A retrospective study to assess the efficacy and safety of eltrombopag in combination with immunosuppressants in treatment-naive patients with SAA

• Register: ChiCTR
• Last refreshed on: 22 April 2024
• Main ID: ChiCTR2200060098
• Date of registration: 2022-05-18
• Prospective Registration: No
• Primary sponsor: The First Affiliated Hospital of Zhejiang University of Traditional Chinese Medicine
• Public title: A retrospective study to assess the efficacy and safety of eltrombopag in combination with immunosuppressants in treatment-naive patients with SAA
• Scientific title: A retrospective study to assess the efficacy and safety of eltrombopag in combination with immunosuppressants in treatment-naive patients with SAA
• Date of first enrolment: 2022-05-05
• Target sample size: Experimental group:132;Control group:66;
• Recruitment status: Pending
• URL: https://www.chictr.org.cn/showproj.html?proj=169582
• Study type: Observational study
• Study design: Cross-sectional
• Phase: 4

Countries of recruitment

China

Contacts

• Name: Deng Shu
• Affiliation: The First Affiliated Hospital of Zhejiang University of Traditional Chinese Medicine

• Name: Deng Shu
• Affiliation: The First Affiliated Hospital of Zhejiang University of Traditional Chinese Medicine

Key inclusion & exclusion criteria

Inclusion criteria: 1. Written study informed consent and informed permission (if applicable) signed by the subject, parent or guardian must be obtained before study participation.
2. Signed written informed consent and informed consent (if applicable), aged >=16 years.
3. The diagnosis is SAA/VSAA.
4. Allogeneic hematopoietic stem cell transplantation (HSCT) is not suitable or HSCT is not an available treatment option (as determined by local practice or national guidelines), or the subject has rejected HSCT.
Exclusion criteria: 1. Previous use of IST, alenzumab, high-dose cyclophosphamide (>=45 mg/kg/ day) containing any ATG/ALG, or previous use of a thrombopoietin receptor agonist.
2. Known to be serologically positive for HIV.
3. Symptomatic paroxysmal nocturnal hemoglobinuria (PNH) and/or >50% PNH clones on polymorphonuclear neutrophils (PMNS) or RBC at enrollment.
4. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >3 times the upper limit of normal (ULN).
5. Creatinine >=2.5 times the upper limit of normal (ULN).
6. Positive HBV DNA test for hepatitis B virus.
7. Participating in other studies at the same time or deemed unsuitable for inclusion by the researcher.
8. Any clinical history of hepatitis C infection or chronic hepatitis B infection; Or any evidence of active hepatitis at the time of subject screening. Laboratory tests show a positive serology for hepatitis C or hepatitis B (HB), defined as a positive HBsAg test. In addition, if HBsAg negative but HBcAb positive (regardless of HBsAb status), an HB DNA test will be performed, and if positive, the subject will be excluded.
9. Cardiac disease (Class II/III/IV on the modified ROSS scale for Pediatric heart failure) should not be included;Cardiac arrhythmias at risk for thrombosis (e.g., atrial fibrillation), pulmonary hypertension, or uncontrolled hypertension (>180/100 mmHg).

Age minimum: 16
Age maximum: 80
Gender: Both

Health Condition(s) or Problem(s) studied

Aplastic anemia

Intervention(s)

Experimental group:Eltrombopag combined with immunosuppressive therapy (IST);Control group:IST;

Primary Outcome(s)

Hematology;Bone marrow routine;

Secondary Outcome(s)

Clinical biochemistry;

Source(s) of Monetary Support

Research group funding

Ethics review

Status: Approved
Approval date: 03/05/2022
Contact:

Wu Chengliang