New hope for sickle cell pain: could iloprost cut opioid use?
NCT ID NCT07498309
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests if iloprost, a drug that widens blood vessels and reduces inflammation, can help adults with sickle cell disease during painful vaso-occlusive crises. About 144 participants hospitalized for a crisis will receive either iloprost or a placebo, plus standard care. The goal is to see if iloprost lowers pain and the need for strong painkillers like opioids over 28 days.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 144 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Mar 2030
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: Patients with major sickle cell syndrome (all genotypes). 2. Age ≥18 years 3. Require hospitalization and IV opioids for VOC treatment. 4. Admitted less than 36 hours before inclusion; H0 = hospital admission time. 5. Have read and signed informed consent. 6. For women: * Of childbearing potential (defined by the CTCG as a fertile woman, after menarche and until menopause, except in cases of permanent sterility, including hysterectomy, bilateral salpingectomy, or bilateral oophorectomy); * Using a highly effective method of contraception according to CTCG recommendations (combined hormonal contraception \[containing estrogens and progestogens\] associated with inhibition of ovulation, progestogen-only hormonal contraception associated with inhibition of ovulation, intrauterine device (IUD), intrauterine hormone-releasing system (IUS), bilateral tubal occlusion, vasectomized partner, sexual abstinence) for at least 4 weeks prior to inclusion and throughout the entire duration of systemic exposure to the study treatment. AND * Having a negative urine pregnancy test at inclusion; * Postmenopausal: Menopause, according to CTCG recommendations, is defined as the absence of menstruation for 12 months without any other medical cause. Elevated follicle-stimulating hormone (FSH) levels in the postmenopausal interval can be used to confirm postmenopausal status in women who are not using hormonal contraception or hormone replacement therapy. However, in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient. 7\. Affiliated with a social security system Exclusion Criteria: 1. Patients with a contraindication to iloprost (ILOPROST ZENTIVA 100 micrograms/mL, solution for dilution for infusion): 1. pregnancy, breastfeeding 2. Hypersensitivity to the active substance or to any of the excipients. 3. Conditions where the risk of bleeding may be increased due to the effects of iloprost on platelets (e.g., active peptic ulcer, trauma, intracranial hemorrhage). 4. severe coronary disease 5. recent MI \<6 months 6. heart failure NYHA II-IV 7. severe arrhythmias 8. suspicion of pulmonary congestion 2. Active smoking 3. Patient presenting with hepatic impairment or renal impairment requiring dialysis 4. Patient presenting with a contraindication to 5% glucose (Glucose 5% FRESENIUS KABI France solution for infusion): 1. Hypersensitivity to corn 2. Uncontrolled hyperglycemia, 3. Decompensated diabetes, 4. Other known glucose intolerances (e.g. situations of metabolic stress, acute shock states, collapse), 5. Hyperosmolar coma, 6. Hyperlactatemia, 7. Metabolic acidosis, 8. Fluid overload. The administration of high volumes may in particular result, due to fluid overload, in the following contraindications: 9. Hyperhydration 10. Acute heart failure 11. Pulmonary edema 5. Hypersensitivity to 5% glucose 6. Severe malnutrition 7. Thiamine deficiency in chronic alcoholic patients 8. Patient presenting with arterial hypotension 9. Patient having experienced a cerebrovascular event within the last 3 months 10. History of documented opioid dependence 11. Individuals deprived of liberty or under legal protection. 12. Patient included in PROSTASICKLE within last 90 days. 13. Participation in another drug trial within previous month.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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CHU de Rouen
Rouen, France
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Sickle cell clues to diabetes risk hidden in DNA
- Can adding common pain drugs reduce morphine needs in sickle cell crises?
- Gene editing offers hope for a One-Time sickle cell cure
- Tiny biochip could reveal sickle cell severity
- Can a milder transplant cure sickle cell and thalassemia in adults?
- Can an antioxidant supplement calm sickle cell blood cells?