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    Summary
    EudraCT Number:2012-002035-29
    Sponsor's Protocol Code Number:M13-098
    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:2012-12-11
    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 number2012-002035-29
    A.3Full title of the trial
    A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 Co administered with Ribavirin (RBV) in Treatment- Experienced Adults with Genotype 1 Chronic Hepatitis C Virus (HCV) Infection (SAPPHIRE-II).
    Studio randomizzato, in doppio cieco e controllato verso placebo per valutare l'efficacia e la sicurezza di ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) e ABT-333 in co-somministrazione con Ribavirina (RBV) in soggetti adulti con infezione cronica da virus dell'epatite C (HCV) di genotipo 1 che hanno ricevuto un trattamento pregresso per l'infezione da HCV (SAPPHIRE 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 co-administered with Ribavirin (RBV) in people that have been previously treated for Hepatitis C Virus (HCV). ''Experimental'' means that they have not been approved by any regulatory agency for sale to the public.
    Studio per valutare la sicurezza e l’efficacia di tre farmaci sperimentali ABT-450, ABT-267 e ABT-333 in co-somministrazione con Ribavirina (RBV) in soggetti che hanno ricevuto un trattamento pregresso per l’infezione da Virus dell’Epatite C (HCV). “Sperimentale” significa che non sono stati approvati da nessuna agenzia regolatoria per la vendita al pubblico.
    A.4.1Sponsor's protocol code numberM13-098
    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 supportAbbVie
    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 pointeuclinicaltrials@abbott.com
    B.5.3 Address:
    B.5.3.1Street AddressAbbott House, Vanwall Business Park, Vanwall
    B.5.3.2Town/ cityMaidenhead, Berkshire
    B.5.3.3Post codeSL6 4XE
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+44 1628 644475
    B.5.5Fax number+44 1628 644330
    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/r/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-450
    D.3.9.3Other descriptive nameABT-450
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number75
    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 number50
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeABT-267
    D.3.9.3Other descriptive nameABT-267
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number12.5
    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.3.9.3Other descriptive nameABT-333
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number250
    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.2.1.2Country which granted the Marketing AuthorisationItaly
    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 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.3.9.2Current sponsor codeRibavirin
    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 Yes
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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
    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.3.9.2Current sponsor codeRibavirin
    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.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 3
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Chronic Hepatitis C Infection
    Infezione Cronica da Virus dell’Epatite C
    E.1.1.1Medical condition in easily understood language
    Chronic Hepatitis C Infection
    Infezione Cronica da Virus dell’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 14.1
    E.1.2Level PT
    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 assess the efficacy (the percentage of subjects achieving SVR12, HCV RNA < lower limit of quantification [LLOQ] 12 weeks following treatment) and safety of ABT- 450/r/ABT-267, and ABT-333 co-administered with RBV for 12 weeks in pegIFN/RBV treatment-experienced HCV genotype 1-infected adults.
    Gli obiettivi primari di questa sperimentazione sono rappresentati dalla valutazione dell'efficacia (percentuale di soggetti che ottengono una risposta virologica sostenuta della durata di 12 settimane, SVR12 (HCV acido ribonucleico (RNA) &lt; limite inferiore di quantificazione [LLOQ] 12 settimane dopo il trattamento) e della sicurezza di ABT-450/r/ABT-267 e ABT-333 in co-somministrazione con RBV per 12 settimane in adulti con infezione da HCV di genotipo 1 precedentemente trattati con pegIFN/RBV.
    E.2.2Secondary objectives of the trial
    The secondary objectives of this study are to assess the percentage of subjects with ALT normalization, the percentage of subjects with virologic failure during treatment, and the percentage of subjects with relapse post-treatment.
    Gli obiettivi secondari di questa sperimentazione sono la valutazione della percentuale di soggetti con normalizzazione dei livelli di ALT, della percentuale di soggetti con fallimento virologico durante il trattamento e della percentuale dei soggetti con recidiva dopo il trattamento.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Males and females 18-70 years old, inclusive - Females must be post-menopausal for more than 2 years or surgically sterile or practicing specific forms of birth control. - Chronic hepatitis C, genotype 1 infection - Failed previous treatment with pegIFN and RBV - No evidence of liver cirrhosis
    • Soggetti di ambo i sessi e di età compresa fra 18 e 70 anni, inclusi • Donne in post-menopausa per più di 2 anni o chirurgicamente sterili o che pratichino metodi contraccettivi specifici • Presenza di infezione cronica da HCV di genotipo 1 • Soggetti che siano stati precedentemente trattati con pegIFN e RBV e non rispondano al trattamento. • Nessun evidenza di danno epatico.
