Clinical Trials Register

Summary
EudraCT Number:	2015-001049-10
Sponsor's Protocol Code Number:	M14-726
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Prematurely Ended
Date on which this record was first entered in the EudraCT database:	2015-07-31
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

2015-001049-10

A.3

Full title of the trial

Open-label Study to Evaluate the Safety and Efficacy of the Combination of Ombitasvir, Paritaprevir/r ± Dasabuvir with Ribavirin (RBV) in Adult Patients with GT1 or GT4 Chronic HCV Infection and Response to Prior Treatment of Early Stage Hepatocellular Carcinoma

Estudio abierto para evaluar la seguridad y eficacia de la combinación de Ombitasvir, Paritaprevir/r ± Dasabuvir con ribavirina (RBV) en pacientes adultos con infección crónica por el virus de la hepatitis C de GT1 o GT4, y con Respuesta al tratamiento previo de un Carcinoma Hepatocelular en estadio inicial

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 Efficacy of Ombitasvir/Paritaprevir/r With or without Dasabuvir and with Ribavirin in Chronic Hepatitis C Virus Genotype 1 or 4 Infected Adults with Successfully Treated Early Stage Hepatocellular Carcinoma

Estudio para evaluar la seguridad y eficacia de Ombitasvir/Paritaprevir/r con o sin Dasabuvir y con Ribavirina en adultos con infección crónica por el virus de la hepatitis C de genotipo 1 o 4, y tratados con respuesta de un Carcinoma Hepatocelular en estadio inicial

A.4.1

Sponsor's protocol code number

M14-726

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	AbbVie Deutschland 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 Inc.
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	Abbvie Ltd.
B.5.2	Functional name of contact point	EU Clinical Trials Helpdesk
B.5.3	Address:
B.5.3.1	Street Address	Abbott House, Vanwall Business Park, Vanwall Road
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	+441628773355
B.5.5	Fax number	+441628672566
B.5.6	E-mail	eu-clinical-trials@abbvie.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	Ombitasvir/Paritaprevir/Ritonavir 12.5 mg/75 mg/50 mg film-coated tablets
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	Ombitasvir/Paritaprevir/Ritonavir
D.3.2	Product code	ABT-450/r/ABT-267
D.3.4	Pharmaceutical form	Film-coated 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	Ombitasvir
D.3.9.1	CAS number	1456607-70-7
D.3.9.2	Current sponsor code	ABT-267
D.3.9.3	Other descriptive name	OMBITASVIR
D.3.9.4	EV Substance Code	SUB131058
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.3.8 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.3.9.2	Current sponsor code	Ritonavir
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.3.8	INN - Proposed INN	PARITAPREVIR
D.3.9.1	CAS number	1456607-71-8
D.3.9.2	Current sponsor code	Paritaprevir (ABT-450)
D.3.9.4	EV Substance Code	SUB166312
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.3.11 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	Yes
D.2.1.1.1	Trade name	Dasabuvir
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	Dasabuvir
D.3.2	Product code	ABT-333
D.3.4	Pharmaceutical form	Film-coated 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	Dasabuvir
D.3.9.1	CAS number	1456607-55-8
D.3.9.2	Current sponsor code	Dasabuvir (ABT-333)
D.3.9.3	Other descriptive name	DASABUVIR
D.3.9.4	EV Substance Code	SUB131059
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.2.5	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	Ribavirin
D.3.2	Product code	Ribavirin
D.3.4	Pharmaceutical form	Film-coated 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.3.9.3	Other descriptive name	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

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

Infección crónica por el virus de la hepatitis C

E.1.1.1

Medical condition in easily understood language

Chronic Hepatitis C Infection

Infección crónica por el virus de la hepatitis 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	18.0
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 safety and efficacy the percentage of subjects achieving a 12-week sustained virologic response ([SVR12] [HCV ribonucleic acid {RNA} < lower limit of quantification {LLOQ} 12 weeks after the last dose of the study drugs]) of coformulated ombitasvir/paritaprevir/ritonavir (OBV/PTV/r), with or without dasabuvir (DSV) coadministered with ribavirin (RBV) for 12 or 24 weeks in adult patients with documented complete response to prior treatment of early stage hepatocellular carcinoma and either genotype 1 or 4 chronic HCV infection.

