Clinical Trials Register

Summary
EudraCT Number:	2016-004499-23
Sponsor's Protocol Code Number:	LIVERHOPE_SAFETY
National Competent Authority:	Netherlands - Competent Authority
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2017-04-11
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

Netherlands - Competent Authority

A.2

EudraCT number

2016-004499-23

A.3

Full title of the trial

Safety and tolerability of the combination of simvastatin plus rifaximin in patients with decompensated cirrhosis: a multicenter, double-blind, placebo controlled randomized clinical trial.

Seguridad y tolerabilidad de la combinación de simvastatina y rifaximina en pacientes con cirrosis descompensada: ensayo clínico multicéntrico aleatorizado, doble-ciego, controlado con placebo.

A.3.1

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

Simvastatin plus rifaximin in decompensated cirrhosis

Simvastatina más rifaximina en cirrosis descompensada

A.4.1

Sponsor's protocol code number

LIVERHOPE_SAFETY

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	IDIBAPS
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	H2020
B.4.2	Country	Spain
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Hospital Clínic
B.5.2	Functional name of contact point	Pere Ginés
B.5.3	Address:
B.5.3.1	Street Address	Villarroel, 170
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	+349322754001713
B.5.5	Fax number	+34932279877
B.5.6	E-mail	pgines@clinic.cat

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	Rifaximin-EIR
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	RIFAXIMIN
D.3.9.1	CAS number	80621-81-4
D.3.9.4	EV Substance Code	SUB10312MIG
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	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.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	Sivastin
D.2.1.1.2	Name of the Marketing Authorisation holder	SIGMA-TAU Industrie Farmaceutiche Riunite SpA Viale Shakespeare, 47 – 00144 Roma
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.3.1	Product name	Sivastin
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	SIMVASTATIN
D.3.9.2	Current sponsor code	SIVASTIN
D.3.9.4	EV Substance Code	SUB10529MIG
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	20 to 40
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
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Film-coated tablet
D.8.4	Route of administration of the placebo	Oral use
D.8 Placebo: 2
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Film-coated tablet
D.8.4	Route of administration of the placebo	Oral use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Patients with decompensated cirrhosis

Pacientes con cirrosis descompensada

E.1.1.1

Medical condition in easily understood language

Patients with decompensated cirrhosis

Pacientes con cirrosis descompensada

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	19.1
E.1.2	Level	PT
E.1.2	Classification code	10019641
E.1.2	Term	Hepatic 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 evaluate the treatment-related toxicity of oral administration of simvastatin plus rifaximin in patients with decompensated cirrhosis.

Evaluar la toxicidad relacionada con el tratamiento de la administración oral de simvastatina más rifaximina en pacientes con cirrosis descompensada.

E.2.2

Secondary objectives of the trial

1.To evaluate the appearance of muscle toxicity as defined using a statin-associated myopathy questionnaire.
2.To evaluate hormone levels: plasma renin concentration, serum aldosterone, plasma norepinephrine and plasma copeptin.
3. To evaluate systemic inflammatory response by measurement in a large array of plasma cytokine levels during the treatment period.
4.To evaluate levels of plasma biomarkers (FABP4, CD-163) and urine biomarkers (NGAL, IL-18, MCP-1, osteopontin and albumin) during the treatment period.
5.To evaluate blood levels of bacterial DNA or bacterial products during the treatment period.
6.To evaluate genetic polymorphisms of statins membrane transporter OATPB1 in patients developing treatment-related toxicity.
7.To evaluate the treatment-related serious adverse events during the treatment period.

1.Evaluar la aparición de toxicidad muscular a través del cuestionario de miopatía relacionado con el uso de estatinas.
2.Evaluar los niveles de hormonas: concentración de renina, aldosterona, norepinefrina y copeptina.
3.Evaluar la respuesta inflamatoria sistémica mediante la medición de los niveles plasmáticos de un gran número de citoquinas durante el periodo de tratamiento del estudio.
4.Evaluar niveles plasmáticos de biomarcadores (FABP4, CD-163) y biomarcadores en orina a (NGAL, IL-18, MCP-1, osteopontina y albúmina) durante el periodo de tratamiento del estudio.
5.Evaluar los niveles en sangre de DNA bacteriano o productos bacterianos durante el periodo de tratamiento del estudio.
6.Evaluar el polimorfismo genético del transportador de membrana OATPB1 en pacientes que desarrollen toxicidad relacionada con el tratamiento.
7.Evaluar los acontecimientos adversos graves relacionados con el tratamiento durante el periodo de tratamiento del estudio.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Age ≥ 18 years old.
2. Cirrhosis defined by standard clinical criteria and ultrasonographic findings and/or histology. Cirrhosis of any etiology may be included. Patients with cirrhosis of autoimmune etiology on treatment with corticosteroids must be on stable corticosteroid dose for ≥3-month period before study inclusion.
3. Child Pugh B/C patients (from 7 to 12 points).
4. Women of child-bearing potential must have a negative pregnancy test in urine before the inclusion of the study and agree to use highly effective contraceptive methods (combined oral pill, injectable or implanted contraceptive, intrauterine device / intrauterine hormone-releasing system) during the study.

1. Edad ≥ 18 años.
2. Cirrosis definida según criterios clínicos estándar y resultados de ultrasonográficos y/o histología. Puede incluirse cirrosis de cualquier etiología. Los pacientes con cirrosis de etiología autoinmune en tratamiento con corticosteroides deberán estar con dosis estables de corticosteroides por ≥ 3 meses previa inclusión en el estudio.
3. Pacientes con Child-Pugh B y C (de 7 a 12 puntos).
4. Las mujeres en edad fértil deben tener una prueba negativa de embarazo en orina antes de la inclusión en el estudio y deben comprometerse a utilizar métodos anticonceptivos altamente eficaces (combinado con píldora oral, anticonceptivo inyectable o implante, dispositivo intrauterino / sistema intrauterino liberador de hormona) durante el estudio.

E.4

Principal exclusion criteria

1. Patients on treatment with statins or rifaximin one month before study inclusion.
2. Patients on the waiting list for liver transplantation.
3. Patients with acute-on-chronic liver failure according to the criteria published by Moreau et al. (see appendix 1)
4. Serum creatinine ≥2 mg/dL.
5. Serum bilirubin>5 mg/dL.
6. INR ≥2.5.
7. Patients with CK elevation of 50% or more above the upper limit of normal at study inclusion.
8. Bacterial infection within 15 days before study inclusion.
9. Gastrointestinal bleeding within 15 days before study inclusion.
10. Current overt hepatic encephalopathy, defined as grade II-IV hepatic encephalopathy.
11. HIV infection.
12. Hepatocellular carcinoma outside Milan criteria, defined as a single nodule ≤5 cm or a maximum of 3 nodules with none >3 cm.
13. Patients on antiviral therapy for HCV or those who have received it within the last 6 months.
14. Patients with previous history of myopathy.
15. Patients on treatment with potent inhibitors of CYP3A4 enzyme (See section 5.2: Concomitant, nonpermitted and permitted medication)
16. Patients on treatment with drugs with potential interactions with simvastatin (see section 5.2: Concomitant, nonpermitted and permitted medication)
17. Patients with a history of significant extrahepatic disease with impaired short-term prognosis, including congestive heart failure New York Heart Association Grade III/IV, COPD GOLD >2, chronic kidney disease with serum creatinine >2mg/dL or under renal replacement therapy.
18. Patients with current extrahepatic malignancies including solid tumours and hematologic disorders.
19. Patients with previous history or increased risk of intestinal obstruction.
20. Pregnancy or breastfeeding.
21. Patients included in other clinical trials in the previous month.
22. Patients with active alcohol consumption of more than 3 units per day.
23. Patients with mental incapacity, language barrier, bad social support or any other reason considered by the investigator precluding adequate understanding, cooperation or compliance in the study.
24. Severe alcoholic hepatitis requiring corticosteroid therapy (Maddrey’s Discriminant function ≥ 32 and/or ABIC score > 6.7).
25. Refusal to give informed consent.
26. Patients with contraindications for statins or rifaximin.
27. Known hypersensitivity to rifaxamin (or rifamycin derivatives) or to simvastatin.

1. Pacientes en tratamiento con estatinas o rifaximina durante el mes antes de la inclusión en el estudio.
2. Pacientes en lista de espera de trasplante hepático.
3. Pacientes con el síndrome de “acute-on-chronic liver failure” de acuerdo con los criterios de Moreau et al (ver apéndice 1).
4. Creatinina sérica ≥ 2 mg/dL.
5. Bilirrubina sérica > 5 mg/dL.
6. INR ≥ 2,5.
7. Pacientes con aumento de los niveles de CK del 50% o superiores del límite alto de la normalidad en el momento de la inclusión en el estudio.
8. Infección bacteriana en los 15 días previos a la inclusión.
9. Hemorragia gastrointestinal en los 15 días previos a la inclusión.
10. Encefalopatía hepática clínica en el momento de la inclusión, definida como grado II a IV.
11. Infección por VIH.
12. Carcinoma hepatocelular fuera de los criterios de Milán, definido como un nódulo único ≥ 5 cm o un máximo de 3 nódulos de los que ninguno sea > 3 cm.
13. Pacientes en tratamiento antiviral para el VHC o que lo hayan recibido en los últimos 6 meses.
14. Pacientes con antecedentes de miopatía.
15. Pacientes que reciban tratamiento con inhibidores potentes de la enzima CYP3A4 (ver sección 5.2: Medicación concomitante no permitida y permitida).
16. Pacientes que reciban tratamiento con fármacos con interacciones potenciales con la simvastatina (ver sección 5.2: Medicación concomitante no permitida y permitida).
17. Pacientes con historia de enfermedad extrahepática significativa con mal pronóstico a corto plazo, incluyendo insuficiencia cardiaca congestiva grado III/IV de la clasificación de New York Heart Association, enfermedad pulmonar obstructiva crónica GOLD >2, enfermedad renal crónica con creatinina sérica > 2 mg/dL o en tratamiento con hemodiálisis.
18. Pacientes con cáncer actual extrahepático, incluyendo tumores sólidos o enfermedades hematológicas.
19. Pacientes con antecedente o con riesgo aumentado de obstrucción intestinal.
20. Embarazo o lactancia.
21. Pacientes incluidos en otros ensayos clínicos en el último mes.
22. Pacientes con consumo activo de alcohol de más de 3 unidades de bebida al dia.
23. Pacientes con incapacidad mental, barrera lingüística mayor, pobre soporte social o alguna otra razón que el investigador considere que no permita una adecuada comprensión, cooperación o seguimiento del estudio.
24. Hepatitis alcohólica severa que requiera tratamiento con corticoides (función discriminante de Maddrey ≥ 32 y/o score ABIC > 6,7).
25. Ausencia de consentimiento informado.
26. Pacientes con contraindicaciones para la rifaximina o la simvastatina.
27. Hipersensibilidad conocida a la rifaximina (o derivados de la rifamicina) o a la simvastatina.

E.5 End points

E.5.1

Primary end point(s)

Change from baseline in transaminases, alkaline phosphatase and creatine kinase during the treatment period, to evaluate treatment-related toxicity.
This quantitative analysis will be complemented by qualitative binary assessment which will consist of:
(1) liver toxicity assessed by the development of liver injury defined as 3-fold increase in serum transaminases to a final value at least 3 times the upper normal limit, or 2-fold increase in serum levels of alkaline phosphatase with respect to baseline value to a final value at least 2 times the upper normal limit, or
(2) muscle toxicity, defined as 5-fold increase in creatinine kinase (CK) levels during treatment.

Cambios desde la visita basal en la toxicidad relacionada con el tratamiento en transaminasas, fosfatasa alcalina y creatina quinasa a las 12 semanas.
Este análisis cuantitativo se complementará con una evaluación cualitativa binaria que consistirá en:
(1) toxicidad hepática evaluada a través del desarrollo de daño hepático definido como un incremento 3 veces por encima de los niveles de transaminasas en suero con respecto al valor basal, a un valor al menos 3 veces superior al límite superior de normalidad o un incremento 2 veces por encima de los niveles de fosfatasa alcalina en suero con respecto al valor basal, a un valor al menos 2 veces superior al límite superior de normalidad, o (2) incremento 5 veces por encima de los niveles de creatinina quinasa (CK) con respecto al valor basal durante el tratamiento.

E.5.1.1

Timepoint(s) of evaluation of this end point

12 weeks

12 semanas

E.5.2

Secondary end point(s)

1. Appearance of muscle toxicity at weeks 2, 4, 6, 8, 10 and 12 as defined using a specific statin-associated myopathy questionnaire (see appendix 2).
2. Changes from baseline in plasma renin concentration, serum aldosterone, plasma norepinephrine, and plasma copeptin levels at weeks 2, 4, 8 and 12.
3. Changes from baseline in a large array of plasma cytokine levels including, but not limited to, VCAM-1, VEGF-A, Fractalkine, MIP-1α, Eotaxin, IP-10, RANTES, GM-CSF, IL-1β, IL-2, ICAM-1, MCP-1, L-6, and IL-8, as well as an oxidized form of albumin, human nonmercaptalbumin-2 (HNA2) at weeks 2, 4, 8 and 12.
4. Changes from baseline in plasma biomarkers FABP4 and CD-163 and urine biomarkers NGAL, IL-18, MCP-1, osteopontin, and albumin at weeks 2, 4, 8 and 12.
5. Changes in blood levels of bacterial DNA or bacterial products at weeks 2, 4, 8 and 12.
6. Assessment of genetic polymorphisms of statins membrane transporter OATPB1 in patients developing treatment-related toxicity (defined as the primary endpoint of the study).
7. Proportion of patients with treatment-related serious adverse events during the study period.

1. Aparición de toxicidad muscular en las semanas 2, 4, 6, 8, 10 y 12 a través del cuestionario de miopatía relacionado con el uso de estatinas.
2. Cambios desde la basal en los niveles de renina en plasma, aldosterona en suero, norepinefrina en suero y copeptina en plasma en las semanas 2, 4, 8 y 12.
3. Cambios desde la basal en los niveles plasmáticos de citoquinas incluidos, pero no limitados a VCAM-1, VEGF-A, Fractalquina, MIP-1α, Eotaxina, IP-10, RANTES, GM-CSF, IL-1β, IL-2, ICAM-1, MCP-1, IL-6 and IL-8, así como la forma oxidada de albúmina y no mercaptoalbúmina humana 2 (HNA2) en las semanas 2, 4, 8 y 12.
4. Cambios desde la basal en biomarcadores plasmáticos FABP4 y CD-163 y biomarcadores en orina NGAL, IL-18, MCP-1, osteopontina y albúmina en las semanas 2, 4, 8 and 12.
5. Cambios desde la basal en los niveles en sangre de DNA bacteriano o productos bacterianos en las semanas 2, 4, 8 and 12.
6. Evaluación del polimorfismo genético del transportador de membrana de estatina OATPB1 en pacientes que desarrollan toxicidad relacionada con el tratamiento (definido como la variable principal del estudio).
7. Proporción de pacientes con acontecimientos adversos graves relacionados con el tratamiento durante todo el periodo de tratamiento del estudio.

E.5.2.1

Timepoint(s) of evaluation of this end point

weeks 2, 4, 6, 7, 10 and 12

semanas 2, 4, 6, 7, 10 y 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

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)

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)

E.8.2.2

Placebo

Yes

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

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

Última visita 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 months

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)

Expected normal treatment

Tratamiento clínico habitual

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

2017-04-11

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2017-05-18

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2018-03-12

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