Clinical Trials Register

Summary
EudraCT Number:	2017-001450-34
Sponsor's Protocol Code Number:	GL-GLAT1-3001
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:	2017-12-21
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

2017-001450-34

A.3

Full title of the trial

An Open-label, Randomized, Multicenter, Phase III Study to Compare the
Immunogenicity, Efficacy, and Safety of Gan & Lee Pharmaceuticals Insulin Glargine Injection to Lantus® (Insulin Glargine Injection) in Adult Subjects with Type 1 Diabetes Mellitus

Estudio de fase III, abierto, aleatorizado y multicéntrico, para comparar la inmunogenicidad, eficacia y seguridad de la inyección de insulina glargina de Gan & Lee Pharmaceuticals con Lantus® (inyección de insulina glargina) en sujetos adultos con diabetes mellitus tipo 1

A.3.1

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

A Clinical Trial to Compare the effectiveness and safety of Gan & Lee Pharmaceuticals Insulin Glargine Injection to Lantus® (Insulin Glargine Injection) in Adults with Type 1 Diabetes Mellitus

Un ensayo clínico para comparar la efectividad y la seguridad de la inyección de insulina glargina de Gan & Lee Pharmaceuticals con Lantus® (inyección de insulina glargina) en adultos con diabetes mellitus tipo 1

A.3.2

Name or abbreviated title of the trial where available

Insulin Glargine vs Lantus® in Adults with Type 1 Diabetes

A.4.1

Sponsor's protocol code number

GL-GLAT1-3001

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	Gan & Lee Pharmaceuticals, USA
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	Gan & Lee Pharmaceuticals, USA
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	Gan & Lee Pharmaceuticals, USA
B.5.2	Functional name of contact point	Chris Houchins, President and CEO
B.5.3	Address:
B.5.3.1	Street Address	1170 US Highway 22 East, Suite 304
B.5.3.2	Town/ city	Bridgewater, NJ
B.5.3.3	Post code	08807
B.5.3.4	Country	United States
B.5.4	Telephone number	18882885395

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Gan & Lee Insulin Glargine injection
D.3.2	Product code	Gan & Lee Insulin Glargine injection
D.3.4	Pharmaceutical form	Solution for injection in pre-filled pen
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Subcutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Insulin Glargine
D.3.9.1	CAS number	160337-95-1
D.3.9.2	Current sponsor code	Gan & Lee Insulin Glargine injection
D.3.10	Strength
D.3.10.1	Concentration unit	U/ml unit(s)/millilitre
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	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)	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	Yes
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	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	Lantus
D.2.1.1.2	Name of the Marketing Authorisation holder	Sanofi-Aventis Deutschland GmbH
D.2.1.2	Country which granted the Marketing Authorisation	Germany
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	Insulin Glargine
D.3.4	Pharmaceutical form	Solution for injection in pre-filled pen
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Subcutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	INSULIN GLARGINE
D.3.9.1	CAS number	160337-95-1
D.3.9.4	EV Substance Code	SUB08196MIG
D.3.10	Strength
D.3.10.1	Concentration unit	U/ml unit(s)/millilitre
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	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)	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

Type 1 diabetes mellitus

diabetes mellitus tipo 1

E.1.1.1

Medical condition in easily understood language

Type 1 diabetes mellitus

diabetes mellitus tipo 1

E.1.1.2

Therapeutic area

Diseases [C] - Nutritional and Metabolic Diseases [C18]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.0
E.1.2	Level	PT
E.1.2	Classification code	10067584
E.1.2	Term	Type 1 diabetes mellitus
E.1.2	System Organ Class	10027433 - Metabolism and nutrition disorders

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

To demonstrate equivalence of Gan & Lee Pharmaceuticals insulin glargine and Lantus® in terms of immunogenicity and efficacy

Demostrar la equivalencia de la insulina glargina de Gan & Lee Pharmaceuticals y Lantus® en términos de inmunogenicidad y eficacia

E.2.2

Secondary objectives of the trial

- Immunogenicity: To evaluate the percentage of subjects with negative anti-insulin antibodies (AIA) at baseline who develop confirmed positive AIA up to Week 26, mean change from baseline in AIA titers between treatment groups, the percentage of subjects with confirmed AIA who develop any anti-insulin neutralizing antibodies up to Week 26, and the percentage of subjects in each treatment group with confirmed positive AIA up to Week 26.
- Safety: To evaluate the safety of Gan & Lee Pharmaceuticals insulin glargine injection in comparison with that of Lantus®
- Efficacy: To evaluate the efficacy of Gan & Lee Pharmaceuticals insulin glargine injection in comparison with that of Lantus®

