Hetrombopag for Lower-risk MDS With Thrombocytopenia: a Prospective,Open-label, Single-arm Study.
NCT05392647 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 28
Last updated 2022-05-26
Summary
The is a phase 2, single-arm, open-label clinical study assessing the efficacy and safety of hetrombopag to increase platelet count in lower-risk MDS patients with thrombocytopenia.
Conditions
Interventions
- DRUG
-
Hetrombopag
All eligible patients were given hetrombopag orally at an initial dose of 5 mg once daily after overnight fasting (\>8 hours of fasting) and at least 2 hours before a meal . The dose of hetrombopag could be modified on the basis of the platelet count of patients after 2 weeks of administration.
Sponsors & Collaborators
-
Tongji Hospital
lead OTHER
Principal Investigators
-
Jia Wei, PhD · Tongji Hospital
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-07-01
- Primary Completion
- 2024-07-30
- Completion
- 2024-12-31
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