Clinical Trials Register

Summary
EudraCT Number:	2007-005851-40
Sponsor's Protocol Code Number:	TPL104054
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:	2008-03-12
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

2007-005851-40

A.3

Full title of the trial

Estudio aleatorizado, doble ciego, controlado con placebo, multicéntrico para evaluar la seguridad y eficacia de Eltrombopag para reducir la necesidad de transfusión de plaquetas en sujetos trombocitopénicos con enfermedad hepática crónica que se van a someter a un procedimiento invasivo programado.
A Randomised, Double-Blind, Placebo-Controlled, Multi-Centre Study to Evaluate the Safety and Efficacy of Eltrombopag to Reduce the Need for Platelet Transfusion in Thrombocytopenic Subjects with Chronic Liver Disease Undergoing Elective Invasive Procedures.

A.3.2

Name or abbreviated title of the trial where available

ELEVATE

A.4.1

Sponsor's protocol code number

TPL104054

A.7

Trial is part of a Paediatric Investigation Plan

Information not present in EudraCT

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	GlaxoSmithKline S.A. España
B.1.3.4	Country	Spain
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
B.4.2	Country
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation
B.5.2	Functional name of contact point

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	Eltrombopag
D.3.2	Product code	SB-497115
D.3.4	Pharmaceutical form	Film-coated tablet
D.3.4.1	Specific paediatric formulation	Information not present in EudraCT
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	Eltrombopag
D.3.9.2	Current sponsor code	SB-497115
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	75
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)	Information not present in EudraCT
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	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	Information not present in EudraCT
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	Information not present in EudraCT
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	Film-coated tablet
D.8.4	Route of administration of the placebo	Oral use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Sujetos trombocitopénicos con enfermedad hepática crónica que se van a someter a un procedimiento invasivo programado.

MedDRA Classification

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

Demostrar la capacidad de eltrombopag, comparado con placebo, de reducir la proporción de pacientes con hepatopatía crónica y trombocitopenia (plaquetas <50.000/microlitro) que reciben transfusiones de plaquetas antes, durante y hasta siete días después de los procedimientos invasivos programados.
To demonstrate the ability of eltrombopag, compared to placebo to reduce the proportion of subjects with chronic liver disease and thrombocytopenia (platelets <50,000/microL) who receive platelet transfusions administered prior to, during and up to seven days following elective invasive procedures.

E.2.2

Secondary objectives of the trial

Evaluar el efecto de eltrombopag en la proporción de pacientes con hemorragia antes, durante y hasta siete días después de los procedimientos invasivos programados.
Evaluar seguridad y tolerabilidad de eltrombopag una vez al día a pacientes trombocitopénicos con hepatopatía crónica antes, durante y después de los procedimientos invasivos programados.
Demostrar la capacidad de eltrombopag comparado con placebo para reducir las transfusiones de plaquetas antes, durante y hasta 30 días después de los procedimientos en pacientes con hepatopatía crónica y un recuento basal de plaquetas <50.000/microL.
Evaluar el efecto de eltrombopag en la utilización de recursos médicos y recuentos de plaquetas antes, durante y hasta 30 días después de los procedimientos invasivos programados.
Describir la farmacocinética de eltrombopag y la relación entre la FC y las correspondientes variables de seguridad y eficacia.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Hombres y mujeres, de edad ≥18 años con hepatopatía crónica.
2. Puntuación de Child-Pugh de <=12.
3. Puntuación del Modelo de Hepatopatía Terminal (MELD) de <= 24.
4. Pacientes candidatos para someterse a un procedimiento invasivo programado y que requieran transfusión de plaquetas.
5. Recuento basal de plaquetas <50.000/microL.
6. Nivel basal de sodio en sangre >130mEq/L.
7. Concentración de hemoglobina >8g/dL estable durante al menos un mes.
8. Una mujer es elegible si:
No es fértil, lo que incluye a toda mujer con:
• Histerectomía
• Ovariectomía bilateral
• Ligadura bilateral de trompas
• Postmenopausia (determinada por cese total de menstruación durante más de un año)
Es fértil, presenta una prueba de embarazo en orina y/o suero en la selección y en el periodo de 24 horas previo a la primera dosis del producto en investigación, y usa uno de los siguientes métodos anticonceptivos aceptables:
• Abstinencia completa de relaciones sexuales durante dos semanas antes de la exposición al fármaco, durante todo el estudio clínico y durante los 28 días posteriores a la finalización o terminación prematura del estudio, para tener en cuenta la eliminación del fármaco del estudio (mínimo de 5 semividas).
• Cualquier dispositivo intrauterino (DIU) con una tasa de fracaso documentada menor de 1% al año.
• Anticoncepción de doble barrera (preservativo con gel espermicida o diafragma con espermicida).
• Pareja masculina que sea estéril (diagnosticado por un profesional médico cualificado) antes de la entrada de la paciente en el estudio, siendo ésta la única pareja sexual de la paciente.
• Anticonceptivos orales (combinados o solamente progesterona).
• Cualquier otro método anticonceptivo con una tasa de fracaso documentado <1% al año.
9. El paciente no tiene limitación física para ingerir o retener medicación oral.
10. El paciente puede comprender y cumplir con los requisitos del protocolo.
11. El paciente puede otorgar su consentimiento informado por escrito y fechado.

