Hemotrial Un proyecto de SEHH

Ensayo clínico

A double-blind, randomised, placebo-controlled, parallel group study to investigate the efficacy, safety, tolerability, pharmacokinetics and pharmacodynamics of SB-497115-GR, a thrombopoietin receptor agonist, administered at 30, 50 and 75 mg as oral tablets once-daily for 6 weeks to adult male and female subjects with refractory, chronic immune thrombocytopenic purpura.

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Resumen

2017-03-15 03:55:17
2004-000367-98
TRA100773
A double-blind, randomised, placebo-controlled, parallel group study to investigate the efficacy, safety, tolerability, pharmacokinetics and pharmacodynamics of SB-497115-GR, a thrombopoietin receptor agonist, administered at 30, 50 and 75 mg as oral tablets once-daily for 6 weeks to adult male and female subjects with refractory, chronic immune thrombocytopenic purpura.
TRA100773

PROMOTORES DEL ENSAYO
Nombre del promotor Organización Persona de contacto País
GlaxoSmithKline Research and Development Limited United Kingdom

Fármacos

  INFORMACIÓN DE FÁRMACOS USADOS:
  FÁRMACO 1:
Test
SB497115 Tablet
Oral use

Detalles del Fármaco (Principio Activo):

Concentración del fármaco:
mg milligram(s) equal

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:
Test
SB497115 Tablet
Oral use

Detalles del Fármaco (Principio Activo):

Concentración del fármaco:
mg milligram(s) equal

25

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 3:
Test
SB497115 Tablet
Oral use

Detalles del Fármaco (Principio Activo):

Concentración del fármaco:
mg milligram(s) equal

50

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:
  PLACEBO 1:

Si
Tablet

Oral use

Información General

Trombopenia

Immune thrombocytopenic purpura (ITP)

To determine the efficacy of SB-497115-GR as a thrombopoietic agent, when administered once daily for 6 weeks to adult patients with refractory chronic ITP.

- To assess the safety and tolerability of SB-497115-GR when administered once daily for 6 weeks to adult patients with refractory chronic ITP.- To characterize the population pharmacokinetic profile of oral SB-497115-GR using a combined sparse and serial pharmacokinetic sampling strategy when administered once daily for 6 weeks to adult patients with refractory chronic ITP.- To determine the pharmacodynamic effect of SB-497115-GR on markers of thrombopoiesis when administered once daily for 6 weeks to adult patients with refractory chronic ITP.- To assess the impact of SB-497115-GR on the incidence and severity of symptoms of thrombocytopenia when administered once daily for 6 weeks to adult patients with refractory chronic ITP.- To assess the impact of SB-497115-GR on the quality of life when administered once daily for 6 weeks to adult patients with refractory chronic ITP.

Information no disponible en EudraCT


1. Diagnosed with chronic ITP at least 6 months prior to screening for this study with a platelet count of <30,000 platelets/?L.2. Refractory patients who have failed at least one previous treatment for chronic ITP, including corticosteroids, immunoglobulins, azathioprin, danazol, immunomodulators and/or splenectomy.3. Subjects treated with maintenance corticosteroid therapy must be receiving a steroid dose that has been stable for at least 1 month. 4. No past history of myocardial infarction or clinically significant ECG findings at screening.5. Normal PT and aPTT, no history of clotting disorder, other than ITP.6. Male, or female subjects that agree to use acceptable methods of contraception [including an intrauterine device (IUD)] and two forms of barrier contraception if engaging in sexual intercourse for at least 7 days prior to the first dose of study medication and continuing until 30 days after the final dose of study medication.7. Aged over 18 years.8. A signed and dated written informed consent is obtained from the subject.

1. Any clinically relevant abnormality, other than ITP, identified on the screening examination or any other medical condition or circumstance, which in the opinion of the Investigator, makes the subject unsuitable for participation in the study. 2. History of thrombosis within the last year.3. For female subjects, a positive serum or urine human chorionic gonadotrophin pregnancy test at screening or predose on Day 1.4. For female subjects, no current hormone replacement therapy or current oral contraceptive use. 5. History of alcohol/drug abuse or dependence within 12 months of the study.6. Treatment with an investigational drug within 30 days or five half-lives (whichever is longer) preceding the first dose of study medication.7. Consumption of aspirin, aspirin-containing compounds, salicylates, milk of magnesia, or nonsteroidal anti-inflammatories (NSAIDs) within 3 weeks of the study start and until the end of the study.8. Consumption of substrates of the cytochrome P450 2C9 isozyme, including diclofenac, ibuprofen, meloxicam, naproxen, flurbiprofen, piroxicam, suprofen, tolbutamide, glipizide, losartan, irbesartan, glibenclamide, glimepiride, amitriptyline, celecoxib, fluoxetine, fluvastatin, glyburide, fluoxetine, fluvastatin, glyburide, nateglinide, phenytoin, rosiglitazone, tamoxifen, torsemide and S-warfarin.9. Consumption of any herbal or dietary supplements, excluding vitamin or mineral supplements, within 1 week of the study start. 10. A complete blood count (CBC) and/or reticulocyte count outside the reference range, except for platelet count.11. History of platelet aggregation that prevents reliable measurement of platelet counts.12. History of infection with HIV, hepatitis B virus or hepatitis C virus.

- Proportion of subjects with a platelet count of >50,000/uL after 42 days of dosing. Patients who meet this criterion will be referred to as treatment responders.

Fase II
  DISEÑO DEL ENSAYO:

Si
Si

No
No

Si
Si

No
No
  COMPARADOR DEL ENSAYO CONTROLADO:

No
Si

No
No

Si

Centros participantes:

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

1
6
  TIEMPO ESTIMADO DURACIÓN DEL ENSAYO EN ESPAÑA:


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

Rango de edad:

0
1

1

Sexo:

1
1

Número planeado de pacientes a incluir:

Para estudios internacionales:

129
422

Investigadores

  INVESTIGADORES QUE PARTICIPAN EN EL ESTUDIO

Estado actual


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