Chronic Idiopathic Thrombocytopenic Purpura MedDRA version: 15.1 Level: PT Classification code 10021245 Term: Idiopathic thrombocytopenic purpura System Organ Class: 10005329 - Blood and lymphatic system disorders
Conditions
Interventions
Product Name: Revolade
Product Code: SB497115
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: ELTROMBOPAG
CAS Number: 496775-61-2
Current Sponsor code: SB497115
Concentration unit: mg mil
Sponsors
GlaxoSmithKline
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subjects must have signed and dated a written informed consent and be able to understand and comply with protocol requirements and instructions. 2. Adults (=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; Provan, 2009]. In addition, a peripheral blood smear should support the diagnosis of ITP with no evidence of other disease causative of thrombocytopenia (e.g., pseudo thrombocytopenia, myelofibrosis). The physical examination should not suggest any disease, which may cause thrombocytopenia other than ITP. 3. Subjects must be physically eligible for serial bone marrow biopsies and must have a bone marrow biopsy performed during screening, and be willing to remain on the study for at least 2 years with annual bone marrow biopsies. 4. Subjects, who previously received eltrombopag or romiplostim, must have completed treatment with these therapies at least 6 months prior to the screening bone marrow biopsy. 5. Subjects must have the following clinical chemistry values: • ALT and AST =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Subjects with any clinically relevant abnormality, other than ITP, 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. Subjects with any concurrent malignant disease and/or a recent history of cancer treatment with systemic chemotherapy and/or radiotherapy. Exception: Subjects with a history of completely resected non-melanoma skin cancer or successfully treated in situ carcinoma are eligible. 3. Subjects with any prior history of arterial or venous thrombosis (stroke, transient ischemic attack, myocardial infarction, deep vein thrombosis or pulmonary embolism), AND = two of the following risk factors: hormone replacement therapy, systemic contraception (containing estrogen), smoking, diabetes, hypercholesterolemia, hypertension, cancer, hereditary thrombophilic disorders (e.g., Factor V Leiden, ATIII deficiency, etc), or any family history of arterial or venous thrombosis. 4. Subjects with screening bone marrow fibers of either MF Grade 3 using European Consensus scale or Grade 4 using Bauermeister scale. 5. Subjects with a QTc >450 msec or > 480 msec for subjects with Bundle Branch Block. 6. Female subjects who are nursing or pregnant (positive serum or urine ß-human chorionic gonadotrophin (ß-hCG) pregnancy test) at screening. 7. Subjects treated with an investigational drug (other than a TPO-R agonist) within 30 days or five half-lives (whichever is longer) preceding the first dose of eltrombopag in the study. (For romiplostim or eltrombopag, see inclusion criterion #4). 8. Subjects treated with any TPO-R agonist other than romiplostim or eltrombopag. 9. Subjects with recent history of alcohol/drug abuse as determined by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the levels of bone marrow fibers (reticulin and/or collagen) at baseline and any change from baseline after 1 and 2 years of treatment with eltrombopag in adult subjects with chronic ITP;Secondary Objective: To describe the long-term safety and tolerability of oral eltrombopag treatment in subjects with chronic ITP;Primary end point(s): The proportion of subjects with presence or absence of bone marrow fibers at baseline and a change from baseline after 1 year and 2 years of eltrombopag treatment. | — |
Countries
Czech Republic, France, Germany, Hungary, Italy
Outcome results
None listed