E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Acute myelogenous leukemia & Idiopathic thrombocytopenic purpura (ITP |
Leucemia mieloide aguda y purpura trombocitopénica idiopática |
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E.1.1.1 | Medical condition in easily understood language |
Acute myelogenous leukemia a cancer of blood cells with the growth of abnormal white blood cells in the bone marrow that interferes with normal blood cell growth. ITP persistent low blood platelets. |
LMA es un tipo de cáncer de células sanguíneas que provoca un crecimiento anormal de leucocitos enmédula ósea interfiriendo con crecimiento normal de estas.En la PTI se mantiene bajo el nºde plaquetas |
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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 | 16.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10000886 |
E.1.2 | Term | Acute myeloid leukemia |
E.1.2 | System Organ Class | 100000004864 |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 16.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10021245 |
E.1.2 | Term | Idiopathic thrombocytopenic purpura |
E.1.2 | System Organ Class | 10005329 - Blood and lymphatic system disorders |
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E.1.3 | Condition being studied is a rare disease | Yes |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The objective of this study is to provide continuing treatment with eltrombopag for subjects who are currently participating in a GSK sponsored investigational study of eltrombopag (parent study) and to collect long term safety data. |
El objetivo de este estudio consiste en ofrecer tratamiento continuado con eltrombopag a los sujetos que estén participando en un estudio de investigación de eltrombopag patrocinado por GSK (estudio original) y en recopilar datos de seguridad a largo plazo. |
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E.2.2 | Secondary objectives of the trial |
Not applicable. |
No aplicable. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Subjects eligible for enrolment in the study must meet all of the following criteria: 1. Written informed consent has been obtained from the subject (or subject?s legally acceptable representative) prior to performance of any study-specific procedure. 2. The subject is participating in a GSK sponsored investigational study of eltrombopag (parent study) within the past 28 days and is receiving clinical benefit without unacceptable toxicity as determined by the investigator. 3. Subjects with a QTc <450msec or <480msec for subjects with bundle branch. 4. Women must be either of non-child bearing potential (see Section 8.4.8.1, for definition) or women with child-bearing potential and men with reproductive potential must be willing to practice acceptable methods of birth control during the study (See Section 8.4.8.1 for acceptable methods of birth control). 5. Women of childbearing potential must have a negative serum pregnancy test within 14 days of the first dose of study treatment and agree to use effective contraception, as defined in Section 8.4.8.1 during the study and for 4 weeks following the last dose of study treatment. 6. Men with a female partner of childbearing potential must have either had a prior vasectomy or agree to use effective contraception as described in Section 6.1 from time of first dose until 16 weeks after the last dose of study treatment. 7. In France, a subject will be eligible for inclusion in this study only if either affiliated to, or a beneficiary of, a social security category. |
Podrán participar en el estudio los sujetos que cumplan todos los criterios siguientes: 1. Obtención del consentimiento informado por escrito del sujeto (o su representante legal) antes de realizar ningún procedimiento específico del estudio. 2. El sujeto está participando en un estudio de investigación de eltrombopag patrocinado por GSK (estudio original) en los últimos 28 días y está obteniendo beneficios clínicos sin toxicidad inaceptable, según lo determinado por el investigador. 3. Sujetos con un intervalo QTc < 450 ms o < 480 ms en aquellos con bloqueo de rama. El QTc es el intervalo QT corregido por la frecuencia cardíaca según la fórmula de Bazett (QTcB), la fórmula de Fridericia (QTcF) u otro método, con interpretación del aparato o manual. A efectos de la elegibilidad y retirada de sujetos, se utilizará el QTcF. A efectos del análisis de datos, se utilizará el QTcF. El QTc deberá basarse en valores únicos o promediados de QTc de electrocardiogramas (ECG) por triplicado obtenidos durante un período breve de registro. 4. Las mujeres no podrán estar en edad fértil (véase la definición en la sección 8.4.8.1) o, en el caso de mujeres en edad fértil y de varones con capacidad reproductiva, deberán mostrarse dispuestos a utilizar métodos anticonceptivos aceptables durante el estudio (véanse los métodos anticonceptivos aceptables en la sección 8.4.8.1). 5. Las mujeres en edad fértil deberán dar negativo en una prueba de embarazo en suero realizada en los 14 días previos a la primera dosis del tratamiento del estudio, así como comprometerse a utilizar un método anticonceptivo eficaz, según se define en la sección 8.4.8.1, durante el estudio y durante las 4 semanas siguientes a la última dosis del tratamiento del estudio. 6. Los varones con una pareja en edad fértil deberán haberse sometido a una vasectomía previa o comprometerse a utilizar un método anticonceptivo eficaz, según se describe en la sección 6.1, desde la primera dosis y hasta 16 semanas después de la última dosis del tratamiento del estudio. 7. En Francia, solo podrán participar en este estudio sujetos afiliados o beneficiarios de algún régimen de la seguridad social. |
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E.4 | Principal exclusion criteria |
Subjects meeting any of the following criteria must not be enrolled in the study: 1. Permanent discontinuation of eltrombopag in the parent study based upon the study treatment discontinuation or study withdrawal criteria from the parent study. Subjects who permanently discontinued treatment because they completed all study related treatments remain eligible. 2. The subject is pregnant or a lactating female. 3. Any serious and/or unstable pre-existing medical, psychiatric disorder or other conditions at the time of transition to this study that could interfere with subject?s safety, obtaining informed consent or compliance with the study procedures, in the opinion of the investigator or GSK Medical Monitor. 4. French subjects: the French subject has participated in any study using an investigational drug during the previous 30 days, with the exception of eltrombopag, in the parent study. |
No podrán participar en el estudio los sujetos que cumplan alguno de los criterios siguientes: 1. Suspensión permanente de eltrombopag en el estudio original basándose en los criterios de suspensión del tratamiento y retirada del estudio del estudio original. Los sujetos que hayan suspendido permanentemente el tratamiento por haber completado todos los tratamientos relacionados con el estudio seguirán siendo elegibles. 2. Participante embarazada o en período de lactancia. 3. Cualquier trastorno médico, psiquiátrico o de otro tipo preexistente que sea grave o inestable en el momento de transición a este estudio y que, en opinión del investigador o monitor médico de GSK, podría interferir en la seguridad del sujeto, la obtención del consentimiento informado o el cumplimiento de los procedimientos del estudio. 4. Sujetos franceses: el sujeto ha participado en otro estudio de un fármaco en investigación en los 30 días precedentes, a excepción de eltrombopag, en el estudio original. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The objective of this study is to provide continuing treatment with eltrombopag for subjects who are currently participating in a GSK sponsored investigational study of eltrombopag (parent study) and to collect long term safety data |
El objetivo de este estudio consiste en ofrecer tratamiento continuado con eltrombopag a los sujetos que estén participando en un estudio de investigación de eltrombopag patrocinado por GSK (estudio original) y en recopilar datos de seguridad a largo plazo. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
End of study |
Fin del estudio. |
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E.5.2 | Secondary end point(s) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 1 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
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 | 4 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 50 |
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 | No |
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 |
Argentina |
Belgium |
Brazil |
Canada |
China |
Czech Republic |
France |
Germany |
Greece |
Hong Kong |
Hungary |
Ireland |
Israel |
Italy |
Korea, Republic of |
Mexico |
Netherlands |
Poland |
Russian Federation |
Spain |
Taiwan |
Thailand |
Tunisia |
United States |
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E.8.7 | Trial has a data monitoring committee | No |
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
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LVLS |
Última visita del último paciente. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 10 |
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 | 10 |