Clinical Trials Register

Summary
EudraCT Number:	2011-005393-32
Sponsor's Protocol Code Number:	M13-101
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

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A. Protocol Information

A.1

Member State Concerned

Italy - Italian Medicines Agency

A.2

EudraCT number

2011-005393-32

A.3

Full title of the trial

An Open-Label Study to Evaluate the Safety, Antiviral Activity and
Pharmacokinetics of Direct-Acting Antiviral Agent (DAA) Treatment in
Combination with Peginterferon α-2a and Ribavirin (pegIFN/RBV) in Chronic Hepatitis C Virus (HCV) Infected Subjects Who Have Experienced
Virologic Failure in a Previous Abbott DAA Combination Study.

Sperimentazione in Aperto per la Valutazione della Sicurezza, dell'attivita' Antivirale e della Farmacocinetica del Trattamento con Agenti Antivirali ad Azione Diretta (DAA) in Combinazione con Interferone Pegilato ±-2a e Ribavirina (pegIFN/RBV) in Soggetti con Infezione Cronica da Virus dell'Epatite C (HCV) che abbiano Manifestato un Fallimento Virologico nell'ambito di una Precedente Sperimentazione Abbott con una Combinazione di DAA.

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

A study to evaluate the safety and effect of treatment with experimental
antiviral drugs in combination with peginterferon α-2a and ribavirin in
people with hepatitis C virus who did not respond to treatment in a
previous Abbott combination study.

Sperimentazione per Valutare la Sicurezza e l’ Effetto del trattamento con farmaci antivirali sperimentali in Combinazione con Interferone Pegilato α-2a e Ribavirina in persone con Virus dell’Epatite C che non hanno risposto al trattamento nell’ambito di una Precedente Sperimentazione in combinazione Abbott.

A.4.1

Sponsor's protocol code number

M13-101

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	AbbVie Deutschland GmbH & Co. KG
B.1.3.4	Country	Germany
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	AbbVie Inc.
B.4.2	Country	United States
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	AbbVie Ltd.
B.5.2	Functional name of contact point	EU Clinical Trials Helpdesk
B.5.3	Address:
B.5.3.1	Street Address	Abbott House, Vanwall Business Park
B.5.3.2	Town/ city	Maidenhead, Berkshire
B.5.3.3	Post code	SL6 4XE
B.5.3.4	Country	United Kingdom
B.5.4	Telephone number	+44 1628 64 4475
B.5.5	Fax number	+44 1628 64 4330
B.5.6	E-mail	euclinicaltrials@abbott.com

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	NA
D.3.2	Product code	ABT-450
D.3.4	Pharmaceutical form	Tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.2	Current sponsor code	ABT-450
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	50
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 2
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	NA
D.3.2	Product code	ABT-267
D.3.4	Pharmaceutical form	Tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.2	Current sponsor code	ABT-267
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	25
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 3
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.2	Country which granted the Marketing Authorisation	Italy
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.4	Pharmaceutical form	Film-coated tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	RIBAVIRIN
D.3.9.1	CAS number	36791-04-5
D.3.9.4	EV Substance Code	SUB10297MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	200
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 4
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Pegasys 180 micrograms solution for injection in pre-filled syringe
D.2.1.1.2	Name of the Marketing Authorisation holder	Roche Registration Limited
D.2.1.2	Country which granted the Marketing Authorisation	European Union
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.4	Pharmaceutical form	Solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Subcutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	PEGINTERFERON ALFA-2A
D.3.9.1	CAS number	198153-51-4
D.3.9.4	EV Substance Code	SUB16452MIG
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	180
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 5
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Norvir 100 mg soft capsules
D.2.1.1.2	Name of the Marketing Authorisation holder	Abbott Laboratories Limited
D.2.1.2	Country which granted the Marketing Authorisation	European Union
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.4	Pharmaceutical form	Capsule, soft
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	RITONAVIR
D.3.9.1	CAS number	155213-67-5
D.3.9.4	EV Substance Code	SUB10342MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	100
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another 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.1.1

Medical condition(s) being investigated

Chronic Hepatitis C infection.

Infezione Cronica da Virus dell’Epatite C.

