Vanderbilt-Ingram Cancer Center

None Provided.

Criteria
 Inclusion Criteria:

 • Diagnosis of primary ITP according to the ASH Guidelines at least 6 months prior to screening, regardless of splenectomy status

 • Subject must be refractory to a prior ITP therapy, having relapsed after at least 1 prior ITP therapy, or ineligible for other ITP therapies; prior therapy includes first-line therapies

 • Age ≥ 1 year and < 18 years at the time of providing informed consent

 • The mean of 2 platelet counts taken during the screening period must be ≤ 30 x 10^9/L with neither count > 35 x 10^9/L

 • A serum creatinine concentration ≤ 1.5 times the laboratory normal range (for each age category) during the screening period

 • Adequate liver function; serum bilirubin ≤ 1.5 times the laboratory normal range during the screening period;AST and ALT ≤ 3.0 times the laboratory normal range during the screening period

 • Hemoglobin > 10.0 g/dL during the screening period

 • Subject and/or subject's legally acceptable representative has provided informed consent prior to any study-specific procedure; subject has provided assent, where required

 Exclusion Criteria:

 • Known 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 in the study

 • Known active or prior malignancy except adequately treated basal cell carcinoma

 • Known history of congenital thrombocytopenia

 • Known history of hepatitis B, hepatitis C, or HIV

 • Known history of H. pylori by urea breath test or stool antigen test within 6 months of enrollment or successfully treated with no evidence of infection

 • Known history of systemic lupus erythematosus, evans syndrome, or autoimmune neutropenia

 • Known history of antiphospholipid antibody syndrome or positive for lupus anticoagulant

 • Known history of disseminated intravascular coagulation, hemolytic uremic syndrome, or thrombotic thrombocytopenic purpura

 • Previous history of venous thromboembolism or thrombotic events

 • Previous use of romiplostim, PEG-rHuMGDF, Eltrombopag, rHuTPO or any platelet producing agent

 • Rituximab (for any indication) or 6-MP within 14 weeks before the screening visit, or anticipated use during the time of the proposed study

 • Splenectomy within 4 weeks of the screening visit

 • All hematopoietic growth factors including IL-11 (oprelvekin) within 4 weeks before 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

 • Known hypersensitivity to any recombinant E coli-derived product (eg, Infergen, Neupogen, Somatropin, and Actimmune)

 • Other criteria may apply