Clinical Trials Register

Summary
EudraCT Number:	2011-002459-33
Sponsor's Protocol Code Number:	MEN_BOC
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2011-09-21
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

Italy - Italian Medicines Agency

A.2

EudraCT number

2011-002459-33

A.3

Full title of the trial

Boceprevir in Combination With Peginterferon Alfa-2b and Ribavirin in Difficult-to-Treat Menopausal Women With Chronic Hepatitis C Genotype 1, either deemed Nonresponders to Peginterferon/Ribavirin or treatment-naives.

Boceprevir in combinazione con Peginterferone Alfa-2b e Ribavirina nelle donne menopausali con epatite cronica C Genotipo 1 Difficult-to-Treat , Non responder a Peginterferone\Ribavirina o treatment-naives

A.3.1

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

Evaluating the effectiveness of therapy whith Boceprevir associated with antiviral therapy standard for chronic hepatitis viruc HCV in a population of menopausal women ganotipe one ever treated or not responsive to previous treatment

Valutazione dell'efficacia della terapia con Boceprevir associato alla antivirale terapia standard per epatite cronica viruc da HCV in una popolazione di donne in menopausa ganotipo 1 mai trattate o non responsive a un precedente trattamento

A.3.2

Name or abbreviated title of the trial where available

MEN_BOC

A.4.1

Sponsor's protocol code number

MEN_BOC

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	AZIENDA OSPEDALIERA POLICLINICO DI MODENA
B.1.3.4	Country	Italy
B.3.1 and B.3.2	Status of the sponsor	Non-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	merk
B.4.2	Country	Italy
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	A.O.U. Policlinico di Modena - U.O. di Gastroenterologia
B.5.2	Functional name of contact point	Anna Ferrari study coordinator
B.5.3	Address:
B.5.3.1	Street Address	via del pozzo 71
B.5.3.2	Town/ city	modena
B.5.3.3	Post code	41124
B.5.3.4	Country	Italy
B.5.4	Telephone number	0594224023
B.5.5	Fax number	0594224419
B.5.6	E-mail	a.ferrari1102@gmail.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	Yes
D.2.1.1.1	Trade name	vicrelis
D.2.1.1.2	Name of the Marketing Authorisation holder	Merck & co
D.2.1.2	Country which granted the Marketing Authorisation	United States
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	Prolonged-release 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	Boceprevir
D.3.9.1	CAS number	394730-60-0
D.3.9.2	Current sponsor code	SCH503034
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	Yes
D.3.11.13.1	Other medicinal product type	inibitore delle proteasi
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	Yes
D.2.1.1.1	Trade name	PEGINTRON*SC 1FL 80MCG+1 KIT
D.2.1.1.2	Name of the Marketing Authorisation holder	SCHERING PLOUGH SpA
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	Solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Cutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	pegintron
D.3.10	Strength
D.3.10.1	Concentration unit	µg/ml microgram(s)/millilitre
D.3.10.2	Concentration type	up to
D.3.10.3	Concentration number	120
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	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	Yes
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.2.1.1.1	Trade name	REBETOL*168CPS 200MG
D.2.1.1.2	Name of the Marketing Authorisation holder	SCHERING PLOUGH SpA
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	Gastro-resistant 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.3.9.4	EV Substance Code	REBETOL
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	range
D.3.10.3	Concentration number	800 to 1200
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

menopausal women with chronic HCV genotype1, naive or previously treated her with standard antiviral therapy

donne in menopausa con epatite cronica da virus HCV genotipo 1, naive o precedentemente trattae con terapia antivirale standard

E.1.1.1

Medical condition in easily understood language

menopausal women with chronic HCV genotype1, naive or previously treated her with standard antiviral therapy

donne in menopausa con epatite cronica da virus HCV genotipo 1, naive o precedentemente trattae con terapia antivirale standard

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	14.0
E.1.2	Level	PT
E.1.2	Classification code	10019744
E.1.2	Term	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 verify whether the addition of Boceprevir 800 mg TID to standard antiviral therapy with PEG IFN alfa 2b (1.5 µg/kg QW) plus Ribavirin (800-1400 mg/day) will determine at least a 25% improvement in SVR in the cohort of difficult-to-treat post-menopausal women with chronic hepatitis C (CHC) genotype 1 (either previous nonresponders to Peginterferon/Ribavirin (RBV) treatment or treatment naïves).

Verificare se l'aggiunta di Boceprevir 800 mg TID alla terapia antivirale standard con PEG IFN alfa 2b (1,5 mcg / kg QW) + Ribavirina (800-1400 mg / die), determina un miglioramento di almeno il 25% della risposta virologica sostenuta (SVR) in una coorte ‘difficult to treat’ di donne post-menopausali con epatite cronica C (CHC) genotipo 1 (non responder a precedenti trattamenti con peginterferone e ribavirina (RBV) o naїve.

E.2.2

Secondary objectives of the trial

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

• Menopausal females with previously documented CHC infection, either (A) relapser or with a >2log10 IU/ml HCV RNA decrease at week 12 in a previous PEG IFN/Ribavirin treatment or (B) naives; • Subject must have a liver biopsy within the last 2 years with histology consistent with CHC and no other etiology. • Subjects with bridging fibrosis or cirrhosis must have an ultrasound within 6 months of the Screening Visit (or between Screening and Day 1) with no findings suspicious for hepatocellular carcinoma (HCC).

