Clinical Trials Register

Summary
EudraCT Number:	2012-001611-23
Sponsor's Protocol Code Number:	V260-035
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:	2012-07-19
Trial results	View results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

Spain - AEMPS

A.2

EudraCT number

2012-001611-23

A.3

Full title of the trial

A Double-Blind, Randomized, COntrolled, Multicenter Study to Evaluate the Safety, Tolerability, and Immunogenicity of a New Formulation of RotaTeq(TM)

Estudio doble ciego, aleatorizado, controlado, multicéntrico para evaluar la seguridad, la tolerabilidad y la inmunogenicidad de una formulación nueva de RotaTeq?

A.3.1

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

A Double-Blind, Randomized, Controlled, Multicenter Study to Evaluate the Safety, Tolerability, and Immunogenicity of a New Formulation of RotaTeq?

Estudio doble ciego, aleatorizado, controlado, multicéntrico para evaluar la seguridad, la tolerabilidad y la inmunogenicidad de una formulación nueva de RotaTeq

A.4.1

Sponsor's protocol code number

V260-035

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	Merck Sharp & Dohme Corp., una filial de Merck & Co., Inc.
B.1.3.4	Country	United States
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Merck Sharp & Dohme Corp., una filial de Merck & Co., Inc.
B.4.2	Country	United States
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Merck Sharp & Dohme Corp., una filial de Merck & Co., Inc.
B.5.2	Functional name of contact point	Melissa Hughes
B.5.3	Address:
B.5.3.1	Street Address	One Merck Drive, P.O. Box 100
B.5.3.2	Town/ city	Whitehouse Station, NJ
B.5.3.3	Post code	08889-0100
B.5.3.4	Country	United States
B.5.4	Telephone number	908473-2358
B.5.5	Fax number	908473-3783
B.5.6	E-mail	Melissa.Hughes@Merck.com

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	RotaTeq
D.2.1.1.2	Name of the Marketing Authorisation holder	Sanofi Pasteur MSD, SNC
D.2.1.2	Country which granted the Marketing Authorisation	United States
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	Rotavirus Vaccine, Live, Oral,Pentavalent
D.3.2	Product code	RotaTeq
D.3.4	Pharmaceutical form	Oral drops, solution
D.3.4.1	Specific paediatric formulation	Yes
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	Pentavalent (G1, G2, G3, G4, and P1) Human-Bovine Reassortant Rotavirus Vaccine
D.3.9.2	Current sponsor code	RotaTeq
D.3.9.3	Other descriptive name	ROTAVIRUS VACCINE, LIVE, ORAL, PENTAVALENT
D.3.9.4	EV Substance Code	SUB25745
D.3.10	Strength
D.3.10.1	Concentration unit	IU international unit(s)
D.3.10.2	Concentration type	range
D.3.10.3	Concentration number	2000000 to 2800000
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	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)	Yes
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	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	New formulation of Rotavirus Vaccine, Live, Oral, Pentavalent
D.3.2	Product code	New formulation of RotaTeq
D.3.4	Pharmaceutical form	Oral drops, solution
D.3.4.1	Specific paediatric formulation	Yes
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	Pentavalent (G1, G2, G3, G4, and P1) Human-Bovine Reassortant Rotavirus Vaccine
D.3.9.2	Current sponsor code	New formulation of RotaTeq
D.3.9.3	Other descriptive name	New formulation of ROTAVIRUS VACCINE, LIVE, ORAL, PENTAVALENT
D.3.9.4	EV Substance Code	SUB25745
D.3.10	Strength
D.3.10.1	Concentration unit	IU international unit(s)
D.3.10.2	Concentration type	range
D.3.10.3	Concentration number	2000000 to 2800000
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	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)	Yes
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

Prevention of rotavirus gastroenteritis in infants and children caused by serotypes G1, G2, G3, G4, and G serotypes that contain P1A[8] (e.g., G9)

Prevención de la gastroenteritis por rotavirus en lactantes y niños causada por los serotipos G1, G2, G3 y G4 y los serotipos G que contienen P1A[8] (por ejemplo, G9).

