Hemotrial Un proyecto de SEHH

Ensayo clínico

A Phase IIIb, randomised, open label study to compare the safety, efficacy and tolerability of anagrelide hydrochloride versus hydroxyurea in high-risk essential thrombocythaemia patients.

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Resumen

2017-03-15 03:56:18
2004-004061-15
SPD422-403
A Phase IIIb, randomised, open label study to compare the safety, efficacy and tolerability of anagrelide hydrochloride versus hydroxyurea in high-risk essential thrombocythaemia patients.
SPD422-403

PROMOTORES DEL ENSAYO
Nombre del promotor Organización Persona de contacto País
Shire Pharmaceutical Development Ltd. United Kingdom

Fármacos

  INFORMACIÓN DE FÁRMACOS USADOS:
  FÁRMACO 1:
Test Xagrid
Shire Pharmaceutical Contracts Ltd Xagrid
Capsule, hard
Oral use

Detalles del Fármaco (Principio Activo):

Concentración del fármaco:
mg milligram(s) equal

0.5

Contenido del fármaco

Si
No

No
Information no disponible en EudraCT

No
No

Information no disponible en EudraCT
Information no disponible en EudraCT

Information no disponible en EudraCT
No

No
No

No
  FÁRMACO 2:
Comparator Hydrea
Bristol-Myers Squibb Hydrea
Capsule, hard
Oral use

Detalles del Fármaco (Principio Activo):

Concentración del fármaco:
mg milligram(s) equal

500

Contenido del fármaco

Si
No

No
Information no disponible en EudraCT

No
No

Information no disponible en EudraCT
Information no disponible en EudraCT

Information no disponible en EudraCT
No

No
No

No
  INFORMACIÓN DE PLACEBOS USADOS:

No hay placebos asignados al ensayo

Información General

Enfermedad Trombótica

Essential thrombocythaemia (ET)

To compare the safety of anagrelide and hydroxyurea in short and long term usage of up to three years with particular reference to cardiovascular safety (as assessed by echocardiography).

To compare the efficacy of anagrelide and hydroxyurea in terms of the platelet count after 6 months of treatment.To compare the efficacy of anagrelide and hydroxyurea in terms of the platelet count after 3 months of treatment.To compare the efficacy of anagrelide and hydroxyurea in terms of the number of patients achieving a complete response.To compare the cytoreductive impact of anagrelide and hydroxyurea on white blood cell and red blood cell lines.To investigate the tolerability of anagrelide and hydroyxurea in short and long term usage of up to three years.To investigate the effects of anagrelide and hydroxyurea on incidence of disease related thrombotic and haemorrhagic events.To compare the average time to response following treatment with anagrelide or hydroxyurea.

Information no disponible en EudraCT


Patients must have given written informed consent to participate in the study.Patients must be aged ?18 yearsPreviously untreated with a cytoreductive agent.Confirmed diagnosis of ET – High Risk ProfileSatisfactory Medical assessment with no clinically significant and relevant abnormalities.If patients are female and of childbearing potential they must have a negative serum pregnancy test prior to entering the study and must agree to use effective birth control for the duration of the study. Pregnant or lactating women are excluded from participation.Patients must be able willing and likely to comply with the study procedures and restrictions.

Patients with diagnosis of any other myeloproliferative disorder (MPD)Any known cause for a secondary thrombocytosis.Previous or current treatment with cytoreductive therapy.Anticoagulant therapies.Anti-aggregant therapies, including aspirin. (Aspirin or other anti-aggregant therapy is allowed up to the point of randomisation).Known or suspected intolerance to the study materials.Known or suspected Heart DiseaseLeft Ventricular Ejection Fraction (LVEF) <55%.Treatment with any medications known to alter ventricular ejection fraction.Life threatening malignancy or neoplasia which in the opinion of the investigator is unrelated to thrombocythaemia,Severe renal impairment defined as creatinine clearance <30ml/min, or severe hepatic impairment defined as elevated transaminases >5xULN.Clinically significant abnormal laboratory values (excluding markers of essential thrombocythaemia) will exclude the patient from the study as will known infection with hepatitis B, hepatitis C or HIV.Patients with a history of drug/alcohol abuse (within the previous 2 years)Patients must not have participated in another investigational study within 30 days prior to enrolment or for a longer duration if specified in local regulations.

The primary outcome for this study is the safety measurement LVEF. LVEF will be measured at predefined intervals (pre-treatment and Months 1, 2, 3, 6, 9, 12, 18, 24, 30 and 36) during the study and the response (slope) in LVEF for each patient will be obtained using linear regression. LVEF will be modelled as a linearfunction of time with a separate slope and intercept for each patient.The mean slope for each treatment group, the difference in the mean slopes between the two treatment groups, and the associated two-sided 95% confidence intervals will be presented. If the 95% CI for difference lies entirely below 2%/year then it will be concluded that the effect of anagrelide on LVEF is no worse than thatobserved for hydroxyurea.

Fase III
  DISEÑO DEL ENSAYO:

Si
Si

Si
No

No
Si

No
No
  COMPARADOR DEL ENSAYO CONTROLADO:

Si
No

No
No

Si

Centros participantes:

Si
Information no disponible en EudraCT
  TIEMPO ESTIMADO DURACIÓN DEL ENSAYO:

6
0
  TIEMPO ESTIMADO DURACIÓN DEL ENSAYO EN ESPAÑA:


  POBLACIÓN DE PACIENTES EN EL ESTUDIO:
  Población de pacientes: 1

Rango de edad:

-1
1

1

Sexo:

1
1

Número planeado de pacientes a incluir:

54

Para estudios internacionales:

184
184

Investigadores

  INVESTIGADORES QUE PARTICIPAN EN EL ESTUDIO

Estado actual


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