Vaso-Occlusive CrisesPhase 3PROSTASICKLENCT07498309
Evaluation of the Efficacy of Iloprost in the Management of Vaso-occlusive Crises in Adult Patients With Sickle Cell Disease
A Phase 3 study testing Iloprost in people with Vaso-Occlusive Crises and Sickle Cell Disease, run by University Hospital, Rouen at 1 site in France.
Trial summary
Sickle cell disease is a severe monogenic genetic disorder caused by an autosomal recessive mutation of the β-globin gene, leading to production of abnormal hemoglobin (HbS). It primarily affects individuals from Africa or the French overseas territories. In France, approximately 26,000 patients are affected. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vaso-Occlusive Crises, Sickle Cell Disease
- What is being tested?
- Iloprost
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 144 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2026to Mar 2030
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patients with a contraindication to iloprost (ILOPROST ZENTIVA 100 micrograms/mL, solution for dilution for infusion):
- pregnancy, breastfeeding
- Hypersensitivity to the active substance or to any of the excipients.
- 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).
- severe coronary disease
- recent MI <6 months
Show all 33Show fewer
- heart failure NYHA II-IV
- severe arrhythmias
- suspicion of pulmonary congestion
- Active smoking
- Patient presenting with hepatic impairment or renal impairment requiring dialysis
- Patient presenting with a contraindication to 5% glucose (Glucose 5%
- FRESENIUS KABI France solution for infusion):
- Hypersensitivity to corn
- Uncontrolled hyperglycemia,
- Decompensated diabetes,
- Other known glucose intolerances (e.g. situations of metabolic stress, acute shock states, collapse),
- Hyperosmolar coma,
- Hyperlactatemia,
- Metabolic acidosis,
- Fluid overload. The administration of high volumes may in particular result, due to fluid overload, in the following contraindications:
- Hyperhydration
- Acute heart failure
- Pulmonary edema
- Hypersensitivity to 5% glucose
- Severe malnutrition
- Thiamine deficiency in chronic alcoholic patients
- Patient presenting with arterial hypotension
- Patient having experienced a cerebrovascular event within the last 3 months
- History of documented opioid dependence
- Individuals deprived of liberty or under legal protection.
- Patient included in PROSTASICKLE within last 90 days.
- Participation in another drug trial within previous month.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mylene HERVET contact
France1 site
CHU de Rouen
Rouen
Dr. GRALL, +332 32 88 58 28, maximilien.grall@chu-rouen.fr
About this study
Official title: Evaluation of the Efficacy of Iloprost in the Management of Vaso-occlusive Crises in Adult Patients With Sickle Cell Disease: Multicenter, Randomized, Double-blind, Placebo-controlled Study
Sickle cell disease is a severe monogenic genetic disorder caused by an autosomal recessive mutation of the β-globin gene, leading to production of abnormal hemoglobin (HbS). It primarily affects individuals from Africa or the French overseas territories. In France, approximately 26,000 patients are affected. Improved care has significantly increased life expectancy.
Vaso-occlusive crises (VOC) are the main clinical complication. They result from polymerization of HbS, deforming red blood cells and causing capillary occlusion, tissue hypoxia, intense bone pain, and frequent hospitalizations. In France in 2015, 25,150 hospitalizations were recorded, 61% of which were for VOC.
Read more
Iloprost is a prostacyclin (PGI2) analogue with vasodilatory, anti-platelet, anti-inflammatory, and antioxidant properties. It is used to treat severe limb ischemia and Raynaud's phenomenon, administered by IV infusion for 5 to 28 days.
It is well tolerated and has shown efficacy for bone pain related to bone marrow edema. Its rapid and sustained action makes it an interesting candidate for VOC, which are comparable to ischemic-origin pain. To date, only one reported case of iloprost use for a VOC exists, showing rapid and lasting improvement.
This randomized, multicenter, double-blind, placebo-controlled clinical trial aims to evaluate the efficacy of iloprost in patients hospitalized for VOC, with the objective of reducing pain and opioid consumption.
This comprehensive approach could significantly improve VOC management.
- Conditions
- Vaso-Occlusive Crises, Sickle Cell Disease
- Being tested
- Iloprost, Placebo
- Medical subject headings
- Vaso-Occlusive Crises, Anemia, Sickle Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IloprostDrug
1 ampoule IV over 6 h daily for 5 days diluted in 250 mL G5%
PlaceboDrug
250 mL G5% IV over 6 h daily for 5 days
| Study group | Role | What they receive |
|---|---|---|
| Iloprost | Experimental | Not described Receives: Drug: Iloprost |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opioid consumption
Mean opioid consumption in morphine equivalent mg/day over the 28 days following randomization
Measured: 28 days following randomization
Secondary outcomes (22)
Mean pain
Mean pain according to the VAS (Visual Analog Scale) over the first 28 days. The VAS used in this study will be a scale from 0 to 10, with ratings ranging from "no pain" (0) to "the worst pain" (10). If the patient has multiple painful areas, the worst pain should be reported.
