Clinical Trials Register

Summary
EudraCT Number:	2019-002733-10
Sponsor's Protocol Code Number:	Dual-Triple-ART
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2019-07-26
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

Expand All Collapse All

A. Protocol Information

A.1

Member State Concerned

Spain - AEMPS

A.2

EudraCT number

2019-002733-10

A.3

Full title of the trial

Exploratory, open-label, randomized clinical trial to assess the efficacy of first-line dual vs. triple antiretroviral therapy (art) in hiv-1 reservoir and in peripheral compartments in hiv-infected patients.

Ensayo clínico abierto, aleatorizado para evaluar el efecto del tratamiento antirretroviral inicial doble vs.triple en el reservorio del VIH-1 y en tejidos periféricos en pacientes infectados por el VIH-1.

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

Dual-Triple-ART

A.4.1

Sponsor's protocol code number

Dual-Triple-ART

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 LLUITA CONTRA LA SIDA
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	Viiv Healthcare
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	Fundació Lluita contra la SIDA
B.5.2	Functional name of contact point	Clinical Research Associate
B.5.3	Address:
B.5.3.1	Street Address	Crta. de Canyet, sn
B.5.3.2	Town/ city	Badalona (Barcelona)
B.5.3.3	Post code	08916
B.5.3.4	Country	Spain
B.5.4	Telephone number	+3493497 8414
B.5.5	Fax number	+3493465 7602
B.5.6	E-mail	afiguerola@fls-rs.com

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	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.3.4	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	Dolutegravir
D.3.9.3	Other descriptive name	Dolutegravir Sodium
D.3.9.4	EV Substance Code	SUB35122
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	Descovy
D.2.1.1.2	Name of the Marketing Authorisation holder	Gilead Sciences Ireland U
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	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	TENOFOVIR ALAFENAMIDE
D.3.9.1	CAS number	379270-37-8
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.3.8 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.3.9.4	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.3.11 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	Lamivudine
D.2.1.1.2	Name of the Marketing Authorisation holder	Gilead Sciences Intl 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.3.4	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	LAMIVUDINE
D.3.9.1	CAS number	134678-17-4
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	300
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

HIV infection

Infección por VIH

E.1.1.1

Medical condition in easily understood language

HIV infection

Infección por VIH

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	LLT
E.1.2	Classification code	10008919
E.1.2	Term	Chronic HIV infection
E.1.2	System Organ Class	100000004862

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 compare changes in the HIV-1 reservoir (proviral HIV-1 DNA in CD4+ T cells) from baseline to week 48 between first-line treatment with DTG+3TC versus DTG +FTC/TAF.

Evaluar el cambio en el reservorio de VIH-1 (VIH ADN proviral en linfocitos CD4+) desde la visita basal hasta la semana 48 de tratamiento comparando tratamiento doble (DTG+3TC) versus triple (DTG +FTC/TAF).

E.2.2

Secondary objectives of the trial

•To compare the following variables during the study period between the two study arms: Plasma viremia decay.
- Proportion of participants with HIV-1 RNA in plasma < 50 copies/mL and < 1 copy/mL.
- Changes in CD4/CD8.
- Changes in cell-associated HIV-1 RNA in CD4+ T cells.
- Changes in plasma and cell-associated p24 .
- Changes in activation (HLA-DR/CD38) and exhaustion (PD-1/TIGIT) markers in different lymphocyte subsets defined by CD3/CD4/CD8/CDR7/CD45RA and CD27 surface markers by multiparametric Flow cytometry.
- Change in Inflammatory markers (sCD14, CRP, IL-6, IL-10, d-dimer, IP-10, sCD163, LFABP and TRAIL) in plasma.
•To evaluate DTG, TFV, FTC and 3TC penetration and distribution in peripheral lymph node.
•To evaluate the longitudinal and spatial association between drug distribution and cell-associated HIV- 1 RNA and DNA expression within peripheral lymph node.
•To evaluate the resistance-associated mutations in those patients who develop virologic failure.