E.1.1.1

Medical condition in easily understood language

Chronic Hepatitis C infection

Infezione Cronica da Virus dell’Epatite C.

E.1.1.2

Therapeutic area

Diseases [C] - Virus Diseases [C02]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	14.1
E.1.2	Level	PT
E.1.2	Classification code	10008912
E.1.2	Term	Chronic hepatitis C
E.1.2	System Organ Class	10021881 - Infections and infestations

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

The primary objective of this study is to evaluate the safety and antiviral efficacy, defined as the percentage of subjects with sustained virologic response 12 weeks post-dosing (SVR12; HCV RNA < LLOQ 12 weeks after the last dose of study drug).

L’obiettivo primario della presente sperimentazione è quello di valutare la sicurezza e l’ efficacia antivirale, definita in base alla percentuale di soggetti con risposta virologica sostenuta dopo 12 settimane dalla fine del trattamento (SVR12;HCV RNA < LLOQ dopo 12 settimane dalla somministrazione dell’ultima dose di medicinale sperimentale).

E.2.2

Secondary objectives of the trial

● to evaluate the percentage of subjects with sustained virologic response 24 weeks post-dosing (SVR24; HCV RNA < LLOQ 24 weeks after the last dose of study drug) and ● to evaluate the percentage of subjects with extended rapid virologic response (eRVR) (HCV RNA < LLOQ at Weeks 4 through 12 of therapy with ABT 450/r plus ABT-267 plus pegIFN plus RBV).

• valutare la percentuale di soggetti con risposta virologica sostenuta dopo 24 settimane dalla fine del trattamento (SVR24;HCV RNA < LLOQ dopo 24 settimane dalla somministrazione dell’ultima dose di medicinale sperimentale) e • valutare la percentuale di soggetti con risposta virologica rapida estesa (eRVR) (HCV RNA < LLOQ dalla Settimana 4 alla fine della Settimana 12 in terapia con ABT450/r, ABT-267, pegIFN, RBV).

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

To be enrolled in this protocol, subjects must meet all of the following inclusion criteria: 1. Subject must have experienced virologic failure as defined in a previous pegIFN-free Abbott DAA combination trial. 2. Female subjects of childbearing potential must be willing to use two effective forms of birth control (not including oral contraceptives or contraceptives containing ethinyl estradiol) while receiving study drug and for 6 months (or per local ribavirin label) after stopping study drug, unless abstinent from sexual intercourse. Females are considered of hildbearing potential unless they are either:  Post menopausal for at least 2 years (defined as amenorrheic for longer than 2 years, age appropriate, and confirmed by a folliclestimulating hormone [FSH] level indicating a postmenopausal state), or  Surgically sterile (defined as history of bilateral tubal ligation, bilateral XML File Identifier: XygKg/iSqRmdRsaKKUjCUNCrMJY= Page 26/36 oophorectomy or hysterectomy). 3. Males must be surgically sterile or agree to practice two effective forms of birth control throughout the course of the study, starting with Study Day 1 and for 6 months (or per local ribavirin label) after the last dose of study drug, unless abstinent from sexual intercourse. 4. Subject must be considered an appropriate candidate for pegIFN, RBV, ABT-450/r and ABT-267 therapy in the opinion of the investigator. 5. Subject is infected with HCV genotype 1 at screening.

Al fine di essere arruolati in questo protocollo, i soggetti dovranno soddisfare tutti i seguenti criteri di inclusione: 1. Soggetti che abbiano manifestato un fallimento virologico secondo quanto definito in una precedente sperimentazione Abbott con una combinazione di DAA che non prevedesse la somministrazione di pegIFN. 2. Donne in età fertile che sono disponibili a utilizzare due metodi efficaci di contraccezione (ad eccezione di contraccettivi orali oppure contraccettivi contenenti etinilestradiolo) durante il trattamento con il medicinale sperimentale e per 6 mesi (oppure per il periodo indicato sul foglietto illustrativo locale della ribavirina) dopo aver interrotto la somministrazione del medicinale sperimentale, a meno che non venga praticata l’astinenza totale dai rapporti sessuali. Le pazienti di sesso femminile saranno considerate in età fertile eccetto che nei seguenti casi: • Donne che sono in menopausa da almeno 2 anni (definita come presenza di amenorrea per un periodo superiore a 2 anni, compatibile per età, e confermata da livelli di ormoni follicolo-stimolanti [FSH] indicativi di uno stato post-menopausale), oppure • Donne che sono chirurgicamente sterili (ovvero sottoposte a legatura bilaterale delle tube, ovariectomia bilaterale o isterectomia). 3. Uomini chirurgicamente sterili oppure che acconsentono ad usare due metodi efficaci di contraccezione nel corso dell'intera sperimentazione, a partire dal Giorno 1 della Sperimentazione e per 6 mesi (oppure per il periodo indicato sul foglietto illustrativo localedella ribavirina) dopo l’assunzione dell'ultima dose del medicinale sperimentale, a meno che non venga praticata l’astinenza totale dai rapporti sessuali. 4. Soggetti considerati dallo sperimentatore candidati idonei a ricevere terapia con pegIFN, RBV, ABT-450/r e ABT-267. 5. Soggetti affetti da HCV di genotipo 1 allo screening.

