RecruitingRare disease

Study Comparing Avatrombopag and Rituximab for Adults with Immune Thrombocytopenia Not Responding to Corticosteroids

Fast replyRegistered 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 Immune Thrombocytopenia (ITP), a condition where the immune system mistakenly attacks and destroys platelets, which are cells that help blood clot. The study is comparing two treatments for ITP: Rituximab, which is given as an infusion, and Avatrombopag, which is taken as a tablet. The purpose of the study is to evaluate how effective these treatments are for adults with ITP who have not responded well to initial treatment with corticosteroids, which are medications that reduce inflammation and suppress the immune system.

Participants in the study will be randomly assigned to receive either Rituximab or Avatrombopag. The study will last for several months, during which time participants will have regular check-ups to monitor their platelet levels and overall health. The goal is to see if either treatment can help maintain a healthy platelet count without the need for additional medications. Participants will also be asked about their quality of life and any side effects they experience during the study.

This trial aims to provide valuable information on the effectiveness of these two treatments for ITP, potentially leading to better management options for patients with this condition. The study will help determine which treatment might be more beneficial in maintaining platelet levels and improving the quality of life for those affected by ITP.

The research process

The trial runs in 5 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, including age and previous treatment history for Immune Thrombocytopenia (ITP).
Written informed consent is required to participate.
Step 2
Randomization
Participants are randomly assigned to one of two treatment groups: Rituximab or Avatrombopag.
Step 3
Treatment phase
For those receiving Rituximab, the medication is administered through an infusion.
Participants in the Avatrombopag group take the medication orally.
The treatment aims to achieve a durable platelet response, defined as maintaining platelet counts above a certain level without additional platelet-elevating agents.
Step 4
Monitoring and assessments
Regular monitoring of platelet counts occurs bi-weekly between weeks 20 and 28.
Quality of life and fatigue are assessed using specific questionnaires at weeks 28 and 78.
Additional assessments include the occurrence of treatment failure and any adverse events.
Step 5
End of study evaluations
The study concludes with evaluations of treatment effectiveness and safety.
Final assessments include changes in quality of life scores and the occurrence of any significant adverse events.

Who can join the trial?

6 criteria

Must be a male or female who is **18 years or older**.
Must have a diagnosis of **primary Immune Thrombocytopenia (ITP)**, which is a condition where the immune system attacks and destroys platelets in the blood, for less than one year.
Must have a **platelet count** of less than **30 x 10⁹/L**. Platelets are small blood cells that help with clotting, and this count should be measured within two weeks before joining the study.
Must have tried a treatment with **corticosteroids** like dexamethasone or prednisone/prednisolone and either did not respond or had a relapse. Dexamethasone should have been taken at **20-40 mg daily for 4 days**, and prednisone/prednisolone at **1 mg/kg for at least two weeks**. Shorter or lower doses are acceptable if they were changed due to side effects.
Must have a **clinical need** for further treatment to increase platelet levels, as determined by the doctor in charge.
Must provide a **signed and dated written informed consent**, which means agreeing to participate in the study after understanding all the details.

Who cannot join the trial?

3 criteria

Patients who have not responded well to a short course of **corticosteroids**. Corticosteroids are medications used to reduce inflammation and suppress the immune system.
Patients who are not adults. This means individuals under the age of 18 cannot participate.
Patients who are part of a vulnerable population. This typically includes groups like pregnant women, children, or those unable to give consent.

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Verified sites

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

Verified
Akershus University Hospital
Lorenskog, Norway
Verified
Helse Bergen HF
Bergen, Norway
Responsive
Universitetssykehuset Nord-Norge HF
Tromsø, Norway

Trial locations

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Investigated drugs

Avatrombopag
is a medication used to help increase the number of platelets in the blood. It is taken orally and works by stimulating the production of platelets, which are important for blood clotting. In this trial, Avatrombopag is being tested to see how well it works for patients with immune thrombocytopenia (ITP) who have not responded well to initial treatment with corticosteroids.
Rituximab
is a medication that targets specific cells in the immune system. It is used to treat various autoimmune conditions, including immune thrombocytopenia (ITP). Rituximab works by reducing the activity of the immune system, which can help increase platelet counts in patients with ITP. This trial is evaluating the effectiveness of Rituximab as a second-line treatment for patients who did not respond adequately to corticosteroids.

What is already known about the treatment

Avatrombopag
Avatrombopag is an oral medication used to treat Immune Thrombocytopenia (ITP), a condition where the immune system attacks and destroys platelets, leading to low platelet counts. It is currently being evaluated in clinical trials as a second-line treatment for adults with ITP who do not respond adequately to corticosteroids. Avatrombopag works by stimulating the production of platelets through the activation of the thrombopoietin receptor, which is involved in the regulation of platelet production. It is classified as a thrombopoietin receptor agonist.
Rituximab
Rituximab is administered via intravenous infusion and is used to treat Immune Thrombocytopenia (ITP) among other conditions. It is being studied in clinical trials as a second-line treatment for adults with ITP who have not responded well to corticosteroids. Rituximab works by targeting and depleting B-cells, a type of white blood cell that plays a role in the immune response, thereby reducing the immune system's attack on platelets. It is classified as a monoclonal antibody.

Investigated diseases

Immune Thrombocytopenia (ITP) – Immune Thrombocytopenia 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 essential for normal blood clotting. ITP can be acute, often resolving within six months, or chronic, lasting longer and requiring ongoing management. Symptoms may include petechiae, which are small red or purple spots on the skin, nosebleeds, and bleeding gums. The severity of symptoms can vary widely among individuals, with some experiencing mild symptoms and others facing more significant bleeding risks. The progression of ITP can be unpredictable, with periods of remission and relapse.