Measured: 28 days following randomization
Length of hospital
Length of hospital stay capped at 28 days
Measured: 28 days following randomization
Acute chest syndrome during hospitalization
Measured: 28 days following randomization
Number of priapism episodes during hospitalization
Measured: 28 days following randomization
hemoglobin level
Change in hemoglobin level (in g/dL) between baseline (day of randomization) and the 5-day assessment, or at hospital discharge if this occurs before 5 days
Measured: 5 days following randomization
reticulocyte count
Change in reticulocyte count (in giga/L) between baseline (day of randomization) and the 5-day assessment, or at hospital discharge if this occurs before 5 days
Measured: 5 days following randomization
lactate dehydrogenase activity
Change in lactate dehydrogenase activity (in IU/L) between baseline (day of randomization) and the 5-day assessment, or at hospital discharge if this occurs before 5 days
Measured: 5 days following randomization
leukocyte count
Change in leukocyte count (in giga/L) between baseline (day of randomization) and the 5-day assessment, or at hospital discharge if this occurs before 5 days
Measured: 5 days following randomization
C-reactive protein
Change in serum C-reactive protein concentration (in mg/L) between baseline (day of randomization) and the 5-day assessment, or at hospital discharge if this occurs before 5 days
Measured: 5 days following randomization
thrombin generation test
Change in thrombin generation test result via thrombin peak height between baseline (day of randomization) and the 5-day assessment, or at hospital discharge if this occurs before 5 days
Measured: 5 days following randomization
D-dimers
Change in D-dimers (μg/L) between baseline (day of randomization) and the 5-day assessment, or at hospital discharge if this occurs before 5 days
Measured: 5 days following randomization
prothrombin fragments 1+2
Change in serum concentration of prothrombin fragments 1+2 (nmol/L) between baseline (day of randomization) and the 5-day assessment, or at hospital discharge if this occurs before 5 days
Measured: 5 days following randomization
thrombomodulin concentration
Change in serum thrombomodulin concentration (ng/mL) between baseline (day of randomization) and the 5-day assessment, or at hospital discharge if this occurs before 5 days
Measured: 5 days following randomization
erythrocyte microvesicles
Change in blood concentration of erythrocyte microvesicles (vesicles/μL) between baseline (day of randomization) and the 5-day assessment, or at hospital discharge if this occurs before 5 days
Measured: 5 days following randomization
S-endothelin concentration
Change in serum S-endothelin concentration (pg/mL) between baseline (day of randomization) and the 5-day assessment, or at hospital discharge if this occurs before 5 days
Measured: 5 days following randomization
E-selectin concentration
Change in serum E-selectin concentration (ng/mL) between baseline (day of randomization) and the 5-day assessment, or at hospital discharge if this occurs before 5 days
Measured: 5 days following randomization
P-selectin concentration
Change in serum P-selectin concentration (ng/mL) between baseline (day of randomization) and the 5-day assessment, or at hospital discharge if this occurs before 5 days
Measured: 5 days following randomization
VCAM-1 concentration
Change in serum VCAM-1 concentration (ng/mL) between baseline (day of randomization) and the 5-day assessment, or at hospital discharge if this occurs before 5 days
Measured: 5 days following randomization
Number of vaso-occlusive crises
occurring within 90 days after randomization, excluding the initial vaso-occlusive crisis
Measured: 90 days following randomization
Total cost of management
Total cost of management including prescription costs (notably iloprost) and costs associated with hospitalizations (from the health insurance perspective)
Measured: 90 days following randomization
Time interval between randomization and last opioid use
Time interval between randomization and last opioid use at 28 days
Measured: 28 days following randomization
Duration of priapism episodes during hospitalization
Measured: 28 days following randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study startSep 2026 (estimated)
- Primary completionMar 2030 (estimated)
- Study completionMar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaso-Occlusive CrisesStudies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07498309
- Sponsor's protocol ID
- 2020/0421/HP
- Other IDs
- 2025-522005-38-00, 2025
- Acronym
- PROSTASICKLE
- Status last verified
- Mar 2026
- First submitted
- 16 Mar 2026
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy of Iloprost in the Management of Vaso-occlusive Crises in Adult Patients With Sickle Cell Disease: Multicenter, Randomized, Double-blind, Placebo-controlled Study
- ClinicalTrials.gov ID
- NCT07498309
- Acronym / sponsor ID
- PROSTASICKLE / 2020/0421/HP
- Conditions
- Vaso-Occlusive Crises, Sickle Cell Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Mar 2030 (estimated)
- Study completion
- Mar 2030 (estimated)
- First posted
- 27 Mar 2026 (actual)
- 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.
