Hemotrial Un proyecto de SEHH

Ensayo clínico

REPEAT. Repeated ExPosure To Eltrombopag in Adults with Idiopathic Thrombocytopenic Purpura. An Open-label repeat dosing study of eltrombopag olamine (SB-497115-GR) in adult subjects, with chronic idiopathic thrombocytopenic purpura (ITP)

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Resumen

2017-03-15 03:59:58
2006-002943-10
TRA108057
REPEAT. Repeated ExPosure To Eltrombopag in Adults with Idiopathic Thrombocytopenic Purpura. An Open-label repeat dosing study of eltrombopag olamine (SB-497115-GR) in adult subjects, with chronic idiopathic thrombocytopenic purpura (ITP)
REPEAT
TRA108057

PROMOTORES DEL ENSAYO
Nombre del promotor Organización Persona de contacto País
GlaxoSmithKline, S.A. 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
Information no disponible en EudraCT

No
No

No
No

Information no disponible en EudraCT
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
Information no disponible en EudraCT

No
No

No
No

Information no disponible en EudraCT
No

No
No

Si
  INFORMACIÓN DE PLACEBOS USADOS:

No hay placebos asignados al ensayo

Información General

Trombopenia

Idiopathic thrombocytopenic purpura (ITP)

To evaluate the effect of eltrombopag on platelet counts when administered during 3 cycles of repeated, intermittent treatment. A cycle is defined as up to 6 weeks on-treatment and up to 4-weeks off-treatment.

• To assess the number of subjects requiring rescue treatments over 3 cycles of therapy.• To assess the safety and tolerability of eltrombopag when administered over 3 cycles of therapy.• To assess anti-platelet antibody levels during the 3 cycles of eltrombopag treatment.• To assess the impact of eltrombopag on the incidence and severity of bleeding symptoms as measured by the WHO Bleeding Scale and ITP Bleeding Score over 3 cycles of therapy.

No


1. Subject has signed and dated a written inform consent.2. Adults (at least >18 years) diagnosed with chronic ITP according to the American Society of Hematology/British Committee for Standards in Hematology (ASH/BCSH) guidelines [George, 1996; BCSH, 2003], and a platelet count +/>20,000/microL and 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. It is important to clearly differentiate the effect of eltrombopag on platelet count from the treatment effects of prior and concomitant ITP therapies. Therefore:a. Previous therapy for ITP with immunoglobulins (IVIg and anti-D) 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.b. Subjects treated with concomitant ITP medication (e.g. corticosteroids or azathioprine) must be receiving a dose that has been stable for a 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. 6. Prothrombin time (PT/INR) and activated partial thromboplastin time (aPTT) must be within 80 to 120% of normal range with no history of hypercoagulable state.7. A complete blood count (CBC), within the reference range (including differential not indicative of a disorder other than ITP), with the following exceptions:• Platelet count >/=20,000/microL and 1500/microL (1.5 x 109/L) is required for inclusion (elevated WBC/ANC above the reference range due to steroid treatment is acceptable).8. The following clinical chemistries MUST NOT exceed the normal reference range by more than 20%: creatinine, ALT, AST, total bilirubin, total albumin and alkaline phosphatase.9. Subject is practicing an acceptable method of contraception (documented in chart). Female subjects (or female partners of male subjects) must either be of non-childbearing potential (hysterectomy, bilateral oophorectomy, bilateral tubal ligation or post-menopausal >1 year), or of childbearing potential and use of one of the following acceptable methods of contraception from two 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, and for males condom plus spermicide);• Male partner is sterile prior to entry into the study and is the only partner of the female;• Systemic contraceptives (combined or progesterone only).10. 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 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 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 AND two or more of the following risk factors: hereditary thrombophilic disorders (eg Factor V Leiden, ATIII deficiency, etc), hormone replacement therapy, systemic contraception (containing estrogen), smoking, diabetes, hypercholesterolemia, medication for hypertension or cancer.4. Pre-existing cardiac disease (congestive heart failure New York Heart Association (NYHA) Grade III/IV, (See Appendix 7), or arrhythmias known to involve the risk of thromboembolic events (e.g. atrial fibrillation), or subjects with a QTc >450 msec.5. Female subjects who are nursing or pregnant (positive serum or urine beta-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. Subjects 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 start and until the end of the study (Refer to Section 5.6.2., ‘Prohibited Medications and Non-Drug Therapies”).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 human immunodeficiency virus (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.

Consistency (durability of response) defined as the proportion of subjects who respond to eltrombopag treatment in Cycle 2 or 3 (given a response in Cycle 1). A response within a cycle is defined as a platelet count >/= 50,000/microL and at least 2x baseline (baseline is defined as Day 1 of each cycle) after up to 42 days of eltrombopag dosing.

Fase II
  DISEÑO DEL ENSAYO:

No
No

Si
No

No
No

No
No
  COMPARADOR DEL ENSAYO CONTROLADO:

No
No

No
No

No

Centros participantes:

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


  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:

16
50

Investigadores

  INVESTIGADORES QUE PARTICIPAN EN EL ESTUDIO

Estado actual


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En Marcha

Inicial