Sickle-Cell DiseasePhase 2NCT02515838
Sevuparin Infusion for the Management of Acute VOC in Subjects With SCD
A Phase 2 study testing Sevuparin in people with Sickle-Cell Disease, run by Modus Therapeutics AB at 20 sites in 7 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 12 to 50 years
- Conditions the study is for
- Sickle-Cell Disease
- What is being tested?
- Sevuparin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 147 participants
- Where
- 20 sitesin 7 countries
- Study dates
- Jul 2015to May 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 20Show fewer
- 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.
Trial locations and contacts
20 sites in 7 countries.
20 sites in 7 countries
Jamaica7 sites
Annotto Bay Hospital
Annotto Bay
Kingston Public Hospital
Kingston
University Hospital of the West Indies
Kingston
Winchester Surgical and Medical Institute
Kingston
Mandeville Regional Hospital
Mandeville
May Pen Public Hospital Clarendon
May Pen
Cornwall Regional Hospital, Jamaica
Montego Bay
Turkey (Türkiye)3 sites
Mersin University Faculty of Medicine
Adana, Mersin
Cukurova University Faculty Of Medicine Tıp Fakültesi
Adana
Dr Antmen
Adana
Bahrain2 sites
Salmaniya Hospital, Kingdom of Bahrain
Manama
Salmaniya Medical Complex, Bahrain
Manama
Lebanon2 sites
American University of Beirut Medical Center, Beirut, Cairo street, Beirut, Lebanon
Beirut
Nini Hospital
Tripoli
Oman2 sites
Sultan Qaboos University Hospital Alkhodh, Oman
Muscat
Sultan Qaboos University
Muscat
Saudi Arabia2 sites
King Fahd Medical City, As Sulimaniyah, Riyadh Saudiarabien
Riyadh
King Saud University, Riyadh, Saudiarabien
Riyadh
About this study
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).
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).
Read the 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
- Being tested
- Sevuparin, Placebo
- Medical subject headings
- Anemia, Sickle Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SevuparinDrug
The Drug Product sevuparin solution for IV infusion
PlaceboOther
Placebo for IV infusion
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo infusion Receives: Other: Placebo |
| Sevuparin | Experimental | Sevuparin infusion Receives: Drug: Sevuparin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to resolution of VOC
Time from start of infusion until resolution of VOC crisis/episode
Measured: From hospitalisation until discharge, defined as freedom from parenteral opioid use and readiness for discharge i.e. from randomisation until day 7
Secondary outcomes (5)
Frequency and pattern of treatment-emergent adverse event (TEAEs)
All events to be reported from randomization until end of study
Measured: Time from start randomsiation until end of study, approximately 1 month 1 week after randomisation
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.
Measured: Pre dose, 1h, 2h, 24h, 1/day (day 3-8)
Mean change in pain intensity
VAS (visual analog scale) every fourth hour. Range from 0 (no pain) to 100 (max pain)
Measured: From baseline (visit 1) until day 3-7
Duration of severest pain,
Defined as time to a 30% reduction in pain intensity (VAS)
Measured: From baseline (visit 1) until day 3-7
Cumulative dose of parenteral opioids
Total dose of parenteral opioids
Measured: From baseline (visit 1) until day 3-7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2015 (estimated)
- Study startJul 2015
- Primary completionMay 2019
- Study completionMay 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sickle-Cell DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 147 participants (actual)
Sponsor and investigators
- Lead sponsor
- Modus Therapeutics AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Ergomed
- Responsible party
- Sponsor
- Investigators
- Dr Bart J Biemond, MD, PhD, Principal investigator, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02515838
- Sponsor's protocol ID
- TVOC01
- Status last verified
- Feb 2019
- First submitted
- 27 Jul 2015
- Last updated
- 16 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
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.
PubMed 33894169
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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).
- ClinicalTrials.gov ID
- NCT02515838
- Acronym / sponsor ID
- TVOC01
- Conditions
- Sickle-Cell Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 147 participants (actual)
- Lead sponsor
- Modus Therapeutics ABIndustry (pharma, biotech, devices)
- Collaborators
- Ergomed
- Study start
- Jul 2015 (actual)
- Primary completion
- May 2019 (actual)
- Study completion
- May 2019 (actual)
- First posted
- 5 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: PlaceboPlacebo infusion |
| Sevuparin | Experimental | Drug: SevuparinSevuparin infusion |
Who may qualify
- Ages
- 12 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SevuparinThe Drug Product sevuparin solution for IV infusion | Drug | Sevuparin |
| PlaceboPlacebo for IV infusion | Other | Placebo |
Primary outcome
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
5 secondary outcomes
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
Pharmacokinetic (PK) characteristics of sevuparin
Time frame: Pre dose, 1h, 2h, 24h, 1/day (day 3-8)
Mean change in pain intensity
Time frame: From baseline (visit 1) until day 3-7
Duration of severest pain,
Time frame: From baseline (visit 1) until day 3-7
Cumulative dose of parenteral opioids
Time frame: From baseline (visit 1) until day 3-7
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2019.
- Derived from this study: PubMed 33894169Biemond 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr Bart J Biemond, MD, PhD principal investigator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
20 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sevuparin in people with Sickle-Cell Disease, run by Modus Therapeutics AB at 20 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in Jamaica, Turkey (Türkiye), Bahrain, Lebanon, Netherlands and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02515838, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2019.