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Clinical Trial Report

Pharmacokinetic profile of defibrotide in patients with renal impairment

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Pages 2631-2641 | Published online: 16 Aug 2016

References

  • BearmanSIThe syndrome of hepatic veno-occlusive disease after marrow transplantationBlood19958511300530207756636
  • RichardsonPGuinanEHepatic veno-occlusive disease following hematopoietic stem cell transplantationActa Haematol20011061–2576811549778
  • KumarSDeLeveLDKamathPSTefferiAHepatic veno-occlusive disease (sinusoidal obstruction syndrome) after hematopoietic stem cell transplantationMayo Clin Proc200378558959812744547
  • JonesRJLeeKSBeschornerWEVenoocclusive disease of the liver following bone marrow transplantationTransplantation19874467787833321587
  • McDonaldGHindsMSFisherLDVeno-occlusive disease of the liver and multiorgan failure after bone marrow transplantation: a cohort study of 355 patientsAnn Intern Med199311842552678420443
  • MohtyMMalardFAbecassisMSinusoidal obstruction syndrome/veno-occlusive disease: current situation and perspectives-a position statement from the European Society for Blood and Marrow Transplantation (EBMT)Bone Marrow Transplant201550678178925798682
  • CorbaciogluSCesaroSFaraciMDefibrotide for prophylaxis of hepatic veno-occlusive disease in paediatric haemopoietic stem-cell transplantation: an open-label, phase 3, randomized controlled trialLancet201237998231301130922364685
  • NaplesJSkeensMBajwaRAnicteric hepatic veno-occlusive disease after hematopoietic stem cell transplantation in children [ASH abstract 5849]Blood2014124215849
  • MyersKCDandoyCEl-BietarJDaviesSMJodeleSVeno-occlusive disease of the liver in the absence of elevation in bilirubin in pediatric patients after hematopoietic stem cell transplantationBiol Blood Marrow Transplant201521237938125300869
  • CoppellJARichardsonPGSoifferRHepatic veno-occlusive disease following stem cell transplantation: incidence, clinical course, and outcomeBiol Blood Marrow Transplant201016215716819766729
  • CarrerasEDíaz-BeyáMRosiñolLMartínezCFernández-AvilésFRoviraMThe incidence of veno-occlusive disease following allogeneic hematopoietic stem cell transplantation has diminished and the outcome improved over the last decadeBiol Blood Marrow Transplant201117111713172021708110
  • Kalayoglu-BesisikSYenerelMNCaliskanYOzturkSBesisikFSarginDTime-related changes in the incidence, severity, and clinical outcome of hepatic veno-occlusive disease in hematopoietic stem cell transplantation patients during the past 10 yearsTransplant Proc20053752285228915964400
  • TsirigotisPDResnickIBAvniBIncidence and risk factors for moderate-to-severe veno-occlusive disease of the liver after allogeneic stem cell transplantation using a reduced intensity conditioning regimenBone Marrow Transplant201449111389139225068424
  • DignanFLWynnRFHadzicNHaemato-oncology Task Force of the British Committee for Standards in HaematologyBritish Society for Blood and Marrow TransplantationBCSH/BSBMT guideline: diagnosis and management of veno-occlusive disease (sinusoidal obstruction syndrome) following haematopoietic stem cell transplantationBr J Haematol2013163444445724102514
  • RichardsonPGRichesMKernanNAPhase 3 trial of defibrotide for the treatment of severe veno-occlusive disease and multi-organ failureBlood2016127131656166526825712
  • CarrerasEBertzBArceseWIncidence and outcome of hepatic veno-occlusive disease after blood or marrow transplantation: a prospective cohort study of the European Group for Blood and Marrow TransplantationBlood19989210359936049808553
  • DeLeveLDMcCuskeyRSWangXCharacterization of a reproducible rat model of hepatic veno-occlusive diseaseHepatology19992961779179110347121
  • HoVTLindenERevtaCRichardsonPGHepatic veno-occlusive disease after hematopoietic stem cell transplantation: review and update on the use of defibrotideSemin Thromb Hemost200733437338817525895
  • CarrerasEEBMT-ESH Handbook Chapter 112012 Available from: http://ebmtonline.forumservice.net/media/11/tex/content_alt/EBMT_Handbook2012_CHAP11.pdfAccessed January 28, 2015
  • DefitelioSummary of product characteristics Available from: http://ec.europa.eu/health/documents/community-register/2015/20150112130561/anx_130561_en.pdfAccessed April 7, 2016
  • US Department of Health and Human Services, Food and Drug AdministrationFDA approves first treatment for rare disease in patients who receive stem cell transplant from blood or bone marrow [FDA News Release] March 30, 2016. Available from: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm493225.htmAccessed March 30, 2016
  • Defitelio® (defibrotide sodium) [prescribing information]Palo Alto, CAJazz Pharmaceuticals, Inc.2016
