Status:
COMPLETED
Evaluating the Safety of Long Term Dosing of Romiplostim (Formerly AMG 531) in Thrombocytopenic Subjects With Myelodysplastic Syndromes (MDS)
Lead Sponsor:
Amgen
Conditions:
Hematology
MDS
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This is an open label extension study of romiplostim for treatment of thrombocytopenia (platelet count ≤ 50 x 10\^9/L) in MDS subjects. The study is designed to assess the long-term safety of treatmen...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
April 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 26 2011
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT00472290
Start Date
April 1 2007
End Date
December 26 2011
Last Update
December 29 2017
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