Clinical Trials Register

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

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A. Protocol Information

A.1

Member State Concerned

Italy - Italian Medicines Agency

A.2

EudraCT number

2012-002035-29

A.3

Full 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.3.1

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

A study to evaluate the safety and effect of 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.4.1

Sponsor's protocol code number

M13-098

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	ABBOTT 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
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	Abbott Laboratories
B.5.2	Functional name of contact point	euclinicaltrials@abbott.com
B.5.3	Address:
B.5.3.1	Street Address	Abbott House, Vanwall Business Park, Vanwall
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 644475
B.5.5	Fax number	+44 1628 644330
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/r/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-450
D.3.9.3	Other descriptive name	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	75
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	50
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.2	Current sponsor code	ABT-267
D.3.9.3	Other descriptive name	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	12.5
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-333
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-333
D.3.9.3	Other descriptive name	ABT-333
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	250
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	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.3.9.2	Current sponsor code	Ribavirin
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.2.1.2	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	Capsule
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.3.9.2	Current sponsor code	Ribavirin
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.8 Information on Placebo
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Tablet
D.8.4	Route of administration of the placebo	Oral use
D.8 Placebo: 2
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Tablet
D.8.4	Route of administration of the placebo	Oral use
D.8 Placebo: 3
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Capsule
D.8.4	Route of administration of the placebo	Oral use

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 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) < 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.2.2

Secondary 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.2.3

Trial contains a sub-study

E.3

Principal 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.4

Principal 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.5.1

Primary 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.5.1.1

Timepoint(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.5.2

Secondary 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.5.2.1

Timepoint(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.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

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)

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

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

Yes

E.8.1.7.1

Other 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.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

Yes

E.8.2.3

Other

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

Mexico

New Zealand

Puerto Rico

Russian Federation

Switzerland

Turkey

United States

E.8.7

Trial 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.8.9.1

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:

360

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

180

F.4.2.2

In 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

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2013-02-08

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2012-12-10

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

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