Status:
COMPLETED
Efficacy and Safety of FG-4592 for Treatment of Anemia in Participants With Lower Risk Myelodysplastic Syndrome (MDS)
Lead Sponsor:
FibroGen
Collaborating Sponsors:
AstraZeneca
Conditions:
Anemia
Myelodysplastic Syndrome
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
PHASE3
Brief 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 per...
Eligibility Criteria
Inclusion
- Key
- Diagnosis of primary MDS classified as very low, low or intermediate risk with \<5% blasts (documented within 12 weeks prior to Day 1)
- Screening Hb \<10 g/dL and ≥6g/dL
- Transfusion independent defined as no red blood cell transfusions within 12 weeks of Day 1
- Erythropoiesis-stimulating agent (ESA)-naïve (not within 30 days of Day 1)
- Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2
- Key
Exclusion
- Diagnosis of secondary MDS
- Significant myelofibrosis (\>2+fibrosis)
- Prior therapy with azacitidine, decitabine, antithymocyte globulin, cyclosporine, thalidomide, or lenalidomide within 12 weeks prior to Day 1
- Baseline erythropoietin level of \>400 units (U)/liter (L)
- Clinically significant anemia due to non-MDS etiologies
- Note: Other inclusion and exclusion criteria may apply.
Key Trial Info
Start Date :
June 6 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 8 2023
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT03303066
Start Date
June 6 2018
End Date
February 8 2023
Last Update
May 3 2023
Active Locations (38)
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1
The First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui, China
2
Anhui Provincial Hospital
Hefei, Anhui, China
3
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
4
China-Japan Friendship Hospital
Beijing, Beijing Municipality, China