Sickle-Cell Disease Clinical Trial
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).
| NCT number | NCT02515838 |
| Other study ID # | TVOC01 |
| Secondary ID | |
| Status | Completed |
| Phase | Phase 2 |
| First received | |
| Last updated | |
| Start date | July 2015 |
| Est. completion date | May 2019 |
| Verified date | February 2019 |
| Source | Modus Therapeutics AB |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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).
| Status | Completed |
| Enrollment | 147 |
| Est. completion date | May 2019 |
| Est. primary completion date | May 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 12 Years to 50 Years |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| Bahrain | Salmaniya Hospital, Kingdom of Bahrain | Manama | |
| Bahrain | Salmaniya Medical Complex, Bahrain | Manama | |
| Jamaica | 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 | |
| Lebanon | American University of Beirut Medical Center, Beirut, Cairo street, Beirut, Lebanon | Beirut | |
| Lebanon | Nini Hospital | Tripoli | |
| Netherlands | Dept of Haematology | Amsterdam | |
| Netherlands | Erasmus MC | Rotterdam | |
| Oman | Sultan Qaboos University | Muscat | |
| Oman | Sultan Qaboos University Hospital Alkhodh, Oman | Muscat | |
| Saudi Arabia | King Fahd Medical City, As Sulimaniyah, Riyadh Saudiarabien | Riyadh | |
| Saudi Arabia | King Saud University, Riyadh, Saudiarabien | Riyadh | |
| Turkey | Cukurova University Faculty Of Medicine Tip Fakültesi | Adana | |
| Turkey | Dr Antmen | Adana | |
| Turkey | Mersin University Faculty of Medicine | Adana | Mersin |
| Lead Sponsor | Collaborator |
|---|---|
| Modus Therapeutics AB | Ergomed |
Bahrain, Jamaica, Lebanon, Netherlands, Oman, Saudi Arabia, Turkey,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Time to resolution of VOC | Time from start of infusion until resolution of VOC crisis/episode | From hospitalisation until discharge, defined as freedom from parenteral opioid use and readiness for discharge i.e. from randomisation until day 7 | |
| Secondary | Frequency and pattern of treatment-emergent adverse event (TEAEs) | All events to be reported from randomization until end of study | Time from start randomsiation until end of study, approximately 1 month 1 week after randomisation | |
| Secondary | Pharmacokinetic (PK) characteristics of sevuparin | 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. | Pre dose, 1h, 2h, 24h, 1/day (day 3-8) | |
| Secondary | Mean change in pain intensity | VAS (visual analog scale) every fourth hour. Range from 0 (no pain) to 100 (max pain) | From baseline (visit 1) until day 3-7 | |
| Secondary | Duration of severest pain, | Defined as time to a 30% reduction in pain intensity (VAS) | From baseline (visit 1) until day 3-7 | |
| Secondary | Cumulative dose of parenteral opioids | Total dose of parenteral opioids | From baseline (visit 1) until day 3-7 |