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Study on the Effectiveness of Eltrombopag in Combination with Other Drugs for Patients with 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 the treatment of immune thrombocytopenia, a condition where the immune system mistakenly attacks and destroys platelets, which are cells that help blood clot. The study will evaluate the effectiveness of a combination of medications compared to standard treatments. The medications being tested include Revolade (eltrombopag), Nplate (romiplostim, also known as AMG 531), Doptelet (avatrombopag), mycophenolate mofetil, ciclosporin, and rituximab. These medications are used to help increase platelet counts and manage symptoms associated with the disease.

The purpose of the study is to evaluate how well these medications work together in treating patients with immune thrombocytopenia. Participants in the study will receive one or more of these medications, or a placebo, over a period of time. The study will monitor the participants' platelet counts and other health indicators at various points to assess the effectiveness of the treatment. The study will also look at the number of patients who achieve remission, meaning their symptoms improve without the need for ongoing therapy.

Throughout the study, participants will have regular visits to check their health and progress. The study will also collect information on the quality of life of participants before, during, and after treatment. This information will help researchers understand the impact of the treatment on daily living. The study aims to provide valuable insights into the management of immune thrombocytopenia and improve treatment options for patients with this condition.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial visit
Upon joining the study, an initial visit is conducted to confirm eligibility. This includes a review of medical history and a physical examination.
A blood test is performed to check platelet count and other relevant biomarkers. Women of childbearing potential undergo a pregnancy test.
Step 2
Treatment initiation
The treatment begins with the administration of rituximab through an intravenous infusion. This is a one-time procedure at the start of the trial.
Following the infusion, mycophenolate mofetil is taken orally. The dosage and frequency are determined by the study protocol.
Step 3
Oral medication phase
Participants take ciclosporin orally as part of the treatment regimen. The dosage and frequency are specified by the study protocol.
Additional oral medications include eltrombopag and avatrombopag, which are film-coated tablets taken as directed.
Step 4
Subcutaneous injection phase
Participants receive romiplostim through subcutaneous injections. The frequency and dosage are outlined in the study protocol.
Step 5
Follow-up visits
Regular follow-up visits are scheduled to monitor progress. These visits occur at specified intervals, such as months 3, 7, 12, and 18.
During these visits, platelet counts are measured, and the need for continued therapy is assessed.
Step 6
Quality of life assessment
Participants complete the SF-36 quality of life questionnaire at various points during the trial to evaluate the impact of treatment on daily life.
Step 7
End of treatment evaluation
At the end of the treatment cycle, a comprehensive evaluation is conducted. This includes measuring platelet counts and assessing remission status.
The number of relapses within 12 months post-treatment is recorded, along with any changes in biomarkers.

Who can join the trial?

8 criteria

Age between 18 and 70 years old.
Ability to understand the study and sign a written agreement to participate.
Ability and willingness to attend study visits and travel to the study center.
Diagnosis of primary immune thrombocytopenia (a condition where the immune system attacks and destroys platelets, which are cells that help blood clot).
Platelet count below 80x10⁹/l (after stopping or while on corticosteroid treatment) and meeting the need for therapy (such as bleeding, need for blood thinners, symptoms affecting daily life, or inability to stop corticosteroids).
Previous treatment with corticosteroids (a type of medication that reduces inflammation) for at least 14 days, after which the doctor decides it is necessary to continue treatment for immune thrombocytopenia.
Women who can have children must have a negative pregnancy test and use effective birth control methods before starting treatment.
Women who can have children must agree to prevent pregnancy and not breastfeed during treatment and for 12 months after the last dose of rituximab (a medication used to treat certain autoimmune diseases). Men must agree to prevent fathering a child during treatment and for 90 days after stopping mycophenolate (a medication that suppresses the immune system).

Who cannot join the trial?

3 criteria

Patients who are not diagnosed with immune thrombocytopenia cannot participate. This is a condition where the immune system attacks and destroys platelets, which are cells that help blood to clot.
Patients who are not within the specified age range cannot participate. The study is open to certain age groups only.
Patients who are part of a vulnerable population cannot participate. This means individuals who might be at a higher risk of harm or exploitation.

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Verified sites

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Fakultni Nemocnice Hradec Kralove
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Novy Hradec Kralove, Czechia

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Investigated drugs

T-MEM is a complex immunomodulatory therapy being tested for its effectiveness in treating patients with immune thrombocytopenia. This therapy involves a combination of four different medicinal products. Each of these products works together to help regulate the immune system, which is important for patients with this condition. The goal of this therapy is to improve the patient's platelet count and reduce the risk of bleeding, which are common issues in immune thrombocytopenia.

What is already known about the treatment

Medication 1 – This medication is part of a complex immunomodulatory therapy being tested for its effectiveness in treating immune thrombocytopenia, a condition where the immune system attacks and destroys platelets in the blood. It is administered as part of a combination treatment, though the specific form and method of application are not detailed in the trial data. Currently, this medication is under investigation in clinical trials, and its status in medical literature is primarily experimental. The main therapeutic indication is to help manage and improve platelet counts in patients with immune thrombocytopenia. The mechanism of action at the molecular level involves modulating the immune system to prevent it from attacking platelets, though the exact details are not specified. It falls under the pharmacological classification of immunomodulatory agents.

Investigated diseases

Immune thrombocytopenia – 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. In its progression, individuals may experience symptoms such as petechiae, which are small red or purple spots on the skin, and prolonged bleeding from cuts. The severity of symptoms can vary, with some people experiencing mild symptoms and others having more severe bleeding issues. Over time, the platelet count may fluctuate, leading to periods of remission and relapse. The disease can affect both children and adults, with varying patterns of progression in each group.