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HEMolyse and Organ damage imPROvement in sickle cell disease by VoxElotor
EU CTIS ID: 2024-513096-41-00
What this study is testing
To evaluate the biological activity of Voxelotor on the reduction of intra vascular hemolysis measured by plasma hemoglobin
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- SS or S-β0 major sickle cell syndrome
- Hemoglobin level < 9 g/dL
- Aged 18 years or older
- Stable dose for at least 3 months if treated with HU, EPO, angiotensin-converting enzyme (ACE), inhibitor/angiotensin receptor blocker (ARB), glutamine or crizanlizumab therapy; at least after 6 months after initiating HU treatment
- Patient with social security
- Female patient must have a negative serum pregnancy test (betaHCGat inclusion W0-V1D1) or evidence of post-menopausal status
You likely can't join if
- Patients in chronic transfusion program or transfused < 3 months before enrolment
- Chronic use of NSAIDs (more than 10 days by month)
- Auto immune disease or infection not controlled or cancer
- VIH, HBV, HCV current infection
- Prior drug hypersensitivity to Voxelotor or excipients
- Known allergy or hypersensitivity to imaging contrast product
See the full eligibility criteria
- SS or S-β0 major sickle cell syndrome
- Hemoglobin level < 9 g/dL
- Aged 18 years or older
- Stable dose for at least 3 months if treated with HU, EPO, angiotensin-converting enzyme (ACE), inhibitor/angiotensin receptor blocker (ARB), glutamine or crizanlizumab therapy; at least after 6 months after initiating HU treatment
- Patient with social security
- Female patient must have a negative serum pregnancy test (betaHCGat inclusion W0-V1D1) or evidence of post-menopausal status
- Effective methods of birth control (e.g., condom, spermicidal gel, oral contraceptive, indwelling intrauterine device, hormonal implant/patch, injections, approved cervical ring) or abstinence from screening through 4 weeks after last Voxelotor dose.
- Patients in chronic transfusion program or transfused < 3 months before enrolment
- Chronic use of NSAIDs (more than 10 days by month)
- Auto immune disease or infection not controlled or cancer
- VIH, HBV, HCV current infection
- Prior drug hypersensitivity to Voxelotor or excipients
- Known allergy or hypersensitivity to imaging contrast product
- Ongoing therapeutic study
- If patient does not have any of the following treatments (HU, Crizanlizumab) he will then be excluded if: Patient meets, at screening, Hydroxyurea/ Crizanlizumab indications of treatment (recurrent painful vaso-occlusive crises, including acute chest syndrome), even if these treatments are inappropriate (e.g. hematologic toxicity antecedent) or if the patient refuses these treatments
- Patient with severe organ involvement: hepatic (TP <50%), renal (eGFR<30 ml / ml/1.73m2 according to CKD/EPI or cardiac (LVEF <45%)
- Transplant patients.
- Pregnancy
- Breast feeding patients
- Homeless patient
- Patient deprived of liberty by judicial or administrative decision or patient under guardianship
- Patient unable to understand the purpose and conditions of the study and unable to give consent
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.