E.1.1.1

Medical condition in easily understood language

Prevention of rotavirus gastroenteritis

Prevención de la gastroenteritis por rotavirus

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	14.1
E.1.2	Level	LLT
E.1.2	Classification code	10039232
E.1.2	Term	Rotavirus gastroenteritis
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 summarize and compare the serum neutralizing antibody (SNA) responses to human rotavirus serotype G1 at 14 days Postdose 3 between recipients of the new formulation and recipients of the current formulation of RotaTeq®.

Resumir y comparar el anticuerpo neutralizador sérico inducido por la vacuna (SNA) contra el serotipo de rotavirus humano G1, 14 días después de la dosis 3 entre los receptores de la formulación nueva y los receptores de la formulación actual de RotaTeq?.

E.2.2

Secondary objectives of the trial

(1) To assess the safety and tolerability of the new formulation of RotaTeq®; (2) To summarize the geometric mean titer (GMT) of SNAs to human rotavirus serotypes G2, G3, G4, and P1A[8] as well as serum anti-rotavirus IgA at 14 days post dose 3 in recipients of the new formulation and recipients of the current formulation of RotaTeq® and; (3) To summarize the proportion of subjects with a ?3-fold rise in SNA titer against human rotavirus serotypes G1, G2, G3, G4, and P1A[8] as well as antibody titer for serum anti-rotavirus IgA from baseline to 14 days Postdose 3 in recipients of the new formulation and recipients of the current formulation.

1.Evaluar la seguridad y la tolerabilidad de la adición de la nueva formulación de RotaTeq?.
2.Resumir las GMT de los SNA inducidos por la vacuna frente a los serotipos de rotavirus humanos G2, G3, G4 y P1A[8] así como la IgA sérica frente a rotavirus 14 días después de la tercera dosis en los receptores de la formulación nueva y en los receptores de la formulación actual de RotaTeq?.
3.Resumir la proporción de pacientes con un aumento de 3 veces o mayor del título de SNA frente a serotipos de rotavirus humano G1, G2, G3, G4 y P1A[8], así como en el título de anticuerpos de IgA sérica frente a rotavirus desde el momento basal hasta 14 días después de la tercera dosis en los receptores de la formulación nueva y en los receptores de la formulación actual de RotaTeq?.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

a. Healthy infant age 6 weeks to 12 weeks (42 to 84 days) at receipt of the first study vaccination (Date of Birth is age Day 1).
b. Parent/legal guardian who agrees to have infant participate by giving written informed consent and is willing and able to comply with study requirements. The subject?s parent/legal guardian may also provide written informed consent for Future Biomedical Research. However, the subject may participate in the main trial without participating in Future Biomedical Research.

a.Lactantes sanos de 6 a 12 semanas (42 a 84 días) de edad a la recepción de la primera vacunación del estudio (la fecha de nacimiento es el día 1 de edad).
b.Padres/tutor que acepten la participación del lactante otorgando su consentimiento informado por escrito y estén dispuestos a cumplir los requisitos del estudio. Los padres/tutor también podrán proporcionar su consentimiento por escrito para la investigación biomédica futura. No obstante, el sujeto puede participar en el ensayo principal sin participar en la investigación biomédica futura.

