Clinical Trials Register

Summary
EudraCT Number:	2015-003152-43
Sponsor's Protocol Code Number:	DECIPHER-3D
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:	2015-11-12
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

2015-003152-43

A.3

Full title of the trial

PILOT STUDY TO EVALUATE THE EFFECTS OF PARITAPREVIR/r, DASABUVIR AND OMBITASVIR ON LIVER FUNCTION AND SYSTEMIC HEMODYNAMIC IN PATIENTS WITH DECOMPENSATED HCV-CIRRHOSIS

Estudio Piloto para evaluar los efectos de PARITAPREVIR/r, DASABUVIR y OMBITASVIR en la función hepática y sistémica hemodinamia en pacientes diagnosticados de cirrosis y VHC con cirrosis descompensada

A.3.1

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

PILOT STUDY TO EVALUATE THE EFFECTS OF PARITAPREVIR/r, DASABUVIR AND OMBITASVIR ON LIVER FUNCTION AND SYSTEMIC HEMODYNAMIC IN PATIENTS WITH DECOMPENSATED HCV-CIRRHOSIS

A.3.2

Name or abbreviated title of the trial where available

DECIPHER-3D

A.4.1

Sponsor's protocol code number

DECIPHER-3D

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	Fundació Clínic per a la Recerca Biomèdica
B.1.3.4	Country	Spain
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	AbbVie Ltd.
B.4.2	Country	United Kingdom
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	CTU -Farmacologia. Hospital clínic
B.5.2	Functional name of contact point	Anna Cruceta
B.5.3	Address:
B.5.3.1	Street Address	Mallorca 183
B.5.3.2	Town/ city	Barcelona
B.5.3.3	Post code	08036
B.5.3.4	Country	Spain
B.5.4	Telephone number	+349322754005380
B.5.5	Fax number	+34932279877
B.5.6	E-mail	acruceta@clinic.ub.es

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	Viekirax 12,5 mg/75 mg/50 mg comprimidos recubiertos con película
D.2.1.1.2	Name of the Marketing Authorisation holder	AbbVie Ltd.
D.2.1.2	Country which granted the Marketing Authorisation	Spain
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	Viekirax 12,5 mg/75 mg/50 mg comprimidos recubiertos con película.
D.3.2	Product code	Cada comprimido recubierto con película contiene 1
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.3.9.2	Current sponsor code	Viekirax
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	25
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	PARITAPREVIR
D.3.9.2	Current sponsor code	Viekirax
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	150
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.3.9.3	Other descriptive name	ritonavir 50 mg
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.3.11 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	comprimido recubierto con película contiene 250 mg de dasabuvir
D.2.1.1.2	Name of the Marketing Authorisation holder	AbbVie Ltd Maidenhead SL6 4XE Reino Unido
D.2.1.2	Country which granted the Marketing Authorisation	Spain
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	Exivera
D.3.2	Product code	Dasabuvir
D.3.4	Pharmaceutical form	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	Exivera
D.3.9.3	Other descriptive name	DASABUVIR SODIUM
D.3.9.4	EV Substance Code	SUB131060
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	500
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.2.1.1.1	Trade name	Ribavirina
D.2.1.1.2	Name of the Marketing Authorisation holder	LABORATORIOS NORMON, S.A. Ronda de Valdecarrizo 6, 28760 ? Tres Cantos ? Madrid (ESPAÑA)
D.2.1.2	Country which granted the Marketing Authorisation	Spain
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	Ribavirna
D.3.4	Pharmaceutical form	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	range
D.3.10.3	Concentration number	200 to 1000
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

PILOT STUDY TO EVALUATE THE EFFECTS OF PARITAPREVIR/r, DASABUVIR AND OMBITASVIR ON LIVER FUNCTION AND SYSTEMIC HEMODYNAMIC IN PATIENTS WITH DECOMPENSATED HCV-CIRRHOSIS

Estudio piloto para la evaluación de los efectos de PARITAPREVIR/r, DASABUVIR y OMBITASVIR sobre la función hepática y la hemodinamia sistémica en pacientes con compensación hepática e infección por VHC

E.1.1.1

Medical condition in easily understood language

THE EFFECTS OF PARITAPREVIR/r, DASABUVIR AND OMBITASVIR ON LIVER FUNCTION AND SYSTEMIC HEMODYNAMIC IN PATIENTS WITH DECOMPENSATED HCV-CIRRHOSIS

evaluación de los efectos de PARITAPREVIR/r, DASABUVIR y OMBITASVIR sobre la función hepática y la hemodinamia sistémica en pacientes con desconpensación hepática e infección por VHC

