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    Summary
    EudraCT Number:2011-005762-38
    Sponsor's Protocol Code Number:M13-393
    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:2012-11-23
    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 number2011-005762-38
    A.3Full title of the trial
    A Randomized, Open-Label Study to Evaluate the Safety and Efficacy of Coadministration of ABT-450 with Ritonavir (ABT-450/r) and ABT-267 in Adults with Chronic Hepatitis C Virus Infection (PEARL-I).
    Sperimentazione Randomizzata in Aperto per la Valutazione della Sicurezza ed Efficacia della Co-somministrazione di ABT-450 e Ritonavir (ABT 450/r) e ABT-267 in Adulti affetti da Infezione Cronica da Virus dell'Epatite C (PEARL-I).
    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 Co-administration of ABT-450 with Ritonavir (ABT-450/r) and ABT-267 in Adults with Chronic Hepatitis C Virus Infection.
    Sperimentazione per Valutare la Sicurezza e gli Effetti della Co-somministrazione di ABT-450 e Ritonavir (ABT 450/r) e ABT-267 in Adulti affetti da Infezione Cronica da Virus dell’Epatite C.
    A.4.1Sponsor's protocol code numberM13-393
    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 codeSL64XE
    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-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: 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 Norvir
    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
    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 10008909
    E.1.2Term Chronic hepatitis
    E.1.2System Organ Class 10019805 - Hepatobiliary disorders
    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 objective of this study is to assess the safety and efficacy (the percentage of subjects with HCV RNA < LLOQ 12 weeks after the last actual dose of study drug [SVR12 actual]) of ABT-450/r and ABT- 267 among treatment naive and prior null responder to pegylated IFN (pegIFN) and ribavirin (RBV) genotype 1b HCV infected subjects.
    L’obiettivo primario di questa sperimentazione è quello di valutare la sicurezza e l ‘efficacia (la percentuale dei soggetti con HCV RNA &lt; LLOQ 12 settimane dopo la somministrazione dell’ultima dose effettiva del medicinale sperimentale [SVR12effettiva]) ) di ABT-450/r e ABT-267 mediante confronto fra soggetti affetti da Infezione Cronica da Virus dell’Epatite C di genotipo 1b naïve rispetto al trattamento e con risposta nulla (null responders) a una pregressa terapia con Interferone pegilato (pegIFN) e ribavirina RBV.
    E.2.2Secondary objectives of the trial
    - To assess the safety and efficacy (the percentage of subjects with SVR12 actual) of two durations of ABT-450/r + ABT-267 among treatment naive genotype 1b HCV infected subjects. - To assess the safety and efficacy (the percentage of subjects with SVR12 actual) of ABT-450/r + ABT-267 among treatment naive genotype 1a and genotype 1b HCV infected subjects.
    - Valutare la sicurezza e l’ efficacia (la percentuale di soggetti con SVR12effettiva) di due periodi di trattamento di ABT-450/ritonavir+ABT-267 fra soggetti, affetti da Infezione Cronica da Virus dell’Epatite C di genotipo 1b, naïve rispetto al trattamento. - Valutare la sicurezza e l’ efficacia (la percentuale di soggetti con SVR12effettiva) di ABT-450/ritonavir+ABT-267 fra soggetti, affetti da Infezione Cronica da Virus dell’Epatite C naïve rispetto al trattamento di genotipo 1a e genotipo 1b.
    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 enrollment. 2. Subjects must meet one of the following categories: • Treatment-naïve: Subject has never received antiviral treatment for hepatitis C infection; •Prior null responders: Subject has documentation that they previously received pegIFN plus RBV for at least 10 weeks and failed to achieve a 2 log10 IU/mL HCV RNA decrease by Week 12 (Week 10 to Week 16). 3. Body mass index (BMI) is ≥ 18 to < 38 kg/m2. BMI 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 screening. 5. Subject has plasma HCV RNA level > 10,000 IU/mL at Screening.
