{"database":"biostudies-literature","file_versions":[],"scores":null,"additional":{"submitter":["Verbout NG"],"funding":["Oregon Health and Science University","NHLBI NIH HHS","U.S. Department of Health &amp; Human Services | NIH | National Heart, Lung, and Blood Institute","Oregon Health and Science University (Oregon Health & Science University)","U.S. Department of Health & Human Services | NIH | National Heart, Lung, and Blood Institute (NHLBI)"],"pagination":["153"],"full_dataset_link":["https://www.ebi.ac.uk/biostudies/studies/S-EPMC11282208"],"repository":["biostudies-literature"],"omics_type":["Unknown"],"volume":["4(1)"],"pubmed_abstract":["<h4>Background</h4>The protein C system regulates blood coagulation, inflammation, and vascular integrity. AB002 is an injectable protein C activating enzyme under investigation to safely prevent and treat thrombosis. In preclinical models, AB002 is antithrombotic, cytoprotective, and anti-inflammatory. Since prophylactic use of heparin is contraindicated during hemodialysis in some end-stage renal disease (ESRD) patients, we propose using AB002 as a short-acting alternative to safely limit blood loss due to clotting in the dialysis circuit.<h4>Methods</h4>This phase 2, randomized, double-blind, placebo-controlled, single-dose study evaluates the safety and tolerability of AB002 administered into the hemodialysis line of ESRD patients during hemodialysis at one study center in the United S"],"journal":["Communications medicine"],"pubmed_title":["Safety and tolerability of the protein C activator AB002 in end-stage renal disease patients on hemodialysis: a randomized phase 2 trial."],"pmcid":["PMC11282208"],"funding_grant_id":["HL147695","R01 HL049413","R01 HL147821","HL139554","R01 HL139554","HL147821","R44 HL147695","Elemental Analysis Core"],"pubmed_authors":["Lorentz CU","Gruber A","Markway BD","Wallisch M","Marbury TC","Shatzel JJ","Di Cera E","Verbout NG","Tucker EI"],"additional_accession":[]},"is_claimable":false,"name":"Safety and tolerability of the protein C activator AB002 in end-stage renal disease patients on hemodialysis: a randomized phase 2 trial.","description":"<h4>Background</h4>The protein C system regulates blood coagulation, inflammation, and vascular integrity. AB002 is an injectable protein C activating enzyme under investigation to safely prevent and treat thrombosis. In preclinical models, AB002 is antithrombotic, cytoprotective, and anti-inflammatory. Since prophylactic use of heparin is contraindicated during hemodialysis in some end-stage renal disease (ESRD) patients, we propose using AB002 as a short-acting alternative to safely limit blood loss due to clotting in the dialysis circuit.<h4>Methods</h4>This phase 2, randomized, double-blind, placebo-controlled, single-dose study evaluates the safety and tolerability of AB002 administered into the hemodialysis line of ESRD patients during hemodialysis at one study center in the United S","dates":{"release":"2024-01-01T00:00:00Z","publication":"2024 Jul","modification":"2026-06-01T06:51:35.782Z","creation":"2025-04-19T13:09:45.899Z"},"accession":"S-EPMC11282208","cross_references":{"pubmed":["39060370"],"doi":["10.1038/s43856-024-00575-y"]}}