This is a prospective, multicenter, randomized, open-label study to investigate the efficacy and safety of eltrombopag plus recombinant human thrombopoietin (rhTPO) versus eltrombopag as treatment for corticosteroid-resistant or relapsed immune thrombocytopenia (ITP) during the COVID-19 pandemic.
During the COVID-19 pandemic, the classical subsequent treatment regimen for ITP of
immunosuppressants and/or steroids might increase patients' susceptibility of virus
infections. To minimize ITP patients' risk during the COVID-19 global crisis and to improve
treatment efficacy, this treatment regimen of eltrombopag plus recombinant human
thrombopoietin (rhTPO) should be investigated.
Recombinant human thrombopoietin (rhTPO) is a full-length glycosylated-TPO produced by
Chinese hamster ovary cells, which showed its effectiveness in ITP in a variety of studies.
Eltrombopag, a small molecule agonist of thrombopoietin receptor (TPO-RA), was recommended as
the subsequent treatment for ITP patients, which also already showed robust efficacy.
Both eltrombopag and rhTPO demonstrated good safety in ITP patients. Since they increase the
number of platelets through different mechanisms, and previous studies demonstrated that they
might exert synergic effect. The investigators hypothesized that the combination of these two
agents could be a promising option for ITP treatment.
This study aimed to evaluate the sustained responses and safety of eltrombopag plus rhTPO as
treatment for corticosteroid-resistant or relapsed ITP patients during the COVID-19 pandemic.
Drug: Eltrombopag
Eltrombopag 25-75 mg oral daily according to platelet response.
Other Name: Revolade
Drug: rhTPO
Rh-TPO 300U/kg subcutaneous injection once daily for 7 consecutive days, followed by a tapering dose in maintenance therapy.
Other Name: TPIAO, tebiao
Inclusion Criteria:
1. Clinically confirmed corticosteroid-resistant or relapsed immune thrombocytopenic
purpura (ITP)
2. Platelet count less than 30×10^9/L on two occasions or Platelets above 30×10^9/L
combined with bleeding manifestation (WHO bleeding scale 2 or above)
3. Subject is ≥ 18 years
4. Subject has signed and provided written informed consent.
5. Fertile patients must use effective contraception during treatment and observational
period
6. Negative pregnancy test
Exclusion Criteria:
1. Have an impaired renal function as indicated by a serum creatinine level > 2.0 mg/dL
2. Have an inadequate liver function as indicated by a total bilirubin level > 2.0 mg/dL
and/or an aspartate aminotransaminase or alanine aminotransferase level > 3×upper
limit of normal
3. Have a New York Heart Classification III or IV heart disease
4. Have a history of severe psychiatric disorder or are unable to comply with study and
follow-up procedures
5. Have active hepatitis B or hepatitis C infection
6. Have a HIV infection
7. Have active infection requiring antibiotic therapy within 7 days prior to study entry
8. Are pregnant or lactating women, or plan to become pregnant or impregnated within 12
months of receiving study drug
9. Previous splenectomy
10. Had previous or concomitant malignant disease
11. Not willing to participate in the study.
12. Expected survival of < 2 years
13. Intolerant to murine antibodies
14. Immunosuppressive treatment within the last 2 weeks
15. Connective tissue disease
16. Autoimmune hemolytic anemia
17. Patients currently involved in another clinical trial with evaluation of drug
treatment
Peking University Insititute of Hematology, Peking University People's Hospital
Beijing, Beijing, China
Investigator: Xiaohui Zhang
zhangxh100@sina.com
Xiaohui Zhang, MD
+86-13522338836
zhangxh100@sina.com
Xuelin Dou, MD
+86-15510491556
dxldw@163.com
Xiaohui Zhang, MD, Principal Investigator
Peking University People's Hospital, Peking University Insititute of Hematology