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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
Sponsor:
Collaborator:
Ergomed
Information provided by (Responsible Party):
Modus Therapeutics AB

Brief 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).

Condition or disease Intervention/treatment Phase
Sickle-Cell Disease Drug: Sevuparin Other: Placebo Phase 2

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).


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 147 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo
Placebo infusion
Other: Placebo
Placebo for IV infusion

Experimental: Sevuparin
Sevuparin infusion
Drug: Sevuparin
The Drug Product sevuparin solution for IV infusion




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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.

  3. 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)

  4. 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)

  5. Cumulative dose of parenteral opioids [ Time Frame: From baseline (visit 1) until day 3-7 ]
    Total dose of parenteral opioids



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Ages Eligible for Study:   12 Years to 50 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Sign a written informed consent (adults, parents) and assent (adolescents)
  • Male or female, age 12-50 years.
  • Diagnosis of Sickle cell disease
  • Subjects admitted for an acute, painful VOC to be treated/or treated with parenteral opioid analgesia.
  • Expectancy of need for hospitalization during at least 48 hours.
  • Be at least 1 year postmenopausal, surgically sterile, or if Women of Child Bearing Potential (WOCBP), e.g. following menarche practicing an effective method of birth control

Exclusion Criteria:

  • Severe hepatic failure/disease, abnormal liver enzyme tests or history of hepatitis B virus (HBV), hepatitis C virus (HCV)
  • Abnormal conjugated (direct) bilirubin 3 fold above ULN
  • History of clinically significant bleeding in vital organs
  • Current clinically significant bleeding, as judged by the investigator
  • Current use of acetylsalicylic acid (ASA), anti-platelet therapy, anticoagulant therapy
  • Abnormal coagulation laboratory values
  • A platelet count <75,000/µL.
  • BMI >35
  • Subjects with more than 5 hospitalizations for VOC during the last 6 months
  • Evidence of acute SCD complications other than VOC at screening
  • The use of strong opioids for > 3 consecutive days during the last 15 days before presenting to the hospital
  • History of chronic drug abuse.
  • Renal dysfunction
  • Known infection (positivity) with human immunodeficiency virus (HIV), HBV or HCV.
  • Significant ECG abnormality
  • History of a clinically significant drug allergy to heparin, LMWH's, sevuparin, or morphine.
  • Use of any investigational agent during the 30 days prior to the first dose.
  • For females: pregnancy, lactating or intention of becoming pregnant
  • Evidence of clinically significant disorders that might interfere with the study aim or safety of the subject
  • Any condition that, in the view of the Investigator, places the subject at high risk of poor treatment compliance or of not completing the study.

Information from the National Library of Medicine

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


Locations
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Bahrain
Salmaniya Hospital, Kingdom of Bahrain
Manama, Bahrain
Salmaniya Medical Complex, Bahrain
Manama, Bahrain
Jamaica
Annotto Bay Hospital
Annotto Bay, Jamaica
Kingston Public Hospital
Kingston, Jamaica
University Hospital of the West Indies
Kingston, Jamaica
Winchester Surgical and Medical Institute
Kingston, Jamaica
Mandeville Regional Hospital
Mandeville, Jamaica
May Pen Public Hospital Clarendon
May Pen, Jamaica
Cornwall Regional Hospital, Jamaica
Montego Bay, Jamaica
Lebanon
American University of Beirut Medical Center, Beirut, Cairo street, Beirut, Lebanon
Beirut, Lebanon
Nini Hospital
Tripoli, Lebanon
Netherlands
Dept of Haematology
Amsterdam, Netherlands
Erasmus MC
Rotterdam, Netherlands
Oman
Sultan Qaboos University Hospital Alkhodh, Oman
Muscat, Oman
Sultan Qaboos University
Muscat, Oman
Saudi Arabia
King Fahd Medical City, As Sulimaniyah, Riyadh Saudiarabien
Riyadh, Saudi Arabia
King Saud University, Riyadh, Saudiarabien
Riyadh, Saudi Arabia
Turkey
Mersin University Faculty of Medicine
Adana, Mersin, Turkey
Cukurova University Faculty Of Medicine Tıp Fakültesi
Adana, Turkey
Dr Antmen
Adana, Turkey
Sponsors and Collaborators
Modus Therapeutics AB
Ergomed
Investigators
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Principal Investigator: Dr Bart J Biemond, MD, PhD Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

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Responsible Party: Modus Therapeutics AB
ClinicalTrials.gov Identifier: NCT02515838     History of Changes
Other Study ID Numbers: TVOC01
First Posted: August 5, 2015    Key Record Dates
Last Update Posted: July 16, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn
Heparin
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action