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Trial record 2 of 3 for:    sevuparin

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE July 27, 2015
First Posted Date  ICMJE August 5, 2015
Last Update Posted Date July 16, 2019
Actual Study Start Date  ICMJE July 2015
Actual Primary Completion Date May 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 27, 2015)
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
Original Primary Outcome Measures  ICMJE
 (submitted: August 2, 2015)
Readiness for discharge [ Time Frame: From hospitalisation until discharge, i.e. readiness for discharge calculated time from randomisation until day 7 ]
Time from start of infusion until resolution of VOC crisis/episode
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 22, 2019)
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: August 2, 2015)
  • Frequency and pattern of treatment-emergent adverse event (TEAEs) [ Time Frame: Time from start randomsiation until end of study, approximatly 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Sevuparin Infusion for the Management of Acute VOC in Subjects With SCD
Official Title  ICMJE 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).
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).
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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Sickle-Cell Disease
Intervention  ICMJE
  • Drug: Sevuparin
    The Drug Product sevuparin solution for IV infusion
  • Other: Placebo
    Placebo for IV infusion
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Placebo infusion
    Intervention: Other: Placebo
  • Experimental: Sevuparin
    Sevuparin infusion
    Intervention: Drug: Sevuparin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 15, 2019)
147
Original Estimated Enrollment  ICMJE
 (submitted: August 2, 2015)
77
Actual Study Completion Date  ICMJE May 2019
Actual Primary Completion Date May 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years to 50 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Bahrain,   Jamaica,   Lebanon,   Netherlands,   Oman,   Saudi Arabia,   Turkey
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02515838
Other Study ID Numbers  ICMJE TVOC01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Modus Therapeutics AB
Study Sponsor  ICMJE Modus Therapeutics AB
Collaborators  ICMJE Ergomed
Investigators  ICMJE
Principal Investigator: Dr Bart J Biemond, MD, PhD Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
PRS Account Modus Therapeutics AB
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP