Clinical Trials Register

Summary
EudraCT Number:	2019-000800-14
Sponsor's Protocol Code Number:	FIS-TAR-01-2019
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2019-11-11
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

2019-000800-14

A.3

Full title of the trial

Effectiveness of a dual therapy based on dolutegravir plus lamivudine on reduction of the viral reservoir, immune recovery and immune activation compared with a triple antiretroviral therapy based on dolutegravir plus tenofovir alafenamide/emtricitabine in patients with HIV infection without prior treatment.

Ensayo clínico fase 4, aleatorizado, para evaluar el efecto en la recuperación inmunológica, en la reducción del reservorio viral y en la activación inmune de una terapia antirretroviral triple basada en dolutegravir más tenofovir alafenamida/emtricitabina versus una biterapia con dolutegravir más lamivudina en pacientes con infección por el VIH sin tratamiento previo.

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

Triple versus double therapy in naives patients

Triple versus doble terapia en pacientes naïves

A.4.1

Sponsor's protocol code number

FIS-TAR-01-2019

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 Pública Andaluza para la Gestión en Salud de Sevilla (FISEVI)
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	Own funding
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	Unidad de Investigación Clínica y ensayos Clínicos
B.5.2	Functional name of contact point	UICEC-HUVR
B.5.3	Address:
B.5.3.1	Street Address	Avenida Manuel Siurot s/n
B.5.3.2	Town/ city	sevilla
B.5.3.3	Post code	41013
B.5.3.4	Country	Spain
B.5.4	Telephone number	0034955013414
B.5.5	Fax number	0034955095338
B.5.6	E-mail	claram.rosso.sspa@juntadeandalucia.es

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Comparator
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	Tivicay
D.2.1.1.2	Name of the Marketing Authorisation holder	ViiV Healthcare
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	Dolutegravir
D.3.2	Product code	EMEA/H/C/002753
D.3.4	Pharmaceutical form	Pastille
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	DOLUTEGRAVIR SODIUM
D.3.9.1	CAS number	1051375-16-6
D.3.9.2	Current sponsor code	EU/1/13/892/001 or EU/1/13/892/002
D.3.9.4	EV Substance Code	SUB130591
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	Lamivudine Teva
D.2.1.1.2	Name of the Marketing Authorisation holder	ViiV Healthcare
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	Dolutegravir
D.3.2	Product code	EMEA/H/C/002753
D.3.4	Pharmaceutical form	Pastille
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	LAMIVUDINE
D.3.9.1	CAS number	134678-17-4
D.3.9.2	Current sponsor code	EMEA/H/C/001113
D.3.9.3	Other descriptive name	3TC
D.3.9.4	EV Substance Code	SUB08392MIG
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: 3
D.1.2 and D.1.3	IMP Role	Comparator
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	Descovy
D.2.1.1.2	Name of the Marketing Authorisation holder	Gilead Science S.L.
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	Tenofovir alafenamida and Emtricitabina
D.3.4	Pharmaceutical form
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	EMTRICITABINE
D.3.9.1	CAS number	143491-57-0
D.3.9.2	Current sponsor code	EU/1/16/1099/003
D.3.9.3	Other descriptive name	FTC
D.3.9.4	EV Substance Code	SUB01882MIG
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.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	TENOFOVIR ALAFENAMIDE
D.3.9.1	CAS number	379270-37-8
D.3.9.2	Current sponsor code	EU/1/16/1099/003
D.3.9.3	Other descriptive name	TAF
D.3.9.4	EV Substance Code	SUB121761
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.3.11 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

Adult patients with HIV infection without previous treatment

Pacientes adultos con infección por VIH sin tratamiento previo.

E.1.1.1

Medical condition in easily understood language

Adult patients with HIV infection without previous treatment

Pacientes adultos con infección por VIH sin tratamiento previo.

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	20.1
E.1.2	Level	PT
E.1.2	Classification code	10020161
E.1.2	Term	HIV infection
E.1.2	System Organ Class	10021881 - Infections and infestations

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.1
E.1.2	Level	LLT
E.1.2	Classification code	10020160
E.1.2	Term	HIV disease
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

To evaluate if a dual therapy based on dolutegravir plus lamivudine (DTG/3TC) will provide a comparable reduction in viral reservoir size than a triple therapy based on dolutegravir plus tenofovir alafenamide / emtricitabine (DTG/F/TAF) after 48 and 96 weeks in treatment-naïve HIV-infected patients.

Evaluar el efecto en la reducción del reservorio viral, de una terapia antirretroviral triple con dolutegravir más tenofoviralafenamida/emtricitabina (D/TAF/F), frente a una biterapia con dolutegravir más lamivudina (D/3TC) en pacientes con infección por el VIH sin tratamiento previo tras los 12 y 24 meses de tratamiento.

E.2.2

Secondary objectives of the trial

• To evaluate the effect on the immune recovery of triple antiretroviral therapy based on DTG / TAF / F, versus a dual therapy based on dolutegravir plus lamivudine DTG/3TC after 48 and 96 weeks in treatment-naïve HIV-infected patients.
• To evaluate if a dual therapy based on DTG/3TC will provide a comparable reduction in immune activation and inflammation than a triple therapy based on DTG/F/TAF after 48 and 96 weeks in treatment-naïve HIV-infected patients.
• Evaluate the reduction of the viral load in semen (this objective will be carried out only in a subgroup of patients belonging to the Hospital Virgen Rocío University, which will consist of a minimum of 15 patients per arm).
• Evaluate the reduction of the viral reservoir in gut-associated lymphoid tissue (GALT) (this objective will be carried out only in a subgroup of patients belonging to the Hospital Universitario Virgen del Rocío University, which will consist of minimum of, 10 patients per arm).

• Evaluar la recuperación inmune deuna triple terapia basada en D/TAF/F, comparada con una biterapia con D/3TC, en pacientes con infección por el VIH sin tratamiento previo tras 12 y 24 meses de tratamiento.
• Evaluar la activación inmunológica y la inflamación de una triple terapia basada en D/TAF/F, comparada con una biterapia con D/3TC, en pacientes con infección por el VIH sin tratamiento previo tras 12 y 24 meses de tratamiento.
• Evaluar la reducción de la carga viral en semen (este objetivo se llevará a cabo solo en un subgrupo de pacientes pertenecientes al Hospital Universitario Virgen Rocío, que constará de un mínimo de 15 pacientes por rama de tratamiento).
• Evaluar la reducción del reservorio viral en tejido linfoide asociado al intestino (GALT) (este objetivo se llevará a cabo solo en un subgrupo de pacientes pertenecientes al Hospital Universitario Virgen del Rocío, que constará de un mínimo de 10 pacientes por rama de tratamiento).

E.2.3

Trial contains a sub-study

Yes

E.2.3.1

Full title, date and version of each sub-study and their related objectives

To evaluate the reduction of viral load in semen and GALT

Evaluar la reducción de la carga viral en semen y en GALT

E.3

Principal inclusion criteria

 Treatment-naïve HIV-1-infected patients ≥ 18 years of age.
 Plasma HIV-1 RNA >5000 and <500.000 copies/ml.
 T lymphocyte CD4+ count in peripheral blood >200/μl.
 Patients of childbearing age should consent to use a highly effective contraceptive method from 15 days before the time of inclusion of the study until 30 days after the end of it. It is considered a highly effective method:
o Complete abstinence from penile-vaginal intercourse from 2 weeks prior to administration of Investigational Product, throughout the study, and for at least 2 weeks after discontinuation of all study medications;
o Any intrauterine device with published data showing that the expected failure rate is <1% per year (not all intrauterine devices meet this criterion)
o Male partner sterilization confirmed prior to the female subject’s entry into the study, and this male is the sole partner for that subject.
o Approved hormonal contraception.
o Any other method with published data showing that the expected failure rate is <1% per year.
 Signed written informed consent prior to inclusion.

 Pacientes ≥ 18 años, infectados con VIH-1 sin tratamiento previo
 Viremia VIH >5000 y<500.000 copias/ml.
 Recuento de linfocitos T CD4+ en sangre periférica>200/µl
 Las pacientes en edad fértil deben consentir utilizar un método contraceptivo altamente efectivo desde 15días antes del momento de la inclusión del estudio hasta 30 días después de la finalización del mismo. Considerándose métodos altamente efectivos los siguientes:
o Abstinencia completa de las relaciones sexuales 2 semanas antes de la administración del Producto en investigación, durante todo el estudio, y durante al menos 2 semanas después de la interrupción de todos los medicamentos del estudio.
o Cualquier dispositivo intrauterino con datos publicados que demuestren que la tasa de fallo esperada sea<1% por año (no todos los dispositivos intrauterinos cumplen con este criterio)
o Esterilización de la pareja masculina confirmada antes de la entrada del sujeto femenino en el estudio, siendo ese hombre la única pareja.
o Anticoncepción hormonal aprobada.
o Cualquier otro método con datos publicados que muestren que la tasa de fallos esperada es <1% por año.
 Consentimiento informado por escrito.

E.4

Principal exclusion criteria

 Acute HIV infection
 T lymphocyte CD4+ count in peripheral blood ≤ 200/µl
 Active opportunistic infection.
 Pregnancy at inclusion or during the follow-up
 Active hepatitis C and/or B virus co-infection.
 ALT ≥ 5 times the ULN, or ALT ≥ 3xULN and bilirubin ≥ 1.5xULN (with >35% direct bilirubin).
 Unstable liver disease (as defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, or persistent jaundice), cirrhosis, known biliary abnormalities (apart from hyperbilirubinemia or jaundice due to Gilbert's syndrome or asymptomatic gallstones).
 Subjects with severe hepatic impairment (Class C) as determined by Child-Pugh classification.
 Current or past disease that requires the use subsidiary of treatment with corticosteroids, immunomodulatory agents, interferon or chemotherapeutic agents.
 Any laboratory abnormality grade 3 or 4 according to the U.S. Department of Health and Human Services, National Institutes of Health, National Institute of Allergy and Infectious Diseases, Division of AIDS (Annex 3)
 Concomitant use of drugs with potential major interactions with the prescribed drugs according the respective full prescribing information.
 Estimated creatinine clearance <50ml/min.
 History or presence of allergy to the study drugs or their components

