Clinical Trials Register

Summary
EudraCT Number:	2012-005591-33
Sponsor's Protocol Code Number:	HIVCOBOC-RGT
National Competent Authority:	Austria - BASG
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2013-06-18
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

Austria - BASG

A.2

EudraCT number

2012-005591-33

A.3

Full title of the trial

Response-guided triple therapy using boceprevir in combination with PEGIFN/RBV in HIV/HCV coinfected patients

Individualisierte Tripeltherapie mit Boceprevir in Kombination mit PEGIFN/RBV bei HIV/HCV koinfizierten Patienten

A.3.1

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

Individualised triple therapy using boceprevir in combination with pegylated interferon and ribavirin in HIV-positive patients with hepatitis C

Individualisierte Tripeltherapie mit Boceprevir in Kombination mit pegyliertem Interferon und Ribavirin bei HIV-postitiven Patienten mit Hepatitis C

A.3.2

Name or abbreviated title of the trial where available

HIVCOBOC-RGT

A.4.1

Sponsor's protocol code number

HIVCOBOC-RGT

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	Universitätsklinik f. Innere Medizin III, Medizinische Universität Wien
B.1.3.4	Country	Austria
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	None
B.4.2	Country	Austria
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Klin. Abt. f. Gastroenterologie u. Hepatologie, Universitätsklinik f. Innere Medizin III, Medizinische Universität Wien
B.5.2	Functional name of contact point	Verantwortlicher Prüfer
B.5.3	Address:
B.5.3.1	Street Address	Währinger Gürtel 18-20
B.5.3.2	Town/ city	Wien
B.5.3.3	Post code	1090
B.5.3.4	Country	Austria
B.5.4	Telephone number	+431404004744
B.5.5	Fax number	+431404004735
B.5.6	E-mail	markus.peck@meduniwien.ac.at

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	Victrelis
D.2.1.1.2	Name of the Marketing Authorisation holder	Merck Sharp & Dohme Ltd
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, hard
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.3.9.3	Other descriptive name	BOCEPREVIR
D.3.9.4	EV Substance Code	SUB31579
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

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Chronic genotype 1 HCV coinfection in HIV-positive patients.

Chronische HCV Genotyp 1 Koinfektion bei HIV-positiven Patienten.

E.1.1.1

Medical condition in easily understood language

Chronic genotype 1 hepatitis C in HIV-positive patients.

Chronische hepatitis C vom Genotyp 1 bei HIV-postiven Patienten.

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	16.0
E.1.2	Level	LLT
E.1.2	Classification code	10065949
E.1.2	Term	HCV coinfection
E.1.2	System Organ Class	10021881 - Infections and infestations

E.1.2 Medical condition or disease under investigation

E.1.2	Version	16.0
E.1.2	Level	PT
E.1.2	Classification code	10020161
E.1.2	Term	HIV infection
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

Primary efficacy objective:
• to assess the rate of sustained virologic response (SVR12) at follow-up week 12 (FU12), which is defined as HCV-RNA negativity by a sensitive PCR assay

Primary safety/tolerability objective:
• to assess the rate of adverse events (AEs) and severe adverse events (SAEs)

Primäres Studienziel Effektivität:
• Erhebung der SVR Rate (SVR12) definiert als HCV-RNA Negativität 12 Wochen nach Ende der Tripeltherapie (FU12)

Primäres Studienziel Verträglichkeit:
• Erhebung der Inzidenz von unerwünschten Ereignissen (UEs) und schwerwiegenden unerwünschten Ereignissen (SUEs)

E.2.2

Secondary objectives of the trial

Secondary efficacy objective:
• to assess the rate of sustained virologic response (SVR24) at follow-up week 24 (FU24), which is defined as HCV-RNA negativity by a sensitive PCR assay

Secondary safety/tolerability objectives:
• to assess the incidence of hematologic AEs
oAnemia
• Grade I: Hb male <12/dL; female <11g/dL
• Grade II: Hb <10g/dL
• Grade III: Hb <8g/d
• Grade IV: Hb <7g/dL
o Thrombocytopenia
• Grade I: Platelets <150 G/L
• Grade II: Platelets <100 G/L
• Grade III: Platelets <50 G/L
• Grade IV: Platelets <20 G/L
o Neutropenia
• Grade I: ANC <1000/µL
• Grade II: ANC <750/µL
• Grade III: ANC <500/µL
• Grade IV: ANC <200/µL
• to assess the frequency and amount of erythropoietin analog (EPO) and granulocyte colony-stimulating factor analog (G-CSF) usage
• to assess the rate of treatment discontinuation due to AEs
• to assess the drop-out rate

