Hemotrial Un proyecto de SEHH

Ensayo clínico

A randomized, double-blind, placebo-controlled phase III study, to evaluate the efficacy, safety and tolerability of eltrombopag olamine (SB-497115-GR), a thrombopoietin receptor agonist, administered for 6 months as oral tablets once daily in adult subjects with previously treated chronic idiopathic thrombocytopenic purpura (ITP).

  • Guardar

  • Imprimir
  • << Volver

Resumen

2017-03-15 03:58:59
2006-000470-78
TRA102537
A randomized, double-blind, placebo-controlled phase III study, to evaluate the efficacy, safety and tolerability of eltrombopag olamine (SB-497115-GR), a thrombopoietin receptor agonist, administered for 6 months as oral tablets once daily in adult subjects with previously treated chronic idiopathic thrombocytopenic purpura (ITP).
RAISE
TRA102537

PROMOTORES DEL ENSAYO
Nombre del promotor Organización Persona de contacto País
GlaxoSmithKline, S.A. GlaxoSmithKline GSK Clinical Support Helpdesk Spain

Fármacos

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

Detalles del Fármaco (Principio Activo):
SB-497115

Concentración del fármaco:
mg/g milligram( equal

25

Contenido del fármaco

Si
No

No
No

No
No

No
No

No
No

No
No

Si
  FÁRMACO 2:
Test
Eltrombopag
SB497115 Tablet
Oral use

Detalles del Fármaco (Principio Activo):
SB-497115

Concentración del fármaco:
mg/g milligram( equal

50

Contenido del fármaco

Si
No

No
No

No
No

No
No

No
No

No
No

Si
  INFORMACIÓN DE PLACEBOS USADOS:
  PLACEBO 1:

Si
Tablet

Oral use

Información General

Trombopenia

Idiopathic thrombocytopenic purpura (ITP)

To determine the efficacy of oral eltrombopag, when administered once daily, for 6 months duration, to previously treated adult subjects with chronic ITP

? To assess ability of eltrombopag to prevent use of rescue treatment ? To describe pharmacodynamics & durability of eltrombopag response? To determine efficacy of oral eltrombopag, when administered once daily for 6 weeks ? To assess safety & tolerability of eltrombopag when administered for 6 months? To describe effect of eltrombopag on reduction of concomitant ITP medications from baseline? To assess impact of eltrombopag on incidence & severity of bleeding symptoms of thrombocytopenia when administered once daily for 6 months ? To assess impact of eltrombopag on health related QoL & patient reported outcomesEXPLORATORY OBJECTIVES:? To assess effect of administration of eltrombopag on anti-platelet antibody levels? To use proteomic analysis to identify proteins that may correlate with safety & tolerability and/or predict response to eltrombopag

No


1. Subject has signed and dated a written informed consent.2. Adults (> or =18 years) diagnosed with chronic ITP according to the American Society for Hematology/British Committee for Standards in Hematology (ASH/BCSH) guidelines [George, 1996; BCSH, 2003], and platelet count < 30,000/microL on Day 1 (or within 24 hours prior to dosing on Day 1). In addition, a peripheral blood smear should support the diagnosis of ITP with no evidence of other causes of thrombocytopenia (e.g. pseudothrombocytopenia, myelofibrosis). The physical examination should not show signs suggestive of any disease other than ITP which may cause thrombocytopenia.3. Subjects who have previously received one or more prior ITP therapies. Previous treatments for ITP include but are not limited to corticosteroids, immunoglobulins, azathioprine, danazol, cyclophosphamide and/or rituximab.4. Subjects must have either initially responded (platelet count > 100,000/microL) to a previous ITP therapy or have had a bone marrow biopsy consistent with ITP within 3 years to rule out myelodysplastic syndromes or other causes of thrombocytopenia.5. Previous therapy for ITP with immunoglobulins (IVIg and anti-D), and cyclophosphamide must have been completed at least 1 week prior to randomization and the platelet count must show a clear downward trend after the last treatment with immunoglobulins. Previous treatment for ITP with splenectomy, rituximab and cyclophosphamide must have been completed at least 4 weeks prior to randomization, or clearly be ineffective.6. Subjects treated with concomitant ITP medication (eg corticosteroids or azathioprine) must be receiving a dose that has been stable for at least 4 weeks prior to randomization. Subjects treated with cyclosporine A, mycophenolate mofetil or danazol must be receiving a dose that has been stable for at least 3 months prior to randomization. The medication should be continued with a stable dose for the initial 6 weeks of study (See Section 9.1.2, ?Concomitant ITP Therapy?) 7. Prothrombin time (PT/INR) and activated partial thromboplastin time (aPTT) must be within 80 to 120% of the normal range with no history of hypercoagulable state.8. A complete blood count (CBC), within the reference range (including WBC differential not indicative of a disorder other than ITP), with the following exceptions:? < 30,000 platelets/microL on Day 1 (or within 24 hours of Day 1) is required for inclusion,? Hemoglobin: Subjects with hemoglobin levels between 10 g/dL (100 g/L) and the lower limit of normal are eligible for inclusion, if anemia is clearly attributable to ITP (excessive blood loss).? ANC >or= 1500/microL (1.5 x 109/L) is required for inclusion (elevated WBC/ANC due to steroid treatment is acceptable).9. The following clinical chemistries MUST NOT exceed the upper limit of normal (ULN) reference range by more than 20%: creatinine, ALT, AST, total bilirubin, and alkaline phosphatase. In addition, total albumin must not be below the lower limit of normal (LLN) by more than 10%10. Subject is practicing an acceptable method of contraception (documented in chart). Female subjects (or female partners of male subjects) must either be non-childbearing potential (hysterectomy, bilateral oopherectomy, bilateral tubal ligation or post-menopausal > 1 year), or childbearing potential & use 1 of the following highly effective methods of contraception (i.e., Pearl Index <1.0%) from 2 weeks prior to administration of study medication, throughout the study, and 28 days after completion or premature discontinuation from the study:? Complete abstinence from intercourse;? Intrauterine device (IUD);? Two forms of barrier contraception (diaphragm plus spermicide, & for males condom plus spermicide);? Male partner is sterile prior to entry into the study & is the only partner of the female;? Systemic contraceptives (combined or progesterone only).11. Subject is able to understand and comply with protocol requirements and instructions and intends to complete the study as planned.

