Long-term Study of Romiplostim in Thrombocytopenic Pediatric Patients With Immune Thrombocytopenia (ITP)

Exclusion Criteria

• •History of a bone marrow stem cell disorder (Any abnormal bone marrow findings other than those typical of ITP must be approved by Amgen before a subject may be enrolled)
• •Prior bone marrow transplant or peripheral blood progenitor cell transplant
• •Active or prior malignancy except non-melanoma skin cancers within the last 5 years
• •History of myelodysplastic syndrome
• •History of bleeding diathesis
• •History of congenital thrombocytopenia
• •History of Hepatitis B, Hepatitis C or human immunodeficiency virus (HIV)
• •History of systemic lupus erythematosus, Evans syndrome, or autoimmune neutropenia
• •History of antiphospholipid antibody syndrome or known positive for lupus anticoagulant
• •History of disseminated intravascular coagulation, hemolytic uremic syndrome, or thrombotic thrombocytopenic purpura
• •History of venous thromboembolism or thrombotic events
• •Previous use of romiplostim or previous use of eltrombopag within 4 weeks of enrollment
• •Previous use of pegylated recombinant human megakaryocyte growth and development factor (PEG-rHuMGDF), recombinant human thrombopoietin (rHuTPO) or any other platelet producing agent
• •Rituximab (for any indication) or 6-mercaptopurine within 8 weeks of enrollment, or anticipated use at any time during the study
• •Splenectomy within 4 weeks of the screening visit
• •Alkylating agents within 8 weeks before the screening visit or anticipated use during the time of the proposed study
• •Vaccinations known to decrease platelet counts within 8 weeks before the screening visit
• •Currently enrolled in another investigational device or drug study, or less than 30 days since ending investigational study
• •Will have investigational procedures while enrolled on study
• •Female subject of child bearing potential (defined as having first menses) not willing to use, in combination with her partner highly effective methods of birth control during treatment and for 1 month after the end of treatment
• •Subject is pregnant or breast feeding, or might become pregnant within 1 month after the end of treatment
• •Subject has known hypersensitivity to any recombinant Escherichia coli derived product (eg, Infergen®, Neupogen®, somatropin, and Actimmune®)
• •Has previously enrolled into this study
• •Will not be available for protocol-required study visits or procedures, to the best of the subject's and investigator's knowledge
• •Any kind of disorder that, may compromise the subject to give written informed consent and/or to comply with all required study procedures