NCT05720234

Avatrombopag Combined With IST as First-line Treatment for SAA

The Efficacy and Safety Study of Avatrombopag Combined With IST as First-line Treatment for Severe Aplastic Anemia, A Single-arm, Phase II Clinical Study

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 53 (estimated)
• Sponsor: Institute of Hematology & Blood Diseases Hospital, China · Academic / Other
• Sex: All
• Age: 12 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

This single-center study aims to evaluate the early efficacy and safety of avatrombopag combined with immunosuppressive therapy (IST) in the first-line treatment of severe aplastic anemia (SAA).

Detailed description

This is a single center, single arm, phase II clinical study. Fifty-three patients will be enrolled. Treatment protocol is as follows: 1) Anti-human thymocyte porcine immunoglobulin (P-ATG 20mg/kg/d) or rabbit anti human thymocyte globulin (R-ATG 3.0mg/kg/d) was administered intravenously for 5 days; 2) Cyclosporine (CSA) is given at 3-5 mg/kg.d in divided doses for at least 6 months. The trough concentration is maintained at 150-250 ng/ml. 3) Avatrombopag is given orally at 60 mg once a day for patients with body weight ≥ 50 kg, and 40 mg orally once a day for patients with body weight\<50 kg, for a total of 12 weeks.

Conditions

• Severe Aplastic Anemia

Interventions

Type	Name	Description
DRUG	avatrombopag	Patients with body weight ≥50kg were given 60mg/day and patients with body weight \< 50kg were given 40mg/day for 12 weeks.

Timeline

• Start date: 2022-11-10
• Primary completion: 2023-11-30
• Completion: 2024-11-30
• First posted: 2023-02-09
• Last updated: 2023-02-09

Locations

1 site across 1 country: China