- Inmunogenicidad: Evaluar el porcentaje de pacientes sin anticuerpos antiinsulínicos (AAI) al inicio que desarrollan AAI positivos confirmados hasta la semana 26, la media del cambio con respecto al inicio de los títulos de AAI entre los grupos de tratamiento, el porcentaje de pacientes con AAI confirmados que desarrollan anticuerpos neutralizantes contra la insulina hasta la semana 26, y el porcentaje de pacientes en cada grupo de tratamiento con AAI positivos confirmados hasta la semana 26
- Seguridad: Evaluar la seguridad de la inyección de insulina glargina de Gan & Lee Pharmaceuticals en comparación con la de Lantus®
- Eficacia: Evaluar la eficacia de la inyección de insulina glargina de Gan & Lee Pharmaceuticals en comparación con la de Lantus®

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Male or nonpregnant, nonlactating female subjects between the ages of 18 and 75 years, inclusive
2. Ability to provide written, signed, and dated informed consent to participate in the study, in accordance with the ICH GCP Guideline E6 and all applicable regulations, before completing any study-related
procedures
3. Ability to understand and fully comply with all study procedures and restrictions
4. Subjects with a confirmed diagnosis of type 1 diabetes mellitus who have been on an approved basal and bolus insulin regimen for at least 6 months (the type or brand of insulin should not have changed in the 6 months before screening)
5. HbA1c < 11.0%
6. BMI ≥ 19 kg/m2 and ≤ 35 kg/m2
7. Adherence to a prudent diet and exercise regimen recommended by the medical provider, and willingness to maintain these consistently for the duration of the study
8. Concomitant medications are allowed, including medications for thyroid disease, provided that a stable dosage has been achieved for at least 90 days before screening, and no significant dosing changes are
anticipated during the study

1. Hombres y mujeres que no estén embarazadas ni en período de lactancia de 18 a 75 años de edad, ambos inclusive.
2. Capacidad de proporcionar el consentimiento informado por escrito firmado y fechado para participar en el estudio, de acuerdo con la directriz E6 de BPC de la ICH y con todos los reglamentos aplicables, antes de llevar a cabo ningún procedimiento relacionado con el estudio.
3. Capacidad de comprender y cumplir plenamente todos los procedimientos y restricciones del estudio.
4. Diagnóstico confirmado de diabetes mellitus tipo 1 y en tratamiento aprobado con insulina basal y en bolo durante un mínimo de 6 meses (el tipo o marca de insulina no debe haber cambiado en los 6 meses previos a la selección).
5. HbA1c <11,0 %.
6. IMC ≥19 kg/m2 y ≤35 kg/m2.
7. Cumplimiento de unas pautas prudentes de alimentación y ejercicio, recomendadas por el médico, y voluntad de mantenerlas con constancia durante todo el estudio.
8. Se permiten los medicamentos concomitantes, incluidos los medicamentos para las enfermedades tiroideas, siempre que se haya alcanzado una dosis estable durante al menos 90 días antes de la selección y no se prevean cambios importantes en la posología durante el estudio (véanse a continuación los criterios de exclusión referentes a medicamentos concomitantes prohibidos específicos).

E.4

Principal exclusion criteria

1. Participation in another clinical study or use of any study drug within 30 days before screening
2. Previous use of a biosimilar insulin, either basal or bolus
3. Diabetic ketoacidosis within a year before screening
4. Brittle type 1 diabetes mellitus within the year before screening (eg, multiple hospitalizations related to diabetes mellitus and/or severe hypoglycemia for which the subject required 3rd party assistance)
5. Any severe, delayed sequela of diabetes mellitus, eg, worsening end-stage renal disease, advanced coronary artery disease, or myocardial infarction within the year before screening, or autonomic peristaltic problems, eg, gastroparesis
6. Anticipated change in insulin used during the study (change in dosage is allowed, but change in type or brand of insulin will result in the subject being withdrawn from the study)
7. Inadequately controlled thyroid disease, defined as a TSH or free T4 value > the upper limit of normal
8. BMI < 19 kg/m2 or > 35 kg/m2
9. Any clinically significant (in the opinion of the Investigator) hematology or chemistry test results at screening, including any liver function test > 3x the upper limit of normal (subjects with elevated
bilirubin due to Gilbert syndrome are eligible to participate)
10. Documented history of anti-insulin antibodies
11. Treatment with glucocorticosteroids, immunosuppressants, or cytostatic agents within 60 days before screening (newly-prescribed or high-dose corticosteroids are prohibited; chronically administered oral,
inhaled, topical, or intra-articular corticosteroids at a stable dosage are allowed if no increase in dose is anticipated during the study
12. Current use of medication intended to cause weight loss or weight gain
13. Alcohol or substance use disorder within the 2 years before screening
14. Any previous treatment with interferons
15. Any history of malignant disease within 5 years before screening, except for adequately treated basal cell carcinoma
16. Severe concomitant physical or psychiatric diseases or conditions
17. A history of a positive test result for HIV, hepatitis B, or hepatitis C; any subject who has a positive test result during the study may continue at the discretion of the Investigator
18. Any history of pancreatitis or pancreatectomy
19. Any diagnosis or condition that requires the subject to undergo procedures that could decrease antibodies in plasma or that would require treatment with immunosuppressant agents
20. Any condition eg, splenectomy, autoimmune disease, or rheumatologic disease, that could affect immunologic responses, could indicate an altered immune system, or could require treatment with a
prohibited medication
21. Any unresolved infection or a history of active infection within 30 days before screening other than mild or viral illness (as judged by the Investigator)
22. Any other disease or condition that in the opinion of the Investigator could confound the study results or limit the subject’s ability to participate in the study or comply with follow-up procedures; or any other factor that would indicate a significant risk of loss to follow up
23. Intolerance or history of hypersensitivity to insulin glargine or any excipient of the IP
24. Inability or unwillingness to wear the CGM sensor as required for the study, or to comply with the concomitant medication requirements regarding the CGM periods