1. Any clinically relevant abnormality, other than ITP, identified on screening examination/any other medical condition or circumstance, which in the opinion of the investigator makes the subject unsuitable for participation in the study or suggests another primary diagnosis (e.g., thrombocytopenia is secondary to another disease). 2. Concurrent malignant disease and/or history of cancer treatment with cytotoxic chemotherapy and/or radiotherapy.3. Any prior history of arterial or venous thrombosis (stroke, transient ischemic attack, myocardial infarction, deep vein thrombosis or pulmonary embolism), AND at least 2 of the following risk factors: hormone replacement therapy, systemic contraception (containing estrogen), smoking, diabetes, hypercholesterolemia, medication for hypertension, cancer, hereditary thrombophilic disorders (e.g., Factor V Leiden, ATIII deficiency, etc), or any other family history of arterial or venous thrombosis4. Pre-existing cardiac disease (congestive heart failure, New York Heart Association [NYHA] Grade III/IV), or arrhythmia known to increase the risk of thromboembolic events (e.g. artrial fibrillation), or subjects with a QTc >450 msec5. Female subjects who are nursing or pregnant (positive serum or urine ?-human chorionic gonadotrophin pregnancy test) at screening or pre-dose on Day 1.6. History of alcohol/drug abuse.7. Treatment with an investigational drug within 30 days or five half-lives (whichever is longer) preceding the first dose of study medication.8. Subject treated with drugs that affect platelet function (including but not limited to aspirin, clopidogrel or NSAIDs) or anti-coagulants for > 3 consecutive days within 2 weeks of the study start and until the end of the study.9. History of platelet agglutination abnormality that prevents reliable measurement of platelet counts.10. All subjects with secondary immune thrombocytopenia, including those with laboratory or clinical evidence of HIV infection, anti-phospholipid antibody syndrome, chronic hepatitis B infection, hepatitis C virus infection, or any evidence for active hepatitis at the time of subject screening. If a potential subject has no clinical history that would support HIV infection or hepatitis infection, no further laboratory screening is necessary; however, standard medical practice would suggest further evaluation of patients who have risk factors for these infections.11. Previous participation in a clinical study with eltrombopag.12. Patients planning to have cataract surgery.13. In France, a subject is neither affiliated with nor a beneficiary of a social security category.

The primary endpoint is the odds of achieving a platelet count at or 50,000/microL and ? 400,000/microL during the 6 month treatment period, for subjects receiving eltrombopag relative to placebo

Fase III
  DISEÑO DEL ENSAYO:

Si
Si

No
No

Si
Si

No
No
  COMPARADOR DEL ENSAYO CONTROLADO:

No
Si

No
No

Si

Centros participantes:

Si
No
  TIEMPO ESTIMADO DURACIÓN DEL ENSAYO:

2
0
  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:

5

Para estudios internacionales:

68
189

Investigadores

  INVESTIGADORES QUE PARTICIPAN EN EL ESTUDIO

Estado actual


 Por Determinar



En Marcha

Inicial