E.4

Principal exclusion criteria

a. History of congenital abdominal disorders, prior rotavirus gastroenteritis, chronic diarrhea, failure to thrive, or abdominal surgery.
b. History of intussusception.
c. Known or suspected impairment of immunological function, including Severe Combined Immunodeficiency (SCID).
d. Known hypersensitivity to any component of the rotavirus vaccine.
e. Prior administration of any rotavirus vaccine.
f. Receipt of an oral polio vaccine (OPV) less than 14 days prior to the administration of study vaccine. Note: Concomitant administration (same-day dosing) of study vaccine and routine vaccines, including OPV, is acceptable per standard vaccination schedule. If non-concomitant administration of OPV is necessary, it is strongly recommended that OPV be given at least 14 days (preferably 28 days) after the study vaccine.
g. Fever, with a rectal temperature ?38.1°C (?100.5°F), or equivalent, at the time of vaccination. Note: Re-schedule the study vaccination visit after complete resolution of febrile illness.
h. Clinical evidence of active gastrointestinal illness. Note: Infants with gastroesophageal reflux disease (GERD) may participate in the study as long as the GERD is well controlled with or without medication.
i. Receipt of 1) systemic corticosteroids (?2mg/kg total daily dose of prednisone or equivalent) since birth, 2) any dose of systemic corticosteroids within 7 days prior to entering study, or 3) expected to require systemic corticosteroids during the course of the study. Subject using non-systemic corticosteroids (e.g., topical, ophthalmic, or inhaled) will be eligible for vaccination.
j. Subject residing in a household with an immunocompromised person, including individuals with congenital immunodeficiency, human immunodeficiency virus (HIV) infection, leukemia, lymphoma, Hodgkin?s disease, multiple myeloma, generalized malignancy, chronic renal failure, organ or bone marrow transplantation, or with those receiving anti-cancer drugs or immunosuppressive chemotherapy, including long-term systemic corticosteroids.
k. Prior receipt of a blood transfusion or blood products, including immunoglobulins.
l. Participation in another interventional study within 14 days prior to the first study vaccination or expected anytime during the study.
m. Receipt of investigational inactivated vaccines within 14 days or investigational live vaccines within 28 days prior to the first study vaccination or expected anytime during the study.
n. Any condition that, in the opinion of the investigator, may interfere with the evaluation of the study objectives.
o. Inability to obtain blood specimen at randomization visit. Note: Re-schedule visit so that baseline specimen may be obtained prior to the first vaccination.

a.Antecedentes de trastornos congénitos abdominales, gastroenteritis por rotavirus previa, diarrea crónica, retraso del crecimiento o cirugía abdominal.
b.Antecedentes de invaginación.
c.Confirmación o sospecha de deterioro de la función inmunitaria, como la inmunodeficiencia combinada grave (SCID = Severe Combined Immunodeficiency).
d.Hipersensibilidad conocida a cualquier componente de la vacuna de rotavirus.
e.Administración previa de cualquier vacuna de rotavirus.
f.Administración de una vacuna antipoliomielítica oral (VPO) menos de 14 días antes de la administración de la vacuna del estudio. Nota: la administración concomitante (administración el mismo día) de la vacuna del estudio y de las vacunas habituales, incluida la vacuna oral de la poliomielitis, es aceptable siguiendo la pauta de vacunación habitual. Si es necesaria la administración no simultánea de la vacuna oral de la poliomielitis, se recomienda encarecidamente que la vacuna antipoliomielítica oral se administre al menos 14 días (preferiblemente 28 días) después de la vacuna del estudio.
g.Fiebre, con una temperatura rectal ?38,1 °C o equivalente en el momento de la vacunación. Nota: reprograme la visita de vacunación del estudio después de la resolución completa de la enfermedad febril.
h.Signos clínicos de enfermedad digestiva activa. Nota: los lactantes con enfermedad por reflujo gastroesofágico (ERGE) podrán participar en el estudio si la ERGE esté bien controlada con o sin medicación.
i.Recepción de 1) corticosteroides sistémicos (? 2 mg/kg de dosis diaria total de prednisona o equivalente) desde el nacimiento, 2) cualquier dosis de corticosteroides sistémicos durante los 7 días anteriores a la incorporación del estudio, o 3) está previsto que necesite corticoides sistémicos durante el curso del estudio. Los sujetos que utilicen corticosteroides no sistémicos (por ejemplo, tópicos, oftálmicos o inhalados) son aptos para la vacunación.
j.Sujetos que residan en un hogar con una persona inmunodeprimida, incluidas personas con inmunodeficiencia congénita, infección por el virus de la inmunodeficiencia humana (VIH), leucemia, linfoma, enfermedad de Hodgkin, mieloma múltiple, tumor maligno generalizado, insuficiencia renal crónica, trasplante de órganos o médula ósea o tratados con fármacos antineoplásicos o quimioterapia inmunodepresora, incluidos los corticosteroides sistémicos a largo plazo.
k.Recepción previa de una transfusión de sangre o hemoderivados, incluidas inmunoglobulinas.
l.Participación en otro estudio de intervención en los 14 días previos a la primera vacunación del estudio o si está previsto hacerlo en cualquier momento durante el estudio.
m.Administración de una vacuna experimental de virus inactivados en los 14 días previos o de vacunas atenuadas experimentales en los 28 días previos a la primera vacunación del estudio o si está previsto hacerlo en cualquier momento durante el estudio.
n.Cualquier afección que, en opinión del investigador, pudiera interferir con la evaluación de los objetivos del estudio.
o.Incapacidad para obtener la muestra de sangre en la visita de aleatorización. Nota: reprogramar la visita para que la muestra basal pueda obtenerse antes de la primera vacunación.

