Sevuparin Infusion for the Management of Acute VOC in Subjects With SCD
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| ClinicalTrials.gov Identifier: NCT02515838 |
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Recruitment Status :
Completed
First Posted : August 5, 2015
Last Update Posted : July 16, 2019
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Sponsor:
Modus Therapeutics AB
Collaborator:
Ergomed
Information provided by (Responsible Party):
Modus Therapeutics AB
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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 |
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 |
| 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
MedlinePlus Genetics related topics:
Sickle cell disease
| Arm | Intervention/treatment |
|---|---|
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Placebo Comparator: Placebo
Placebo infusion
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Other: Placebo
Placebo for IV infusion |
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Experimental: Sevuparin
Sevuparin infusion
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Drug: Sevuparin
The Drug Product sevuparin solution for IV infusion |
Primary Outcome Measures :
- 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 :
- 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
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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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Sponsors and Collaborators
Modus Therapeutics AB
Ergomed
Investigators
| Principal Investigator: | Dr Bart J Biemond, MD, PhD | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Modus Therapeutics AB |
| ClinicalTrials.gov Identifier: | NCT02515838 |
| 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 |