• Donne in menopausa con infezione cronica da epatite C precedentemente documentata, relapser o che hanno presentato una riduzione < 2 log10 UI / ml di RNA di HCV alla 12a settimana di un precedente trattamento con ribavirina/PEG IFN (A) o naïves(B); • Pazienti con biopsia epatica eseguita negli ultimi 2 anni con un’istologia compatibile con epatite cronica C e nessun’altra eziologia; • Pazienti con fibrosi a ponte o cirrosi con un’ecografia eseguita entro 6 mesi dalla visita di screening (o tra screening e 1 ° giorno di arruolamento) senza riscontro di lesioni sospette per carcinoma epatocellulare (HCC);

E.4

Principal exclusion criteria

•For protocol (A), menopausal women with a null response (<2log10 IU/ml HCV RNA decrease at week 12) in a previous PEG IFN/Ribavirin treatment. •Coinfection with the human immunodeficiency virus (HIV) or hepatitis B virus (HBsAg positive). •Treatment with any investigational drug within 30 days of the randomization visit in this study. •Participation in any other clinical trial within 30 days of randomization or intention to participate in another clinical trial during participation in this study. •Evidence of decompensated liver disease including, but not limited to, a history or presence of clinical ascites, bleeding varices, or hepatic encephalopathy. •Diabetic and/or hypertensive subjects with clinically significant ocular examination findings: retinopathy, cotton wool spots, optic nerve disorder, retinal hemorrhage, or any other clinically significant abnormality. •Pre-existing psychiatric condition(s). •Clinical diagnosis of substance abuse of the specified drugs within the specified timeframes. •Any known pre-existing medical condition that could interfere with the subject's participation in and completion of the study. •Evidence of active or suspected malignancy, or a history of malignancy, within the last 5 years (except adequately treated carcinoma in situ and basal cell carcinoma of the skin). Subjects under evaluation for malignancy are not eligible. •Subjects who had life-threatening serious adverse event (SAE) during screening period. •Protocol-specified hematologic, biochemical, and serologic criteria: Hemoglobin <12 g/dL for females and <13 g/dL for males; Neutrophils <1500/mm^3 (blacks: <1200/mm^3); Platelets <100,000/mm^3; Direct bilirubin >1.5 x upper limit of normal (ULN) •Serum albumin < lower limit of normal (LLN) •Thyroid-stimulating hormone (TSH) >1.2 x ULN or <0.8 x LLN of laboratory, with certain exceptions. •Serum creatinine >ULN of the laboratory reference. •Protocol-specified serum glucose concentrations. •Prothrombin time/partial thromboplastin time (PT/PTT) values >10% above laboratory reference range. •Anti-nuclear antibodies (ANA) >1:320.

Per il protocollo (A), donne menopausali con una risposta nulla (riduzione <2log10 UI/ml di HCV RNA alla 12a settimana) ad un precedente trattamento con PEG IFN/Ribavirina. • Co-infezione con il virus dell'immunodeficienza umana (HIV) o con il virus dell'epatite B (HBsAg positività). • Partecipazione a qualsiasi altra sperimentazione clinica entro 30 giorni dalla randomizzazione o intenzione di partecipare a un altro studio clinico durante la partecipazione a questo studio. •Evidenza di malattia epatica scompensata tra cui, ma non solo, ascite clinica presente o pregressa, sanguinamento da varici, o encefalopatia epatica. • Soggetti diabetici e / o ipertesi con riscontro all’esame oftamologico di: retinopatia, maculopatia, patologia del nervo ottico, emorragia retinica, o qualsiasi altra anomalia clinicamente significativa. • Condizione psichiatrica pre-esistente. • La diagnosi clinica di abuso di sostanze o uso di farmaci specifici entro i termini specificati. • Ogni condizione medica pre-esistente che possa interferire con la partecipazione del soggetto e il completamento dello studio. • riscontro e/o sospetto di malattia neoplastica o con storia di tumore maligno negli ultimi 5 anni (ad eccezione di carcinoma in situ adeguatamente trattati e carcinoma delle cellule basali della pelle). I soggetti in corso di valutazione per neoplasie maligne non sono arruolabili. • I soggetti che abbiano presentato evento avverso serio (SAE) con pericolo di vita durante il periodo di screening. • Criteri ematologici, biochimici e sierologici specificati nel protocollo con i seguenti valori: emoglobina <12 g/dl per le donne e <13 g/dL per i maschi; neutrofili <1.500/mm ^ 3 (i neri: <1200/mm ^ 3), piastrine <100.000/mm ^ 3; bilirubina diretta> 1,5 volte il limite superiore del valore normale (ULN). • albumina sierica <al limite inferiore di normalità (LLN) • ormone tireostimolante (TSH)>1.2 x ULN o <0,8 x LLN di laboratorio, con alcune eccezioni. • Il valore di creatinina sierica > ULN rispetto ai valori di riferimento del laboratorio. • Valori di glicemia specificati nel Protocollo. • Il tempo di protrombina / tempo di tromboplastina parziale (PT / PTT) con valori >10% sopra il limite del laboratorio di riferimento. • Gli anticorpi antinucleo (ANA) > 1:320.

E.5 End points

E.5.1

Primary end point(s)

E.5.1.1

Timepoint(s) of evaluation of this end point

72 week

72 settimane

E.5.2

Secondary end point(s)

E.5.2.1

Timepoint(s) of evaluation of this end point

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

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

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

Yes

E.8.1.7.1

Other trial design description

I dati sopra riportati riguardano il braccio non responders a precedenti trattamenti

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

Yes

E.8.2.2

Placebo

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

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

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

LVLP

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:

170

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

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

F.3.3.1

Women of childbearing potential not using contraception

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

240

F.4.2

For a multinational trial

F.4.2.1

In the EEA

240

F.4.2.2

In the whole clinical trial

240

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)

ABOUT 15 VISITS IN 6 MOUNTHS DURING THERAPY + 24 WEEKS OF FOLLOW UP

circa 15 visite in 6 mesi durante la terapia + 24 settimane di follow-up

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

2011-12-06

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2011-09-13

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

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