Clinical Evaluation of Eltrombopag in Chronic Idiopathic Thrombocytopenic Purpura (ITP)
Condition: Idiopathic Thrombocytopenic Purpura; Purpura, Thrombocytopenic, Idiopathic
MeSH terms: Purpura; Purpura, Thrombocytopenic; Purpura, Thrombocytopenic, Idiopathic
Intervention: Eltrombopag oral tablets
Intervention description: Eltrombopag oral tablets once daily
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 19.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: eltrombopag; thrombopoietin receptor agonist; ITP; blood platelet

Summary:

      An open-label, dose-adjustment extension study to evaluate the safety and efficacy of
      eltrombopag for treatment of subjects with ITP who have previously been enrolled in the
      eltrombopag trial TRA108109 (NCT00540423).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject has signed and dated written informed consent.

          -  Subject (>=20 years) diagnosed with ITP.

          -  Subject previously enrolled in TRA108109 (NCT00540423) must have completed the
             treatment and follow-up periods as defined in that protocol.

          -  Subject has no intercurrent medical event at risk of thrombosis such as thrombophilia.

          -  Prolongation of prothrombin time and activated partial thromboplastin time (aPTT) must
             be within 1.2 times the upper limit of the normal range with no history of
             hypercoagulable state.

          -  A complete blood count (CBC), within the reference range, with the following
             exceptions:

          -  Hemoglobin: patients with haemoglobin level < the lower limit of normal are eligible
             for inclusion if hemorrhage is present.

          -  Neutrophil count >= 1,500/L (1.5x10E9/L) is required for inclusion.

          -  The following clinical chemistries MUST NOT exceed 1.2 times the upper limit of the
             normal reference range: creatinine, total bilirubin and alkaline phosphatase.

          -  The following clinical chemistries MUST NOT exceed 2 times the upper limit of the
             normal reference range: ALT and AST.

          -  Albumin must be not less than 80% of the lower limit of normal.

          -  Female subjects must either be:

          -  of non-childbearing potential (hysterectomy, bilateral oophorectomy, bilateral tubal
             ligation or post-menopausal > 1 year), or

          -  of childbearing potential and have a negative pregnancy test and agree to use
             contraceptive methods specified in the GSK List of Highly Effective Methods for
             Avoidance of Pregnancy from two weeks prior to administration of study medication,
             throughout the study, and 28 days after completion or premature discontinuation from
             the study:

          -  Reticulocyte count within the reference range or elevated in case of bleeding.

        Exclusion Criteria:

          -  Any severe medical condition (cardiac, hepatic or renal disorder) other than chronic
             ITP. (Note: "Severe" is defined as >= Grade 3 as a rule according to the
             "Classification of the Severity of Adverse Experiences (PAB/SD Notification No.80,
             dated 29 June 1992)

          -  History of suspected or confirmed arterial or venous thrombosis (e.g., myocardial
             infarction, deep vein thrombosis) within the last 1 year.

          -  History of drug/alcohol abuse or dependence within the last 1 year.

          -  Suspected blood disorder other than ITP.

          -  Suspected platelet aggregation abnormality.

          -  Suspected cyclic thrombocytopenia.

          -  Suspected Evans Syndrome.

          -  Subjects who met the GSK Liver Stopping Criteria in the previous eltrombopag study
             TRA108109 (NCT00540423).

          -  Current or history of HIV infection or hepatitis B virus or hepatitis C virus
             infections.

          -  Current malignancy or history of malignancy that was treated with chemotherapy or
             radiotherapy.

          -  Female subjects who are nursing or pregnant, who may be pregnant, or who contemplate
             pregnancy during the study period.

          -  Subjects who are deemed unsuitable for the study by the investigator (or
             subinvestigator).

          -  Treatment with an investigational drug within 30 days preceding the first dose of
             study medication.

          -  Pre-existing cardiovascular disease, or arrhythmia known to increase the risk of
             thromboembolic events (e.g. atrial fibrillation).