Sekundäres Studienziel Effektivität:
• Erhebung der SVR Rate (SVR24) definiert als HCV-RNA Negativität 24 Wochen nach Ende der Tripletherapie (FU24)

Sekundäres Studienziel Verträglichkeit:
• Erhebung der Inzidenz von hämatologischen Nebenwirkungen: Anämie (Grad I: männlich Hb <12/dL/weiblich Hb <11g/dL, Grad II: Hb <10g/dL, Grad III: Hb <8g/d, Grad IV: Hb <7g/dL), Thrombozytopenie (Grad I: Thrombozytenzahl <150 G/L, Grad II: Thrombozytenzahl <100 G/L; Grad III: Thrombozytenzahl <50 G/L; Grad IV: Thrombozytenzahl <20 G/L), Neutropenie (Grad I: ANC <1000/µL; Grad II: ANC <750/µL; Grad III: ANC <500/µL; Grad IV: ANC <200/µL
• Erhebung der Frequenz und Dosierung von Erythropoetin (EPO) und Granulozyten-koloniestimulierende Faktor (G-CSF) Analoga
• Erhebung der Inzidenz von Therapieabbruch auf Grund von unerwünschten Ereignissen (UEs)
• Erhebung der Studienabbruchrate

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

• Confirmed HIV infection (anti-HIV1/2 antibody positive)
• Chronic HCV infection (anti-HCV positive, HCV-RNA detectable for >6 months)
• HCV-genotype (HCV-GT) 1 infection
• Age ≥18 years and ≤65 years
• No prior treatment with BOC/PEGIFN/RBV
• CD4+ cell count >200 cells/µL
• Stable antiretroviral therapy (ART) including tenofovir/emtricitabine (Truvada®, Gilead) and raltegravir (Isentress®, MSD) with HIV-RNA <50 copies/mL
• Valid result on transient elastography or liver biopsy within 6 months prior to enrollment

• Bestätigte HIV-Infektion
• Chronische HCV-Infektion
• HCV-Genotyp 1 Infektion
• Alter ≥18 und ≤65 Jahre
• Keine Vorbehandlung mit BOC/PEGIFN/RBV
• CD4+ Zellzahl >200 Zellen/µL
• Stabile antiretrovirale Therapie mit Tenofovir/Emtricitabine (Truvada®, Gilead) und Raltegravir (Isentress®, MSD) mit HIV-RNA <50 Kopien/mL
• Verfügbarkeit eines validen Resultates der transienten Elastographie der Leber oder einer Leberbiopsie innerhalb der letzten 6 Monate vor dem Studieneinschluss

E.4

Principal exclusion criteria

• HCV-genotype other than HCV-GT1
• Ongoing alcohol abuse (average daily alcohol consumption >50g)
• Ongoing illicit drug abuse
• Significant cardiac disease (ejection fraction <40% at echocardiography)
• Significant pulmonary disease (COPD stage GOLD III/IV)
• Significant renal disease (serum creatinine >1.5 mg/dL)
• Cirrhotic patients (as defined by METAVIR F4 in liver biopsy or liver stiffness >12.3 kPa[1]) with decompensated liver disease (Child-Pugh stage B/C)
• Chronic liver diseases other than hepatitis C virus infection (hepatitis B virus infection: HBsAg positivity, nonalcoholic steatohepatitis, autoimmune hepatitis, primary biliary cirrhosis, hemochromatosis, Wilson’s disease, alpha-1 antitrypsin deficiency, cystic fibrosis)
• Unwillingness to give written informed consent
• Pregancy and breastfeeding

