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ILOPROST

Clinical trials are investigating ILOPROST in severe frostbite and in sickle cell disease with vaso-occlusive crisis. These studies are looking at how well it works, how safe it is in these settings, and whether it can improve outcomes such as amputation rates or opioid use.

Table of Contents

Clinical trial overview

These studies are looking at ILOPROST in two different emergency conditions: severe frostbite and sickle cell disease with vaso-occlusive crisis.[1][2] Both are Phase 3 interventional trials, which means the treatment is being tested in people to see how well it works in real clinical care settings.[1][2]

Both studies are authorised and use a comparison group, so the results can help show whether ILOPROST changes important patient outcomes compared with another treatment or with placebo.[1][2]

Frostbite treatment study

The first trial is titled Frostbite Treatment Study comparing tPA and iloprost therapy and includes severe frostbite injury to the extremities.[1] It plans to enroll 100 participants and is designed as a randomized study, meaning patients are assigned by chance to one of the study groups.[1]

This study compares ILOPROST with ALTEPLASE, also called tPA, and it uses a non-inferiority design.[1] Non-inferiority means the study is trying to show that ILOPROST is not worse than the comparison treatment by more than a small, pre-set amount.[1]

The main outcome is the level of distal extremity or digital amputation, which means whether fingers or toes, or the farthest parts of the arms or legs, need to be removed because of damage from frostbite.[1] The study also plans to collect long-term functional outcome data and blood-related laboratory values before and after treatment.[1]

Sickle cell vaso-occlusive crisis study

The second trial is called Evaluation of the efficacy of iloprost in the management of vaso-occlusive crises in adult patients with sickle cell, and it is also known as PROSTASICKLE.[2] It includes adults with sickle cell anaemia who are having a vaso-occlusive crisis, which is a painful episode caused by blocked blood flow in small vessels.[2]

This study is multicentre, randomized, double-blind, and placebo-controlled.[2] Multicentre means it is being done in more than one hospital or study site, and placebo-controlled means one group receives a comparison infusion without the active treatment.[2]

The trial plans to enroll 144 participants and will test a maximum 5-day infusion of ILOPROST against placebo during hospitalization, with a maximum hospital stay of 21 days.[2] The main question is whether ILOPROST can reduce opioid consumption, measured as morphine equivalent milligrams per day over the 28 days after randomization.[2]

Main outcomes being measured

In clinical trials, an endpoint is the main result the researchers want to measure.[1][2] Endpoints help show whether the treatment makes a real difference for patients.[1][2]

  • Frostbite trial endpoint: the level of distal extremity or digital amputation, with extra follow-up on long-term function.[1]
  • Sickle cell trial endpoint: mean opioid use in morphine equivalent mg/day during the 28 days after randomization.[2]

These outcomes focus on what matters most to patients: avoiding tissue loss in frostbite and reducing pain medicine needs during sickle cell crisis.[1][2]

What patients should know about participation

These studies do not include all people with frostbite or sickle cell disease; they focus on specific groups that match the trial rules.[1][2] The frostbite study is for severe cases, while the sickle cell study is for adults with sickle cell anaemia and a vaso-occlusive crisis.[1][2]

Because the studies are Phase 3, they are meant to provide stronger evidence about how ILOPROST performs in real patients.[1][2] The trial data also show that the researchers are collecting clinical outcomes and, in the frostbite study, blood test values before and after treatment.[1]

Trial ID Phase Condition studied Status Enrollment
2024-520291-10-01 Phase 3 Frostbite injury to extremities Authorised 100
2025-522005-38-00 Phase 3 Sickle cell anaemia with vaso-occlusive crisis Authorised 144

FAQ

  • What conditions are being studied in ILOPROST trials? The trials are studying severe frostbite injury to the extremities and vaso-occlusive crisis in adults with sickle cell disease. These are serious conditions where blood flow problems can cause major pain or tissue damage.
  • Who can take part in these studies? One study includes severe frostbite cases, and the other includes adult patients with sickle cell anaemia who are having a vaso-occlusive crisis. Each trial has its own entry rules, so not everyone with these conditions will qualify.
  • What phase are the ILOPROST trials? Both listed studies are Phase 3 trials. Phase 3 means the treatment is being tested in a larger group of people to compare how well it works and to monitor outcomes more closely.
  • What are the trials trying to measure? The frostbite study is measuring the level of distal extremity or digital amputation. The sickle cell study is measuring mean opioid use over 28 days after randomization.
  • Are these ILOPROST studies randomized? Yes. The frostbite study randomizes patients into two groups, and the sickle cell study is multicentre, randomized, and double-blind. Double-blind means neither the patient nor the study team knows who gets the study treatment or placebo during the trial.

Ongoing Clinical Trials on ILOPROST

  • Study of the effectiveness of iloprost compared to a placebo for treating vaso-occlusive crises in adults with sickle cell disease

    Not yet recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    France

  • Study on Frostbite Treatment for Severe Cases Using Alteplase and Iloprost

    Not yet recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Finland

Glossary

  • Phase 3: A late-stage clinical trial that studies a treatment in a larger group of people to learn more about how well it works and to watch outcomes carefully.
  • Interventional study: A trial where researchers give a treatment or intervention and then measure the results.
  • Randomized: Participants are placed into study groups by chance, not by choice.
  • Double-blind: A study design where the patient and the study team do not know which treatment the patient is receiving.
  • Placebo: A comparison treatment that looks like the study treatment but does not contain the active drug.
  • Vaso-occlusive crisis: A painful episode in sickle cell disease caused by blocked blood flow in small blood vessels.
  • Frostbite: Injury caused by freezing of body tissue, often affecting fingers, toes, ears, or other exposed areas.
  • Extremities: The outer parts of the body, such as arms, hands, legs, and feet.
  • Digital amputation: Removal of a finger or toe, usually because the tissue is too damaged to survive.
  • Opioid consumption: How much opioid pain medicine is used. In this study, it is measured in morphine equivalent dose, which lets different opioid medicines be compared on the same scale.
  • Randomization: The process of assigning people to different study groups by chance.

References

  1. https://clinicaltrials.gov/study/2024-520291-10-01
  2. https://clinicaltrials.gov/study/2025-522005-38-00