NCT04728789

Avatrombopag Usage in NSAA

Status unknown Phase 2, PHASE3 Last updated 28 January 2021

What this trial tests

Phase 2, PHASE3 trial testing Avatrombopag 20 MG in Aplastic Anemia in 40 participants. Status unknown.

Timeline

1 February 2021

Primary endpoint
31 December 2022

30 June 2023

Quick facts

Lead sponsor	Peking Union Medical College Hospital
Phase	Phase 2, PHASE3
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	40
Start date	1 February 2021
Primary completion	31 December 2022
Estimated completion	30 June 2023
Sites	1 location across China

Drugs / interventions tested

• Avatrombopag 20 MG

Conditions studied

• Aplastic Anemia — all drugs for Aplastic Anemia →
• Drug Effect — all drugs for Drug Effect →

Sponsor

Peking Union Medical College Hospital

Who can join

Adults 18 to 75, any sex, with Aplastic Anemia or Drug Effect. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a multicenter, open-label, prospective one arm study to explore the efficacy and safety of Avatrombopag in non-severe aplastic anemia. Patients meeting the inclusion and exclusion criteria would be recruited. Treatment of Avatrombopag would be started with 20mg/day. The dosage would be increased by 20 mg/day every 2 weeks if the platelet count remains less than 20×10e9/L and reduced if the platelet count reaches over than 150×10e9/L. The dosage could range from 20mg/week to 60mg/day. All patients would receive treatment for at least 6 months except that the platelet \<20×10e9/L at the dosage of 60mg/day for 4 weeks or the platelet ≥200×10e9/L at the dosage of 20mg/week for 2 weeks. The hematological response rate and safety will be recorded and compared at every month after starting the study treatment. The patients would be followed up for at least 6 months.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Avatrombopag, a promising novel thrombopoietin receptor agonist for refractory/relapsed/intolerant non-severe aplastic anemia: a phase 2 single-arm clinical trial.
   Wan Z, Chen M, Han B. · · 2023 · cited 13× · PMID 37318085 · DOI 10.1080/07853890.2023.2224044