Clinical Trials Register

Summary
EudraCT Number:	2009-011786-80
Sponsor's Protocol Code Number:	526H04
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2009-11-26
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

Spain - AEMPS

A.2

EudraCT number

2009-011786-80

A.3

Full title of the trial

Estudio de fase 2a/b, aleatorizado y controlado, de la eficacia y la seguridad de PEG-rIL-29 administrado en combinación con ribavirina a sujetos con infección crónica por el virus de la hepatitis C no tratada previamente //

RANDOMIZED, CONTROLLED PHASE 2a/b STUDY OF THE EFFICACY AND SAFETY OF PEG-rIL-29 ADMINISTERED IN COMBINATION WITH RIBAVIRIN TO TREATMENT-NAIVE SUBJECTS WITH CHRONIC
HEPATITIS C VIRUS INFECTION

A.3.2

Name or abbreviated title of the trial where available

EMERGE

A.4.1

Sponsor's protocol code number

526H04

A.7

Trial is part of a Paediatric Investigation Plan

Information not present in EudraCT

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	ZymoGenetics, Inc.
B.1.3.4	Country	United States
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
B.4.2	Country
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation
B.5.2	Functional name of contact point

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	PEG-rIL-29
D.3.4	Pharmaceutical form	Solution for injection
D.3.4.1	Specific paediatric formulation	Information not present in EudraCT
D.3.7	Routes of administration for this IMP	Subcutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.1	CAS number	914617-98-4
D.3.9.2	Current sponsor code	PEG-rIL-29
D.3.9.3	Other descriptive name	PEGylated recombinant IL-29
D.3.10	Strength
D.3.10.1	Concentration unit	µg/ml microgram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	500
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.1	CAS number	914617-98-4
D.3.9.2	Current sponsor code	PEG-rIL-29
D.3.9.3	Other descriptive name	PEGylated recombinant IL-29
D.3.10	Strength
D.3.10.1	Concentration unit	µg/ml microgram(s)/millilitre
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	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)	Information not present in EudraCT
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	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	Information not present in EudraCT
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	Information not present in EudraCT
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	Yes
D.2.1.1.1	Trade name	PEGASYS
D.2.1.1.2	Name of the Marketing Authorisation holder	Hoffmann-La Roche Limited, Canada
D.2.1.2	Country which granted the Marketing Authorisation	Canada
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	peginterferon alfa-2a
D.3.4	Pharmaceutical form	Solution for injection
D.3.4.1	Specific paediatric formulation	Information not present in EudraCT
D.3.7	Routes of administration for this IMP	Subcutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	PEGINTERFERON ALFA 2A
D.3.9.1	CAS number	198153-51-4
D.3.10	Strength
D.3.10.1	Concentration unit	µg/ml microgram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	180
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)	Information not present in EudraCT
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	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	Information not present in EudraCT
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	Information not present in EudraCT
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	RIBASPHERE®
D.2.1.1.2	Name of the Marketing Authorisation holder	THREE RIVERS PHARMACEUTICALS, LLC, USA
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	Tablet
D.3.4.1	Specific paediatric formulation	Information not present in EudraCT
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.3.10	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)	Information not present in EudraCT
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	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	Information not present in EudraCT
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	Information not present in EudraCT
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

Infección crónica por el virus de la hepatitis C

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	12.0
E.1.2	Level	LLT
E.1.2	Classification code	10008912
E.1.2	Term	Chronic hepatitis C

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

Fase 2a
Parte 1:El objetivo principal de la parte 1 es caracterizar la farmacocinética de una dosis fija única de PEG-rIL-29 por vía subcutánea (SC) en monoterapia en 4 niveles de dosis diferentes a sujetos con infección crónica por VHC no tratada previamente.
Parte 2
El objetivo principal de la parte 2 es evaluar la seguridad y tolerabilidad del tto repetido durante un máximo de 48 semanas con 4 niveles de dosis de PEG-rIL-29 administrado por vía subcutánea en forma de dosis fija en combinación con ribavirina.Fase 2b
El objetivo ppal de la fase 2b es evaluar la eficacia y la seguridad hasta la semana 12 de un máximo de 4 niveles de dosis de PEG-rIL-29, seleccionados de la fase 2a, administrado por vía subcutánea en forma de dosis fija en combinación con ribavirina, comparación con peginterferón alfa-2a administrado subcutaneo con ribavirina, en tto de VHC no tratatos anteriormente.

E.2.2

Secondary objectives of the trial

fase 2a Parte 1: 1. Evaluación de seguridadu tolerabilidad de dosis unica de PEG-rIL-29 frente a una dosis fija de PEG-alfa-2a. 2. Evaluar los cambios séricos de niveles VCH ARN para una dosis fija de PEGrIL- 29 comparada con dosis fija de peginterferon alfa-2a. Part 2: 1. Caracterizar la farmacocinética de dosis reptetidas de PEG-rIL-29 administradas a dosis fija en combinación con ribavirina.
2. Evaluar la eficacia de dosis repetidas con PEG-rIL-29 a dosis fijas en combinación con rivabirina comparada con PEG alfa-2a en combinación con ribavirina Fase 2b: 1. Comparara seguridad y tolerabilidad de PEG-rIL-29, combinada con ribavirin con PEGalfa-2a combinada con ribavirin. 2. Comparar eficacia de PEG-rIL-29 hasta la semana 48 como dosis fija sobre un rango de niveles de dosis fijas en combinación con rivabirina, con la administración de PEG alfa-2a