•Comparar la evolución temporal de las siguientes variables entre ambos grupos de estudio:
-Descenso en la carga viral en plasma
-Proporción de participantes con ARN del HIV en plasma < 50 copias/ml y < 1 copia/ml
-Cambios en CD4/CD8
-Cambios en niveles de p24 asociada a células
-Cambios en los marcadores de activación (HLA-DR/CD38) y de agotamiento (PD-1/TIGIT) en diferentes subconjuntos de linfocitos definidos por los marcadores de superficie CD3/CD4/CD8/CDR7/CD45RA y CD27 por citometría multiparamétrica de flujo
-Cambios en marcadores inflamatorios (sCD14, CRP, IL-6, IL-10, d-dimer, IP-10, sCD163, LFABP and TRAIL) en plasma
•Evaluar penetración y distribución de DTG, TFV, FTC y 3TC en el ganglio linfático periférico
•Evaluar la asociación longitudinal y espacial entre la distribución de los antirretrovirales y la expresión de RNA-HIV y DNA-VIH dentro del ganglio linfático
•Evaluar las mutaciones de resistencia asociadas a los pacientes que desarrollen fallo virológico

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Age ≥18 years.
2. Documented HIV-1 infection (confirmed by a NAT/PCR test).
3. Naïve to cART (Pre-exposure prophylaxis with FTC/TDF or TAF/FTC or post-exposure prophylaxis will be allowed if more than 4 weeks before the screening visit).
4. Willing and able to be adherent to antiretroviral therapy for the duration of the study.
5. Willing to comply with the requirements of the protocol and available for follow-up for the planned duration of the study.
6. In the opinion of the principal investigator or designee, the participant has understood the information provided and capable of giving written informed consent.
7. If female in fertile age and heterosexually active; using an effective method of contraception (hormonal contraception, intra-uterine device (IUD), or anatomical sterility in self or partner*) from 14 days prior to the first study product administration until at least 12 weeks after the last study product administration; all female participants must be willing to undergo urine pregnancy tests at time points specified in the Schedule of Procedures.

1. Edad ≥18 años.
2. Infección VIH documentada y confirmada por una prueba PCR.
3. Sin TAR previo (Se permitirá la profilaxis pre-exposición con FTC/TDF o la profilaxis post-exposición en el caso de que hayan tenido lugar más de 4 semanas antes de la visita de Screening)
4. Estar dispuesto y ser capaz de tomar el TAR durante toda la duración del estudio.
5. Estar dispuesto a cumplir con los requisitos del protocolo y acudir a todas las visitas durante el estudio.
6. En opinión del equipo investigador, el participante ha comprendido la información proporcionada y es capaz de dar su consentimiento informado por escrito
7. Si mujer en edad fértil y heterosexualmente activa; utilizar un método anticonceptivo eficaz (anticoncepción hormonal, dispositivo intrauterino (DIU) o esterilidad anatómica en sí misma o en la pareja *) desde 14 días antes de su inclusión en el estudio y al menos hasta 12 semanas después del final del estudio; todas las participantes deben estar dispuestas a someterse a pruebas de embarazo en orina en los momentos especificados en el calendario de Procedimientos.

E.4

Principal exclusion criteria

1. Exposure to any antiretroviral drug within the 4 weeks prior to the screening visit.
2. HIV-1 RNA in plasma >500,000 copies/mL.
3. Active AIDS-defining illness within the prior 4 weeks.
4. Chronic hepatitis B (positive HBsAg).
5. Chronic hepatitis C (positive IgG HCV confirmed by positive HCV RNA in plasma).
6. Estimated glomerular filtration rate (eGFR) <50 mL/min.
7. Advance liver function impairment (Child-Pugh C).
8. Use of systemic chemotherapy within the 12 months before the screening visit.
9. Use of systemic corticosteroids during more than 7 consecutive days within the 3 months before the screening visit.
10. Concomitant treatment with co-medications with known drug-drug interactions with study drugs.
11. History or clinical manifestations of any physical or psychiatric disorder which could impair the subject’s ability to complete the study.
12. Any other current or prior therapy which, in the opinion of the investigators, would make the individual unsuitable for the study or influence the results of the study.
13. In women, pregnancy or breastfeeding.