Los objetivos principales de este estudio consisten en evaluar la seguridad y eficacia, mediante el porcentaje de sujetos que logren una respuesta virológica sostenida a las 12 semanas ([RVS12] [ácido ribonucleico {ARN} del VHC < límite inferior de cuantificación {LIC} 12 semanas después de la última dosis de los fármacos del estudio]), de ombitasvir/paritaprevir/ritonavir (OBV/PTV/r) en coformulación, con o sin dasabuvir (DSV) administrado junto con ribavirina (RBV), durante 12 o 24 semanas en pacientes adultos con respuesta completa documentada al tratamiento de un carcinoma hepatocelular (CHC) en estadio inicial y con infección crónica por VHC de genotipo 1 o 4.

E.2.2

Secondary objectives of the trial

The secondary objectives are to assess:
1. the percentage of subjects with virologic failure during treatment,
2. the percentage of subjects with relapse post-treatment,
3. the percentage of subjects with long term clinical outcomes during a period of 3 years of follow-up, including de novo HCC lesions, liver decompensation, unexpected liver transplant, liver related death, or any of the above, among subjects who were treated for HCV and achieved SVR12 and those who did not, and
4. the percentage of subjects with recurrent HCV infection post liver transplant out of all subjects with liver transplant during the study stratified by duration of treatment and HCV suppression status prior to transplant (as appropriate).

Los objetivos secundarios consisten en evaluar:

1. Porcentaje de sujetos con fracaso virológico durante el tratamiento.
2. Porcentaje de sujetos con recidiva después del tratamiento.

3. Porcentaje de sujetos con resultados clínicos a largo plazo durante un período de 3 años de seguimiento, entre ellos, lesiones nuevas de CHC, descompensación hepática, trasplante hepático inesperado, muerte relacionada con el hígado o cualquiera de los anteriores, de entre los pacientes tratados para el VHC y que logren una RVS12, y los que no.

4. Porcentaje de sujetos con infección recurrente por el VHC tras el trasplante de hígado de entre todos los que se sometan a un trasplante hepático durante el estudio, estratificados en función de la duración del tratamiento y el estado de supresión del VHC antes del trasplante (según proceda).

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Main Inclusion:
1. Male or female, at least 18 years of age at time of screening.
2. Chronic HCV infection prior to study enrollment with screening laboratory results indicating HCV genotype 1 or 4 infection.
3. Early stage HCC diagnosed based on the typical hallmark of HCC (hypervascular in the arterial phase with washout in the portal venous or delayed phases)
4. Compensated cirrhosis defined as a Child-Pugh score of 5 or 6 at Screening.
5. Documented complete response to HCC treatment.
6. Females must be post-menopausal for more than 2 years or surgically sterile or practicing acceptable forms of birth control

Criterios de inclusion principales:
1. Hombres o mujeres, con una edad mínima de 18 años en el momento de selección.
2. Infección crónica por el VHC antes de la inclusión en el estudio con unos resultados analíticos en el periodo de selección que indiquen genotipo del VHC 1 o 4.
3. Diagnóstico de CHC de estadio temprano basado en el rasgo distintivo característico del CHC (hipervascular en la fase arterial con lavado en la fase venosa portal o diferida).
4. Cirrosis compensada, definida como una puntuación de Child-Pugh de 5 o 6 en la visita de selección
5. Respuesta completa documentada al tratamiento del CHC
6. Las mujeres deben ser post-menopáusicas durante más de dos años o esteriles quirúrgicamente, o practicar formas aceptables de control de natalidad.

E.4

Principal exclusion criteria

Main Exclusion:
1. Use of known strong or moderate inducers of cytochrome P450 3A (CYP3A) in subjects receiving OBV/PTV/r with and without DSV, strong inducers and inhibitors (e.g., gemfibrozil) of cytochrome P450 2C8 (CYP2C8) in subjects receiving OBV/PTV/r with DSV, medications contraindicated for ritonavir or RBV (for those that receive RBV) within 2 weeks or 10 half-lives (if known), whichever is longer, prior to study drug . For medications contraindicated with AbbVie's 2-DAA and 3-DAA regimen, refer to the recommended prescribing information section of the approved local product labels.
2. Positive test result for hepatitis B surface antigen (HBsAg) or anti-human immunodeficiency virus antibody (HIV Ab).
3. Patients not eligible for liver transplantation due to significant cardio vascular or pulmonary disease.
4. Clinically significant abnormalities, other than HCV infection, in a subject with HCC based upon the medical history, physical examination, vital signs, laboratory profile and a 12-lead electrocardiogram (ECG) that make the subject an unsuitable candidate for this study in the opinion of the investigator.

