI) compreso fra ≥ 18 e &lt; 38 kg/m2. Il valore BMI viene calcolato dividendo il peso espresso in kilogrammi (kg) per l'altezza in metri (m) al quadrato. 4. Infezione cronica da HCV di genotipo 1 per almeno 6 mesi prima dello Screening per questa Sperimentazione. Per infezione cronica da HCV si intendono i seguenti casi: • Positività agli anticorpi anti-HCV oppure all’ HCV RNA almeno 6 mesi prima dello Screening, e positività all’ HCV RNA e agli anticorpi anti-HCV al momento dello Screening; oppure • Positività agli anticorpi anti-HCV e HCV RNA al momento dello Screening con biopsia epatica indicativa di infezione cronica da HCV (oppure biopsia epatica eseguita prima dell'arruolamento che dimostra evidenza di epatite C cronica). 5. Soggetti con livelli plasmatici di HCV RNA &gt; 10.000 Unità Internazionali (IU)/mL allo Screening.
    E.4Principal exclusion criteria
    1.History of severe, life-threatening or other significant sensitivity to any drug. 2.Females who are pregnant or breastfeeding or males whose partner is pregnant or is planning to become pregnant within 6 months (or 7 months if required by local RBV label) after their last dose of study drug/RBV. 3.Recent (within 6 months prior to study drug administration) history of drug or alcohol abuse that could preclude adherence to the protocol. 4.Positive test result for hepatitis B surface antigen (HBsAg) or anti-HIV antibodies (anti-HIV Ab). 5.Any current or past clinical evidence of cirrhosis (e.g., ascites, esophageal varices), or a liver biopsy showing cirrhosis or bridging fibrosis.
    1. Storia di ipersensibilità grave, potenzialmente fatale o altrimenti significativa a qualsiasi farmaco. 2. Soggetti di sesso femminile che sono in stato di gravidanza o stanno allattando, oppure soggetti di sesso maschile la cui partner/le cui partner sono in stato di gravidanza o intendono programmare una gravidanza entro 6 mesi (o 7 mesi se indicato sul foglietto illustrativo locale della ribavirina) dopo l'ultima somministrazione del medicinale sperimentale/RBV. 3. Storia recente (nei 6 mesi precedenti la somministrazione del medicinale sperimentale) di abuso di droghe o alcol che, potrebbe impedire l'aderenza al protocollo. 4. Positività al test per l'antigene di superficie dell'epatite B (HBsAg) o per gli anticorpi anti-HIV (anti-HIV Ab). 5. Qualsiasi evidenza clinica presente o pregressa di ascite, o varici esofagee, o biopsia pregressa che documenta la presenza di cirrosi.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is the percentage of all subjects with SVR12.
    L’obiettivo primario di efficacia è la percentuale dei soggetti che raggiungono una SVR12.
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 weeks after last dose of study drugs.
    12 settimane dopo la somministrazione dell’ultima dose dei medicinali sperimentali.
    E.5.2Secondary end point(s)
    1. The percentage of subjects with SVR24, RVR, and EOTR; 2. The percentage of subjects within each population (null-responders, non responders/partial responders, and relapsers) with SVR12, SVR24, RVR, and EOTR.
    1. La percentuale di soggetti che raggiungono una SVR24 ,RVR, e EOTR; 2. La percentuale di soggetti che raggiungono una SVR12, SVR24, RVR e EOTR nelle diverse popolazioni, (null responders, non-responder/partial responder e relapsers).
    E.5.2.1Timepoint(s) of evaluation of this end point
    24 weeks after last dose of study drug.
    24 settimane dopo la somministrazione dell’ultima dose del medicinale sperimentale.
    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 Yes
    E.6.11Pharmacogenomic Yes
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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
    Non applicabile
    Not applicable
    E.8.2.4Number of treatment arms in the trial2
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA20
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Puerto Rico
    Switzerland
    United States
    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 Subject Last Visit.
    Ultima visita dell'ultimo soggetto.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months18
    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 months18
    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.1.1Number of subjects for this age range: 0
    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: 100
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 state48
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 70
    F.4.2.2In the whole clinical trial 120
    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 direct acting antiviral agent (DAA) and who do not achieve and maintain virologic suppression (HCV RNA less than lower limit of quantification), or who relapse post DAA therapy, may be offered participation in a separate, Abbott-sponsored treatment study, or may be offered another off-study (non-Abbott) treatment regimen, as determined appropriate by the investigator.
    A tutti i soggetti che hanno ricevuto almeno una dose di agenti antivirali ad azione diretta (DAA) e che non hanno raggiunto e mantenuto soppressione virologica (HCV RNA < LLOQ), o che hanno manifestato recidiva dopo terapia con DAA, potrebbe essere offerta la partecipazione in una sperimentazione separata con Abbott come promotore, o potrebbe essere offerto un altro regime di terapia non sperimentale (non Abbott), come ritenuto appropriato dallo sperimentatore.
    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 Decision2012-09-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-09-11
    P. End of Trial
    P.End of Trial StatusCompleted
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
    European Medicines Agency © 1995-2019 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    Legal notice
    EMA HMA