• Anderer HCV-Genotyp als HCV-Genotyp 1
• Anhaltender täglicher Alkoholkonsum >50g
• Bedeutende kardiale Erkankung (Auswurffraktion <40% in der Echokardiographie)
• Bedeutende pulmonale Erkrankung (COPD Stadium GOLD III/IV)
• Bedeutende Nierenerkrankung (Serumkreatinin >1.5 mg/dL)
• Zirrhotische Patienten (Lebersteifigkeit >12.3 kPa/METAVIR F4 mit dekompensierter Lebererkrankung Child-Pugh B/C)
• Andere chronische Lebererkrankungen als Hepatitis C (Hepatitis B, Nichtalkoholische Fettleberhepatitis, Autoimmunhepatitis, Primäre biliäre Zirrhose, Hämochromatose, M. Wilson, Alpha-1 Antitrypsinmangel)
• Verweigerung der informierten Einwilligung
• Schwangerschaft und Stillzeit
• Frauen mit Schwangerschaftswunsch

E.5 End points

E.5.1

Primary end point(s)

Primary efficacy endpoint:
• Rate of sustained virologic response (SVR12) at follow-up week 12 (FU12), which is defined as HCV-RNA negativity by a sensitive PCR assay

Primary safety/tolerability endpoint:
• Rate of adverse events (AEs) and severe adverse events (SAEs)

Primärer Effektivitätsendpunkt:
• SVR Rate (SVR12) definiert als HCV-RNA Negativität 12 Wochen nach Ende der Tripeltherapie (FU12)

Primärer Verträglichkeitsendpunkt:
• Inzidenz von unerwünschten Ereignissen (UEs) und schwerwiegenden unerwünschten Ereignissen (SUEs)

E.5.1.1

Timepoint(s) of evaluation of this end point

See E.5.1

Siehe E.5.1

E.5.2

Secondary end point(s)

Secondary efficacy endpoint:
• Rate of sustained virologic response (SVR24) at follow-up week 24 (FU24), which is defined as HCV-RNA negativity by a sensitive PCR assay

Secondary safety/tolerability endpoints:
• Incidence of hematologic AEs

Sekundärer Effektivitätsendpunkt:
• SVR Rate (SVR24) definiert als HCV-RNA Negativität 24 Wochen nach Ende der Tripletherapie (FU24)

Sekundäre Verträglichkeitsendpunkte:
• Inzidenz von hämatologischen Nebenwirkungen: Anämie (Grad I: männlich Hb <12/dL/weiblich Hb <11g/dL, Grad II: Hb <10g/dL, Grad III: Hb <8g/d, Grad IV: Hb <7g/dL), Thrombozytopenie (Grad I: Thrombozytenzahl <150 G/L, Grad II: Thrombozytenzahl <100 G/L; Grad III: Thrombozytenzahl <50 G/L; Grad IV: Thrombozytenzahl <20 G/L), Neutropenie (Grad I: ANC <1000/µL; Grad II: ANC <750/µL; Grad III: ANC <500/µL; Grad IV: ANC <200/µL
• Frequenz und Dosierung von Erythropoetin (EPO) und Granulozyten-koloniestimulierende Faktor (G-CSF) Analoga
• Inzidenz von Therapieabbruch auf Grund von unerwünschten Ereignissen (UEs)
• Studienabbruchrate

E.5.2.1

Timepoint(s) of evaluation of this end point

See E.5.2

Siehe E.5.2

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

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)

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

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

E.8.3

The trial involves single site in the Member State concerned

Yes

E.8.4

The trial involves multiple sites in the 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

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

LVLS

Letzter Studientermin des letzten Studienteilnehmers

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

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

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:

F.1.3

Elderly (>=65 years)

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.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)

In the the case of both premature termination of parcipation in and premature termination of the study, patients will be further treated at the HIV & Liver outpatient ward of the Division of Gastroenterology and Hepatology, Department of Internal Medicine III, Medical University of Vienna. The same applies to further care after the end of the trial.

Sowohl im Falle einer vorzeitigen Beendigung Ihrer Studienteilnahme als auch eines vorzeitigen Studienabbruchs ist Ihre weiterführende Betreuung in der HIV & Liver Ambulanz der Klinischen Abteilung für Gastroenterologie und Hepatologie, Universitätklinik für Innere Medizin III, Medizinische Universität Wien gewährleistet. Selbiges gilt für Ihre Nachbetreuung nach Studienende.

G. Investigator Networks to be involved in the Trial
G.4 Investigator Network to be involved in the Trial: 1
G.4.1	Name of Organisation	Vienna HIV & Liver Study Group
G.4.3.4	Network Country	Austria

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

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2013-07-29

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2013-02-12

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2015-06-17

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