E.4

Principal exclusion criteria

To be enrolled in this protocol, subjects must not meet any of the following exclusion criteria: 1. In subjects with a null or partial response to pegIFN/RBV treatment (at the time of enrollment into the previous Abbott DAA combination study), the presence of variants relative to the appropriate prototypic reference sequence (H77 for 1a or Con1 for 1b) at any of the following amino acid positions: NS3 protease 155, 156, or 168; NS5A 28, 29, 30, 31, 32, 58, or 93. 2. Females who are pregnant or plan to become pregnant, or breastfeeding, or males whose partners are pregnant or planning to become pregnant. 3. Use of known inhibitors (e.g., ketoconazole) or inducers (e.g., phenobarbital, rifampin, carbamazepine, St. John's Wort) of CYP3A and OATP1B1 (e.g., cyclosporine) within 1 month prior to study drug administration. 4. Use of any medications contraindicated for use with pegIFN, RBV or ritonavir within 2 weeks prior to study drug administration or 10 halflives, whichever is longer. Prior to entering the study, subjects must be able to safely discontinue the contraindicated medication or switch to an acceptable alternative under supervision of the investigator. 5. Discontinuation of antiviral therapy due to intolerance or a DAA or RBV associated adverse event in a previous Abbott DAA combination study.

Al fine di essere arruolati in questo protocollo, i soggetti non devono presentare alcuno dei seguenti criteri di esclusione: 1. Nei soggetti con una precedente risposta nulla o parziale al trattamento con pegIFN/RBV (al momento dell'arruolamento nella precedente sperimentazione Abbott con una combinazione di DAA), presenza di varianti rispetto alla sequenza prototipica standard appropriata (H77 per il genotipo 1a o Con1 per il genotipo 1b) in una qualsiasi delle seguenti posizioni di aminoacidi: proteasi NS3 155, 156 o 168; NS5A 28, 29, 30, 31, 32, 58 o 93. 2. Soggetti di sesso femminile che sono in stato di gravidanza o intendono programmare una 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. 3. Uso di noti inibitori (ad esempio, ketoconazolo) oppure induttori (ad esempio, fenobarbitale, rifampicina, carbamazepina, erba di San Giovanni) del CYP3A e OATP1B1 (ad esempio, ciclosporina) durante il mese precedente la somministrazione del medicinale sperimentale. 4. Uso di qualsiasi medicinale la cui assunzione concomitante con pegIFN, RBV o ritonavir sia controindicata, nelle 2 settimane precedenti la somministrazione del medicinale sperimentale o per un periodo di tempo corrispondente a dieci volte l’emivita del medicinale, quale dei due periodi sia il più lungo. Prima di essere arruolati nella sperimentazione, i soggetti devono essere in grado di poter interrompere in sicurezza il medicinale controindicato oppure assumere una terapia alternativa accettabile, sotto la supervisione dello sperimentatore 5. Soggetti che nell'ambito di una precedente sperimentazione Abbott con una combinazione di DAA hanno interrotto una terapia antivirale a causa di problemi di tollerabilità o di un evento avverso correlato a DAA o RBV.