    1. Soggetti di ambo i sessi e di età compresa fra 18 e 70 anni al momento dell'arruolamento. 2. Soggetti che rientrano in una delle seguenti categorie: • Naïve rispetto al trattamento: nessun trattamento antivirale pregresso per l'infezione da epatite C o • Risposta nulla (null responders) a una pregressa terapia: soggetti con documentata terapia precedente di almeno 10 settimane con pegIFN eRBV senza ottenere una riduzione pari a 2 log10 IU/ml dei livelli di HCV RNA alla settimana 12 (fra le Settimane 10 e 16). 3. Indice di massa corporea (BMI) compresa 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 nella sperimentazione. 5. Soggetti con livelli plasmatici di HCV RNA &gt; 10.000 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. 3. Recent history of drug or alcohol abuse that could preclude adherence to the protocol. 4. Positive test result for hepatitis B surface antigen or anti-HIV antibodies. 5. Any current or past clinical evidence of cirrhosis such as ascites or esophageal varices, or prior biopsy showing cirrhosis.
    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. 3. Storia recente di abuso di droga o di alcolici che potrebbe impedire l'aderenza al protocollo. 4. Positività al test per l’antigene di superficie dell’epatite B oppure per gli anticorpi anti-HIV. 5. Qualsiasi evidenza clinica presente o pregressa di cirrosi quale 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 subjects with SVR12 actual (HCV RNA < LLOQ 12 weeks after the last actual dose of study drug). The primary comparison will be between Groups 2 and 3. Additional comparisons between Groups 1 and 2 and Groups 2 and 4 will be performed, provided that Groups 1 and 4 are enrolled.
    L’endpoint primario di efficacia è rappresentato dalla percentuale dei soggetti con SVR12 effettiva (HCV RNA ≤LLOQ 12 settimane dopo l’ultima dose effettiva del medicinale sperimentale). Il principale confronto verrà effettuato fra il Gruppo 2 ed il Gruppo 3. Verranno effettuati ulteriori confronti fra Gruppo 1 e Gruppo 2 e fra Gruppo 2 e Gruppo 4 , se verranno arruolati soggetti nell’ambito dei Gruppi 1 e 4.
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 weeks after last dose of study drug.
    12 settimane dopo la somministrazione dell’ultima dose del medicinale sperimentale.
    E.5.2Secondary end point(s)
    ● The percentage of subjects with SVR24 actual (HCV RNA < LLOQ 24
    weeks after the last actual dose of study drug),
    ● The percentage of subjects with EOTR (HCV RNA < LLOQ at Week 8 for
    Group 1 or at Week 12 for Groups 2, 3 and 4).
    For each secondary efficacy variable, comparisons between Groups 1 and
    2, Groups 2 and 3, and Groups 2 and 4 will be performed, provided that
    Groups 1 and 4 are enrolled.
    • Percentuale dei soggetti con SVR24 effettiva (HCV RNA < LLOQ 24 settimane dopo l’ultima dose effettiva del medicinale sperimentale),
    • Percentuale di soggetti con EOTR (HCV RNA < LLOQ alla Settimana 8 per il Gruppo 1 o alla Settimana 12 per il Gruppo 2, 3 e 4).
    Per ciascuna variabile di efficacia secondaria, verranno effetuati confronti tra Gruppo 1 e 2, Gruppo 2 e 3, e Gruppo 2 e 4, verranno arruolati soggetti nell’ambito dei Gruppi 1 e 4.
    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 trial4
    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 EEA27
    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
    Turkey
    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 months22
    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 months22
    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: 140
    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 state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 80
    F.4.2.2In the whole clinical trial 160
    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 DAA and who do not achieve and maintain virologic suppression (HCV RNA < LLOQ), 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 DAA e che non hanno raggiunto e mantenuto soppressione virologica (HCV RNA < LLOQ), o che hanno manifestato recidiva dopo terapia con DAA, potrebbe essere offeta 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 Decision2013-01-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-11-15
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-02-17
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