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

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What is this study about?

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.

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.

2 randomization

Participants are randomly assigned to one of two treatment groups: Rituximab or Avatrombopag.

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.

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.

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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Oslo Universitetssykehus HF Oslo Norway

Other Sites

Site Name City Country Status
St. Olavs Hospital HF Trondheim Norway
Ostfold Hospital Trust Fredrikstad Norway
Universitetssykehuset Nord-Norge HF Tromsø Norway
Sørlandet sykehus Kristiansand Kristiansand Norway
Vestfold Hospital Trust Tonsberg Norway
Helse Stavanger HF Stavanger Norway
Nordlandssykehuset HF Bodo Norway
Haakk Fxixm Hi Haugesund Norway
Hmvfa Neysbfgisnspej Hp Levanger Norway
Amtnqenp Uanwkjwjri Hckbleeo Lorenskog Norway
Hfkwa Bilhou Hy Bergen Norway

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Norway Norway
Recruiting
01.02.2024

Trial locations

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.

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.

Trial ID:
2023-505573-32-00
Protocol code:
RGCH006
Trial Phase:
Therapeutic confirmatory (Phase III)

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