An open label extension study to evaluate the safety of long term dosing of AMG 531 in trombocytopenic subjects with myelodysplastic syndromes (MDS).
Phase 2
- Conditions
- 10018865Myelodysplasia
- Registration Number
- NL-OMON31052
- Lead Sponsor
- Amgen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 2
Inclusion Criteria
Completion of an end of study visit in AMG 531 study 20050159 or 20060198 study for the treatment of thrombocytopenia in subjects with IPSS low to int-1 MDS.
Exclusion Criteria
Evidence of progression/transformation of disease
Prior history of leukemia or aplastic anemia
Prior histor of bone marrow or stem cell transplantation
Receipt of hypomethylating agents or immunomodulating agents, high-dose chemotherapy targeted at MDS, or histone deacetylase inhibitors
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The incidence of all adverse events including clinically significant changes in<br /><br>laboratory values and incidence of antibody formation </p><br>
- Secondary Outcome Measures
Name Time Method <p>• The incidence of bleeding events.<br /><br>• The incidence of platelet transfusions.<br /><br>• The duration of platelet response. </p><br>