E.5 End points

E.5.1

Primary end point(s)

The GMT of vaccine-induced SNA to human rotavirus serotype G1

El criterio de valoración principal de la inmunogenicidad será los títulos de SNA frente al serotipo de rotavirus humano G1.

E.5.1.1

Timepoint(s) of evaluation of this end point

14 days after dose 3

14 días después de la dosis 3

E.5.2

Secondary end point(s)

(1) Number of participants with Tier 1 (diarrhea, vomiting, elevated temperature, irritability, and intusussception) adverse events; (2) GMTs of SNAs to human rotavirus serotype G2, G3, G4, P1A[8], and serum anti-rotavirus IgA; (3) Number of participants with ? to 3-fold rise in titers of SNA to human rotavirus serotypes G1, G2, G3, G4, and P1A[8], and serum anti-rotavirus IgA

Número de participantes con nivel 1 (diarrea, vómitos, temperatura elevada, irritabilidad e invaginación) de efectos adversos, (2) GMT de los SNA inducidos por la vacuna frente a los serotipos de rotavirus humanos G2, G3, G4 y P1A[8] así como la IgA sérica (3) proporción de pacientes con un aumento de 3 veces o mayor del título de SNA frente a serotipos de rotavirus humano G1, G2, G3, G4 y P1A[8], así como en el título de anticuerpos de IgA sérica

E.5.2.1

Timepoint(s) of evaluation of this end point

Secondary Endpoint #1: Through 14 days after Dose 3; Secondary Endpoint #2: Through 14 days after Dose 3;.Secondary Endpoint #3: From Day 1 before Dose 1 vaccination to 14 days after Dose 3;

Variable secundaria 1: A traves de los 14 días después de la dosis 3;Variable secundaria 2:A traves de los 14 días después de la dosis 3.Variable secundaria 3: Desde al día 1 antes de la dosis 1 de vacunación después de la dosis 3.

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

Yes

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

Yes

E.6.12

Pharmacoeconomic

E.6.13

Others

Yes

E.6.13.1

Other scope of the trial description

Immunogenicity

Inmunogenidad

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

E.7.3

Therapeutic confirmatory (Phase III)

Yes

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

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

Vacuna contra el rotavirus

Rotavirus Vaccine

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

Yes

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.6.3

If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned

Canada

Czech Republic

Denmark

Israel

Mexico

Poland

Spain

Sweden

United States

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

LPLV

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

Yes

F.1.1

Number of subjects for this age range:

800

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)

Yes

F.1.1.4.1

Number of subjects for this age range:

800

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

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

Yes

F.3.2

Patients

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

Yes

F.3.3.6.1

Details of subjects incapable of giving consent

Infants between the ages of 6 to 12 weeks are to be enrolled, requiring written consent from parent or legal guardian.

Niños comprendidos entre 6 y 12 semanas de edad que vayan a ser reclutados, se requiere el consentimiento de sus padres o del tutor legal.

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

110

F.4.2

For a multinational trial

F.4.2.1

In the EEA

450

F.4.2.2

In the whole clinical trial

800

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)

Not applicable.

No aplica.

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

2012-09-28

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2012-08-06

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

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