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©2022 Stanford Medicine
Not Recruiting
Trial ID: NCT00472290
An Open Label Extension Study Evaluating the Safety of Long Term Dosing of Romiplostim in Thrombocytopenic Subjects With Myelodysplastic Syndromes (MDS)
Professor of Medicine (Hematology)
Inclusion Criteria
- Subject completed a romiplostim study for the treatment of thrombocytopenia in
subjects with MDS
- Subject has an Eastern Cooperative Oncology (ECOG) performance status of 0 to 2
- Subject had a platelet count ≤ 50 x 10^9/L since the final dose of investigational
product in the parent study
- Subject or his/her legally acceptable representative provided written informed consent
before any study-specific procedures were initiated
Exclusion Criteria
- Subject has been diagnosed with AML or has a blast count ≥ 10% by peripheral blood or
bone marrow biopsy
- Subject has a prior history of leukemia
- Subject has a prior history of bone marrow or stem cell transplantation
- Subject has a prior malignancy (other than in situ cervical cancer, controlled
prostate cancer, or basal cell cancer of the skin) unless treated with curative intent
and without evidence of disease for ≥ 3 years before randomization
- Subject has active or uncontrolled infections
- Subject has unstable angina, congestive heart failure [New York Heart Association
(NYHA) > class II], uncontrolled hypertension (diastolic > 100 mmHg), uncontrolled
cardiac arrhythmia, or recent (within 1 year) myocardial infarction
- Subject has a history of arterial thrombosis (eg, stroke or transient ischemic attack)
in the past year
- Subject has a history of venous thrombosis that currently requires anti-coagulation
therapy
- Subject received interleukin (IL)-11 within 4 weeks of screening
- Subject previously received a thrombopoietic growth factor (other than romiplostim)
- Subject has a known hypersensitivity to any recombinant E coli-derived product (eg,
Infergen®, Neupogen®, Somatropin, Actimmune)
- Subject is currently enrolled in investigational device or drug study(ies), has not
yet completed at least 4 weeks since ending investigational device or drug study(ies)
(other than parent romiplostim study), or subject is receiving other investigational
agent(s)/device(s)
- Subject is of child-bearing potential and is evidently pregnant (eg, positive human
chorionic gonadotropin [HCG] test) or is breast feeding
- Subject is not using adequate contraceptive precautions
- Subject has any kind of disorder that compromises his/her ability to give written
informed consent (and does not have a legally acceptable representative) or is unable
to comply with study procedures
drug: Romiplostim (formerly AMG 531)
Not Recruiting
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Mai Tran
6507238594