NCT02515838

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

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).

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 147 (actual)
• Sponsor: Modus Therapeutics AB · Industry
• Sex: All
• Age: 12 Years – 50 Years
• Healthy volunteers: Not accepted

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).

Detailed description

This will be a phase II, multi-centre, randomized, double-blind, placebo-controlled study designed to assess preliminary efficacy, safety and pharmacokinetics (PK) of 2-7 days continuous IV administration of sevuparin for the management of acute VOC in subjects with SCD. Adults and adolescents ≥ 12 years of age will be randomized to treatment with sevuparin or placebo (ratio 1:1).

Conditions

• Sickle-Cell Disease

Interventions

Type	Name	Description
DRUG	Sevuparin	The Drug Product sevuparin solution for IV infusion
OTHER	Placebo	Placebo for IV infusion

Timeline

• Start date: 2015-07-01
• Primary completion: 2019-05-01
• Completion: 2019-05-01
• First posted: 2015-08-05
• Last updated: 2019-07-16

Locations

20 sites across 7 countries: Bahrain, Jamaica, Lebanon, Netherlands, Oman, Saudi Arabia, Turkey (Türkiye)