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Study of Efficacy and Safety of Eltrombopag in Lower-risk MDS Patients With Platelet Transfusion Dependence
Sponsor: Novartis Pharmaceuticals
Summary
This study is designed to evaluate the efficacy and safety of eltrombopag monotherapy in Japanese adult patients with platelet transfusion-dependent lower-risk Myelodysplastic syndromes (LR-MDS).
Official title: A Randomized, Double-blind, Placebo-controlled, Japan Local Phase II Clinical Study Comparing Eltrombopag Monotherapy Versus Placebo in Adult Lower-risk Myelodysplastic Syndromes (MDS) Patients With Platelet Transfusion Dependence
Key Details
Gender
All
Age Range
20 Years - 100 Years
Study Type
INTERVENTIONAL
Enrollment
36
Start Date
2021-05-25
Completion Date
2026-12-09
Last Updated
2026-03-19
Healthy Volunteers
No
Conditions
Interventions
Eltrombopag
Eltrombopag comes in 12.5 mg \& 25 mg tablets and is taken orally once per day (QD)
Placebo
Placebo comes in 12.5 mg \& 25 mg tablets and is taken orally once per day (QD)
Locations (20)
Novartis Investigative Site
Narita, Chiba, Japan
Novartis Investigative Site
Kurume, Fukuoka, Japan
Novartis Investigative Site
Ohtake, Hiroshima, Japan
Novartis Investigative Site
Nishinomiya, Hyōgo, Japan
Novartis Investigative Site
Kanazawa, Ishikawa-ken, Japan
Novartis Investigative Site
Isehara, Kanagawa, Japan
Novartis Investigative Site
Yokohama, Kanagawa, Japan
Novartis Investigative Site
Sendai, Miyagi, Japan
Novartis Investigative Site
Nagasaki, Nagasaki, Japan
Novartis Investigative Site
Sakai, Osaka, Japan
Novartis Investigative Site
Bunkyo-ku, Tokyo, Japan
Novartis Investigative Site
Itabashi Ku, Tokyo, Japan
Novartis Investigative Site
Shimonoseki, Yamaguchi, Japan
Novartis Investigative Site
Aomori, Japan
Novartis Investigative Site
Chiba, Japan
Novartis Investigative Site
Fukushima, Japan
Novartis Investigative Site
Gifu, Japan
Novartis Investigative Site
Kumamoto, Japan
Novartis Investigative Site
Osaka, Japan
Novartis Investigative Site
Yamagata, Japan