E.4

Principal exclusion criteria

1. Pacientes con hipersensibilidad, intolerancia o alergia conocidas a cualquiera de los ingredientes de los comprimidos de eltrombopag.
2. Evidencia de trombosis de la vena porta en imágenes abdominales en los 3 meses previos al comienzo del estudio.
3. Antecedentes de trombosis arterial o venosa, incluido el síndrome de Budd-Chiari, Y ≥ dos de los siguientes factores de riesgo: trastornos trombofílicos hereditarios (como Factor V Leiden, deficiencia de ATIII, etc.), terapia hormonal sustitutiva, tratamiento anticonceptivo sistémico (con estrógenos), tabaquismo, diabetes, hipercolesterolemia, medicación para hipertensión o cáncer.
4. Cualquier condición patológica asociada a una hemorragia presente activa de Grado 3 o 4 de la OMS.
5. Infección activa que precise tratamiento antibiótico sistémico. Se permite el empleo profiláctico de antibióticos.
6. Mujeres embarazadas o en periodo de lactancia.
7. Tratamiento con un fármaco en investigación en los 30 días o cinco semividas (el periodo que sea más largo) antes de la primera dosis de medicación del estudio.
8. Antecedentes de anomalías de la agregación plaquetaria que impidan una medición fiable del número de plaquetas.
9. Antecedentes de porfiria.
10. Participación previa en el estudio TPL104054.

E.5 End points

E.5.1

Primary end point(s)

Proporción de pacientes con hepatopatía crónica y trombocitopenia (plaquetas <50.000microL) que no precisen una transfusión de plaquetas antes, durante y hasta siete días después de los procedimientos invasivos programados.

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

Yes

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

Yes

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

Yes

E.6.13.1

Other scope of the trial description

Platelet Function Test

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

Information not present in EudraCT

E.7.1.2

Bioequivalence study

Information not present in EudraCT

E.7.1.3

Other

Information not present in EudraCT

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

Yes

E.8.2.3

Other

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

Information not present in EudraCT

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

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

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	No
F.1.1.1	In Utero	Information not present in EudraCT
F.1.1.2	Preterm newborn infants (up to gestational age < 37 weeks)	Information not present in EudraCT
F.1.1.3	Newborns (0-27 days)	Information not present in EudraCT
F.1.1.4	Infants and toddlers (28 days-23 months)	Information not present in EudraCT
F.1.1.5	Children (2-11years)	Information not present in EudraCT
F.1.1.6	Adolescents (12-17 years)	Information not present in EudraCT
F.1.2	Adults (18-64 years)	Yes
F.1.3	Elderly (>=65 years)	No
F.2 Gender
F.2.1	Female	Yes
F.2.2	Male	Yes
F.3 Group of trial subjects
F.3.1	Healthy volunteers	No
F.3.2	Patients	Yes
F.3.3	Specific vulnerable populations	Yes
F.3.3.1	Women of childbearing potential not using contraception	No
F.3.3.2	Women of child-bearing potential using contraception	Yes
F.3.3.3	Pregnant women	No
F.3.3.4	Nursing women	No
F.3.3.5	Emergency situation	No
F.3.3.6	Subjects incapable of giving consent personally	No
F.3.3.7	Others	No
F.4 Planned number of subjects to be included
F.4.1	In the member state	40
F.4.2	For a multinational trial
F.4.2.1	In the EEA	150
F.4.2.2	In the whole clinical trial	500

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

2008-05-06

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2008-04-25

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2009-10-15

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