The Combination of Eltrombopag and Recombinant Human Thrombopoietin (rhTPO) Versus Eltrombopag Monotherapy as Subsequent Treatment for Immune Thrombocytopenia During the COVID-19 Pandemic
试验速览
- 阶段
- 2 期
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- No response
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinically confirmed corticosteroid-resistant or relapsed immune thrombocytopenic purpura (ITP)
- •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)
- •Subject is ≥ 18 years
- •Subject has signed and provided written informed consent.
- •Fertile patients must use effective contraception during treatment and observational period
- •Negative pregnancy test
排除标准
- •Have an impaired renal function as indicated by a serum creatinine level > 2.0 mg/dL
- •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
- •Have a New York Heart Classification III or IV heart disease
- •Have a history of severe psychiatric disorder or are unable to comply with study and follow-up procedures
- •Have active hepatitis B or hepatitis C infection
- •Have a HIV infection
- •Have active infection requiring antibiotic therapy within 7 days prior to study entry
- •Are pregnant or lactating women, or plan to become pregnant or impregnated within 12 months of receiving study drug
- •Previous splenectomy
- •Had previous or concomitant malignant disease
- •Not willing to participate in the study.
- •Expected survival of < 2 years
- •Intolerant to murine antibodies
- •Immunosuppressive treatment within the last 2 weeks
- •Connective tissue disease
- •Autoimmune hemolytic anemia
- •Patients currently involved in another clinical trial with evaluation of drug treatment
研究组 & 干预措施
eltrombopag plus rhTPO
Combination of eltrombopag and rhTPO
干预措施: Eltrombopag (Drug)
eltrombopag plus rhTPO
Combination of eltrombopag and rhTPO
干预措施: rhTPO (Drug)
eltrombopag
Eltrombopag monotherapy
干预措施: Eltrombopag (Drug)
结局指标
主要结局
No response
时间窗: 6 months
No response (NR) was defined as platelet count \< 30 × 10\^9/L or a less than two fold increase in platelet count from baseline or the presence of bleeding. Platelet count must be measured on two occasions more than a day apart.
Complete response
时间窗: 6 months
A complete response (CR) was defined as a sustained (≥ 3 months) platelet count ≥ 100×10\^9/L.
Response
时间窗: 6 months
A response (R) was defined as a sustained (≥ 3 months) platelet count ≥ 30×10\^9/L without recurrence of thrombocytopenia.
Relapses
时间窗: 6 months
A relapses was defined as platelet count falls below 30×10\^9/L or bleeding accrues after achieving R or CR.
次要结局
- DOR (duration of response)(6 months)
- Initial response(1 month)
- TOR (time to response)(6 months)
- Treatments associated adverse events(6 months)
- Early response(7 days)
- Durable response(6 months)
- Reduction in bleeding symptoms(6 months)
研究者
Xiao Hui Zhang
Vice president of Peking Univeristy Institute of Hematology
Peking University People's Hospital