Status:
UNKNOWN
Hetrombopag for Lower-risk MDS With Thrombocytopenia: a Prospective，Open-label, Single-arm Study.
Lead Sponsor:
Tongji Hospital
Conditions:
Myelodysplastic Syndromes
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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.
Detailed Description
The is a phase 2, single-arm, open-label clinical study assessing the efficacy and safety of hetrombopag to increase platelet count in patients with very low, low, or intermediate risk myelodysplastic...
Eligibility Criteria
Inclusion
- 18 years or older；
- Confirmed diagnosis of MDS based on 2016 WHO (World Health Organization) and classification with very low, low or intermediate (score ≤ 3.5) risk according to the revised International Prognostic Scoring System (IPSS-R).
- Platelets \< 30 x 10\^9/L or platelets \< 50 x 10\^9/L with active bleeding at screening.
- Eastern Cooperative Oncology Group (ECOG) performance score ≤ 2；
- Ability to understand information material and written informed consent.
Exclusion
- Severe active bleeding/infection or any other uncontrolled severe condition;
- History of treatment with thrombopoietin receptor agonists (eltrombopag, avatrombopag, romiplostim, etc.) or recombinant human thrombopoietin with 1 month prior;
- Patients with known active hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) at screening（If hepatitis B surface antigen or hepatitis B core antibody are positive, HBV-DNA testing are needed. If positive, it suggests a viral replication and subjects will be excluded. If hepatitis C antibody are positive, HCV-RNA testing are needed. If positive, it suggests a viral replication and subjects will be excluded）;
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \>2.5 x upper limit of normal (ULN), total bilirubin \>2.5 x ULN, creatinine \>1.5 x ULN;
- History of portal hypertension or cirrhosis；
- History of any types of solid tumors within 5 years prior, whether the tumors has been treated, metastasized or relapsed (except basal cell carcinoma);
- History of congestive heart failure requiring medical management, cardiac arrhythmias, peripheral arteriovenous thrombosis within 1 years prior, or myocardial infarction or cerebral infarction within 3 months prior;
- ECOG performance score ≥ 3;
- Female subjects who are pregnant or breastfeeding, or subjects who are planning pregnancy within 6 months;
- Women of child-bearing potential and men must agree to use contraception prior to study entry and for the duration of study participation;
- Participated in other clinical trials within 3 months prior;
- Any condition which, in the investigator's opinion, deems the subject an unsuitable candidate to receive study drug.
Key Trial Info
Start Date :
July 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT05392647
Start Date
July 1 2022
End Date
December 31 2024
Last Update
May 26 2022
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