Actively Recruiting

Phase 2
Phase 3
Age: 18Years - 65Years
All Genders
NCT06202625

Efficacy and Safety of Avatrombopag in the Treatment of Thrombocytopenia After Haplo-HSCT

Led by Peking University People's Hospital · Updated on 2024-10-01

142

Participants Needed

14

Research Sites

76 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

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.

CONDITIONS

Official Title

Efficacy and Safety of Avatrombopag in the Treatment of Thrombocytopenia After Haplo-HSCT

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

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 form
Not Eligible

You will not qualify if you...

  • Active infection
  • ALT or AST higher than 3 times the upper limit of normal or total bilirubin higher 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 congestive heart failure, arrhythmia increasing thromboembolism risk, angina, or prior coronary interventions
  • Treatment with platelet-promoting drugs within two weeks before enrollment
  • Positive for hepatitis B surface antigen, hepatitis C antibody, or HIV antibody
  • Known allergy to avatrombopag or its ingredients
  • Secondary or multiple hematopoietic stem cell transplantations
  • Pregnant, breastfeeding, or fertile females refusing contraception during and one month after trial
  • Participation in other investigational clinical trials within 30 days prior to baseline visit, except observational studies
  • Deemed unsuitable for enrollment by investigator due to medical history or conditions
  • Use of certain medications during trial including rhIL-11, rhTPO, TPO receptor agonists, or desitabine

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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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

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Research Team

H

Haixia Fu

CONTACT

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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Efficacy and Safety of Avatrombopag in the Treatment of Thrombocytopenia After Haplo-HSCT | DecenTrialz