Comparison of Thromboembolic Events in Patients Undergoing Thromboprophylactic Treatment With ENOXA® vs Lovenox®

Phase 4 Completed 168 enrolled Les Laboratoires des Médicaments Stériles

RandomizedParallel-groupSingle-blindPrevention

Summary

Prospective, monocentric, randomized, parallel group, rater-blinded study using two formulations of Enoxaparin sodium (ENOXA® vs LOVENOX®) to compare the thromboembolic events (symptomatic and asymptomatic) in patients undergoing gastrointestinal cancer surgery and thromboprophylactic treatment with either Enoxaparin formulations. The study has a secondary focus as to evaluate the immunogenicity of the two formulations of Enoxaparin through a subgroup analysis. Study followup duration is up to 30 days post surgical procedure.

Timeline

Start: 2015-10
Primary completion: 2020-07
Completion: 2020-07-10

Outcome

Met primary endpoint

paper Analysis of the difference in means using Student's t test demonstrated the equivalence of the two treatments. PMID 37910523 ↗

paper BE and BSE are equivalent. PMID 37910523 ↗

Publications

Dziri C, Ben Hmida W, Dougaz W, Khalfallah M, Samaali I, Jerraya H, Bouasker I, Nouira R. Biosimilar versus branded enoxaparin to prevent postoperative venous thromboembolism after surgery for digestive tract cancer: Randomized trial. PLoS One. 2023 Nov 1;18(11):e0293269. doi: 10.1371/journal.pone.0293269. eCollection 2023.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Enoxaparin sodium	Other / unclassified	4000 iu	Subcutaneous