Sevuparin Infusion for the Management of Acute VOC in Subjects With SCD
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|ClinicalTrials.gov Identifier: NCT02515838|
Recruitment Status : Completed
First Posted : August 5, 2015
Last Update Posted : July 16, 2019
|Condition or disease||Intervention/treatment||Phase|
|Sickle-Cell Disease||Drug: Sevuparin Other: Placebo||Phase 2|
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).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||147 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||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).|
|Actual Study Start Date :||July 2015|
|Actual Primary Completion Date :||May 2019|
|Actual Study Completion Date :||May 2019|
Placebo Comparator: Placebo
Placebo for IV infusion
The Drug Product sevuparin solution for IV infusion
- Time to resolution of VOC [ Time Frame: From hospitalisation until discharge, defined as freedom from parenteral opioid use and readiness for discharge i.e. from randomisation until day 7 ]Time from start of infusion until resolution of VOC crisis/episode
- Frequency and pattern of treatment-emergent adverse event (TEAEs) [ Time Frame: Time from start randomsiation until end of study, approximately 1 month 1 week after randomisation ]All events to be reported from randomization until end of study
- Pharmacokinetic (PK) characteristics of sevuparin [ Time Frame: Pre dose, 1h, 2h, 24h, 1/day (day 3-8) ]PK characteristics of sevuparin during and after administration of sevuparin as a continuous IV infusion (subgroup) ◦Area under the plasma concentration versus time curve (AUC) of Sevuparin.
- Mean change in pain intensity [ Time Frame: From baseline (visit 1) until day 3-7 ]VAS (visual analog scale) every fourth hour. Range from 0 (no pain) to 100 (max pain)
- Duration of severest pain, [ Time Frame: From baseline (visit 1) until day 3-7 ]Defined as time to a 30% reduction in pain intensity (VAS)
- Cumulative dose of parenteral opioids [ Time Frame: From baseline (visit 1) until day 3-7 ]Total dose of parenteral opioids
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02515838
|Principal Investigator:||Dr Bart J Biemond, MD, PhD||Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)|