Active not recruitingPHASE3INTERVENTIONAL

Romiplostim Plus Dexamethasone vs Dexamethasone in Patients With Newly Diagnosed Primary Immune Thrombocytopenia

This study is looking at a new way to treat primary immune thrombocytopenia (ITP), a condition where your body doesn't have enough blood cells called platelets. Platelets help your blood clot, so not having enough can cause bruising and bleeding. The study is comparing two treatments: romiplostim given with dexamethasone, against dexamethasone given alone. Dexamethasone is a common treatment for ITP. Romiplostim is another medicine that helps your body make more platelets. The main goal is to find out if the combination treatment works better at keeping platelet counts stable and preventing serious bleeding after six months. This is a Phase 3 study, meaning it's one of the final steps before a treatment might become widely available.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Enrolment target

129

Start

02 Dec 2022

Estimated completion

24 Oct 2026

Primary Immune Thrombocytopenia

What is this study about?

Imagine your body has tiny helpers called platelets that act like sticky bandaids, helping your blood clot when you get a cut. If you have a condition called primary immune thrombocytopenia (ITP), your body doesn't have enough of these important platelets. This can lead to easy bruising, red spots on your skin, or even more serious bleeding.

Doctors often treat ITP with medicine like dexamethasone, which is a type of steroid. There's also another medicine called romiplostim that helps your body make more platelets. This study wants to see if giving both romiplostim and dexamethasone together works better than just giving dexamethasone alone, especially for people who have just been diagnosed with ITP.

The main aim of this study is to check if the combination of romiplostim and dexamethasone helps keep your platelet count stable for a longer time and prevents bleeding without you needing extra ITP treatments for at least six months after you finish the study medicine. They will also look at how quickly your platelet count improves, how your quality of life is, and any side effects you might experience. This research is important because it could help doctors find the best way to treat ITP when someone is first diagnosed.

Key takeaways

This study compares two ITP treatments: a combination of romiplostim and dexamethasone, vs. dexamethasone alone.
It aims to see if the combination treatment is better for newly diagnosed ITP patients.
The main goal is sustained platelet levels and preventing bleeding without other ITP treatments for 6 months after the study.
Participation could last up to 18 months, with regular check-ups.
You will know which treatment group you are in (open-label study).

Who may be eligible?

To join this study, you need to be at least 18 years old and have been newly diagnosed with primary ITP. This means you haven't received treatment for ITP before. Your platelet count must be low, either below 30,000, or below 50,000 if you're also having bleeding problems. Your kidneys also need to be working properly.

There are also some reasons why you might not be able to join. For example, if you've already had certain treatments for ITP in the months leading up to the study, or if you've had surgery to remove your spleen recently. You also can't participate if you have certain active infections like Hepatitis B or C, or if you have severe liver disease.

It's important to remember that these are just some of the main rules. The study doctor will go through all the detailed requirements with you to see if this study is a good fit for your situation.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Have you recently been diagnosed with ITP and not yet treated for it?
Is your platelet count low (below 30,000, or below 50,000 with bleeding)?
Do you have good kidney function?
Have you avoided certain ITP treatments in the past few months (e.g., rituximab, other growth factors)?
Do you have severe liver disease or active certain viral infections (e.g., Hepatitis B/C)? (If yes to this, you might not be eligible)

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you'll be randomly assigned to one of two groups, like flipping a coin. One group will receive romiplostim plus dexamethasone, and the other will receive dexamethasone alone. You won't get to choose which group you're in, and neither will the doctors. This helps make the study fair.

You'll take romiplostim (if you're in that group) for up to 12 months. Dexamethasone will be given according to a set schedule. Regular visits will be needed to check your platelet counts, general health, and to look for any side effects. After you stop taking the study medicines, you'll be followed up for another six months to see how you're doing. This means your total involvement could last up to 18 months.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. You might benefit from closer medical attention and potentially receive a treatment that could be more effective. However, there's no guarantee the treatment will work for you, and you might experience side effects from the medicines. The study doctors and nurses will monitor you very closely for any problems. You'll be given detailed information about all known side effects. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (30)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

IRCCS AOU di Bologna, Seràgnoli Institute of Hematology
Verified postcode
Bologna, Italy
ASST Fatebenefratelli Sacco - Ospedale L. Sacco
Verified postcode
Milan, Italy
Grande Ospedale Metropolitano Niguarda
Verified postcode
Milan, Italy
Azienda Ospedaliero-Universitaria Policlinico Umberto I / SAPIENZA Universitá di Roma
Verified postcode
Rome, Italy
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Verified postcode
Rome, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Verified postcode
Rome, Italy
Hospital del Mar
Verified postcode
Barcelona, Spain
Centre Sociosanitari Sant Jordi de la Vall D'Hebron
Verified postcode
Barcelona, Spain
Complejo Asistencial Universitario de Burgos
Verified postcode
Burgos, Spain
Complejo Hospitalario Universitario A Coruña
Verified postcode
A Coruña, Spain
Hospital Universitario Virgen de las Nieves
Verified postcode
Granada, Spain
Hospital General Universitario Gregorio Marañón
Verified postcode
Madrid, Spain

Common questions

What is ITP?

ITP stands for Primary Immune Thrombocytopenia. It's a condition where your body's immune system mistakenly attacks and destroys your platelets, which are blood cells essential for clotting.

What is romiplostim?

Romiplostim is a medicine that helps your body produce more platelets. It's designed to increase your platelet count when it's too low.

What is dexamethasone?

Dexamethasone is a strong steroid medicine commonly used to reduce inflammation and suppress the immune system, often used to treat ITP.

How long will I be in the study?

You could be on the study medicine for up to 12 months, followed by another 6 months of check-ups, so your total participation could be up to 18 months.

Will I know which treatment I'm getting?

Yes, this is an 'open-label' study, which means both you and your doctor will know which treatment you are receiving.