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Mujeres y hombres entre 18 y 70 años.
2. Sin tto previo para infección crónica de VHC, aparte de un máximo de 2 semanas de tratamiento en monoterapia con un antiviral de acción directa 3. 3.ARN del VHC de genotipo 1, 2, 3 ó 44. HCV RNA >o =100,000 IU/mL 5. ALT y AST >o =5.0 × ULN
6. Ausencia de cirrosis, excepto 10 personas por grupo de tto en la fase 2b. 7.Sin antecedentes de carcinoma hepatocelular , ni carcinoma hepatocelular
en los 12 meses previos 8. Alfafetoproteina <100 ng/mL 9. ECG sin alteraciones clínicas.
10. Recuento plaquetar >o= 90,000/mm3; Neutrófilos>o=1500/mm3; Hgb >o= 12 en hombres y >o=11 g/dL en mujeres
11. PTT <1.5 × ULN; fibrinogen >o= al límite inferior normal
12. Acalarmiento renal >o=50 mL/min
13. TSH y/o T4 entre 0.8 y 1.2 veces el limite normal
limit, o controlada la función tiroidal por el investigardro. 14. Explración retilan hecha <o = 1 año de la randomización. Para diabéticos, hipertensos o con otros factores de riesgo de enfermedad retiniana la exploración hecha por un oftalmólogo durante el screening.15. Capaz de entender y firmar el consentimiento informado.
16. Mujeres fértiles con prueba negativa sérica de embarazo o de orina en las 72 horas previas al tto.
17. Hombres y mujeres fértiles deben utilizar 2 métodos anticonceptivos combinados. Uno de ellos de barrera.18. BMI entre 18 y 39 kg/m2.

E.4

Principal exclusion criteria

1. Infección por el VHC de genotipo mixto
2. Historia actual o antecedentes de hepatopatía descompensada3. 3. Actualmente en periodo de lactancia o amamantando4. 4. Con pareja femenina embarazada 5.Haber recibido cualquier fármaco en investigación en los 60 dias previos a la droga de estudio. 6. Cancer excepto carcinoma in situ de cuello de útero o carcinoma cutáneo basocelular o espinocelular adecuadamente tratado) en los 5 años previos al reclutamiento
7. Uso de inmunosupresores sistémicos 8. Uso de heparia y warfarinas 9. Prueba positiva para el antígeno de superficie de la hepatitis B, anticuerpos frente al virus de la inmunodeficiencia humana (VIH)-1 o VIH-2 en la selección
10. Abuso de sustancias, alcohol...6 meses antes de la inclusión. En tratamiento con metadona pueden ser elegibles. Uso de marihuana terapéutica es posible. 11. Transfusiones sanguíneas 30 dias antes de la randomización.12.Uso de factores de crecimiento hematológicos en los 90 días previos a la aleatorización del estudio
13. Antecedente de miocariopatía, isquemia cardiaca o isquemia o enfermedad cerebrovascular , angina infarto o infarto miocardio o accidente cerebrovascular 12 meses antes de la inclusión
14. hemoglobinopatía o anemia hemolítica
15. enfermedad hepática distinta de infección hepatitis C.16..Historia previa o actual de neumopatía intersticial o sarcoidosis
17.Historia de trasplante de órgano; se permite el trasplante de córnea previo18.Historia de enfermedad de tipo inmunitario salvo excepciones 19. Enfermedad psiquiatrica a menos que esté controlada. 20.Trastorno epiléptico activo salvo excepciones 21.Cualquier otra contraindicación conocida para el tratamiento con peginterferón alfa-2a o ribavirina
22.Antibióticos, antimicóticos o antivirales sistémicos para el tratamiento de una infección activa en los 14 días previos al reclutamiento 23. En diálisis
24. Sujetos que en opinión del médico no deben participar por su estado clínico.

E.5 End points

E.5.1

Primary end point(s)

Fase 2a: Parte 1 Objetivo principal:
- niveles séricos de PEG-rIL-29

Fase 2a: Parte 2 Objetivo principal:
- Incidencia global de reducciones de la dosis de PEG-rIL-29 y DLT

Fase 2b Objetivo principal:
- Eficacia
- Porporcion de sujetos con VHC RNa indetectable en la semana 12-
- Seguridad
- Incidencia y seguridad de loes efectos adversos hasta la semana 12

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

Yes

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

Yes

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

Information not present in EudraCT

E.7.1.2

Bioequivalence study

Information not present in EudraCT

E.7.1.3

Other

Information not present in EudraCT

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

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

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.8.3

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

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

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	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.1.3	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	Yes
F.3.3.1	Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2009-11-26.	Yes
F.3.3.2	Women of child-bearing potential using contraception	Yes
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	50
F.4.2	For a multinational trial
F.4.2.1	In the EEA	480
F.4.2.2	In the whole clinical trial	600

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

2010-05-06

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2010-01-08

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2012-01-19

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