Chronic liver disease (CLD)-related thrombocytopenia can limit the feasibility of invasive procedures. Recombinant human thrombopoietin (rhTPO) has demonstrated a favorable safety profile without hepatotoxicity. We evaluated the efficacy and safety of rhTPO in patients with CLD-related thrombocytopenia who were undergoing elective invasive procedures. In this multicenter, randomized (2:1), double-blind, placebo-controlled phase III trial, 120 adult Chinese patients with CLD-related thrombocytopenia (platelet count < 50 & times; 10(9)/L) received rhTPO (n = 80) or placebo (n = 40) once daily for up to 5 or 7 days. The primary endpoint was the proportion of patients with sustained platelet counts >= 50 & times; 10(9)/L from 24 h before invasive procedure to 7 days post-procedure, without requiring emergency bleeding management. The primary endpoint was achieved by 85.0% of patients in the rhTPO group versus 12.5% in the placebo group (p < 0.0001). Preoperatively, platelet counts >= 50 & times; 10(9)/L were achieved in 92.5% and 20.0% of patients in the rhTPO and placebo groups, respectively (p < 0.0001). Platelet transfusion was avoided in 92.5% of rhTPO-treated patients versus 25.0% of placebo-treated patients (p < 0.0001). The median duration of platelet counts >= 50 & times; 10(9)/L was significantly longer with rhTPO than with placebo (21.0 vs. 3.0 days, p = 0.0007). Treatment-related treatment-emergent adverse events (TEAEs) occurred in 12.5% of patients in both the rhTPO and placebo groups. No treatment-related serious adverse events were reported. Overall, rhTPO was effective and well tolerated in patients with CLD-related thrombocytopenia and may represent a viable therapeutic option for those undergoing elective invasive procedures.
[1]Peking Univ First Hosp, Dept Gastroenterol, Beijing, Peoples R China.
[2]Peking Univ First Hosp, Dept Infect Dis, Beijing, Peoples R China.
[3]Liaocheng Peoples Hosp, Dept Infect Dis, Liaocheng, Shandong, Peoples R China.
[4]First Hosp Jilin Univ, Dept Hepatol, Jilin, Peoples R China.
[5]Henan Prov Peoples Hosp, Dept Infect Dis, Zhengzhou, Henan, Peoples R China.
[6]Qingdao Municipal Hosp, Dept Hepatol, Qingdao, Shandong, Peoples R China.
[7]Third Peoples Hosp Zhenjiang, Dept Hepatol, Zhenjiang, Peoples R China.
[8]Chongqing Med Univ, Affiliated Hosp 2, Dept Infect Dis, Chongqing, Peoples R China.
[9]Southern Med Univ, Nanfang Hosp, Dept Infect Dis, Guangzhou, Guangdong, Peoples R China.
[10]Sixth Peoples Hosp Shenyang, Dept Hepatol, Shenyang, Liaoning, Peoples R China.
[11]Capital Med Univ, Beijing Ditan Hosp, Ctr Liver Dis, Beijing, Peoples R China.
[12]Guangzhou Med Univ, Guangzhou Peoples Hosp 8, Dept Hepatol, Guangzhou, Guangdong, Peoples R China.
[13]Second Hosp Nanjing, Dept Infect & Liver Dis, Nanjing, Jiangsu, Peoples R China.
[14]Sichuan Univ, West China Hosp, Dept Liver Surg, Chengdu, Sichuan, Peoples R China.
[15]Sichuan Univ, West China Hosp, Liver Transplantat Ctr, Chengdu, Sichuan, Peoples R China.
[16]Capital Med Univ, Beijing Youan Hosp, Dept Gastroenterol & Hepatol, Beijing, Peoples R China.
[17]Capital Med Univ, Beijing Youan Hosp, Dept 4, Liver Dis Ctr, Beijing, Peoples R China.
[18]Dalian Med Univ, Hosp 2, Dept Infect Dis, Dalian, Liaoning, Peoples R China.
[19]Nanchang Univ, Affiliated Hosp 2, Dept Gastroenterol, Nanchang, Jiangxi, Peoples R China.
[20]Wenzhou Med Univ, Affiliated Hosp 1, Dept Infect Dis, Wenzhou, Zhejiang, Peoples R China.
[21]Kunming Med Univ, Affiliated Hosp 2, Dept Gastroenterol, Kunming, Yunnan, Peoples R China.
[22]Wuhan Univ, Renmin Hosp, Dept Gastroenterol, Wuhan, Hubei, Peoples R China.
[23]Guangzhou First Peoples Hosp, Dept Gastroenterol, Guangzhou, Guangdong, Peoples R China.
[24]Zhengzhou Univ, Affiliated Hosp 1, Dept Infect Dis, Zhengzhou, Henan, Peoples R China.
[25]Fujian Med Univ, Mengchao Hepatobiliary Hosp, Dept Hepatopancreatobiliary Surg, Fuzhou, Fujian, Peoples R China.
[26]Fujian Med Univ, Affiliated Hosp 2, Dept Hepatobiliary & Pancreat Surg, Fuzhou, Fujian, Peoples R China.
[27]Cent South Univ, Dept Infect Dis, Xiangya Hosp, Changsha, Hunan, Peoples R China.
[28]Hebei Med Univ, Hosp 3, Dept Integrated Tradit Chinese & Western Med Hepat, Shijiazhuang, Hebei, Peoples R China.
[29]Guizhou Prov Peoples Hosp, Dept Infect Dis, Anshun, Guizhou, Peoples R China.
[30]Zunyi Med Univ, Affiliated Hosp, Dept Intervent, Zunyi, Guizhou, Peoples R China.
[31]Tianjin Peoples Hosp, Dept Hepatol & Gastroenterol, Tianjin, Peoples R China.
[32]Fudan Univ, Zhongshan Hosp, Dept Gastroenterol & Hepatol, Shanghai, Peoples R China.
[33]Nanchang Univ, Affiliated Hosp 2, Dept Gen Surg, Div Hepatobiliary Pancreat Surg, Nanchang, Jiangxi, Peoples R China.
[34]Wenzhou Med Univ, Affiliated Hosp 1, Dept Hepatobiliary & Pancreat Surg, Wenzhou, Zhejiang, Peoples R China.
[35]Sun Yat Sen Univ, Affiliated Hosp 1, Dept Intervent Oncol, Guangzhou, Guangdong, Peoples R China.
[36]Xiamen Univ, Dept Hepatobiliary Surg, Zhongshan Hosp, Xiamen, Fujian, Peoples R China.
[37]Bengbu Med Univ, Affiliated Hosp 1, Dept Gen Surg, Bengbu, Anhui, Peoples R China.
[38]Shenzhen Third Peoples Hosp, Dept Hepatol, Shenzhen, Guangdong, Peoples R China.
[39]Liuzhou Peoples Hosp, Dept Hepatobiliary Surg, Liuzhou, Guangxi, Peoples R China.
[40]Shanxi Med Univ, Hosp 1, Dept Infect Dis, Taiyuan, Shanxi, Peoples R China.
[41]Sichuan Univ, West China Hosp, Dept Gastroenterol, Chengdu, Sichuan, Peoples R China.
[42]Zhejiang Univ, Affiliated Hosp 1, State Key Lab Diag & Treatment Infect Dis, Sch Med, Hangzhou, Zhejiang, Peoples R China.
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