Sickle cell disease is a severe monogenic genetic disorder caused by an autosomal recessive mutation of the β-globin gene, leading to production of abnormal hemoglobin (HbS). It primarily affects individuals from Africa or the French overseas territories. In France, approximately 26,000 patients are affected. Improved care has significantly increased life expectancy.
Vaso-occlusive crises (VOC) are the main clinical complication. They result from polymerization of HbS, deforming red blood cells and causing capillary occlusion, tissue hypoxia, intense bone pain, and frequent hospitalizations. In France in 2015, 25,150 hospitalizations were recorded, 61% of which were for VOC.
Iloprost is a prostacyclin (PGI2) analogue with vasodilatory, anti-platelet, anti-inflammatory, and antioxidant properties. It is used to treat severe limb ischemia and Raynaud's phenomenon, administered by IV infusion for 5 to 28 days.
It is well tolerated and has shown efficacy for bone pain related to bone marrow edema. Its rapid and sustained action makes it an interesting candidate for VOC, which are comparable to ischemic-origin pain. To date, only one reported case of iloprost use for a VOC exists, showing rapid and lasting improvement.
This randomized, multicenter, double-blind, placebo-controlled clinical trial aims to evaluate the efficacy of iloprost in patients hospitalized for VOC, with the objective of reducing pain and opioid consumption.
This comprehensive approach could significantly improve VOC management.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Iloprost | Experimental | Drug: Iloprost |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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);
- 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
Key exclusion criteria (33 listed)
- Patients with a contraindication to iloprost (ILOPROST ZENTIVA 100 micrograms/mL, solution for dilution for infusion):
- Active smoking
- Patient presenting with hepatic impairment or renal impairment requiring dialysis
- Patient presenting with a contraindication to 5% glucose (Glucose 5%
- Hypersensitivity to 5% glucose
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 |
|---|---|---|
| Iloprost1 ampoule IV over 6 h daily for 5 days diluted in 250 mL G5% | Drug | Iloprost |
| Placebo250 mL G5% IV over 6 h daily for 5 days | Drug | Placebo |
Primary outcome
Opioid consumption
Time frame: 28 days following randomization
Mean opioid consumption in morphine equivalent mg/day over the 28 days following randomization
22 secondary outcomes
Mean pain
Time frame: 28 days following randomization
Length of hospital
Time frame: 28 days following randomization
Acute chest syndrome during hospitalization
Time frame: 28 days following randomization
Number of priapism episodes during hospitalization
Time frame: 28 days following randomization
hemoglobin level
Time frame: 5 days following randomization
reticulocyte count
Time frame: 5 days following randomization
lactate dehydrogenase activity
Time frame: 5 days following randomization
leukocyte count
Time frame: 5 days following randomization
C-reactive protein
Time frame: 5 days following randomization
thrombin generation test
Time frame: 5 days following randomization
D-dimers
Time frame: 5 days following randomization
prothrombin fragments 1+2
Time frame: 5 days following randomization
thrombomodulin concentration
Time frame: 5 days following randomization
erythrocyte microvesicles
Time frame: 5 days following randomization
S-endothelin concentration
Time frame: 5 days following randomization
E-selectin concentration
Time frame: 5 days following randomization
P-selectin concentration
Time frame: 5 days following randomization
VCAM-1 concentration
Time frame: 5 days following randomization
Number of vaso-occlusive crises
Time frame: 90 days following randomization
Total cost of management
Time frame: 90 days following randomization
Time interval between randomization and last opioid use
Time frame: 28 days following randomization
Duration of priapism episodes during hospitalization
Time frame: 28 days following randomization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Vaso-Occlusive Crises
Not yet recruitingPhase 1
Buprenorphine for the Management of Pain in Children With Sickle Cell Disease
Sickle Cell Disease (SCD), Sickle Cell Disease Vaso-occlusive Crisis
RecruitingPhase 2
Safety of Anumigilimab (CSL324) in Adults With Sickle Cell Disease (SCD)
Sickle Cell Disease
Not yet recruiting
Hypoxic Red Blood Cells in Sickle Cell Anemia
Sickle Cell Anaemia, Sickle Cell Anemia Crisis
Recruiting
Virtual Reality for SCD VOC
Sickle Cell Disease
RecruitingPhase 3
A Study to Investigate the Efficacy and Safety of Crizanlizumab (5 mg/kg) Compared With Placebo in Adolescent and Adult Sickle Cell Disease Patients Who Experience Frequent Vaso-Occlusive Crises (SPARKLE)
Sickle Cell Disease
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.
Mylene HERVET contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Iloprost in people with Vaso-Occlusive Crises and Sickle Cell Disease, run by University Hospital, Rouen at 1 site in France.
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 33 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: opening soon, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maximilien GRALL (+332 32 88 58 28, Maximilien.Grall@chu-rouen.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Opioid consumption (time frame: 28 days following randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Mar 2026.