Combination of Eltrombopag With Immunosuppressive Therapy in East-Asian Patients With Severe Aplastic Anemia

NCT04328727 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2026-01-13

Study results available
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Summary

This study was designed to evaluate the efficacy and safety of eltrombopag when added to r-ATG and CsA in treatment naive East-Asian adult and pediatric patients with severe aplastic anemia (SAA).

Conditions

  • Severe Aplastic Anemia (SAA)

Interventions

DRUG

eltrombopag

Tablet 25mg and 12.5mg

DRUG

rabbit anti-thymocyte globulin (r-ATG)

r-ATG 25 mg sterile lyophilized powder in 10 mL vials for IV use

DRUG

cyclosporine A (CsA)

CsA 25mg Capsule or CsA 5.0g/50mL solution for oral use

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-04
Primary Completion
2022-06-10
Completion
2024-12-06

Countries

  • China
  • Japan
  • South Korea
  • Taiwan

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04328727 on ClinicalTrials.gov