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

NCT ID: NCT02515838

Last Updated: 2019-07-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 147 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-07-31
• Study Completion Date: 2019-05-31

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).

Conditions

Sickle-Cell Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo

Placebo infusion

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Placebo for IV infusion

Sevuparin

Sevuparin infusion

Group Type: EXPERIMENTAL

Sevuparin

Intervention Type: DRUG

The Drug Product sevuparin solution for IV infusion

Interventions

Sevuparin

The Drug Product sevuparin solution for IV infusion

Intervention Type: DRUG

Placebo

Placebo for IV infusion

Intervention Type: OTHER

Eligibility 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.

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ergomed

INDUSTRY

Sponsor Role: collaborator

Modus Therapeutics AB

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dr Bart J Biemond, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Locations

Salmaniya Hospital, Kingdom of Bahrain

Manama, , Bahrain

Salmaniya Medical Complex, Bahrain

Manama, , Bahrain

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

American University of Beirut Medical Center, Beirut, Cairo street, Beirut, Lebanon

Beirut, , Lebanon

Nini Hospital

Tripoli, , Lebanon

Dept of Haematology

Amsterdam, , Netherlands

Erasmus MC

Rotterdam, , Netherlands

Sultan Qaboos University Hospital Alkhodh, Oman

Muscat, , Oman

Sultan Qaboos University

Muscat, , Oman

King Fahd Medical City, As Sulimaniyah, Riyadh Saudiarabien

Riyadh, , Saudi Arabia

King Saud University, Riyadh, Saudiarabien

Riyadh, , Saudi Arabia

Mersin University Faculty of Medicine

Adana, Mersin, Turkey (Türkiye)

Cukurova University Faculty Of Medicine Tıp Fakültesi

Adana, , Turkey (Türkiye)

Dr Antmen

Adana, , Turkey (Türkiye)

Countries

Bahrain; Jamaica; Lebanon; Netherlands; Oman; Saudi Arabia; Turkey (Türkiye)

References

Biemond BJ, Tombak A, Kilinc Y, Al-Khabori M, Abboud M, Nafea M, Inati A, Wali Y, Kristensen J, Kowalski J, Donnelly E, Ohd J; TVOC01 Investigators Group. Sevuparin for the treatment of acute pain crisis in patients with sickle cell disease: a multicentre, randomised, double-blind, placebo-controlled, phase 2 trial. Lancet Haematol. 2021 May;8(5):e334-e343. doi: 10.1016/S2352-3026(21)00053-3.

Reference Type: DERIVED

PMID: 33894169 (View on PubMed)

Other Identifiers

TVOC01

Identifier Type: -

Identifier Source: org_study_id