Clinical Trials Register

Summary
EudraCT Number:	2010-021196-85
Sponsor's Protocol Code Number:	BNIT-PRV-301
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Prematurely Ended
Date on which this record was first entered in the EudraCT database:	2011-11-24
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

Expand All Collapse All

A. Protocol Information

A.1

Member State Concerned

Spain - AEMPS

A.2

EudraCT number

2010-021196-85

A.3

Full title of the trial

A Randomized, Double-blind, Phase 3 Efficacy Trial of PROSTVAC-V/F ± GM-CSF in Men With Asymptomatic or Minimally Symptomatic Metastatic, Castrate-Resistant Prostate Cancer

Ensayo de eficacia aleatorizado de doble ciego y fase 3 de PROSTVAC-V/F ± FEC-GM en hombres que tienen cáncer de próstata asintomático o mínimamente sintomático metastásico resistente a la castración.

A.3.1

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

To determine whether PROSTVAC alone or in combination with GM-CSF is effective in prolonging overall survival in men with few or no symptoms from metastatic, castrate-resistant prostate cancer.

Determinar si PROSTVAC sólo o en combinación con FEC-GM es efectivo en prolongar la supervivencia global en hombres con cáncer de próstata metastático asintomático o mínimamente sintomático, resistente a la castración.

A.4.1

Sponsor's protocol code number

BNIT-PRV-301

A.5.2

US NCT (ClinicalTrials.gov registry) number

NCT01322490

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	BN ImmunoTherapeutics, 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	BN ImmunoTherapeutics, 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	BN ImmunoTherapeutics, Inc.
B.5.2	Functional name of contact point	Clinical Research
B.5.3	Address:
B.5.3.1	Street Address	2425 Garcia Avenue
B.5.3.2	Town/ city	Mountain View, CA
B.5.3.3	Post code	94043
B.5.3.4	Country	United States
B.5.4	Telephone number	+1 650 681 4660
B.5.5	Fax number	+1 866 268 2676
B.5.6	E-mail	wayne.godfrey@bn-it.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	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	PROSTVAC-V
D.3.2	Product code	PROSTVAC-V
D.3.4	Pharmaceutical form	Suspension for injection
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.3.9.1	CAS number	1225283-43-1
D.3.9.2	Current sponsor code	PROSTVAC-V
D.3.9.3	Other descriptive name	PROSTVAC-V-PSA-TRICOM in aqueous solution for injection
D.3.10	Strength
D.3.10.1	Concentration unit	U unit(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	200000000
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	Yes
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	PROSTVAC-F
D.3.2	Product code	PROSTVAC-F
D.3.4	Pharmaceutical form	Suspension for injection
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.3.9.1	CAS number	1225283-42-0
D.3.9.2	Current sponsor code	PROSTVAC-F
D.3.9.3	Other descriptive name	PROSTVAC-F: PROSTVAC-F-PSA-TRICOM in aqueous solution for injection
D.3.10	Strength
D.3.10.1	Concentration unit	Other
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	1000000000
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	Yes
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	Leukine
D.2.1.1.2	Name of the Marketing Authorisation holder	Genzyme Corporation
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	GM-CSF
D.3.4	Pharmaceutical form	Lyophilisate for solution for injection
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.3.9.1	CAS number	123774-72-1
D.3.9.3	Other descriptive name	GRANULOCYTE MACROPHAGE COLONY STIM FACTOR
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.2	Concentration type	not less then
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.8 Information on Placebo
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Suspension for injection
D.8.4	Route of administration of the placebo	Subcutaneous use
D.8 Placebo: 2
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Solution for injection
D.8.4	Route of administration of the placebo	Subcutaneous use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Asymptomatic or Minimally Symptomatic Metastatic, Castrate-Resistant Prostate Cancer

Cáncer de próstata asintomático o mínimamente sintomático metastático, resistente a la castración.

E.1.1.1

Medical condition in easily understood language

Prostate Cancer in men who experience few or no symptoms and do not respond to treatment with hormones.

Hombres con cáncer de próstata con pocos o sin síntomas y que no responden al tratamiento con hormonas.

E.1.1.2

Therapeutic area

Diseases [C] - Cancer [C04]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	14.0
E.1.2	Level	PT
E.1.2	Classification code	10060862
E.1.2	Term	Prostate cancer
E.1.2	System Organ Class	10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

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 ascertain whether the survival of patients randomized to Arm V+G (PROSTVAC plus GM-CSF) or to Arm V (PROSTVAC) is superior to that from patients randomized to Arm P (placebo control).