 Infección aguda por VIH
 Embarazo en el momento de la inclusión o durante el periodo de seguimiento.
 Co-infección activa por virus B o C de la hepatitis.
 ALT ≥ 5 veces el ULN, o ALT ≥ 3xULN y bilirrubina ≥ 1.5xULN (con> 35% de bilirrubina directa).
 Enfermedad hepática inestable (definida por la presencia de ascitis, encefalopatía, coagulopatía, hipoalbuminemia, varices esofágicas o gástricas, o ictericia persistente), cirrosis, anomalías biliares conocidas,hiperbilirrubinemia o ictericia debido al síndrome de Gilbert o cálculos biliares asintomáticos.
 Sujetos con insuficiencia hepática grave (Clase C) según la clasificación de Child-Pugh.
 Neoplasias pasadas o actuales subsidiarias de tratamiento con corticosteroides, inmunomoduladores, interferón o quimioterapia.
 Anomalías de laboratorio grado 3 o 4 en las determinaciones analíticas habituales durante el seguimiento de estos pacientes (anexo 3).
 Uso concomitante de medicamentos con posibles interacciones importantes con los fármacos del estudio según la información de la ficha técnica de los productos.
 Aclaramiento estimado de creatinina <50ml/min.
 Antecedentes o presencia de alergia a los fármacos del estudio o sus componentes.

E.5 End points

E.5.1

Primary end point(s)

Mean changes in proviral HIV-DNA and HIV-RNA in PBMCs after 48 and 96 weeks of treatment

Cambios en el ADN y ARN-VIH tras 48 y 96 semanas de tratamiento. .

E.5.1.1

Timepoint(s) of evaluation of this end point

Changes after 24, 48 and 96 moths of treatment according to variable.

Tras 24, 48 y 96 semanas de tratamiento.

E.5.2

Secondary end point(s)

 Immune recovery measured as the CD4 + / CD8 + ratio
 Viral reservoir size, evaluated by proviral HIV-DNA in PBMCs.
 Immune activation assessed by the expression of HLA-DR and CD38 in both of CD4+ and CD8+ T.
 Expression of markers for recent thymic emigrants (CD31), proliferation (Ki67), dysfunction (PD-1), senescence (CD57), and apoptosis (annexin V) in both CD4+ and CD8+ T cells.
 Pro-inflammatory soluble mediator in plasma expression (TNF-α, IL-1β, IL-6, IP-10, IFN- γ, MIP-1α , MIP-1β, hs-CRP and D-dimers) determined by ELISA.
 Changes in proviral DNA (DNA-HIV) and HIV transcripts (RNA-HIV) in PBMCs and purified CD4 + lymphocytes.
 Monocytes activation (plasma sCD14 and sCD163)
 Decrease of RNA-HIV in seminal plasma.

 Recuperación inmunológica medida como el cociente CD4+/CD8+
 Inmuno-activación medida como expresión de HLA-DR y CD38 en linfocitos T CD4+ y CD8+.
 Activación monocítica en los niveles plasmáticos de sCD14 y sCD163.
 Expresión de los siguientes marcadores en linfocitos T CD4+ y CD8+: Ki67 (proliferación), PD-1 (disfunción), CD57 (senescencia), Anexina V (apoptosis) y CD31 (recién emigrado del timo).
 Concentraciones de los siguientes mediadores pro-inflamatorios: TNF-α, IL-1β, IL-6, IP-10, IFN- γ, MIP-1α, MIP-1β, hsPCR y D-dímeros.
 Cambios en ADN proviral (ADN-VIH) y transcritos del VIH (RNA-VIH) en PBMCs y linfocitos CD4+ purificados.
 Disminución del ARN-VIH en plasma seminal.
 Cambios del reservorio viral en GALT, medido como ADN y ARN del VIH.

E.5.2.1

Timepoint(s) of evaluation of this end point

Changes after 3, 6, 12 and 24 moths of treatment according to variable.

Tras 3, 6, 12 y 24 meses de 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)

E.7.4

Therapeutic use (Phase IV)

Yes

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)

E.8.2.2

Placebo

E.8.2.3

Other

Yes

E.8.2.3.1

Comparator description

Triple terapia (Dolutegravir, Tenofovir, Emtricitabine)

Triple Therapy (Dolutegravir, Tenofovir, Emtricitabine)

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

Six months after the final visit of the last patient included to analyze the data and write the final report.

Seis meses después de la visita final del último paciente incluido para analizar los datos y escribir el informe final.

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.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)

Treatment after study as per investigators juice according to GCP

A juicio del investigador, de acuerdo con las BPC

G. Investigator Networks to be involved in the Trial
G.4 Investigator Network to be involved in the Trial: 1
G.4.1	Name of Organisation	UICEC-HUVR
G.4.3.4	Network Country	Spain

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2020-02-07

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2020-02-03

P. End of Trial
P.	End of Trial Status	Ongoing

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Select Rare Disease:
IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
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