E.1.1.2

Therapeutic area

Diseases [C] - Digestive System Diseases [C06]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.0
E.1.2	Level	LLT
E.1.2	Classification code	10024667
E.1.2	Term	Liver cirrhosis
E.1.2	System Organ Class	10019805 - Hepatobiliary disorders

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 investigate the effects of treatment on liver function and systemic hemodynamics in patients with decompensated HCV-related cirrhosis

Investigar los efectos del tratamiento en la hemodinamia h y lafunción hepáticas en pacientes con cirrosis descompensada y VHC

E.2.2

Secondary objectives of the trial

- To investigate the efficacy (SVR12) of Ombitasvir/Paritaprevir/ritonavir + Dasabuvir + Ribavirin in patients with Child B cirrhosis.
- To evaluate the effect of treatment on the development of complications of cirrhosis.
- To investigate the effect of treatment on systemic inflammation and endothelial function.
- To evaluate the effect of treatment on quality of life.
- To determine the safety of this antiviral combination in patients with decompensated cirrhosis.
- To investigate the effect of SVR12 on changes of gut microbiota in patients with decompensated cirrhosis.
- To assess the effects of SVR12 on cirrhosis regression

-Para investigar la eficacia (SVR12) de OmbitasvirParitaprevirritonavir Dasabuvir ribavirina en pacientes con cirrosis infantil B.
-Evaluar el efecto del tratamiento sobre el desarrollo de complicaciones de la cirrosis.
-Para investigar el efecto del tratamiento sobre la inflamación sistémica y la función endotelial.
-Evaluar el efecto del tratamiento sobre la calidad de vida.
-Para determinar la seguridad de esta combinación de antivirales en pacientes con cirrosis descompensada.
-Para investigar el efecto de SVR12 sobre los cambios de la microbiota intestinal en pacientes con cirrosis descompensada.
-Para evaluar los efectos de SVR12 en la regresión de cirrosis

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

- Age between 18 and 75 year- old.
- Child B cirrhosis (7-9 points) with present or previous history of decompensation (ascites, hepatic encephalopathy or bacterial infection).
- Genotype 1b infection.
- Inclusion after 4 weeks of resolution of hepatic encephalopathy, gastrointestinal bleeding or bacterial infection.
- Viral load VHC?10000 UI/L

-Edad entre 18 y 75 años de edad.
-Cirrosis infantil B (7-9 puntos) con historia actual o anterior de la descompensación (ascitis, encefalopatía hepática o infección bacteriana).
-Infección de genotipo 1b.
-Incorporación después de 4 semanas de la resolución de la encefalopatía hepática, hemorragia gastrointestinal o infección bacteriana.
-Carga viral UIL VHC?10000

E.4

Principal exclusion criteria

- Compensated cirrhosis.
- Hepatocellular carcinoma.
- Serum creatinine > 1.5 mg/dL.
- Complications of cirrhosis associated with very poor outcome: refractory ascites, acute-on-chronic liver failure, hepatorenal syndrome, hyponatremia (serum sodium < 125 mEq/L), chronic persistent hepatic encephalopathy.
- Total bilirubin > 10 mg/dL.
- Severe extrahepatic diseases: cardiovascular, respiratory, cerebrovascular and poorly controlled diabetes that according to the investigator can difficult the antiviral therapy.
- Platelets < 30 x 109 cells/L.
- Neutrophil count < 0.5 x 109 cells/L.
- Hemoglobin < 9 g/dL.
- HIV infection.
- Hepatitis B infection.
- Active intake of toxic amounts of alcohol or recreational drugs.
- Use of any medication listed in the following table

- cirrosis Compensada
-Hepatocarcinoma.
-Suero creatinina 1.5 mgdL.
-Complicaciones de la cirrosis asociada con muy mal resultado: ascitis refractaria, insuficiencia hepática aguda-crónica, síndrome hepatorrenal, hiponatremia (suero sodio 125 mEqL), encefalopatía hepática persistente crónica.
-Total bilirrubina 10 mgdL.
-Enfermedades extrahepáticas graves: cardiovascular, respiratoria, cerebrovascular y mal controlada la diabetes que según el investigador puede difícil la terapia antiviral.
-Plaquetas 30 x 109 cellsL.
-Recuento neutrófilos 0,5 x 109 cellsL.
-GdL hemoglobina 9.
-La infección por VIH.
-Hepatitis B infección.
-Activa ingesta de cantidades tóxicas de alcohol o drogas recreativas.
-Uso de los medicamentos enumerados en la tabla anexa

E.5 End points

E.5.1

Primary end point(s)

Improvement of liver function defined by a decrease in ?2 points in Child-Pugh score at 3 months after the end of antiviral therapy.