Determinar si la supervivencia de pacientes aleatorizados al brazo V+G (PROSTVAC+ FEC-GM) o al brazo V (PROSTVAC) es superior a los pacientes aleatorizados la brazo P (Placebo control).

E.2.2

Secondary objectives of the trial

To ascertain whether a greater proportion of patients randomized to Arm V+G or to Arm V remain event-free at six months as compared to the patients randomized to Arm P.

Determinar si es mayor la proporción de pacientes aleatorizados al brazo V+G o al brazo V que permanecen sin eventos a los 6 meses comparado con los pacientes aleatorizados al brazo P.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Signed Informed Consent
2. Men, 18 - 85 years of age
3. Castrate testosterone level < 50 ng/dl
4. Documented metastatic prostate cancer with progressive disease post surgical castration during androgen suppression therapy or during complete androgen blockade therapy and withdrawal. Documented by either criterion a (Radiological progression), OR criterion b (PSA progression).
a. Radiological progression defined as any new or enlarging bone lesions or growing lymph node disease, consistent with prostate cancer.
OR
b. PSA progression defined by sequence of rising values separated by > 1 week (2 separate increasing values) over a threshold minimum of 2.0 ng/ml. (PCWG2 PSA eligibility criteria).
5. Chemotherapy naïve. No prior chemotherapy for metastatic prostate cancer. Neo-adjuvant or adjuvant chemotherapy for primary prostate cancer is permissible if >3 years prior.
6. Vaccinia-experienced (previous smallpox vaccination)
7. ECOG Performance Score of 0 or 1
8. Life expectancy >= 1 year
9. Bone Marrow function:
- Absolute neutrophil count >= 1,500/mm3
- Hemoglobin >= 10 g/dL
- Platelet count >= 100,000/mm3
10. Hepatic Function:
- AST and ALT <= 2.5 times upper limit of normal (ULN)
- Bilirubin <= 1.5 times ULN
11. Renal Function:
- Creatinine <= 1.5 times ULN
12. Currently using a GnRH agonist or antagonist (unless surgically castrated)

1.Consentimiento informado firmado
2.Hombres de 18 a 85 años de edad.
3.Niveles de castración testosterona < 50 ng/dl.
4.Cáncer de próstata metastásico documentado con enfermedad progresiva después de la castración quirúrgica, durante el tratamiento de privación androgénica o durante el tratamiento de bloqueo androgénico completo y retirada. Documentado por el criterio A (progresión radiológica) O BIEN por el criterio B (progresión por PSA).
a.Progresión radiológica definida como cualquier lesión ósea nueva o que aumenta de tamaño, o enfermedad creciente de ganglios linfáticos, compatible con cáncer de próstata.
O BIEN b.Progresión de PSA definida por la secuencia de valores crecientes separados por > 1 semana (2 valores crecientes separados) sobre un umbral mínimo de 2 ng/ml(criterios de elegibilidad PSA del PCWG2).
5.Sin quimioterapia previa.Sin quimioterapia previa para cáncer de próstata metastásico.La quimioterapia complementaria o neocomplementaria para cáncer de próstata primario es permisible si se hizo > 3 años antes.
6.Experiencia con la vacuna (vacunación previa contra la viruela).
7.Estado general de ECOG de 0 ó 1.
8.Esperanza de vida >= 1 año.
9.Función de la médula ósea:
-Recuento absoluto de neutrófilos > =1.500/mm^3
-Hemoglobina >= 10 g/dl
-Recuento de plaquetas > o = 100.000/mm^3
10. Función hepática:
-AST y ALT <= 2,5 veces el límite superior normal (LSN)
-Bilirrubina <= 1,5 veces el LSN
11. Función renal: - Creatinina <= 1,5 veces el LSN.
12. Estar utilizando actualmente un agonista o antagonista de la GnRH (salvo castración quirúrgica).

