Study of ACE-536 for the Treatment of Anemia in Patients With Myelodysplastic Syndromes (MDS)
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|ClinicalTrials.gov Identifier: NCT01749514|
Recruitment Status : Recruiting
First Posted : December 13, 2012
Last Update Posted : October 17, 2017
|Condition or disease||Intervention/treatment||Phase|
|Anemia||Drug: ACE-536||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||128 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 2, Open Label, Ascending Dose Study of ACE-536 for the Treatment of Anemia in Patients With Low or Intermediate-1 Risk Myelodysplastic Syndromes (MDS)|
|Study Start Date :||January 2013|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||June 2019|
Subjects assigned to 1 of 7 possible dosing groups.
Subjects receive ACE-536 administered subcutaneously (SC) every 3 weeks for up to 5 cycles.
Other Name: luspatercept
- Proportion of patients who have a modified erythroid response (mHI-E). [ Time Frame: Assessed at approximately 28 weeks from patient screening. ]mHI-E defined as a hemoglobin increase of ≥ 1.5 g/dL from baseline for ≥ 14 days (in the absence of red blood cell [RBC] transfusions) in non-transfusion dependent patients, or, a reduction of either ≥ 4 units or ≥ 50% of units of RBCs transfused compared to pre treatment in transfusion dependent patients.
- Number of patients with adverse events. [ Time Frame: From treatment initiation to End-of-Study visit (approximately 28 weeks later). ]
- Rates of erythroid, neutrophil and platelet (HI-E, HI-N and HI-P) responses. [ Time Frame: Measured during any 8 week period on study, up to 28 weeks from patient screening, compared with the 8-week period prior to study day 1. ]
- Time to mHI-E response and HI-E response and duration of mHI-E and HI-E response. [ Time Frame: Measured over the course of study, up to approximately 24 weeks from initiation of dosing on study day 1. ]
- Frequency of RBC transfusions in transfusion-dependent patients. [ Time Frame: Approximately 28 weeks from patient screening. ]
- ACE-536 pharmacokinetics (e.g., serum half-life, peak serum concentration, time to peak concentration, etc.). [ Time Frame: Measured at multiple time points over the course of treatment, from study day 1 to approximately 24 weeks. ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01749514
|Contact: Clinical Trials Manageremail@example.com|
|Acceleron Investigative Site||Recruiting|