Sevuparin Infusion for the Management of Acute VOC in Subjects With SCD

Phase 2 Completed 147 enrolled Modus Therapeutics AB Ergomed GmbH · collab

RandomizedParallel-groupQuadruple-blindTreatment

Summary

A Multi-Centre, Phase II, Randomized, Double-Blind, Placebo-Controlled Study to investigate Efficacy and Safety of Sevuparin Infusion for the Management of Acute Vaso-Occlusive Crisis (VOC) in Subjects with Sickle-Cell Disease (SCD).

Timeline

Start: 2015-07
Primary completion: 2019-05
Completion: 2019-05

Outcome

Missed primary endpoint

paper primary endpoint showed no significant difference in median time to vaso-occlusive crisis resolution between the sevuparin and placebo groups PMID 33894169 ↗

paper hazard ratio 0·89 [0·6-1·3]; p=0·55 PMID 33894169 ↗

release “sevuparin did not demonstrate a meaningful clinical benefit in this large Phase 2 study, particularly as SCD patients” modustx.com ↗

Publications

Biemond BJ, Tombak A, Kilinc Y, Al-Khabori M, Abboud M, Nafea M, Inati A, Wali Y, Kristensen J, Kowalski J, Donnelly E, Ohd J; TVOC01 Investigators Group. Sevuparin for the treatment of acute pain crisis in patients with sickle cell disease: a multicentre, randomised, double-blind, placebo-controlled, phase 2 trial. Lancet Haematol. 2021 May;8(5):e334-e343. doi: 10.1016/S2352-3026(21)00053-3.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Sevuparin	Other / unclassified	18 mg/kg	Intravenous