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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 : Recruiting
First Posted : August 5, 2015
Last Update Posted : November 27, 2018
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).


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 133 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).
Study Start Date : July 2015
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : March 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.



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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


Contacts
Contact: Dr. Bart J Biemond, MD, PhD b.j.biemond@amc.uva.nl

Locations
Bahrain
Salmaniya Hospital, Kingdom of Bahrain Recruiting
Manama, Bahrain
Contact: Dr Najat Mahdi, MD         
Salmaniya Medical Complex, Bahrain Recruiting
Manama, Bahrain
Contact: Dr. Mohamed Hassan Nafea, MD         
Jamaica
Annotto Bay Hospital Completed
Annotto Bay, Jamaica
Kingston Public Hospital Completed
Kingston, Jamaica
University Hospital of the West Indies Completed
Kingston, Jamaica
Winchester Surgical and Medical Institute Completed
Kingston, Jamaica
Mandeville Regional Hospital Completed
Mandeville, Jamaica
May Pen Public Hospital Clarendon Completed
May Pen, Jamaica
Cornwall Regional Hospital, Jamaica Completed
Montego Bay, Jamaica
Lebanon
American University of Beirut Medical Center, Beirut, Cairo street, Beirut, Lebanon Recruiting
Beirut, Lebanon
Contact: Dr Miguel Abboud, MD         
Nini Hospital Recruiting
Tripoli, Lebanon
Contact: Dr. Adlette Inati, MD         
Netherlands
Dept of Haematology Recruiting
Amsterdam, Netherlands
Contact: Dr. Bart J Biemond, MD PhD         
Erasmus MC Completed
Rotterdam, Netherlands
Oman
Sultan Qaboos University Hospital Alkhodh, Oman Recruiting
Muscat, Oman
Contact: Prof. Yasser Wali, MD         
Sultan Qaboos University Recruiting
Muscat, Oman
Contact: Dr. Murtadha Al-Khabori , MD         
Saudi Arabia
King Fahd Medical City, As Sulimaniyah, Riyadh Saudiarabien Recruiting
Riyadh, Saudi Arabia
Contact: Alaa Morsi, MD         
King Saud University, Riyadh, Saudiarabien Recruiting
Riyadh, Saudi Arabia
Contact: Rahman Al Sultan, MD         
Turkey
Mersin University Faculty of Medicine Recruiting
Adana, Mersin, Turkey
Contact: Dr. Anıl Tombak, MD         
Cukurova University Faculty Of Medicine Tıp Fakültesi Recruiting
Adana, Turkey
Contact: Prof. Yurdanur Kilinc, MD         
Dr Antmen Recruiting
Adana, Turkey
Contact: Dr Antmen, MD         
Sponsors and Collaborators
Modus Therapeutics AB
Ergomed
Investigators
Principal Investigator: Dr Bart J Biemond, MD, PhD Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

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: November 27, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn