Clinical Trials Register

Summary
EudraCT Number:	2017-000432-34
Sponsor's Protocol Code Number:	GESIDA9516
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:	2017-04-21
Trial 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

2017-000432-34

A.3

Full title of the trial

A PHASE III, OPEN-LABEL, MULTICENTRIC CLINICAL TRIAL OF A SINGLE ARM OF 16 LENGTHS OF TIME TO EVALUATE RETENTION WITH ELBASVIR / GRAZOPREVIR PLUS SOFOSBUVIR AND RIBAVIRIN IN PATIENTS WITH HEPATITIS C CHRONIC GENOTYPES 1.4 WHO HAVE FAILED TO TREAT WITH A REGIME BASED ON AN INHIBITOR OF THE NS5A

ENSAYO CLÍNICO EN FASE III, ABIERTO, MULTICÉNTRICO DE UN ÚNICO BRAZO DE 16 SEMANAS DE DURACIÓN PARA EVALUAR EL RETRATAMIENTO CON ELBASVIR/GRAZOPREVIR MÁS SOFOSBUVIR Y RIBAVIRINA EN PACIENTES CON HEPATITIS C CRÓNICA GENOTIPOS 1,4 QUE HAN FALLADO AL TRATAMIENTO CON UN REGIMEN BASADO EN UN INHIBIDOR DE LA NS5A

A.3.1

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

A.3.2

Name or abbreviated title of the trial where available

C-RESCUE

A.4.1

Sponsor's protocol code number

GESIDA9516

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	Fundación SEIMC-GESIDA
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	MSD
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	Fundacion SEIMC-GESIDA
B.5.2	Functional name of contact point	Maria Yllescas
B.5.3	Address:
B.5.3.1	Street Address	C/ Agustin de Betancourt Nº 13 entreplanta
B.5.3.2	Town/ city	MAdrid
B.5.3.3	Post code	28003
B.5.3.4	Country	Spain
B.5.4	Telephone number	0034915568025
B.5.5	Fax number	0034915542283
B.5.6	E-mail	myllescas@f-sg.org

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	Zepatier
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.3.4	Pharmaceutical form	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	ELBASVIR
D.3.9.1	CAS number	1370468-36-2
D.3.9.3	Other descriptive name	ELBASVIR
D.3.9.4	EV Substance Code	SUB174125
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	GRAZOPREVIR
D.3.9.1	CAS number	1350514-68-9
D.3.9.3	Other descriptive name	GRAZOPREVIR
D.3.9.4	EV Substance Code	SUB174126
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	100
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	Sovaldi
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.3.4	Pharmaceutical form	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	SOFOSBUVIR
D.3.9.1	CAS number	1190307-88-0
D.3.9.3	Other descriptive name	SOFOSBUVIR
D.3.9.4	EV Substance Code	SUB121170
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	400
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.2.1.2	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.3.4	Pharmaceutical form	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	800 to 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.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

HCV infection

Infección VHC

E.1.1.1

Medical condition in easily understood language

Hepatitis C

E.1.1.2

Therapeutic area

Diseases [C] - Virus Diseases [C02]

MedDRA Classification

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 assess the efficacy, in terms of the rate of patients achieving SVR12, of ELB / GRA retreatment plus SOF and ribavirin for 16 weeks in patients infected with hepatitis C virus genotypes 1, 4 who have failed treatment with regimens based In NS5A

Evaluar la eficacia, en términos de tasa de pacientes que alcanzan la RVS12, del retratamiento con ELB/GRA más SOF y ribavirina durante 16 semanas en pacientes infectados por el virus de la hepatitis C genotipos 1, 4 que han fallado al tratamiento con regímenes basados en NS5A

E.2.2

Secondary objectives of the trial

-Analyze the impact of VARs NS5A on RVS12 that is achieved with ELB / GRA plus SOF and ribavirin in patients with HCV genotype 1a, genotype 1b, genotype 4, for whom treatment with NS5A based regimens failed.
- Analyze the impact of VARs NS5A on RVS24 that is achieved with ELB / GRA plus SOF and ribavirin in patients with HCV genotypes 1, 4 who have failed treatment with regimens based on NS5A.
- Analyze the occurrence of resistance in patients who do not reach SVR12 after 16 weeks of re-treatment with ELB / GRA plus SOF and ribavirin.
- Analyze the impact of VARs NS5A on RVS12 that is achieved with ELB / GRA plus SOF and ribavirin in HIV-1 patients
- Analyze the impact of ELB / GRA retreatment plus SOF and ribavirin in HIV-1 subjects
Develop HIV-1 virological failure.
- Evaluate the safety profile of the treatment combination formed by ELB / GRA plus SOF and ribavirin.

- Analizar el impacto de VARs NS5A en RVS12 que se logra con ELB/GRA más SOF y ribavirina en pacientes con VHC genotipo 1a, genotipo 1b, genotipo 4, para los cuales haya fallado el tratamiento con regímenes basados en NS5A.
- Analizar el impacto de VARs NS5A en RVS24 que se logra con ELB/GRA más SOF y ribavirina en pacientes con VHC genotipos 1, 4 que han fallado el tratamiento con regímenes basados en NS5A.
- Analizar la aparición de resistencias en aquellos pacientes que no alcancen RVS12 tras 16 semanas de retratamiento con ELB/GRA más SOF y ribavirina.
- Analizar el impacto de VARs NS5A en RVS12 que se logra con ELB/GRA más SOF y ribavirina en pacientes VIH-1
- Analizar el impacto del retratamiento con ELB/GRA más SOF y ribavirina en sujetos VIH-1 que
desarrollen fallo virológico VIH-1.
- Evaluar el perfil de seguridad de la combinación de tratamiento formada por ELB/GRA más SOF y ribavirina.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

- Adults with chronic HCV genotype 1, 4 infection with or without HIV infection aged 18 years or above
- Concentration of HCV RNA plasma of at least 1000 IU / mL
- Subjects previously treated with NS5A-based regimens for at least 8 weeks.
- Patients with HCV relapse after receiving a complete treatment with NS5A-based AAD regimen for at least 8 weeks and becoming undetectable at the end of treatment. Relapse is defined as a confirmed HCV RNA detectable upon completion of NS5A-based AAD therapy against HCV.
- Subjects with compensated hepatic cirrhosis (Child A) could be included.
- For patients with HIV coinfection:
- Being infected with HIV-1, documented by any HIV rapid test with the corresponding license and confirmed by a Western blot or second antibody test using a method other than the initial rapid HIV method and / or E / CIA or By HIV-1 p24 antigen or viral load of HIV-1 RNA plasma.
- Be on stable HIV antiretroviral therapy (ART) for at least 4 weeks prior to entry into the study using a dual ITN backbone of tenofovir or abacavir and emtricitabine or lamivudine PLUS raltegravir or dolutegravir or rilpivirine (with CD4 + > 100 cells / mm 3 and undetectable HIV-1 RNA at baseline. Results from prior analysis will be accepted within 24 weeks prior to study entry).

- Adultos con infección crónica de VHC genotipo 1, 4 con o sin infección por VIH con una edad de 18 años o superior
- Concentración de plasma de ARN del VHC de al menos 1000 UI/mL
- Sujetos previamente tratados con regímenes basados en NS5A durante al menos 8 semanas.
- Sujetos con recaída de VHC tras recibir un tratamiento completo con régimen de AAD basado en NS5A durante al menos 8 semanas y tras llegar a ser indetectable al final del tratamiento. La recaída se define como un ARN del VHC confirmado detectable tras la finalización de la terapia de AAD basado en NS5A contra VHC.
- Se podría incluir a sujetos con cirrosis hepática compensada (Child A).
- Para pacientes con coinfección por VIH:
--Estar infectado por VIH-1, documentado mediante cualquier prueba rápida de VIH con la licencia correspondiente y confirmado mediante una prueba Western blot o una segunda prueba de anticuerpos mediante un método distinto al método rápido inicial de VIH y/o E/CIA o mediante antígeno p24 VIH-1 o carga viral de plasma de ARN del VIH-1.
--Estar en terapia antiretroviral estable de VIH (TARV) durante al menos 4 semanas antes de la entrada en el estudio mediante un backbone dual ITIN de tenofovir o abacavir y emtricitabina o lamivudina MÁS raltegravir o dolutegravir o rilpivirina (con recuento de células T CD4+ > 100 células/mm3 y ARN del VIH-1 indetectable en visita basal. Se aceptarán los resultados de una analítica previa dentro de las 24 semanas antes de la entrada del estudio).

E.4

Principal exclusion criteria

- Subjects with hepatitis other than C or steatosis.
- Subjects previously treated less than 8 weeks with regimens based on NS5A.
- Evidence of previous hepatocellular carcinoma although it has criteria of cure
- Subjects with past or current decompensated liver disease; Only decompensated patients who have received a liver transplant and have not decompensated after transplantation will be included.
- Subjects suspected of clinical or genotypic reinfection of HCV.
- Subject with HCV response regrowth while receiving NS5A-based ADA therapy against HCV. Said regrowth is defined as a confirmation of detectable HCV RNA after achieving undetectable HCV RNA during NS5A-based ADA therapy against HCV.
- Recent history of drug or alcohol abuse.
- Important comorbidities.
- Pregnant women, breastfeeding, or women who do not use contraceptive methods, if they are women of childbearing age. Women of childbearing age are defined as those women who have not undergone permanent infertility procedures or who have been amenorrheic for less than 12 months.
- Subjects with a glomerular filtration rate lower than 30 ml / min.

- Sujetos con hepatitis distinta de la C o esteatosis.
- Sujetos previamente tratados menos de 8 semanas con regímenes basados en NS5A.
- Evidencias de carcinoma hepatocelular previo aunque tenga criterios de curación
- Sujetos con enfermedad hepática descompensada pasada o actual; sólo se incluirán los pacientes descompensados que hayan recibido un trasplante hepático y no se haya descompensado después del trasplante.
- Sujetos con sospecha de reinfección clínica o genotípica de VHC.
- Sujeto con rebrote de respuesta al VHC mientras recibe terapia de AADs basados en NS5A contra el VHC. Dicho rebrote se define como una confirmación de ARN del VHC detectable tras lograr un ARN del VHC indetectable durante la terapia de AADs basados en NS5A contra el VHC.
- Historial reciente de abuso de drogas o alcohol.
- Comorbilidades importantes.
- Mujeres embarazadas, en periodo de lactancia, o mujeres que no utilicen métodos anticonceptivos, si son mujeres en edad fértil. Se definen mujeres en edad fértil como aquellas mujeres que no hayan sido sometidas a procedimientos de infertilidad permanente o que sean amenorreicas desde hace menos de 12 meses.
- Sujetos con una tasa de filtrado glomerular inferior a 30 ml/min.

E.5 End points

E.5.1

Primary end point(s)

- Rate of patients achieving SVR12.

- Tasa de pacientes que alcanzan la RVS12.

E.5.1.1

Timepoint(s) of evaluation of this end point

Week 12 post treatment.

Semana 12 post tratamiento

E.5.2

Secondary end point(s)

- The proportion of subjects infected with HCV genotype 1a with reference VARsNS5A that achieve RVS12.
- The proportion of subjects infected with HCV genotype 1b with reference VARsNS5A that achieve RVS12.
- The proportion of subjects infected with HCV genotype 4 with reference to NS5A VARs that achieved RVS12.
- The proportion of subjects infected with HCV genotype 1a with reference VARsNS3 that achieve RVS12.
- The proportion of subjects infected with HCV genotype 1b with reference to NS3 VARs that achieved RVS12.
- The proportion of subjects infected with HCV genotype 4 with reference to NS3 VARs that achieved RVS12.
- The proportion of subjects infected with HCV genotypes 1.4 with reference VARs NS5A who achieved RVS24.
- Viral resistance variants (VARs) will be analyzed for NS5A or elbasvir, NS3 or grazoprevir and NS5B or SOF at any time in the study.
- The proportion of subjects who develop HIV-1 virological failure (HIV RNA> 200 copies / mL), confirmed in 2 consecutive tests with at least 2 weeks between them.

The secondary security variables are:
- The proportion of subjects experiencing adverse events of high laboratory values who report as ECI at any time during the study period.
- The proportion of subjects with adverse experiences:
1. At least one adverse experience
2. Adverse experience related to medication
3. Severe adverse experience
4. A serious adverse experience related to medication
5. An adverse experience leading to disruption

- La proporción de sujetos infectados con VHC genotipo 1a con referencia VARsNS5A que logren RVS12.
- La proporción de sujetos infectados con VHC genotipo 1b con referencia VARsNS5A que logren RVS12.
- La proporción de sujetos infectados con VHC genotipo 4 con referencia VARs NS5A que logren RVS12.
- La proporción de sujetos infectados con VHC genotipo 1a con referencia VARsNS3 que logren RVS12.
- La proporción de sujetos infectados con VHC genotipo 1b con referencia VARs NS3 que logren RVS12.
- La proporción de sujetos infectados con VHC genotipo 4 con referencia VARs NS3 que logren RVS12.
- La proporción de sujetos infectados con VHC genotipos 1,4 con referencia VARs NS5A que logren RVS24.
- Se analizará la aparición de variantes de resistencia (VARs) virales a NS5A o elbasvir, a NS3 o grazoprevir y a NS5B o SOF en cualquier momento del estudio.
- La proporción de sujetos que desarrollen fallo virológico VIH-1 (ARN del VIH > 200 copias/mL), confirmado en 2 pruebas consecutivas con al menos 2 semanas entre sí.

Las variables secundarias de seguridad son:
- La proporción de sujetos que experimentan eventos adversos de valores elevados de laboratorio que se comuniquen como ECI en cualquier momento durante el periodo del estudio.
- La proporción de sujetos con experiencias adversas:
1. Al menos una experiencia adversa
2. Una experiencia adversa relacionada con la medicación
3. Una experiencia adversa grave
4. Una experiencia adversa grave relacionada con la medicación
5. Una experiencia adversa que lleva a la interrupción

E.5.2.1

Timepoint(s) of evaluation of this end point

- Week 12 post treatment, week 24 post treatment.
- At any time during the study

- Semana 12 post tratamiento, semana 24 post tratamiento
- En cualquier momento del estudio

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)

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

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.8.2.4

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

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

Last patient last visit

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

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

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

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)

The routine clinical practics

Práctica clínica 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

2017-05-31

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2017-05-25

P. End of Trial
P.	End of Trial Status	Prematurely Ended
P.	Date of the global end of the trial	2017-06-23

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