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ACTIVE NOT RECRUITING
NCT04797000
PHASE2

Study of Efficacy and Safety of Eltrombopag in Lower-risk MDS Patients With Platelet Transfusion Dependence

Sponsor: Novartis Pharmaceuticals

View on ClinicalTrials.gov

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

Interventions

DRUG

Eltrombopag

Eltrombopag comes in 12.5 mg \& 25 mg tablets and is taken orally once per day (QD)

DRUG

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