Clinical Trials Register

Summary
EudraCT Number:	2011-001096-39
Sponsor's Protocol Code Number:	MV25600
National Competent Authority:	Slovakia - SIDC (Slovak)
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2012-07-30
Trial 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

Slovakia - SIDC (Slovak)

A.2

EudraCT number

2011-001096-39

A.3

Full title of the trial

An International, Multi-Center Study Evaluating the Correlation of IL28B Genotypes with Chronic Hepatitis C Disease Characteristics and Patient Demographics

Medzinárodné, multicentrické klinické skúšanie hodnotiace koreláciu genotypov IL28B s demografickými údajmi pacientov a charakteristikou ochorenia u pacientov s chronickou hepatitídou C

A.3.1

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

A clinical study with many of countries and sites participating. This study wants to look into the relationship of the genotype IL28B in patients from all over the world which are suffering from an inflammation of the liver with hepatitis C virus

A.4.1

Sponsor's protocol code number

MV25600

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	F.Hoffmann-La Roche Ltd.
B.1.3.4	Country	Switzerland
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	F. Hoffmann-La Roche Ltd
B.4.2	Country	Switzerland
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	F.Hoffmann-La Roche Ltd
B.5.2	Functional name of contact point	Trial Information Support Line-TISL
B.5.3	Address:
B.5.3.1	Street Address	Grenzacherstrasse 124
B.5.3.2	Town/ city	Basel, Switzerland
B.5.3.3	Post code	4070
B.5.4	Telephone number	004161688 1111
B.5.5	Fax number	004161691 9319
B.5.6	E-mail	global.rochegenentechtrials@roche.com

D. IMP Identification

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

E.1.1.1

Medical condition in easily understood language

Inflammation of the liver caused by infection with Hepatitis C virus

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	LLT
E.1.2	Classification code	10008912
E.1.2	Term	Chronic hepatitis C
E.1.2	System Organ Class	10021881 - Infections and infestations

E.1.2 Medical condition or disease under investigation

E.1.2	Version	14.1
E.1.2	Level	LLT
E.1.2	Classification code	10019752
E.1.2	Term	Hepatitis C virus (HCV)
E.1.2	System Organ Class	10022891 - Investigations

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

Correlation of Interleukin 28B (IL28B) genotypes
rs12979860 (CC vs. TC vs. TT) and rs8099917 (TT vs. GT vs. GG) with liver fibrosis related to CHC

E.2.2

Secondary objectives of the trial

- Correlation of IL28B genotypes (rs12979860 and
rs8099917) with liver inflammation related to CHC
- Correlation of IL28B genotypes (rs12979860 and
rs8099917) with demographics in patients with CHC
- Distribution of IL28B genotypes (rs12979860 and
rs8099917) in patients with CHC in different HCV
genotypes and in different countries
- Correlation between the two IL28B genotypes
(rs12979860 and rs8099917) in patients with CHC
- Distribution of inosine triphosphatase (ITPA) genotypes rs1127354 (AA vs. CA vs. CC) and rs7270101 (CC vs. AC vs. AA) in patients with CHC in different HCV genotypes and in different countries
- In treatment experienced patients, retrospective
analysis of
- Correlation between IL28B genotypes (rs12979860
and rs8099917) and previous treatment outcome
- Correlation between ITPA genotypes (rs1127354 and rs7270101) and hemoglobin (Hb) decline during prior treatment

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

- Adult (according to local legislation) male or female
patients
- Chronic hepatitis C (CHC)
- Patients naïve to CHC treatment or patients who
received prior interferon (IFN) based therapy for CHC
for whom data on treatment received (type of therapy, dose, duration) and treatment outcome (i.e. rapid virological response [RVR], complete early virological response [cEVR], partial early virological response [pEVR], end of treatment response [EoT), sustained virological response [SVR], relapse, breakthrough, nonresponse) of prior therapy is available. In addition information on fibrosis stage prior to the previous treatment course is required.
- Written informed consent

E.4

Principal exclusion criteria

- Co-infection with hepatitis B
- History or other evidence of decompensated liver
disease
- History of major organ transplantation with an existing functional graft (including liver transplantation)
- End stage renal disease

E.5 End points

E.5.1

Primary end point(s)

IL28B genotypes rs12979860 (CC vs. TC vs. TT) and rs8099917 (TT vs. GT vs. GG)

E.5.1.1

Timepoint(s) of evaluation of this end point

Please refer to protocol MV25600, Section 5, Schedule of Assessments and Procedures

E.5.2

Secondary end point(s)

ITPA genotypes rs1127354 (AA vs. CA vs. CC) and rs7270101 (CC vs. AC vs. AA)

E.5.2.1

Timepoint(s) of evaluation of this end point

Please refer to protocol MV25600, Section 5, Schedule of Assessments and Procedures

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

E.6.4

Safety

E.6.5

Efficacy

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

Yes

E.6.11

Pharmacogenomic

Yes

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)

E.7.4

Therapeutic use (Phase IV)

Yes

E.8 Design of the trial

E.8.1

Controlled

E.8.1.1

Randomised

E.8.1.2

Open

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

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

170

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

Argentina

Chile

Lebanon

Mexico

Pakistan

Serbia

Syria

Taiwan

Thailand

Turkey

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

The end of the study is defined as last patient last visit. Last patient last visit is the date at which the last data point from the last patient, which is required for statistical analysis was received.

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	No
F.1.1.1	In Utero	No
F.1.1.2	Preterm newborn infants (up to gestational age < 37 weeks)	No
F.1.1.3	Newborns (0-27 days)	No
F.1.1.4	Infants and toddlers (28 days-23 months)	No
F.1.1.5	Children (2-11years)	No
F.1.1.6	Adolescents (12-17 years)	No
F.1.2	Adults (18-64 years)	Yes
F.1.3	Elderly (>=65 years)	Yes
F.2 Gender
F.2.1	Female	Yes
F.2.2	Male	Yes
F.3 Group of trial subjects
F.3.1	Healthy volunteers	No
F.3.2	Patients	Yes
F.3.3	Specific vulnerable populations	No
F.3.3.1	Women of childbearing potential not using contraception	No
F.3.3.2	Women of child-bearing potential using contraception	No
F.3.3.3	Pregnant women	No
F.3.3.4	Nursing women	No
F.3.3.5	Emergency situation	No
F.3.3.6	Subjects incapable of giving consent personally	No
F.3.3.7	Others	No
F.4 Planned number of subjects to be included
F.4.1	In the member state	64
F.4.2	For a multinational trial
F.4.2.1	In the EEA	2573
F.4.2.2	In the whole clinical trial	4200

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

2012-07-05

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2012-07-10

P. End of Trial
P.	End of Trial Status	Ongoing

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