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A Study of Avatrombopag in Adults With Aplastic Anemia Who Did Not Respond to, Cannot Receive, or Had Return of Disease After Standard Treatment

NCT07786922 · Status: NOT_YET_RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2026-08-26

No results posted yet for this study

Summary

This research study is testing a medicine called avatrombopag in adults with aplastic anemia, a rare condition where the bone marrow does not produce enough blood cells. The study will include about 26 participants from Japan, South Korea, and Taiwan whose disease has not responded to standard treatment, who cannot receive standard treatment, or whose disease has returned after previous treatment. The goal is to learn how well avatrombopag works and how safe it is for these patients.

Conditions

  • Aplastic Anemia

Interventions

DRUG

Avatrombopag 20 mg Oral Tablet

Trial participants will receive avatrombopag as 20 mg film-coated tablets. On-site administration by the trial team is required on (1) Day 1/Visit 2 (first dose) and (2) the first day a participant is titrated to 80 mg once daily (earliest Visit 6).

Sponsors & Collaborators

  • Sobi, Inc.

    collaborator INDUSTRY

  • CMIC Co, Ltd. Japan

    collaborator INDUSTRY

  • Swedish Orphan Biovitrum

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-31
Primary Completion
2028-06-30
Completion
2029-12-31
FDA Drug
Yes

More Related Trials

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 NCT07786922 on ClinicalTrials.gov