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

Summary

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

• Thrombocytopenia
• Stem Cell Transplant Complications

Interventions

DRUG

avatrombopag

The avatrombopag 20mg/d will be orally taken from +D7 after haplo-HSCT until meeting the adjustment indication or to +D60 after haplo-HSCT; When PLT\<50×10\^9/L or PLT transfusion-dependent on the +D30 after haplo-HSCT, increase avatrombopag dosage to 40 mg/d; When PLT≥80×10\^9/L and without PLT transfusion within avatrombopag dosage at 40 mg/d, decrease avatrombopag dosage to 20 mg/d; When PLT≥80×10\^9/L for 7 consecutive days or PLT≥300×10\^9/L and without PLT transfusion, stop avatrombopag; When PLT\<50×10\^9/L or PLT transfusion-dependent after stopping avatrombopag , reuse avatrombopag at 40 mg/d.

DRUG

Placebo

The placebo 20mg/d will be orally taken from +D7 after haplo-HSCT until meeting the adjustment indication or to +D60 after haplo-HSCT; When PLT\<50×10\^9/L or PLT transfusion-dependent on the +D30 after haplo-HSCT, increase placebo dosage to 40 mg/d; When PLT≥80×10\^9/L and without PLT transfusion within placebo dosage at 40 mg/d, decrease placebo dosage to 20 mg/d; When PLT≥80×10\^9/L for 7 consecutive days or PLT≥300×10\^9/L and without PLT transfusion, stop placebo; When PLT\<50×10\^9/L or PLT transfusion-dependent after stopping placebo, reuse placebo at 40 mg/d.

Sponsors & Collaborators

• Xiangya Hospital of Central South University

  collaborator OTHER

• Sichuan Provincial People's Hospital

  collaborator OTHER

• First Affiliated Hospital of Harbin Medical University

  collaborator OTHER

• The First Affiliated Hospital of Zhengzhou University

  collaborator OTHER

• First Affiliated Hospital of Xinjiang Medical University

  collaborator OTHER

• Shanxi Bethune Hospital

  collaborator OTHER

• 920th Hospital of Joint Logistics Support Force of People's Liberation Army of China

  collaborator OTHER

• Tang-Du Hospital

  collaborator OTHER

• The First Affiliated Hospital of Nanchang University

  collaborator OTHER

• Peking University People's Hospital

  lead OTHER

Principal Investigators

• Xiaohui Zhang · Peking University People's Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-05-13

Primary Completion

2024-10-30

Completion

2025-10-30

Countries

• China

Study Locations