1. Participación en otro estudio clínico o uso de algún fármaco del estudio en los 30 días anteriores a la selección.
2. Uso previo de una insulina biosimilar, ya sea basal o en bolo.
3. Cetoacidosis diabética en el año anterior a la selección.
4. Diabetes mellitus tipo 1 lábil en el año anterior a la selección (p. ej., múltiples hospitalizaciones relacionadas con la diabetes mellitus o hipoglucemia grave que requirió la asistencia del paciente por parte de terceros).
5. Cualquier secuela grave y tardía de la diabetes mellitus, p. ej., empeoramiento de la nefropatía terminal, coronariopatía avanzada o infarto de miocardio en el año anterior a la selección, o problemas peristálticos autonómicos como gastroparesia.
6. Cambio previsto en la insulina utilizada durante el estudio (se permite el cambio de posología, pero el cambio del tipo o la marca de la insulina provocará que el paciente sea retirado del estudio).
7. Enfermedad tiroidea insuficientemente controlada, definida por la presencia de valores de TSH o T4 libre >límite superior de la normalidad.
8. IMC <19 kg/m2 o >35 kg/m2.
9. Cualquier resultado de importancia clínica (según el investigador) en las pruebas de hematología o bioquímica efectuadas en la selección, como valores en las pruebas funcionales hepáticas >3 veces el límite superior de la normalidad (los pacientes con bilirrubina elevada debido al síndrome de Gilbert son aptos para participar).
10. Antecedentes documentados de anticuerpos antiinsulínicos.
11. Tratamiento con glucocorticoesteroides, inmunosupresores o citostáticos en los 60 días previos a la selección (los corticoesteroides recién prescritos o en dosis altas están prohibidos; los corticoesteroides orales, inhalados, tópicos o intraarticulares de administración prolongada a una pauta posológica estable están permitidos si no está previsto aumentar la dosis durante el estudio; véase en la Sección ‎8.6.4 una lista de los medicamentos prohibidos).
12. Uso en curso de medicamentos para perder o ganar peso.
13. Trastorno por consumo de alcohol o drogas en los 2 años previos a la selección.
14. Tratamiento previo con interferones.
15. Antecedentes de neoplasia maligna en los 5 años anteriores a la selección, excepto carcinoma basocelular debidamente tratado.
16. Enfermedades o trastornos psiquiátricos o físicos concomitantes.
17. Antecedentes de un resultado positivo en las pruebas de detección del VIH, hepatitis B o hepatitis C; si un paciente presenta un resultado positivo durante el estudio, podrá continuar a criterio del investigador.
18. Antecedentes de pancreatitis o pancreatectomía.
19. Diagnóstico o enfermedad que requiera que el paciente se someta a procedimientos que podrían disminuir la cantidad de anticuerpos en plasma o que precise tratamiento con inmunosupresores.
20. Cualquier afección, p. ej., esplenectomía, enfermedad autoinmune o enfermedad reumática, que pudiera afectar a las respuestas inmunitarias, ser indicativa de un trastorno del sistema inmunitario, o requerir tratamiento con un medicamento prohibido.
21. Cualquier infección no resuelta o antecedentes de infección activa en los 30 días previos a la selección, exceptuando las enfermedades leves o víricas (según el criterio del investigador).
22. Cualquier otra enfermedad o afección que, en opinión del investigador, pueda confundir los resultados del estudio o limitar la capacidad del paciente para participar en el estudio o cumplir los procedimientos de seguimiento; o cualquier otro factor que apunte a un riesgo importante de pérdida para el seguimiento.
23. Intolerancia o antecedentes de hipersensibilidad a la insulina glargina o a alguno de los excipientes del PEI.
24. Incapacidad o falta de voluntad para usar el sensor de MCG requerido en el estudio o para cumplir los requisitos relativos a los medicamentos concomitantes en relación con los períodos de MCG.