E.4

Principal exclusion criteria

1. Cancer-related pain requiring scheduled opioid narcotics for control (prn <= 2x per week is allowed)
2. Metastasis to organ systems other than lymph nodes and/or bone
3. LDH >= 2 times ULN
4. Alkaline phosphatase ? 2 times ULN
5. Estimated PSA doubling time of <1 month as established within 6 months of the anticipated first dose of vaccine or placebo. A minimum of 3 PSA level determinations, at least 2 weeks apart (over a 6 month time-period), is required for assessment.
6. Concurrent or prior Provenge (sipuleucel-T) immunotherapy for prostate cancer
7. Receipt of an investigational agent within 30 days (or 60 days for an antibody-based therapy) of the first planned dose of PROSTVAC. There is no exclusion to previous experimental therapy provided dosing/treatment is completed at least 30 days prior to the first planned dose of vaccine unless otherwise noted (#5, #14 this section).
8. History of prior malignancies other than prostate cancer within the past 3 years, excluding basal or squamous cell carcinoma of the skin
9. Congestive heart failure (NYHA Class II, III, or IV), unstable angina, ventricular or hemodynamically significant atrial arrhythmia, or cardiovascular disease such as stroke or myocardial infarction (current or within the past 6 months)
10. Significant medical abnormality (defined as a pre-existing AE/condition >=Grade 3 according to NCI CTCAE v 4.0). Patients with a known history of a CLINICALLY NON-SIGNIFICANT laboratory parameter (or Clinically Significant as defined by institutional normal ranges, but in the opinion of the Investigator, consistent with values seen for patients with mCRPC) may be eligible provided a written approval is granted by the study Medical Monitor prior to enrollment.
11. Confirmed positive for HIV, hepatitis B, and /or hepatitis C
12. Prior solid organ or bone marrow transplant
13. Immunodeficiency or splenectomy
14. Concurrent immunosuppressive therapy
15. Inflammatory eye disease requiring steroid treatment
16. Chronic administration (defined as daily or every other day for continued use > 14 days) of systemic corticosteroids within 28 days of the first planned dose of PROSTVAC. Use of inhaled steroids, nasal sprays, and topical creams for small body areas is allowed.
17. History of or active autoimmune disease. Autoimmune neutropenia, thrombocytopenia, or hemolytic anemia, systemic lupus erythematosis, Sjogren's syndrome, scleroderma, myasthenia gravis, Goodpasture's syndrome, Addison's disease, Hashimoto's thyroiditis, or Graves disease. Persons with vitiligo are not excluded. Diabetics are not excluded if the condition is well controlled.
18. Known allergy to eggs, egg products, aminoglycoside antibiotics (for example, gentamicin or tobramycin), or GM-CSF. Patients with a known or suspected allergy to radiological contrast agents are eligible, but this must be noted in the patient's medical history and in the chart notes.
19. History of atopic dermatitis or active skin condition (acute, chronic, exfoliative) that disrupts the epidermis
20. Previous adverse reactions to smallpox vaccination
21. Unable to avoid close contact or household contact with the following high-risk individuals for three weeks after the Day 1 vaccination: (a) children <= 3 years of age, (b) pregnant or nursing women, (c) individuals with prior or concurrent extensive eczema or other eczemoid skin disorders, or (d) immunocompromised individuals, such as those with HIV.
22. Any condition which, in the opinion of the investigator, would prevent full participation in this trial (including the long-term follow-up), or would interfere with the evaluation of the trial endpoints
23. Study personnel

