Phase II study of avatrombopag in thrombocytopenic patients with cirrhosis undergoing an elective procedure

Journal of Hepatology

Volumn 61, Issue 6, 2014, Pages 1253-1259

  Terrault, Norah A ^a   Hassanein, Tarek ^b   Howell, Charles D ^c   Joshi, Shobha ^d   Lake, John ^e   Sher, Linda ^f   Vargas, Hugo ^g   McIntosh, Joe ^h   Tang, Shande ^h   Jenkins, Tim M ⁱ  

^a UNIVERSITY OF CALIFORNIA   (United States)

^b Southern California Liver Centers   (United States)

^c UNIVERSITY OF MARYLAND SCHOOL OF MEDICINE   (United States)

^d TULANE UNIVERSITY SCHOOL OF MEDICINE   (United States)

^e UNIVERSITY OF MINNESOTA   (United States)

^f UNIVERSITY OF SOUTHERN CALIFORNIA   (United States)

^g MAYO CLINIC HOSPITAL   (United States)

^h EISAI INC   (United States)

ⁱ EISAI CO LTD   (Japan)

Author keywords

Avatrombopag; Chronic liver disease; Cirrhosis; Elective procedure; Platelet; Thrombocytopenia; Thrombopoietin receptor agonist

Indexed keywords

AVATROMBOPAG; PLACEBO; 1-(3-CHLORO-5-((4-(4-CHLORO-2-THIENYL)-5-(4-CYCLOHEXYLPIPERAZIN-1-YL)THIAZOL-2-YL)CARBAMOYL)-2-PYRIDYL)PIPERIDINE-4-CARBOXYLIC ACID; THIAZOLE DERIVATIVE; THIOPHENE DERIVATIVE; THROMBOPOIETIN RECEPTOR;

ABDOMINAL PAIN; ADULT; ARTICLE; ASCITES; CONTROLLED STUDY; DIARRHEA; DOPPLER FLOWMETRY; DOSE RESPONSE; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; ELECTIVE SURGERY; FATIGUE; FEMALE; FEVER; FOLLOW UP; GASTROINTESTINAL HEMORRHAGE; HEADACHE; HEPATIC ENCEPHALOPATHY; HUMAN; LIVER CIRRHOSIS; LOADING DRUG DOSE; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; NAUSEA; PHASE 2 CLINICAL TRIAL; PORTAL HYPERE; PORTAL HYPERTENSION; PORTAL VEIN THROMBOSIS; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RECTUM HEMORRHAGE; SENSITIVITY ANALYSIS; STOMACH DISEASE; THROMBOCYTE COUNT; THROMBOCYTE TRANSFUSION; THROMBOCYTOPENIA; TREATMENT OUTCOME; TREATMENT RESPONSE; VOMITING; AGONISTS; CLINICAL TRIAL; COMPLICATION; DRUG EFFECTS; INCIDENCE; MIDDLE AGED; RISK FACTOR; THROMBOCYTE;

BLOOD PLATELETS; DOSE-RESPONSE RELATIONSHIP, DRUG; DOUBLE-BLIND METHOD; ELECTIVE SURGICAL PROCEDURES; FATIGUE; FEMALE; HEADACHE; HUMANS; INCIDENCE; LIVER CIRRHOSIS; MALE; MIDDLE AGED; NAUSEA; PLATELET COUNT; RECEPTORS, THROMBOPOIETIN; RISK FACTORS; THIAZOLES; THIOPHENES; THROMBOCYTOPENIA;

EID: 84922710745     PISSN: 01688278     EISSN: 16000641     Source Type: Journal    
DOI: 10.1016/j.jhep.2014.07.007     Document Type: Article

References (14)

1. F.N. Bashour, J.C. Teran, and K.D. Mullen Prevalence of peripheral blood cytopenias (hypersplenism) in patients with nonalcoholic chronic liver disease Am J Gastroenterol 95 2000 2936 2939
2. F. Violi, S. Basili, V. Raparelli, P. Chowdary, A. Gatt, and A.K. Burroughs Patients with liver cirrhosis suffer from primary haemostatic defects? Fact or fiction? J Hepatol 55 2011 1415 1427
3. R. Stasi Pathophysiology and therapeutic options in primary immune thrombocytopenia Blood Transfus 9 2011 262 273
4. N. Afdhal, J. McHutchison, and R. Brown Thrombocytopenia associated with chronic liver disease J Hepatol 48 2008 1000 1007
5. E.G. Giannini, A. Greco, S. Marenco, E. Andorno, U. Valente, and V. Savarino Incidence of bleeding following invasive procedures in patients with thrombocytopenia and advanced liver disease Clin Gastroenterol Hepatol 8 2010 899 902
6. L.B. Seeff, G.T. Everson, and T.R. Morgan Complication rate of percutaneous liver biopsies among persons with advanced chronic liver disease in the HALT-C trial Clin Gastroenterol Hepatol 8 2010 877 883
7. F.R. Ponziani, M.A. Zocco, and C. Campanale Portal vein thrombosis: insight into physiopathology, diagnosis, and treatment World J Gastroenterol 16 2010 143 155
8. L. Amitrano, and M.A. Guardascione Management of portal vein thrombosis in cirrhotic patients Mediterr J Hematol Infect Dis 1 2009 e2009014
9. N.H. Afdhal, E.G. Giannini, and G. Tayyab Eltrombopag before procedures in patients with cirrhosis and thrombocytopenia N Engl J Med 367 2012 716 724
10. B. McClelland, and M. Contreras Appropriateness and safety of blood transfusion BMJ 330 2005 104 105
11. N.L. Shah, P.G. Northup, and S.H. Caldwell A clinical survey of bleeding, thrombosis, and blood product use in decompensated cirrhosis patients Ann Hepatol 11 2012 686 690
12. M. Fukushima-Shintani, K. Suzuki, and Y. Iwatsuki AKR-501 (YM477) in combination with thrombopoietin enhances human megakaryocytopoiesis Exp Hematol 36 2008 1337 1342
13. M. Fukushima-Shintani, K. Suzuki, and Y. Iwatsuki AKR-501 (YM477) a novel orally-active thrombopoietin receptor agonist Eur J Haematol 82 2009 247 254
14. J.B. Bussel, J. Zhang, S. Tang, J. McIntosh, and D.J. Kuter A randomized, double-blind, placebo-controlled phase II trial on the efficacy, safety and tolerability of E5501 (AKR501) in subjects with chronic immune thrombocytopenia (ITP) Blood 116 2010 A71