E.5 End points

E.5.1

Primary end point(s)

- Efficacy: The change in HbA1c from baseline at 26 weeks of study treatment
- Immunogenicity: The percentage of subjects in each treatment group who develop treatment induced AIA up to Week 26

- Eficacia: Cambio en la HbA1c desde el inicio hasta la semana 26 de tratamiento del estudio.
- Inmunogenicidad: Porcentaje de pacientes en cada grupo de tratamiento que desarrollan AAI inducidos por el tratamiento hasta la semana 26.

E.5.1.1

Timepoint(s) of evaluation of this end point

26 weeks

26 semanas

E.5.2

Secondary end point(s)

- Immunogenicity:
o The percentage of subjects in each treatment group with negative AIA at baseline who develop confirmed positive AIA up to Week 26
o The mean change from baseline in each treatment group in AIA titers after Week 26
o The percentage of subjects in each treatment group with confirmed AIA who develop any anti-insulin neutralizing antibodies up to Week 26
o The percentage of subjects in each treatment group with confirmed positive AIA up to Week 26
- Safety:
o The incidence and severity of all treatment-emergent adverse events and the following subgroups:
• Hypoglycemia, which will be fully documented prospectively in the
Hypoglycemic Events Record
• Serious adverse events, including fatal events
• Adverse events leading to termination of the study treatment and/or early withdrawal from the study
• IP-related adverse events
o The incidence of clinically significant laboratory abnormalities
o The incidence of clinically significant abnormalities in ECG and vital signs
- Efficacy:
o The number and percentage of subjects who achieve an FBG test result of ≤ 6.0 mmol/L (< 108.0 mg/dL) at Week 26
o The number and percentage of subjects who achieve a HbA1c of < 7.0% at Week 26
o The change in the 24-hour mean weighted glucose (MWG), defined as the total area under the curve (AUC) obtained with CGM divided by the total daily dose of IP, from baseline

- Inmunogenicidad
o Porcentaje de pacientes en cada grupo de tratamiento sin AAI al inicio que desarrollan AAI positivos confirmados hasta la semana 26.
o Media del cambio con respecto al inicio en los títulos de AAI tras la semana 26 en cada grupo de tratamiento.
o Porcentaje de pacientes en cada grupo de tratamiento con AAI confirmados que desarrollan anticuerpos neutralizantes contra la insulina hasta la semana 26.
o Porcentaje de pacientes en cada grupo de tratamiento con AAI positivos confirmados hasta la semana 26.
• Seguridad
o Incidencia y gravedad de todos los acontecimientos adversos surgidos durante el tratamiento y de los siguientes subgrupos:
Hipoglucemia, que se documentará de forma prospectiva y minuciosa en el Registro de Episodios Hipoglucémicos.
Acontecimientos adversos graves, incluyendo los mortales.
Acontecimientos adversos que provoquen la suspensión del tratamiento del estudio o la retirada prematura del estudio.
Acontecimientos adversos relacionados con el PEI.
o Incidencia de anomalías analíticas de importancia clínica.
o Incidencia de anomalías de importancia clínica en el ECG y las constantes vitales.
• Eficacia
o Número y porcentaje de pacientes con un valor de GA ≤6,0 mmol/l (<108,0 mg/dl) en la semana 26.
o Número y porcentaje de pacientes con un valor de HbA1c <7,0 % en la semana 26.
o Variación de la glucosa media ponderada (GMP) de 24 horas, definida como el área bajo la curva (AUC) total obtenida con la MCG dividida entre la dosis diaria total del PEI, desde el inicio.

E.5.2.1

Timepoint(s) of evaluation of this end point

Week 26,
Safety - throughout study

Semana 26,
Seguridad - durante todo el 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

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

Yes

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

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

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

Czech Republic

Germany

Hungary

Poland

Russian Federation

Spain

Ukraine

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

Last Patient Last Visit

Ultima Visita Ultimo Paciente

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial 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:

470

F.1.3

Elderly (>=65 years)

F.1.3.1

Number of subjects for this age range:

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.4.2

For a multinational trial

F.4.2.1

In the EEA

126

F.4.2.2

In the whole clinical trial

522

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)

return to Standard of Care

regresar al tratamiento estándar

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

2018-01-30

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2018-01-24

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2019-07-17

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