1.Exposición a cualquier medicamento antirretroviral dentro de las 4 semanas previas a la visita de selección.
2.ARN del VIH-1 en plasma> 500,000 copias / ml.
3.Enfermedad activa definitoria de SIDA en las 4 semanas previas.
4.Hepatitis B crónica (HBsAg positivo).
5.Hepatitis C crónica (IgG HCV positivo confirmado por ARN de HCV positivo en plasma).
6.Tasa de filtración glomerular estimada (eGFR) <50 ml / min.
7.Deterioro de la función hepática avanzada (Child-Pugh C).
8.Uso de quimioterapia sistémica durante los 12 meses previos a la visita de selección.
9.Uso de corticosteroides sistémicos durante más de 7 días consecutivos durante los 3 meses previos a la visita de selección.
10.Tratamiento concomitante con fármacos que tengan interacciones relevantes con los medicamentos del estudio.
11.Historia o manifestaciones clínicas de cualquier trastorno físico o psiquiátrico que pueda afectar la capacidad del participante para completar el estudio.
12.Cualquier otra tratamiento actual o previo que, en opinión de los investigadores, haga que el individuo no sea adecuado para el estudio o influya en los resultados del mismo.
13.En mujeres, embarazo o lactancia.

E.5 End points

E.5.1

Primary end point(s)

Change in proviral HIV-1 DNA in CD4+ Tcells from baseline to week 48.

Evaluar cambio en el ADN proviral del VIH en células CD4+ desde la visita basal hasta la semana 48.

E.5.1.1

Timepoint(s) of evaluation of this end point

Week 48

Semana 48

E.5.2

Secondary end point(s)

1. Comparative dynamics of plasma viremia decay during the study period.
2. Proportion of participants with HIV-1 RNA in plasma below 50 copies/mL and below 1 copy/mL at 48 weeks.
3. Changes in the ratio CD4/CD8.
4. Change in cell-associated HIV-1 RNA in CD4+ T cells from baseline to week 48.
5. Change in plasma and cell-associated p24 (single molecule assay) from baseline to week 48.
6. Change in activation (HLA-DR/CD38) and exhaustion (PD-1/TIGIT) markers from baseline to week 48 indifferent lymphocyte subsets defined by CD3/CD4/CD8/CDR7/CD45RA and CD27 surface markers by multiparametric Flow cytometry.
7. Change in inflammatory markers (sCD14, CRP, IL-6, IL-10, d-dimer, IP-10, sCD163, LFABP and TRAIL) from baseline to week 48.
8. DTG, TFV, FTC and 3TC penetration and distribution in peripheral lymph node.
9. Longitudinal and spatial association between drug distribution and cell-associated HIV-1 RNA and DNA expression within peripheral lymph node from baseline to week 48.
10. Resistance-associated mutations in those patients who develop virologic failure during the study.

1.Comparación de la dinámica de la carga viral en plasma durante el período de estudio.
2.Proporción de participantes con ARN del HIV en plasma <50 copias/ml y < 1 copia/ml
3.Cambios en CD4/CD8
4.Cambios en el ARN del VIH en células CD4 desde la visita basal a la semana 48
5.Cambios desde la visita basal hasta la semana 48 en los niveles de p24 asociada a células
6.Cambios en los marcadores de activación (HLA-DR/CD38) y de agotamiento (PD-1/TIGIT) desde la visita basal hasta la semana 48 en diferentes subconjuntos de linfocitos definidos por los marcadores de superficie CD3/CD4/CD8/CDR7/CD45RA y CD27 por citometría multiparamétrica de flujo.
7.Cambios en marcadores inflamatorios (sCD14, CRP, IL-6, IL-10, d-dimer, IP-10, sCD163, LFABP and TRAIL) en plasma
8.Evaluar penetración y distribución de DTG, TFV, FTC y 3TC en el nódulo linfático periférico.
9.Evaluar la asociación longitudinal y espacial entre la distribución de los antirretrovirales y la expresión de RNA-HIV y DNA-VIH dentro del ganglio linfático desde la visita basal hasta la semana 48.
10.Evaluar las mutaciones de resistencia asociadas a los pacientes que desarrollen fallo virológico

E.5.2.1

Timepoint(s) of evaluation of this end point

Week 48

Semana 48

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)

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)

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

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

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)

None

Ninguno

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

2019-08-13

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2019-07-26

P. End of Trial
P.	End of Trial Status	Completed

Select Country:	Select Age Range:
Select Trial Status:	Select Trial Phase:
Select Gender:
Select Date Range: to
Select Rare Disease:
IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
Clear advanced search filters

Austria
Belgium
Bulgaria
Croatia
Cyprus
Czechia
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Iceland
Ireland
Italy
Latvia
Liechtenstein
Lithuania
Luxembourg
Malta
Netherlands
Norway
Poland
Portugal
Romania
Slovakia
Slovenia
Spain
Sweden
United Kingdom
Outside EU/EEA

Clinical trials