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

Modus Therapeutics

Status and phase

Completed

Phase 2

Conditions

Sickle-Cell Disease

Treatments

Drug: Sevuparin

Other: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT02515838

TVOC01

Details and patient eligibility

About

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).

Full 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).

Enrollment

147 patients

Sex

All

Ages

12 to 50 years old

Volunteers

No Healthy Volunteers

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.