Study of Efficacy and Safety of Eltrombopag in Lower-risk MDS Patients With Platelet Transfusion Dependence
Condition(s) studied
Investigational drug(s) / intervention(s)
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)
Study 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).
Eligibility
Primary outcome measure(s)
- Percentage of participants who achieve platelet transfusion independence at Week 24 — Week 24
Platelet transfusion independence is defined as the absence of platelet transfusion for at least 8 weeks. Platelet count should be higher than the baseline count.
Trial sites (20)
| Facility | City | Region | Status |
|---|---|---|---|
| Novartis Investigative Site | Narita | Chiba | |
| Novartis Investigative Site | Kurume | Fukuoka | |
| Novartis Investigative Site | Ohtake | Hiroshima | |
| Novartis Investigative Site | Nishinomiya | Hyōgo | |
| Novartis Investigative Site | Kanazawa | Ishikawa-ken | |
| Novartis Investigative Site | Isehara | Kanagawa | |
| Novartis Investigative Site | Yokohama | Kanagawa | |
| Novartis Investigative Site | Sendai | Miyagi | |
| Novartis Investigative Site | Nagasaki | Nagasaki | |
| Novartis Investigative Site | Sakai | Osaka | |
| Novartis Investigative Site | Bunkyo-ku | Tokyo | |
| Novartis Investigative Site | Itabashi Ku | Tokyo | |
| Novartis Investigative Site | Shimonoseki | Yamaguchi | |
| 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 |
More Novartis Pharmaceuticals trials in Japan
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT04797000 on ClinicalTrials.gov ↗ ← All trials in Japan