Clinical Trials Register

Summary
EudraCT Number:	2015-002353-35
Sponsor's Protocol Code Number:	M15-462
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:	2018-02-23
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

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A. Protocol Information

A.1

Member State Concerned

Italy - Italian Medicines Agency

A.2

EudraCT number

2015-002353-35

A.3

Full title of the trial

A Single-Arm, Open-Label, Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Renally-Impaired Adults with Chronic Hepatitis C Virus Genotype 1 – 6 Infection (EXPEDITION-4

Sperimentazione in aperto a braccio singolo per valutare l’efficacia e la sicurezza di ABT-493/ABT-530 in soggetti adulti con compromissione renale affetti da infezione cronica da Virus dell’Epatite C di Genotipo 1 – 6 (EXPEDITION-4

A.3.1

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

A Study to evaluate the Effect and Safety of experimental drugs ABT-493/ABT-530 in adults with Chronic Hepatitis C Virus Genotype 1-6 Infection and Renal Impairment.

Sperimentazione per valutare l’efficacia e la sicurezza dei farmaci sperimentalii ABT-493/ABT-530 in soggetti adulti con compromissione renale affetti da infezione cronica da Virus dell’Epatite C di Genotipo 1 – 6.

A.3.2

Name or abbreviated title of the trial where available

N.A.

A.4.1

Sponsor's protocol code number

M15-462

A.5.4

Other Identifiers

Name:

N.A.

Number:

N.A.

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	AbbVie House, Vanwall Business Park, Vanwall Road
B.5.3.2	Town/ city	Maidenhead, Berkshire
B.5.3.3	Post code	SL6 4UB
B.5.3.4	Country	United Kingdom
B.5.4	Telephone number	0044 1628 561090
B.5.5	Fax number	0044 1628 461153
B.5.6	E-mail	eu-clinical-trials@abbvie.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	ABT-493 / ABT-530
D.3.2	Product code	ABT-493 / ABT-530
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
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	ABT-493
D.3.9.2	Current sponsor code	ABT-493
D.3.9.3	Other descriptive name	ABT-493
D.3.9.4	EV Substance Code	SUB131084
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.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	ABT-530
D.3.9.2	Current sponsor code	ABT-530
D.3.9.3	Other descriptive name	ABT-530
D.3.9.4	EV Substance Code	SUB131083
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	40
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	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
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 HCV Genotype 1-6 Infection.

Infezione cronica da Virus dell’Epatite C di Genotipo 1 – 6.

E.1.1.1

Medical condition in easily understood language

Chronic Hepatitis C Virus 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	20.1
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

To assess the virologic response to 12 weeks of treatment with ABT- 493/ABT-530 by determining the percentage of subjects who achieved a sustained virologic response at 12 weeks post-treatment (SVR12) and to evaluate safety of ABT-493/ABT-530 in adults with chronic HCV genotype 1 – 6 infection with chronic renal impairment.

Valutare la risposta virologica a 12 settimane di trattamento con ABT493/ABT-530 determinando la percentuale di soggetti che raggiungono una risposta virologica sostenuta a 12 settimane dopo il trattamento (SVR12) e valutare la sicurezza di ABT-493/ABT-530 in soggetti adulti affetti da infezione cronica da HCV di genotipo 1 – 6 e da compromissione renale cronica.

E.2.2

Secondary objectives of the trial

● The percentages of subjects with on-treatment virologic failure;
● The percentages of subjects with post-treatment relapse;
● To assess pharmacokinetics of ABT-493/ABT-530 and the emergence and persistence of viral variants in this treatment regimen.

• La percentuale di soggetti che manifestano fallimento virologico in corso di trattamento;
• La percentuale di soggetti con recidiva post-trattamento;
• Valutare la farmacocinetica di ABT-493/ABT-530 e la presenza e persistenza delle varianti virali in questo regime di trattamento.

E.2.3

Trial contains a sub-study

Yes

E.2.3.1

Full title, date and version of each sub-study and their related objectives

Amd. 1-Wed Sep 16 00:00:00 CEST 2015-Optional pharmacogenetic.-Pharmacogenetics.
Pharmacokinetics.16/09/2015.Amd 1.

Amd. 1-Wed Sep 16 00:00:00 CEST 2015-Optional pharmacogenetic.-Pharmacogenetics.
Optional pharmacokinetic.

E.3

Principal inclusion criteria

1. Male or female at least 18 years of age at time of Screening.
2. Screening laboratory result indicating chronic HCV GT1-6 infection.
3. Subject must be HCV treatment-naïve or have received prior HCV treatment with IFN or pegIFN with or without RBV, pegIFN/RBV plus SOF, or SOF plus RBV.
4. Subject must have chronic renal impairment (CKD stage 4 or 5).

1. Soggetti di ambo i sessi e di età pari o superiore a 18 anni al momento dello Screening.
2. Soggetti con infezione cronica da HCV di genotipo 1-6 confermato da analisi di laboratorio allo Screening.
3. Soggetti naïve al trattamento anti-HCV o soggetti che abbiano ricevuto trattamento anti-HCV pregresso con IFN o pegIFN con o senza RBV, pegIFN/RBV + SOF, o SOF + RBV.
4. Soggetti con pre-esistente compromissione renale cronica (CKD stadio 4 o 5)

E.4

Principal exclusion criteria

1. History of severe, life-threatening or other significant sensitivity to any excipients of the study drug.
2. Female who is pregnant, planning to become pregnant during the study, or breastfeeding; or male whose partner is pregnant or planning to become pregnant during the study.
3. Recent (within 6 months prior to study drug administration) history of drug or alcohol abuse that could preclude adherence to the protocol in the opinion of the investigator.
4. Positive test result at Screening for hepatitis B surface antigen (HBsAg) or anti-human immunodeficiency virus antibody (HIV Ab).
5. HCV genotype performed during screening indicating co-infection with more than one HCV genotype.