E.5 End points

E.5.1

Primary end point(s)

The primary efficacy endpoint is the percentage of subjects with sustained virologic response 12 weeks after the last actual dose of study drug (including DAA, pegIFN, and RBV) (SVR12actual; HCV RNA < LLOQ 12 weeks after the last actual dose of study drug). The percentage of subjects with SVR12actual and the corresponding 95% exact binomial confidence interval will be calculated overall and by treatment group in the prior study.

L’endpoint primario di efficacia è rappresentato dalla percentuale di soggetti con risposta virologica sostenuta dopo 12 settimane dalla somministrazione dell’ultima dose effettiva del medicinale sperimentale (compresi DAA, pegIFN, e RBV) (SVR12effettiva HCV RNA< LLOQ 12 settimane dopo la somministrazione dell’ultima dose del medicinale sperimentale). La percentuale di soggetti con SVR12effettiva e il corrispondente intervallo di confidenza binomiale esatto al 95% saranno calcolati globalmente e per gruppo di trattamento nell’ambito della sperimentazione precedente.

E.5.1.1

Timepoint(s) of evaluation of this end point

12 weeks after the last dose of study drug.

12 settimane dopo la somministrazione dell’ultima dose del medicinale sperimentale.

E.5.2

Secondary end point(s)

The secondary efficacy endpoints are the percentage of subjects with sustained virologic response 24 weeks after the last actual dose of study drug (including DAA, pegIFN, and RBV) (SVR24actual; HCV RNA < LLOQ 24 weeks after the last actual dose of study drug) and the percentage of subjects with eRVR (HCV RNA < LLOQ at TI Weeks 4 through 12). The percentage of subjects with SVR24actual and eRVR and the corresponding 95% exact binomial confidence intervals will be calculated overall and by treatment group in the prior study.

Gli endpoint secondari di efficacia sono rappresentati dalla percentuale di soggetti con risposta virologica sostenuta dopo 24 settimane dalla somministrazione dell’ultima dose effettiva del medicinale sperimentale (compresi DAA, pegIFN, e RBV) (SVR24effettiva HCV RNA< LLOQ 24 settimane dopo la somministrazione dell’ultima dose del medicinale sperimentale) e dalla percentuale di soggetti con eRVR (HCV RNA < LLOQ dalla Settimana 4 alla fine della Settimana 12 nel Sottostudio 1). La percentuale dei soggetti con SVR24effettiva ed eRVR ed i corrispondenti intervalli di confidenza binomiali esatti al 95% saranno calcolati globalmente e per gruppo di trattamento della sperimentazione precedente.

E.5.2.1

Timepoint(s) of evaluation of this end point

24 weeks after the 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.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

Yes

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

Yes

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

E.8.1.2

Open

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

E.8.2.3

Other

Yes

E.8.2.3.1

Comparator description

non applicabile

not applicable

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

Yes

E.8.5.1

Number of sites anticipated in the EEA

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

Yes

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.6.3

If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned

Australia

Canada

New Zealand

Puerto Rico

Switzerland

Turkey

United States

E.8.7

Trial has a data monitoring committee

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

LVLS

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

E.8.9.2

In all countries concerned by the trial days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1

Number of subjects for this age range:

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

200

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.4.2

For a multinational trial

F.4.2.1

In the EEA

110

F.4.2.2

In the whole clinical trial

250

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)

No further treatment is planned after sbjs have ended their participation in the study. This study offers intensified therapy with DAAs plus pegIFN and RBV for subjects who have failed treatment for HCV infection in a previous pegIFN-free Abbott study. Safety assessments, HCV viral levels and monitoring for viral resistance are performed for 48 weeks following the last dose of study treatment. PegIFN and RBV will be offered as a non-protocol treatment if the sbj fails in this study.

Non è previsto alcun ulteriore trattamento dopo che i soggetti hanno completato la sperimentazione. Le valutazioni di sicurezza, le concentrazioni virali dell HCV e il monitoraggio della resistenza virale verranno effettuati per 48 settimane a seguito dell ultima dose del trattamento sperimentale. PegIFN e RBV verranno offerti come trattamento fuori protocollo se il soggetto fallisce in questa sperimentazione.

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2012-11-24

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2012-10-30

P. End of Trial
P.	End of Trial Status	Completed

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IMP with orphan designation in the indication
Orphan Designation Number:
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