Mejora de la función hepática, definida por una disminución ? 2 puntos en la puntuación de Child-Pugh a los 3 meses después del final de la terapia antiviral.

E.5.1.1

Timepoint(s) of evaluation of this end point

decrease in ?2 points in Child-Pugh score at 3 months after the end of antiviral therapy
-

disminucion de ?2 points in Child-Pugh a los 3 meses tras finalizar el tratamiento

E.5.2

Secondary end point(s)

- Decrease in portal pressure 6 months after the end of treatment.
- Decrease in the incidence of complications of cirrhosis during treatment and for a 6-months follow up period after treatment. A composite end point of complications of cirrhosis will be analyzed, including ascites, hepatic encephalopathy , bacterial infections and gastrointestinal bleeding. The development of the first of any of these five complications described above will define the occurrence of the end-point.
- Changes in circulatory function assessed by plasma renin activity (PRA) and noradrenalin at the end of treatment and 6 months after the end of treatment with respect to baseline.
- Changes in systemic inflammatory response and endothelial function assessed by cytokine, endotoxin and von Willebrand factor levels at the end of treatment and 6 months after the end of treatment with respect to baseline.
- Improvement in quality of life evaluated by Short-form 36 (SF-36) and Chronic Liver Disease (CLDQ) questionnaires 6 months after the end of treatment with respect to baseline.
- Changes in gut microbiota will be evaluated by analysis of fecal phylogenetic profiles before and after treatment.
- Effects of SVR12 on cirrhosis regression will be assessed by transcriptome analysis of liver tissue samples before and 12w after treatment.

-Disminución de la presión portal 6 meses después del final del tratamiento.
-Disminución en la incidencia de complicaciones de la cirrosis durante el tratamiento y un seguimiento de 6 meses plazo después del tratamiento. Se analizará un punto final compuesto de complicaciones de la cirrosis, incluyendo ascitis, encefalopatía hepática, las infecciones bacterianas y sangrado gastrointestinal. El desarrollo de la primera de cualquiera de estas cinco complicaciones descritas anteriormente define la ocurrencia del punto final.
-Cambios en la función circulatoria, determinado por la actividad de renina plasmática (PRA) y noradrenalina al final del tratamiento y 6 meses después del final del tratamiento con respecto a la línea de base.
-Cambios en la respuesta inflamatoria sistémica y la función endotelial evaluada por los niveles de citoquinas, endotoxinas y von Willebrand factor al final del tratamiento y 6 meses después del final del tratamiento con respecto a la línea de base.
-Mejora en la calidad de vida evaluada por Short-form 36 (SF-36) y cuestionarios de enfermedad del hígado crónica (CLDQ) 6 meses después del final del tratamiento con respecto a la línea de base.
-Cambios en la microbiota intestinal se evaluará mediante el análisis de los perfiles filogenéticos fecales antes y después del tratamiento.
-Efectos del SVR12 en la regresión de cirrosis serán evaluadas por análisis de transcriptoma de muestras de tejido del hígado antes y 12w después del tratamiento.

E.5.2.1

Timepoint(s) of evaluation of this end point

Virological end-points
- SVR4 (sustained virological response 4 weeks the end of all study therapy). The subject has HCV RNA < 15 IU/ml 4 weeks after the end of all study therapy.
- SVR12 (sustained virological response 12 weeks the end of all study therapy). The subject has HCV RNA < 15 IU/ml 12 weeks after the end of all study therapy

SVR4 (sostenida respuesta virológica 4 semanas al final de todo estudio terapia). El sujeto tiene VHC ARN 15 IUml 4 semanas después del final de todo estudio terapia.
-SVR12 (sostenida respuesta virológica 12 semanas al final de todo estudio terapia). El sujeto tiene VHC ARN 15 IUml 12 semanas después del final de la terapia de estudio todos

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

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

Yes

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)

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

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

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

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

F.3.3.3

Pregnant women

Yes

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)

none

ninguna

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

2016-02-04

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2015-10-19

P. End of Trial
P.	End of Trial Status	Prematurely Ended

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