Study on the Safety of TAK-755, Rituximab, and Glucocorticoids for Patients with Immune-Mediated Thrombotic Thrombocytopenic Purpura (iTTP)

2 1 1 1

What is this study about?

This clinical trial is focused on studying a rare blood disorder called immune-mediated thrombotic thrombocytopenic purpura (iTTP). This condition causes blood clots to form in small blood vessels, leading to a low platelet count, which can result in bleeding and other serious health issues. The study is testing a treatment called TAK-755 (rADAMTS13), which is a type of protein therapy designed to help manage this condition. The trial will also involve the use of other medications, including Rituximab, a monoclonal antibody, and Glucocorticoids, which are a type of steroid medication.

The purpose of the study is to assess the safety of TAK-755 in treating patients with iTTP. Participants in the study will receive the treatment through an intravenous infusion, which means the medication is given directly into a vein. The study will compare the effects of TAK-755 with minimal or no plasma exchange, a procedure that is often used to treat iTTP by removing and replacing the plasma in the blood. The trial will monitor participants over a period to observe any side effects and to see how well the treatment works in managing the disease.

Throughout the study, researchers will track various health indicators to understand the treatment’s impact on the disease. This includes monitoring the occurrence of any adverse events, the time it takes for patients to respond to the treatment, and any changes in specific blood markers. The study aims to provide valuable information on how TAK-755 can be used to treat iTTP effectively and safely, potentially offering a new option for managing this challenging condition.

1 joining the study

Upon joining the study, the patient will be required to provide a signed informed consent form. This is a document that confirms the patient’s understanding and agreement to participate in the study.

The patient must be 18 years or older and have been diagnosed with immune-mediated thrombotic thrombocytopenic purpura (iTTP).

2 initial assessment

An initial assessment will be conducted to confirm the diagnosis of iTTP. This includes checking the platelet count and looking for signs of hemolytic anemia, such as elevated levels of lactate dehydrogenase (LDH) or the presence of schistocytes in the blood.

3 treatment administration

The patient will receive the medication TAK-755, also known as recombinant ADAMTS13 (rADAMTS13), through an intravenous infusion. This means the medication will be administered directly into the bloodstream.

The frequency and dosage of the medication will be determined by the study protocol and the patient’s response to treatment.

4 monitoring and follow-up

Throughout the study, the patient will be monitored for any side effects or adverse events. This includes regular blood tests to check for changes in platelet count and other relevant biomarkers.

The study aims to assess the safety and effectiveness of TAK-755 in treating iTTP, with minimal to no plasma exchange (PEX).

5 completion of study

The study is expected to be completed by December 2025. Upon completion, the patient’s health and response to the treatment will be evaluated to determine the overall effectiveness of the medication.

The patient will be informed of the study results and any further steps if necessary.

Who Can Join the Study?

  • The person must sign a form to show they agree to join the study. If they can’t sign, someone legally allowed to sign for them can do it.
  • The person must be 18 years old or older when they are checked for the study.
  • The person must have been diagnosed with iTTP, which is a condition involving low platelets and broken red blood cells. This is shown by:
    • Thrombocytopenia: This means having a low number of platelets, which are cells that help stop bleeding. The count should be less than 100,000 per microliter.
    • Microangiopathic hemolytic anemia: This means the red blood cells are being destroyed. It is shown by high levels of LDH (a substance in the blood) being more than twice the normal limit, or by seeing broken red blood cells in a blood test.
  • The person must agree to follow all the study rules and procedures.
  • Women who can have children must have a negative pregnancy test and agree to use very effective birth control during the study. Men who are sexually active must agree to use effective birth control during the study.

Who Cannot Join the Study?

  • There are no specific reasons listed that would prevent a patient from participating in this study.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Hospital Universitario Y Politecnico La Fe Valencia Spain
Medical University Of Vienna Vienna Austria

Other Sites

Site Name City Country Status
Hospital General Universitario Gregorio Maranon Madrid Spain
Instytut Hematologii I Transfuzjologii Warsaw Poland
Geniko Nosokomeio Thessalonikis George Papanikolaou Thessaloniki Greece
Virgen del Rocío University Hospital Sevilla Spain
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico Milan Italy
Hospital Universitario De Cruces Barakaldo Spain
Apmnacj Oyatswuolkz Ucedtzaurvtye Cozseyglfjxk Dbhug Sszxpt E Dyglv Swspzfb Du Txsjmd Turin Italy

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

Trial status

Country Status Recruitment Start
Austria Austria
Not recruiting
26.04.2023
Greece Greece
Not recruiting
26.04.2023
Italy Italy
Not recruiting
26.04.2023
Poland Poland
Not recruiting
26.04.2023
Spain Spain
Not recruiting
26.04.2023

Trial locations

Investigated drugs:

TAK-755 (rADAMTS13) is a medication being studied for its safety and effectiveness in treating a condition called immune-mediated thrombotic thrombocytopenic purpura (iTTP). This condition involves the formation of small blood clots throughout the body, which can lead to serious health problems. TAK-755 is designed to help break down these clots and improve blood flow, potentially reducing the symptoms and complications associated with iTTP.

Immune-mediated thrombotic thrombocytopenic purpura (iTTP) – This is a rare blood disorder characterized by the formation of small blood clots throughout the body, which can lead to a low platelet count. The disease occurs when the immune system mistakenly attacks an enzyme called ADAMTS13, which is responsible for regulating blood clotting. As a result, large molecules of von Willebrand factor accumulate, causing platelets to clump together and form clots. These clots can block small blood vessels, leading to various symptoms such as fatigue, bruising, and neurological issues. The progression of iTTP can be unpredictable, with periods of remission and exacerbation. It requires careful monitoring to manage the symptoms and prevent complications.

Trial ID:
2023-507787-39-00
Protocol code:
TAK-755-2001
NCT ID:
NCT05714969
Trial Phase:
Therapeutic exploratory (Phase II)

Other Trials to Consider

  • Study on the Use of [18F]PSMA-1007 PET/CT Imaging for Detecting Prostate Cancer in Patients with Newly Diagnosed High-Risk or Very-High-Risk Conditions

    Recruiting

    3 1 1 1
    France Germany Italy The Netherlands Spain
  • Study on the Safety and Effectiveness of C1 Esterase Inhibitor and Sodium Chloride for Patients with Aneurysmal Subarachnoid Hemorrhage

    Recruiting

    2 1 1
    Investigated diseases:
    The Netherlands