Efficacy and Safety of Avatrombopag in the Treatment of Thrombocytopenia After Haplo-HSCT
Recruiting now · Phase 2/Phase 3 · Has a placebo group
Conditions studied: Thrombocytopenia, Stem Cell Transplant Complications
In brief
In this study, investigators aim to evaluate the efficacy of avatrombopag in thrombocytopenic patients after haploidentical hematopoietic stem cell transplantation (haplo-HSCT) through a prospective, multi-center, double-blinded, randomized placebo-controlled clinical trial.
Key facts
- Study ID
- NCT06202625
- Run by
- Peking University People's Hospital
- People needed
- 142
- Starts
- 2024-05-13
- Expected to finish
- 2025-10-30
- Last updated by the study team
- 2024-10-01
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Male or female, aged between 18-65 years;
- PLT<20×10\^9/L or transfusion dependent on +D7 after haplo-HSCT;
- Agree to receive the treatment of avatrombopag after Haplo-HSCT and sign the informed consent form.
You may not qualify if…
- With active infection;
- ALT or AST>3ULN, or total Bil>2ULN
- Ccr<50 mL/min;
- With the history of arteriovenous thrombosis;
- With history of cardiovascular disease (such as NYHA Class III/IV congestive heart failure, arrhythmia that increases the risk of thromboembolic events [such as atrial fibrillation] and angina), and subjects who have undergone coronary stent implantation, angioplasty, or coronary artery bypass grafting;
- With treatment of drugs to promote platelet production two weekes before enrollment, including but not limited to rhTPO and TPO-RA;
- HBsAg or anti-HCV or anti-HIV positive;
- Known to be allergic to avatrombopag and any of its excipients;
- With secondary or multiple HSCT;
- Females who were pregnant or breastfeeding or who had fertile ability but refuse to take effective contraceptive measures during and one month after this trial;
- With any other clinical trial of investigational product or device within 30 days prior to the baseline visit, except for observational study;
- Deemed unsuitable for enrollment by the investigator for any history of or concomitant medical condition.
- Concomitant medication:The rhIL-11, rhTPO or TPO-RA(such as eltrombopag, hetrombopag and romiplostim) and desitabine, etc. were not allowed for use during this trial.
Where it is running
- Peking University Shenzhen Hospital — Shenzhen, Guangdong, China (enrolling)
- Peking University People's Hospital — Beijing, Beijing Municipality, China (enrolling)
- The First Affiliated Hospital, Harbin Medical University — Harbin, Heilongjiang, China
- The First Affiliated Hospital of Zhengzhou University — Zhengzhou, Henan, China
- Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology — Wuhan, Hubei, China
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology — Wuhan, Hubei, China
- Xiangya Hospital, Central South University — Changsha, Hunan, China
- The First Affiliated Hospital of Nanchang University — Nanchang, Jiangxi, China
- Shanxi Tumor Hospital Affiliated to Shanxi Medical University — Taiyuan, Shanxi, China
- Tangdu Hospital, PLA Air Force Military Medical University — Xi’an, Shanxi, China
- Xinqiao Hospital, Army Military Medical University — Chongqing, Sichuan, China
- 920th Hospital of Joint Logistics Support Force of People's Liberation Army of China — Kunming, Yunnan, China
- Chinese Academy of Medical Sciences & Peking Union Medical College — Tianjin, China
- Guangzhou First People's Hospital, School of Medicine, South China University of Technology — Guangzhou, Guangdong, China
Full record on ClinicalTrials.gov
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