    E.4Principal exclusion criteria
    -Positive screen for drugs or alcohol -Significant sensitivity to any drug -Use of contraindicated medications within 2 weeks of dosing -Abnormal laboratory tests -Positive hepatitis B surface antigen and anti-Human Immunodeficiency Virus antibody
    • Screening positivo per abuso di droghe o alcool • Sensibilità significativa a qualsiasi farmaco • Uso di farmaci controindicati entro 2 settimane dal trattamento • Risultati di laboratorio alterati • Positività all'antigene di superficie per l'Epatite B o agli anticorpi per il virus dell’Immunodeficienza umana
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is the percentage of subjects with SVR12.
    L’endpoint primario di efficacia è rappresentato dalla percentuale di soggetti con SVR12.
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 weeks after last dose of study drug.
    12 Settimane dopo l’ultima dose di farmaco sperimentale.
    E.5.2Secondary end point(s)
    1. The percentage of subjects in either treatment group with ALT normalization at the end of treatment (defined as ALT ≤ ULN at Final DB Treatment Visit for subjects with ALT > ULN at Baseline); 2. The percentage of subjects in the active treatment group with virologic failure during treatment (defined as confirmed HCV RNA ≥ LLOQ after HCV RNA < LLOQ during treatment or HCV RNA ≥ LLOQ at the end of treatment); 3. The percentage of subjects in the active treatment group with posttreatment relapse (defined as HCV RNA ≥ LLOQ between end of treatment and 12 weeks after the last dose of study drugs among subjects completing treatment and with HCV RNA < LLOQ at the end of treatment).
    1) Percentuale di soggetti con normalizzazione dei livelli di ALT alla fine del trattamento in entrambi i gruppi di trattamento (definita come ALT ≤ ULN alla Visita Finale di Trattamento nell'ambito del Periodo di Trattamento DB per i soggetti con ALT > ULN al Baseline); 2) Percentuale di soggetti nel braccio di trattamento attivo con fallimento virologico durante il trattamento (definito come confermato HCV RNA ≥ LLOQ dopo HCV RNA < LLOQ durante il trattamento o HCV RNA ≥ LLOQ alla fine del trattamento); 3) Percentuale di soggetti nel gruppo di trattamento attivo con recidiva dopo il trattamento (definito come HCV RNA ≥ LLOQ tra la fine del trattamento e 12 Settimane dopo l’ultima dose di farmaco sperimentale fra i soggetti che stanno completando il trattamento e con HCV RNA < LLOQ alla fine del trattamento).
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. At the end of treatment (last dose of study drug in the trial); 2. During treatment or at the end of treatment (last dose of study drug) in the active treatment group; 3. At the end of treatment and between the end of treatment and 12 weeks after the last dose of study drugs among subjects completing treatment in the active treatment group.
    1. Alla fine del trattamento (ultima dose di farmaco sperimentale); 2. Durante il trattamento o alla fine del trattamento (ultima dose di farmaco sperimentale) nel gruppo di trattamento attivo; 3. Alla fine del trattamento e tra la fine del trattamento e 12 Settimane dopo l’ultima dose di farmaco sperimentale fra i soggetti che stanno completando il trattamento nel gruppo di trattamento attivo.
    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 No
    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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    12 settimane in doppio cieco seguite da 12 settimane in aperto per i soggetti
    12 week double-blind followed by 12 week open label for subjects.
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA42
    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
    Australia
    Canada
    Mexico
    New Zealand
    Puerto Rico
    Russian Federation
    Switzerland
    Turkey
    United States
    E.8.7Trial has a data monitoring committee Yes
    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 years2
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    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.1.1Number 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: 360
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 40
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 180
    F.4.2.2In the whole clinical trial 400
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    All subjects may participate in an Abbott observational study to evaluate the durability of virologic response for subjects who achieve SVR and subjects who fail treatment. All subjects who do not achieve and maintain virologic suppression (HCV RNA < LLOQ), or who relapse post DAA therapy, may enter another Abbott study including ABT-450/r + ABT 267 + pegIFN/RBV. Subjects may be offered another non-Abbott treatment as determined appropriate by the investigator.
    Tutti i soggetti che raggiungono SVR e falliscono il trattamento, possono partecipare ad uno studio osservazionale Abbott per valutare la risposta virologica. Tutti i soggetti che non raggiungono e mantengono una soppressione virologica, o che ripresentano la malattia in seguito alla terapia con DAA, possono partecipare ad un altro studio Abbott con ABT-450/r+ABT-267+pegIFN/RBV. Ai soggetti potrebbe essere offerto un altro trattamento non di Abbott se ritenuto opportuno dal PI.
    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 Decision2013-02-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-12-10
    P. End of Trial
    P.End of Trial StatusCompleted
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