Actively Recruiting
Efficacy and Safety of Avatrombopag in the Treatment of Thrombocytopenia After Haploidentical Hematopoietic Stem Cell Transplantation: Prospective, Multi-center, Double-blinded, Randomized Placebo-controlled Study
Led by Peking University People's Hospital · Updated on 2024-10-01
142
Participants Needed
14
Research Sites
52 weeks
Total Duration
On this page
Sponsors
P
Peking University People's Hospital
Lead Sponsor
X
Xiangya Hospital of Central South University
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness of avatrombopag in patients who develop thrombocytopenia after haploidentical hematopoietic stem cell transplantation (haplo-HSCT). Thrombocytopenia, including primary isolated thrombocytopenia and secondary failure of platelet recovery, is a serious complication that can lead to bleeding, infection, and affect overall survival, disease-free survival, and non-relapse mortality. This trial is a prospective, multi-center, double-blinded, randomized placebo-controlled study designed to provide evidence for avatrombopag's use in this setting. Participants are randomly assigned to receive either avatrombopag or a placebo starting on day 7 after haplo-HSCT. The starting dose is 20 mg daily taken orally, with adjustments based on platelet levels or transfusion dependence up to day 60 after transplantation. Dosage may be increased to 40 mg daily if platelet counts remain low by day 30, or decreased or stopped if platelet counts improve. Routine treatments and platelet transfusions are permitted as needed during the study. Throughout the study, participants will have their platelet levels monitored regularly, along with assessments of neutrophil recovery, graft-versus-host disease, infections, and survival outcomes up to one year post-transplant. The primary measurement is the proportion of patients achieving a platelet count of at least 50×10^9/L by day 60 without requiring platelet transfusion for seven or more consecutive days. Secondary outcomes include platelet counts at other time points, transfusion needs, and survival rates. Safety and treatment response will be closely followed during the trial period.
CONDITIONS
Brief Title
Efficacy and Safety of Avatrombopag in the Treatment of Thrombocytopenia After Haplo-HSCT
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female, aged between 18-65 years
- Platelet count less than 20 × 10^9/L or transfusion dependent on day 7 after haplo-HSCT
- Agree to receive avatrombopag treatment after haplo-HSCT and sign informed consent
You will not qualify if you...
- Active infection
- ALT or AST levels greater than 3 times the upper limit of normal or total bilirubin greater than 2 times the upper limit of normal
- Creatinine clearance less than 50 mL/min
- History of arteriovenous thrombosis
- History of cardiovascular disease such as severe heart failure, arrhythmias increasing thromboembolic risk, angina, or past coronary interventions
- Use of platelet-promoting drugs (rhTPO, TPO receptor agonists) within two weeks before enrollment
- Positive for hepatitis B surface antigen, hepatitis C antibody, or HIV antibody
- Allergy to avatrombopag or its ingredients
- Secondary or multiple hematopoietic stem cell transplants
- Pregnancy, breastfeeding, or fertile females refusing contraception during and one month after the trial
- Participation in another investigational product or device trial within 30 days prior to baseline, except observational studies
- Any other medical condition deemed unsuitable by the investigator
- Use of certain medications such as rhIL-11, rhTPO, TPO receptor agonists, or decitabine during the trial not allowed
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - From day 7 to day 60 after haplo-HSCT
Participants take avatrombopag or placebo orally starting from day 7 after haplo-HSCT until day 60, with possible dose adjustments based on platelet counts and transfusion needs.
Regular visits during treatment period to monitor platelet levels and adjust dosage as needed
Duration - Up to 1 year after haplo-HSCT
Participants are monitored for graft-versus-host disease, infection, overall survival, disease-free survival, and non-relapse mortality up to one year after haplo-HSCT.
Periodic visits up to 1 year after haplo-HSCT for safety and efficacy assessments
Trial Site Locations
Total: 14 locations
1
Peking University People's Hospital
Beijing, Beijing Municipality, China, 100044
Actively Recruiting
2
Guangzhou First People's Hospital, School of Medicine, South China University of Technology
Guangzhou, Guangdong, China
Not Yet Recruiting
3
Peking University Shenzhen Hospital
Shenzhen, Guangdong, China
Actively Recruiting
4
The First Affiliated Hospital, Harbin Medical University
Harbin, Heilongjiang, China
Not Yet Recruiting
5
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Not Yet Recruiting
6
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
Not Yet Recruiting
7
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
Not Yet Recruiting
8
Xiangya Hospital, Central South University
Changsha, Hunan, China, 410008
Not Yet Recruiting
9
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
Not Yet Recruiting
10
Shanxi Tumor Hospital Affiliated to Shanxi Medical University
Taiyuan, Shanxi, China
Not Yet Recruiting
11
Tangdu Hospital, PLA Air Force Military Medical University
Xi’an, Shanxi, China
Not Yet Recruiting
12
Xinqiao Hospital, Army Military Medical University
Chongqing, Sichuan, China
Not Yet Recruiting
13
920th Hospital of Joint Logistics Support Force of People's Liberation Army of China
Kunming, Yunnan, China, 650100
Not Yet Recruiting
14
Chinese Academy of Medical Sciences & Peking Union Medical College
Tianjin, China
Not Yet Recruiting
Research Team
H
Haixia Fu
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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