Criterios de exclusión principales:
1. Uso de inductores potentes o moderados del citocromo P450 3A (CYP3A) en los sujetos tratados con OBV/PTV/r con y sin DSV, inductores e inhibidores potentes (por ejemplo, gemfibrozilo) del citocromo P450 2C8 (CYP2C8) en los sujetos tratados con OBV/PTV/r y DSV, medicamentos contraindicados con ritonavir o RBV (en los tratados con RBV en las 2 semanas, o el equivalente a 10 semividas del fármaco (si se conoce), lo que suponga más tiempo, previas a la administración del fármaco del estudio. En cuanto a los medicamentos contraindicados con una pauta de 2 o 3 antivirales de acción directa (AAD) de AbbVie, consulte la sección relativa a información sobre prescripción recomendada de las fichas técnicas locales.
2. Resultado positivo en el análisis de antígeno de superficie del virus de la hepatitis B (HbsAg) o de anticuerpos contra el virus de la inmunodeficiencia humana (Ac anti-VIH).
3. Pacientes no aptos para trasplante de hígado por una enfermedad cardiovascular o pulmonar importante.
4. Anomalías concomitantes de importancia clínica, aparte de la infección por el VHC, en sujetos con HCC, basado en la historia médica, exploración física, constantes vitales, resultados del laboratorio, electrocardiograma, que en opinión del investigador convierten al sujeto en un candidato inadecuado para participar en este estudio o recibir la pauta farmacológica.

E.5 End points

E.5.1

Primary end point(s)

The primary efficacy endpoint is the percentage of subjects with SVR12 (HCV RNA < LLOQ 12 weeks after the last actual dose of study drug).

El criterio de valoración principal será el porcentaje de sujetos con RVS12 (ARN del VHC < LIC, 12 semanas después de la última dosis real de los fármacos del estudio).

E.5.1.1

Timepoint(s) of evaluation of this end point

12 weeks after last dose of study drugs

12 semanas después de la última dosis del fármaco

E.5.2

Secondary end point(s)

The secondary endpoints are:
1. the percentage of subjects with virologic failure during treatment,
2. the percentage of subjects with relapse post-treatment, and
3. the percentage of subjects with long term clinical outcomes during a period of 3 years of follow-up, including de novo HCC lesions, liver decompensation, unexpected liver transplant, liver related death, or any of the above, among subjects who were treated for HCV and achieved SVR12 and those who did not achieve SVR12.
4. the percentage of subjects with recurrent HCV infection post liver transplant out of all subjects with liver transplant during the study stratified by duration of treatment and HCV suppression status prior to transplant (as applicable).

Los criterios de valoración secundarios serán:
1. Porcentaje de sujetos con fracaso virológico durante el tratamiento.
2. Porcentaje de sujetos con recidiva después del tratamiento.
3. Resultados clínicos a largo plazo de interés durante un período de 3 años de seguimiento, definidos como: lesiones de CHC de novo, descompensación hepática, trasplante de hígado inesperado, muerte relacionada con el hígado o cualquiera de las anteriores, entre los sujetos que hayan recibido tratamiento contra el VHC y hayan logrado una RVS12, y los que no.
4. Porcentaje de sujetos con infección recurrente por el VHC tras el trasplante de hígado de entre todos los que se sometan a un trasplante hepático durante el estudio, estratificados en función de la duración del tratamiento y el estado de supresión del VHC antes del trasplante (según proceda).

E.5.2.1

Timepoint(s) of evaluation of this end point

Treatment Day 1 to end of treatment, and end of treatment to 168 weeks post treatment

Tratamiento desde Dia 1 al final del periodo de tratamiento, y final del tratamiento hasta 1688 semanas de periodo posterior al tratamiento

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

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.8.2.4

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

Canada

United States

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

LVLS

Última Visita del Último Paciente

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.1.1.1

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)

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

F.4.2.2

In the whole clinical trial

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)

Upon completion of treatment, subjects are followed for 168 weeks after the last dose of study drug. Additional plans for treatment will be at the investigator's discretion.

Tras la finalización del tratamiento los sujetos son seguidos durante 168 semanas tras la última dosis de la medicación de estudio. Los planes adicionales para el tratamiento serán a discreción del investigador principal

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

2015-09-24

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2015-09-17

P. End of Trial
P.	End of Trial Status	Prematurely Ended
P.	Date of the global end of the trial	2016-02-03

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IMP with orphan designation in the indication
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