Efficacy and Safety of FG-4592 for Treatment of Anemia in Subjects With Lower Risk MDS

• Status: Recruiting
• Trial end date: 2023-05-31
• Target enrollment: 0
• Participant gender: All

Summary

The objective of this study to evaluate the efficacy and safety of FG-4592 for the treatment of anemia in Chinese subjects with lower risk MDS.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: FibroGen
• Collaborator: AstraZeneca

Criteria

Key Inclusion Criteria:

• Diagnosis of primary MDS classified as very low, low or intermediate risk with <5% blasts of >= 4 weeks duration

• Screening Hb <10 g/dL and ≥6g/dL

• Transfusion independent defined as no red blood cell transfusions within 12 weeks of Day 1

• ESA-naïve (less than 4 weeks of ESA treatment in total, and not within 30 days of Day 1)

• ECOG of 0-2 at screen

Key Exclusion Criteria:

• Diagnosis of secondary MDS

• Significant myelofibrosis (>2+fibrosis)

• Any prior therapy with antithymocyte globulin, azacitidine, or decitabine. Or Prior therapy with cyclosporine, thalidomide , or lenalidomide within 12 weeks prior to Day

• Screen serum erythropoietin level of >500 mIU/mL

• Clinically significant anemia due to non-MDS etiologies