NCT03303066

Efficacy and Safety of FG-4592 for Treatment of Anemia in Participants With Lower Risk Myelodysplastic Syndrome (MDS)

A Phase 2/3 Trial of FG-4592 for Treatment of Anemia in Subjects With Lower Risk Myelodysplastic Syndrome

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 43 (actual)
• Sponsor: Kyntra Bio · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

This is a Phase 2/3 trial with sequential Phase 2 and Phase 3 components. In each part, there is an up to 4 weeks screening period followed by a treatment period of 26 weeks and a 4 week follow-up period.

Conditions

• Anemia
• Myelodysplastic Syndrome

Interventions

Type	Name	Description
DRUG	FG-4592	Oral
DRUG	Placebo	Oral

Timeline

• Start date: 2018-06-06
• Primary completion: 2023-01-11
• Completion: 2023-02-08
• First posted: 2017-10-05
• Last updated: 2023-05-03

Locations

38 sites across 1 country: China