1. Soggetti con storia di sensibilità grave, potenzialmente fatale o altrimenti significativa a qualsiasi eccipiente del medicinale sperimentale.
2. Soggetti di sesso femminile in stato di gravidanza, che intendono incominciare una gravidanza durante il periodo della sperimentazione o che stanno allattando, o soggetti di sesso maschile le cui partner sono in stato di gravidanza o intendono iniziare una gravidanza durante il periodo della sperimentazione.
3. Storia recente (nei 6 mesi precedenti la somministrazione del medicinale sperimentale) di abuso di sostanze stupefacenti o di alcolici che a giudizio dello sperimentatore impedirebbe l’aderenza al protocollo.
4. Positività allo Screening per l’antigene di superficie dell’epatite B (HBsAg) o per l’anticorpo al virus dell’immunodeficienza umana (HIV Ab).
5. Risultati del test eseguito durante lo screening per rilevare il genotipo HCV che indica la presenza di co-infezione con più di un genotipo del virus HCV.

E.5 End points

E.5.1

Primary end point(s)

The percentage of subjects with SVR 12 (HCV RNA < LLOQ 12 weeks after the last actual dose of study drug).

Percentuale di soggetti con SVR12 (HCV RNA < LLOQ 12 settimane dopo l’ultima dose di medicinale sperimentale effettivamente somministrata).

E.5.1.1

Timepoint(s) of evaluation of this end point

12 weeks after last dose of study drug.

12 settimane dopo l’ultima dose di medicinale sperimentale.

E.5.2

Secondary end point(s)

* The percentage of subjects with on treatment virologic failure (defined as confirmed increase of > 1 log10 IU/mL above nadir during treatment, confirmed HCV RNA ≥ 100 IU/mL after HCV RNA < LLOQ during treatment, or HCV RNA ≥ LLOQ at the end of treatment with at least 6 weeks of treatment);
* The percentage of subjects with post-treatment relapse (defined as confirmed HCV RNA ≥ LLOQ between end of treatment and 12 weeks after the last dose of study drug among subjects who completed treatment as planned with HCV RNA < LLOQ at the end of treatment;
with further breakdown by relapse versus reinfection based on HCV population sequencing).

• La percentuale di soggetti che manifestano fallimento virologico in corso di trattamento (definito come aumento confermato di almeno 1 log10 UI/mL rispetto al nadir durante il trattamento, conferma di livelli di HCV RNA ≥ 100 successivamente a riscontri di HCV RNA < LLOQ in corso di trattamento oppure HCV RNA ≥ LLOQ alla fine del trattamento della durata di almeno 6 settimane);
• La percentuale di soggetti con recidiva post-trattamento (definita come livelli confermati di HCV RNA ≥ LLOQ nell’intervallo compreso fra la conclusione del trattamento e 12 settimane dopo l’ultima dose del medicinale sperimentale nei soggetti che hanno portato a termine il trattamento come da programma e che presentano livelli di HCV RNA < LLOQ alla fine del trattamento; con ulteriore suddivisione tra i soggetti con recidiva rispetto ai reinfetti basata sul sequenziamento della popolazione con HCV).

E.5.2.1

Timepoint(s) of evaluation of this end point

* Start of treatment (Day 1) until End of Treatment.
* 12 weeks after end of treatment

• Inizio del Trattamento (Giorno 1) fino alla fine del trattamento;
• 12 settimane dopo l’ultima dose di 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

Yes

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)

E.7.3

Therapeutic confirmatory (Phase III)

Yes

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

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

Information not present in EudraCT

E.8.1.6

Cross over

Information not present in EudraCT

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

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

Information not present in EudraCT

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

Belgium

Canada

France

Greece

Italy

New Zealand

United Kingdom

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

Information not present in EudraCT

F.1.1.2

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

Information not present in EudraCT

F.1.1.3

Newborns (0-27 days)

Information not present in EudraCT

F.1.1.4

Infants and toddlers (28 days-23 months)

Information not present in EudraCT

F.1.1.5

Children (2-11years)

Information not present in EudraCT

F.1.1.6

Adolescents (12-17 years)

Information not present in EudraCT

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

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

Yes

F.3.3.2

Women of child-bearing potential using contraception

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

F.4.2.2

In the whole clinical trial

100

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)

Subjects will receive ABT-493/ABT-530 throughout the Treatment Period for 12 weeks or until premature discontinuation of study drug, followed by a 24 week Post-Treatment Period. At the subject's last study visit, the investigator will discuss the appropriate subsequent treatment with the subject.
Abbvie will not provide commercially available drug or any other therapy once the subject's participation is concluded.

I soggetti riceveranno ABT-493/ABT-530 per 12 settimane durante il periodo di trattamento o fino a discontinuazione prematura dalla sperimentazione, successivamente ci sarà un periodo di Post-trattamento di 24 settimane. All’ultima visita del soggetto, il medico sperimentatore discuterà con il soggetto l’appropriata terapia successiva. Abbvie non fornirà farmaco disponibile in commercio o qualsiasi altra terapia al termine della partecipazione del soggetto alla 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

2016-02-09

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2016-01-21

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2017-01-26

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