The Safety and Efficacy Study of Avatrombopag Switch in TPO-RA Refractory AA (NCT05518331) | Clinical Trial Compass
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The Safety and Efficacy Study of Avatrombopag Switch in TPO-RA Refractory AA
China39 participantsStarted 2022-06-01
Plain-language summary
This study was a single-arm, multicenter, phase Î clinical study. Patients admitted to the enrollment unit center with a confirmed diagnosis of TDNSAA/VSAA/SAA, treated with IST (p/r-ATG+CSA) in combination with TPO-RA (including eltrombopta or hydtrombopta) for at least 3 months with no hematologic response at 6-month follow-up, and who were not suitable or unwilling to undergo hematopoietic stem cell transplantation (HSCT), were to another novel TPO-RA avatrombopta, 40-60 mg (weight \<80 kg), in addition to maintaining the original immunosuppressive therapy ( CSA or equivalent immune potency drugs), switch to another new TPO-RA avatropa 40-60 mg (40 mg daily for weight \<80 kg; 60 mg daily for weight \>80 kg) orally once daily for at least 3 months and follow up for 3 months to determine the hematologic response and to assess the safety of the drug
Who can participate
Age range14 Years
SexALL
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Inclusion criteria
✓. Patients with confirmed TDNSAA/SAA/VSAA aplastic anemia who received standard IST therapy for at least 6 months, combined with Haitrombopag (15mg/d) or Eltrombopag (\>50mg/d) for at least 3 Patients who have not obtained a hematological response (NR) for months and are not suitable or unwilling to undergo HSCT
✓. Age \> 14 years old, male or female.
✓. Subjects must complete all screening assessments listed in the trial protocol.
✓. ECOG score ≤ 2 points.
✓. Before the start of the research procedure, the patient or guardian should fully understand the research procedure and purpose and sign the informed consent form. If the patient's signature is not conducive to the treatment of the disease, the patient's immediate family should sign the informed consent form.
Exclusion criteria
✕. Patients with severe infectious diseases (uncured tuberculosis, pulmonary aspergillosis, various bacterial and viral infections) and active bleeding that cannot be controlled after standard treatment.
✕. Patients with AIDS, active viral hepatitis B, and hepatitis C RNA nucleic acid test positive.
What they're measuring
1
The rate of HR in patients after switching to avatrombopag.
Timeframe: 3 months
2
Incidence of Treatment-Emergent Adverse Events as assessed by information on Common Toxicity Criteria (CTC) AE grading
Timeframe: 3 months
3
Percentage of patients with transformation
Timeframe: 3 months
Trial details
NCT IDNCT05518331
SponsorInstitute of Hematology & Blood Diseases Hospital, China