← Back to all trials
Active Not Recruiting
NCT05490446
A Study of Tebapivat (AG-946) in Participants With Anemia Due to Lower-Risk Myelodysplastic Syndromes (LR-MDS)
Conditions: Myelodysplastic Syndromes
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE2
Enrollment: 87
Sponsor: Agios Pharmaceuticals, Inc.
Location: Innovative Clinical Research Institute Whittier Lakewood California
Summary
This purpose of this study is to establish proof of concept of tebapivat in participants with LR-MDS in Phase 2a and to evaluate the effect of tebapivat on transfusion independence (TI) in participants with LR-MDS in phase 2b.
Eligibility Criteria
Inclusion Criteria:
Phase 2a
1. At least 18 years of age at the time of providing informed consent;
2. Documented diagnosis of myelodysplastic syndromes (MDS) according to World Health Organization (WHO) classification (Arber et al, 2016), that meets Revised International Prognostic Scoring System (IPSS-R) classification of lower-risk disease (risk score: ≤3.5) and \2.5 × ULN (unless due to hepatic iron deposition)
* Serum bilirubin \>ULN, if the elevation is associated with clinically symptomatic choledocholithiasis, cholecystitis, biliary obstruction, or hepatocellular disease
7. Renal dysfunction, as defined by an eGFR \
Source: ClinicalTrials.gov (NCT05490446). StuddyBuddy aggregates publicly available trial information.