  • RichardsonPGSoifferRJAntinJHDefibrotide for the treatment of severe hepatic veno-occlusive disease and multiorgan failure after stem cell transplantation: a multicenter, randomized, dose-finding trialBiol Blood Marrow Transplant20101671005101720167278
  • RichardsonPTomblynMKernanNDefibrotide (DF) in the treatment of severe hepatic veno-occlusive disease (VOD) with multi-organ failure (MOF) following stem cell transplantation (SCT): results of a phase 3 study utilizing a historical control [ASH abstract 654]Blood200911422654
  • RichardsonPGCorbaciogluSHoVTDrug safety evaluation of defibrotideExpert Opin Drug Saf201312112313623228043
  • BianchiGBaroneDLanzarottiEDefibrotide, a single-stranded polydeoxyribonucleotide acting as an adenosine receptor agonistEur J Pharmacol19932382–33273348405101
  • EissnerGMulthoffGGerbitzAFludarabine induces apoptosis, activation, and allogenicity in human endothelial and epithelial cells: protective effect of defibrotideBlood2002100133434012070045
  • EchartCIacobelliMRichardsonPPre-clinical evidence for an anti-tumor activity of defibrotide, a DNA-based, endothelium stabilizing drug [ASCO abstract 14144]J Clin Oncol200725Suppl 1814144
  • PalmerKJGoaKLDefibrotide. A review of its pharmacodynamic and pharmacokinetic properties, and therapeutic use in vascular disordersDrugs19934522592947681375
  • PortaRCalvaniABPescadorRMantovaniMPrinoGAbsorption through the peritoneum of the macromolecular profibrinolytic drug defibrotide in the rabbitSemin Thromb Hemost19911744044061803509
  • RichardsonPGEliasADKrishnanATreatment of severe veno-occlusive disease with defibrotide: compassionate use results in response without significant toxicity in a high-risk populationBlood19989237377449680339
  • BonominiVVangelistaAFrascàGA new antithrombotic agent in the treatment of acute renal failure due to hemolytic-uremic syndrome and thrombotic thrombocytopenic purpuraNephron19843721446547211
  • VangelistaAFrascàGMRaimondiCLiviano-D’ArcangeloGBonominiVEffects of defibrotide in acute renal failure due to thrombotic microangiopathyHaemostasis198616Suppl 151543754836
  • FrascàGMMartelloMSestigianiECanovaCVangelistaABonominiVEffects of defibrotide treatment in patients with IgA nephropathy and reduced renal functionNephrol Dial Transplant19961123923938700366
  • US Department of Health and Human Services, Food and Drug AdministrationGuidance for industry: pharmacokinetics in patients with impaired renal function – study design, data analysis, and impact on dosing and labeling, draft guidance [March 2010] Available from: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatory-Information/Guidances/UCM204959.pdfAccessed March 16, 2015
  • European Medicines AgencyNote for guidance on the evaluation of the pharmacokinetics of medicinal products in patients with impaired renal function [2004] Available from: http://www.emea.europa.eu/pdfs/human/ewp/022502en.pdfAccessed February 23, 2015
  • VerbeeckRKMusuambaFTPharmacokinetics and dosage adjustment in patients with renal dysfunctionEur J Clin Pharmacol200965875777319543887
  • FisherJJohnstonAMHollandTKPharmacokinetics, absorption, distribution and disposition of [125I]-defibrotide following intravenous or oral administration in the ratThromb Res199370177908511753
  • US Department of Health and Human Services, Food and Drug AdministrationGuidance for industry: bioanalytical method validation [May 2001] Available from: http://www.fda.gov/downloads/Drugs/Guidances/ucm070107.pdfAccessed April 2, 2015
  • European Medicines AgencyGuideline on Bioanalytical Method Validation2011 Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2011/08/WC500109686.pdfAccessed May 19, 2015
  • SongJCWhiteCMClinical pharmacokinetics and selective pharmacodynamics of new angiotensin converting enzyme inhibitors: an updateClin Pharmacokinet200241320722411929321
  • JanusNLaunay-VacherVDerayGThyssAThariatJManagement of chemotherapy in hemodialysis patientsBull Cancer201299337138022133734
  • Matuszkiewicz-RowińskaJMałyszkoJWojtaszekEKulickiPDosing of antibiotics in critically ill patients: are we left to wander in the dark?Pol Arch Med Wewn20121221263064023165329
  • YuRZGearyRSLevinAAPharmacokinetics and pharmacodynamics of antisense oligonucleotidesMeibohmBPharmacokinetics and Pharmacodynamics of Biotech Drugs: Principles and Case Studies in Drug DevelopmentWeinheim, GermanyWiley-VCH Verlag GmbH & Co. KGaA200693115
  • GearyRSYuRZLevinAAPharmacokinetics of phosphorothioate antisense oligodeoxynucleotidesCurr Opin Investig Drugs200124562573
  • GearyRSAntisense oligonucleotide pharmacokinetics and metabolismExpert Opin Drug Metab Toxicol20095438139119379126