1.Dolor relacionado con el cáncer que tengan pautados opioides para tratar el dolor (prn <= 2 veces por semana está permitido).
2.Metástasis en sistemas orgánicos que no sean ganglios linfáticos y/o huesos.
3.LDH >= 2 veces el LSN.
4.Fosfatasa alcalina >= 2 veces el LSN.
5.PSA estimada que se duplique en < de 1 mes según se establezca en el plazo de 6 meses de la primera dosis prevista de vacuna o placebo.Se requiere para la evaluación un mínimo de determinaciones de nivel de 3 PSA, con una separación de por lo menos 2 semanas (en un período de 6 meses).
6.Inmunoterapia para el cáncer de próstata concomitante o previa con Provenge (sipuleucel-T).
7.Uso de un producto en investigación en el plazo de 30 días (o 60 días para un tratamiento basado en anticuerpos) de la primera dosis planeada de PROSTVAC.No hay exclusión de tratamiento experimental previo siempre que las dosis o el tratamiento se hayan completado al menos 30 días antes de la primera dosis planeada de vacuna salvo que se especifique lo contrario (puntos 5 y 14 de esta sección).
8.Antecedentes de neoplasias que no sean cáncer de próstata en el plazo de los últimos 3 años, excepto carcinoma basocelular o carcinoma espinocelular de la piel.
9.Insuficiencia cardíaca congestiva (NYHA clase II, III o IV), angina de pecho inestable, arritmia ventricular o arritmia auricular hemodinámicamente significativa, o enfermedades cardiovasculares tales como accidente cerebrovascular o infarto de miocardio (actuales o en los últimos 6 meses).
10.Anomalía médica significativa (definida como afección o reacciones adversas preexistentes >=grado 3 según NCI CTCAE v. 4.0).Pacientes con antecedentes conocidos de parámetro de laboratorio NO SIGNIFICATIVO CLÍNICAMENTE (o clínicamente significativos según lo definido por intervalos institucionales normales, pero que según la opinión del investigador coincidan con valores vistos para pacientes con CPmRC) pueden ser elegibles, siempre que el monitorr médico del estudio otorgue una aprobación por escrito antes de la inclusión.
11.Resultado positivo confirmado para VIH, hepatitis B y/o hepatitis C.
12.Trasplante previo de un órgano o médula ósea.
13.Inmunodeficiencia o esplenectomía.
14.Tratamiento inmunosupresor concomitante.
15.Enfermedad ocular inflamatoria que requiera tratamiento con esteroides.
16.Administración crónica (definida como diaria o de cada dos días para uso continuado > 14 días) de corticosteroides sistémicos en el plazo de 28 días de la primera dosis planeada de PROSTVAC.Está permitido el uso de esteroides inhalados, aerosoles nasales y pomadas tópicas para áreas reducidas del cuerpo.
17.Antecedentes de enfermedad autoinmune o enfermedad autoinmune activa.Neutropenia autoinmune, trombocitopenia o anemia hemolítica, lupus eritematoso sistémico, síndrome de Sjogren, esclerodermia, miastenia grave, síndrome de Goodpasture, enfermedad de Addison, tiroiditis de Hashimoto o enfermedad de Graves-Basedow.No se excluye a las personas con vitíligo.No se excluye a la diabetes si está bien controlada.
18.Alergia conocida al huevo, a productos derivados de huevos, a antibióticos aminoglucósidos (por ejemplo, gentamicina o tobramicina) o a FEC-GM. Los pacientes con alergia comprobada o potencial a agentes de contraste radiológicos son elegibles, pero esto debe indicarse en la anamnesis o en la historia clínica del paciente.
19.Antecedentes de dermatitis atópica o afección activa de la piel (aguda, crónica, exfoliativa) que altera la epidermis.
20.Reacciones adversas previas a vacunación contra la viruela.
21.Imposibilidad de evitar el contacto directo o en el hogar con los siguientes individuos de alto riesgo durante tres semanas después de la vacunación del día 1:(a) niños <= 3 años de edad, (b) mujeres lactantes o embarazadas, (c) individuos con eccema extenso previo o concomitante, u otras enfermedades eccematoides de la piel, o (d) individuos inmunodeprimidos, como aquellos con VIH.
22.Toda afección que, en la opinión del investigador, evitaría la participación plena en este ensayo (incluido el seguimiento a largo plazo) o interferiría en la evaluación de los criterios de valoración del ensayo.
23.Personal del estudio.

E.5 End points

E.5.1

Primary end point(s)

- Overall survival

Supervivencia global.

E.5.1.1

Timepoint(s) of evaluation of this end point

Study closure or death.

Cierre del ensayo o muerte.

E.5.2

Secondary end point(s)

- Proportion of event-free patients (radiological progression or chemotherapy initiation) at six months compared to placebo

Proporción de pacientes libres de eventos (progresión radiológica o iniciación de quimioterápia) a los seis meses comparado con placebo

E.5.2.1

Timepoint(s) of evaluation of this end point

Six months.

Seis meses

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)

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

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)

E.8.2.2

Placebo

Yes

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

105

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

Australia

Austria

Belgium

Canada

Chile

Czech Republic

Denmark

Estonia

France

Germany

Iceland

Israel

Lithuania

Mexico

Netherlands

Panama

Poland

Russian Federation

Spain

Switzerland

United Kingdom

United States

E.8.7

Trial has a data monitoring committee

Yes

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

The end of the trial is defined as the last anticipated visit of the last patient enrolled.

El final del ensayo se define como la última visita prevista del último paciente incluido.

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

Number of subjects for this age range:

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:

300

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

900

F.2 Gender

F.2.1

Female

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.4.2

For a multinational trial

F.4.2.1

In the EEA

349

F.4.2.2

In the whole clinical trial

1200

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)

Standard of care.

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

2012-03-16

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2012-01-12

P. End of Trial
P.	End of Trial Status	Prematurely Ended

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