Evaluation of the Efficacy of Iloprost in the Management of Vaso-occlusive Crises in Adult Patients With Sickle Cell Disease

NCT07498309 | Not Yet Recruiting Phase 3 DMC

• 2 other identifiers: 2020/0421/HP2025-522005-38-00
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Vaso-Occlusive Crises; Sickle Cell Disease

Outcome Measures

Primary Outcomes (1)

• Opioid consumption

  Mean opioid consumption in morphine equivalent mg/day over the 28 days following randomization

  28 days following randomization

Secondary Outcomes (22)

• Mean pain

  28 days following randomization

• Length of hospital

  28 days following randomization

• Acute chest syndrome during hospitalization

  28 days following randomization

• Number of priapism episodes during hospitalization

  28 days following randomization

• hemoglobin level

  5 days following randomization

Study Arms (2)

Iloprost

EXPERIMENTAL

Drug: Iloprost

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Iloprost DRUG

1 ampoule IV over 6 h daily for 5 days diluted in 250 mL G5%

Iloprost

Placebo DRUG

250 mL G5% IV over 6 h daily for 5 days

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• \. Affiliated with a social security system

You may not qualify if:

• 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
• 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,

Sponsors & Collaborators

• University Hospital, Rouen: lead

Study Sites (1)

CHU de Rouen

Rouen, France

Location

MeSH Terms

Conditions

Vaso-Occlusive Crises; Anemia, Sickle Cell

Interventions

Iloprost

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Central Study Contacts

Maximilien GRALL

CONTACT

+332 32 88 58 28; Maximilien.Grall@chu-rouen.fr

Mylene HERVET

CONTACT

mylene.hervet@chu-rouen.fr

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2026
• First Posted: March 27, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): March 1, 2030
• Study Completion (Estimated): March 1, 2030
• Last Updated: March 27, 2026

Record last verified: 2026-03

Locations

FR (1)