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

NCT02515838 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 147

Last updated 2019-07-16

No results posted yet for this study

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).

Conditions

  • Sickle-Cell Disease

Interventions

DRUG

Sevuparin

The Drug Product sevuparin solution for IV infusion

OTHER

Placebo

Placebo for IV infusion

Sponsors & Collaborators

  • Ergomed

    collaborator INDUSTRY

  • Modus Therapeutics AB

    lead INDUSTRY

Principal Investigators

  • Dr Bart J Biemond, MD, PhD · Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-07-31
Primary Completion
2019-05-31
Completion
2019-05-31

Countries

  • Bahrain
  • Jamaica
  • Lebanon
  • Netherlands
  • Oman
  • Saudi Arabia
  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02515838 on ClinicalTrials.gov