Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Amgen
Age
1–17
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Diagnosis of primary ITP according to the American Society of Hematology (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; aspartate aminotransferase (AST) and alanine aminotransferase (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
You may not be if
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 human immunodeficiency virus (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, pegylated recombinant human megakaryocyte growth and development factor (PEG-rHuMGDF), Eltrombopag, recombinant human thrombopoietin (rHuTPO) or any platelet producing agent
Rituximab (for any indication) or 6-mercaptopurine (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 interleukin-11 (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
Clareo Health | Safety and Efficacy Study of Romiplostim to Treat Immune Thrombocytopenia (ITP) in Pediatric Patients
