Estudio primario
No clasificado
The investigators hypothesis is that eltrombopag given to patients with moderate to very severe aplastic anemia will result in an increase in platelet counts. The investigators hypothesize that in patients with moderate to very severe aplastic anemia, treatment with eltrombopag will lead to fewer platelet transfusions, red blood cell transfusions, and fewer bleeding events. The investigators hypothesize that in patients with moderate to very severe aplastic anemia, eltrombopag will have an acceptable toxicity rate \<3%, at doses that result in increased platelet counts. Finally the investigators hypothesize that plasma eltrombopag levels in peripheral blood will correlate with improved platelet counts.
Revisión sistemática
No clasificado
Revisión sistemática
No clasificado
Eltrombopag is clinically approved for use in immune thrombocytopenia (ITP), chronic hepatitis C-related thrombocytopenia, and aplastic anemia and suitable for children; however, data on its overall safety profile are scarce. This study aimed to explore the clinical features of adverse drug events (ADEs) associated with eltrombopag in different age groups using ICSRs from the World Health Organization database VigiBase and the US Food and Drug Administration Adverse Event Reporting System database from 2008 to 2022 in combination with a meta-analysis of data from randomized clinical trials in the literature from inception to July 28, 2022. We conducted disproportionality analyses by grouping patients into the following age groups: 0-17 (0-23 months,2-11 years, 12-17 years), 18-64, and ≥65 years. The ADEs about hepatobiliary disorders, thrombosis, skin and subcutaneous tissue disorders, infections and so on were observed more differently in each age group. Meta-analysis results showed differences in the four system organ classes between adults and children with
Estudio primario
No clasificado
Este artículo está incluido en 1 Revisión sistemática Revisiones sistemáticas (1 referencia) 1 Síntesis amplia Síntesis amplias (1 referencia)
Estudio primario
No clasificado
OBJECTIVE To provide a reference for the safe use of thrombopoietin receptor agonists romiplostim and eltrombopag in clinic. METHODS FDA adverse event reporting system (FAERS) in the United States was adopted to collect adverse drug event (ADE) reports of romiplostim and eltrombopag from their launch in the United States to September 30, 2022; the ADE signals of the two drugs were analyzed using the reporting odds ratio (ROR) method and the comprehensive standard method of the UK Medicines and Healthcare Products Regulatory Agency. RESULTS A total of 14 021 and 4 431 ADE reports were collected about romiplostim and eltrombopag, respectively, with a gender composition of more females than males. After signal screening, 563 ADE signals were obtained about romiplostim, involving 25 system organ classes (SOC); eltrombopag had 433 ADE signals, involving 26 SOC. The most frequently reported ADE for both drugs was platelet count decreased (2 060, 1 585 cases), which was mentioned in their drug instructions. In terms of signal intensity, romiplostim exhibited the highest signal for abnormal thrombopoietin levels (ROR of 2 268.85), while eltrombopag had the highest signal for positive dengue virus test (ROR of 954.50), with neither of these signals mentioned in their respective drug instructions. CONCLUSIONS The ADE of romiplostim and eltrombopag mainly affects the blood and lymphatic system, and there are many new suspicious high-risk signals.
Estudio primario
No clasificado
Primary Objective: To assess safety of eltrombopag in pediatric patients undergoing intensive chemotherapy for malignant solid tumors.
Secondary Objectives: To assess the efficacy of eltrombopag in increasing platelet count up to 2 weeks after completion of chemotherapy in pediatric patients undergoing intensive chemotherapy for malignant solid tumors.
Hypothesis: The hypothesis is that eltrombopag an oral thrombopoietin receptor agonist will increase the platelet count safely and efficaciously in children having chemotherapy induced thrombocytopenia while on therapy for solid tumors.
Estudio primario
No clasificado
Randomized, open-label, multicenter study to compare the efficacy and safety of zanubrutinib plus eltrombopag compared to eltrombopag monotherapy for the first-line treatment of adults with chronic immune thrombocytopenia (ITP).
Estudio primario
No clasificado
Estudio primario
No clasificado
Primary Objective: To evaluate the efficacy of 6-week Eltrombopag to treat immune thrombocytopenia with chronic hepatitis B virus infection. Secondary Objective: To evaluate the efficacy and safety of 6-week and 22-week Eltrombopag to treat immune thrombocytopenia with chronic hepatitis B virus infection.
Estudio primario
No clasificado
Primary immune thrombocytopenia (ITP) is an acquired autoimmune hemorrhagic disease. ITP patients have an increased risk of bleeding and the clinical symptoms are petechia, ecchymosis, organ hemorrhage and even life‐threatening bleeding. The mortality rate in ITP is increased approximately 60% compared with age‐ and sex matched comparisons, bleeding is one of the leading causes of death, thus treating and preventing bleeding is particularly important for those patients. In most cases, platelet count is negatively correlated with the severity of bleeding. Correcting low platelets is the main measure to prevent bleeding in patients with ITP. Recombinant human thrombopoietin (rhTPO), a full‐length glycated TPO, is a recombinant form of c‐Mpl ligand that competes with endogenous TPO for binding to TPO receptors (TPO‐R, c‐Mp0), many clinical trials have shown that rhTPO can efficiently and safely stimulate platelet production, increase peripheral blood platelet count. The State Food and Drug Administration approved the drug as the second‐line treatment for patients with ITP in 2005. Eltrombopag is an oral, synthetic non‐peptide small molecule human thrombopoietin receptor agonist approved by the US FDA in November 2008 for the treatment of patients with chronic ITP, which were inefficiently by use of glucocorticoids, immunoglobulin or splenectomy. However, pharmacokinetic study of eltrombopag showed that Asians have twice the drug exposure rate than non‐Asians, so eltrombopag may have different effects in different populations. Therefore, this trial will compare the efficacy and safety of intravenous rhTPO or oral use of eltrombopag after 14 days of treatment in Chinese ITP patients.