A Prospective, One-arm and Open Clinical Study to Assess Efficacy and Safety of Avatrombopag in the Treatment of Pediatric Primary Immune Thrombocytopenia

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

To evaluate the safety and efficacy of avatrombopag in the treatment of pediatric primary immune thrombocytopenia in patients who have been treated with eltrombopag before and switched to avatrobopag because of poor efficacy, excessive platelet fluctuation or intolerance, or patient preference, economic reasons, and other reasons.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 6
Maximum Age: 18
Healthy Volunteers: f
View:

• Age 6-18 years old (including both ends), male and female;

• Diagnosed with primary immune thrombocytopenia (ITP);

• Patients who had previously received eltrombopag treatment and then converted to avatrombopag treatment because of ineffectiveness (platelet count \< 30×10\^9/L after eltrombopag treatment, or platelet count increased less than 2 times of the basic value, or bleeding) or large platelet fluctuation or due to patient preference, economic reasons and other reasons;

• Cardiac function of the New York Society of Cardiac Function ≤ 2;

• Understand the study procedure and voluntarily sign the informed consent.

Locations
Other Locations
China
Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
RECRUITING
Tianjin
Contact Information
Primary
Lei Zhang, MD
zhanglei1@ihcams.ac.cn
+86 13502118379
Backup
Ting Sun, MD
sunting@ihcams.ac.cn
+8615822339131
Time Frame
Start Date: 2024-03-01
Estimated Completion Date: 2025-12
Participants
Target number of participants: 60
Treatments
Experimental: Treatment group: Avatrombopag
Sixty subjects will be enrolled with the indicated treatment dose of avatrombopag
Sponsors
Collaborators: The Second Affiliated Hospital of Kunming Medical University, Henan Cancer Hospital, Tianjin Children's Hospital, Tianjin Medical University Second Hospital
Leads: Institute of Hematology & Blood Diseases Hospital, China

This content was sourced from clinicaltrials.gov