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Study Comparing Romiplostim and Dexamethasone with Dexamethasone Alone for Patients with Newly Diagnosed Primary Immune Thrombocytopenia

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a condition known as Primary Immune Thrombocytopenia (ITP), which is a disorder that can lead to easy or excessive bruising and bleeding due to low levels of platelets in the blood. The study aims to compare the effectiveness and safety of two different treatments for patients who have been newly diagnosed with this condition. The treatments being compared are a combination of romiplostim and dexamethasone, versus dexamethasone alone. Romiplostim is a medication that helps increase platelet production, while dexamethasone is a type of steroid that can reduce inflammation and modify the body's immune response.

The purpose of the study is to evaluate whether the combination of romiplostim and dexamethasone is more effective than dexamethasone alone in achieving a sustained response in patients, meaning that their platelet levels remain stable without the need for additional ITP treatments. The study will observe patients over a period of time to see if they can maintain healthy platelet levels and avoid significant bleeding episodes. Participants will receive either the combination treatment or dexamethasone alone, and their progress will be monitored by healthcare professionals.

Throughout the study, patients will be regularly assessed to ensure their safety and to track the effectiveness of the treatments. The study will last for several months, with the goal of determining which treatment option provides the best long-term results for individuals with newly diagnosed primary immune thrombocytopenia. This research is important for improving treatment strategies and outcomes for people affected by this condition.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, eligibility is confirmed based on specific criteria such as age, diagnosis of primary immune thrombocytopenia (ITP), platelet counts, and serum creatinine levels.
Step 2
Treatment allocation
Participants are randomly assigned to one of two treatment groups: one receiving romiplostim plus dexamethasone, and the other receiving dexamethasone alone.
Step 3
Treatment administration
For those in the romiplostim plus dexamethasone group, romiplostim is administered as a subcutaneous injection. The specific dosage and frequency are determined by the study protocol.
Dexamethasone is taken orally. The dosage and duration are specified in the study protocol.
Step 4
Monitoring and follow-up
Participants undergo regular monitoring to assess platelet counts and any bleeding symptoms. This monitoring helps evaluate the effectiveness and safety of the treatment.
The primary goal is to achieve a sustained response without any ITP treatment for at least 6 months, with platelet counts maintained at a certain level and without significant bleeding.
Step 5
End of treatment evaluation
After 6 months from treatment cessation, an evaluation is conducted to determine the proportion of participants achieving the desired platelet count and response without further treatment.
Step 6
Long-term follow-up
Participants are followed for up to 12 months to assess long-term outcomes, including sustained response and safety.

Who can join the trial?

4 criteria

You must be at least 18 years old when you sign the consent form to join the study.
You should have a new diagnosis of a condition called primary immune thrombocytopenia (ITP), which means your body has a low number of platelets, the cells that help your blood clot. You should not have received any treatment for ITP before.
Your platelet count should be less than 30,000 per microliter of blood. If your platelet count is less than 50,000 per microliter, you should also have symptoms of bleeding.
Your serum creatinine level, which is a measure of kidney function, should be 1.5 mg/dL or lower.

Who cannot join the trial?

5 criteria

Patients who have a different condition than primary immune thrombocytopenia cannot participate. This condition is a disorder where the immune system attacks and destroys platelets, which are cells that help blood clot.
Patients who are not within the specified age range cannot participate. The age range for this study is not specified in the provided data.
Patients who are part of a vulnerable population cannot participate. Vulnerable populations include groups like pregnant women, children, or those unable to give consent.
Patients who do not meet the study's gender requirements cannot participate. This study includes both male and female participants.
Patients who have any other medical conditions or factors that the study has not specified as acceptable cannot participate.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

ASST Fatebenefratelli Sacco
Verified
Milan, Italy
Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Paz
Responsive
Madrid, Spain
Universita Degli Studi Di Roma La Sapienza
Responsive
Rome, Italy

Trial locations

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Investigated drugs

Romiplostim
is a medication used to help increase the number of platelets in the blood. It is often used in patients with a condition called immune thrombocytopenia (ITP), where the body does not have enough platelets, leading to easy bruising and bleeding. In this trial, romiplostim is being tested to see if it can help maintain a higher platelet count when used together with another medication.
Dexamethasone
is a type of steroid medication that is used to reduce inflammation and suppress the immune system. In this trial, dexamethasone is used to help increase platelet counts in patients with newly diagnosed primary immune thrombocytopenia (ITP). The study is comparing the effects of using dexamethasone alone versus using it in combination with another medication to see which approach is more effective in maintaining platelet levels.

What is already known about the treatment

Romiplostim
Romiplostim is administered as an injection under the skin. It is currently being studied in clinical trials for its effectiveness in treating primary immune thrombocytopenia, a condition where the immune system mistakenly attacks and destroys platelets. The medication works by stimulating the bone marrow to produce more platelets, helping to prevent bleeding. Romiplostim is classified as a thrombopoietin receptor agonist, which means it activates specific receptors to increase platelet production.
Dexamethasone
Dexamethasone is taken orally in the form of tablets. It is a well-established medication used in the treatment of various inflammatory and autoimmune conditions, including primary immune thrombocytopenia. Dexamethasone works by suppressing the immune system and reducing inflammation, which helps to increase platelet counts. It is classified as a corticosteroid, a type of medication that mimics the effects of hormones produced by the adrenal glands.

Investigated diseases

Primary Immune Thrombocytopenia – This is a disorder characterized by a low platelet count, which can lead to easy or excessive bruising and bleeding. The condition occurs when the immune system mistakenly attacks and destroys platelets, which are necessary for normal blood clotting. In many cases, the onset is sudden, and symptoms can vary from mild to severe. The disease can progress with episodes of low platelet counts, leading to symptoms such as petechiae, nosebleeds, or bleeding gums. Over time, some individuals may experience periods of remission where symptoms improve or disappear. The progression can be unpredictable, with some people experiencing chronic symptoms while others may have a more transient course.