Study on the Effectiveness and Safety of Human Normal Immunoglobulin (IV) for Adults with Chronic Immune Thrombocytopenia

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What is this study about?

This clinical trial is focused on studying a condition known as Chronic Immune Thrombocytopenia (ITP), which is a disorder that can lead to easy or excessive bruising and bleeding due to low levels of platelets in the blood. The treatment being tested in this study is called KIg10, which is a form of Human Normal Immunoglobulin given through an intravenous infusion. This means the medicine is delivered directly into the bloodstream through a vein.

The purpose of the study is to evaluate how effective and safe KIg10 is for adults with chronic ITP. Participants in the study will receive the treatment and have their platelet levels monitored to see if there is an increase, which is a sign of improvement. The study will also check for any side effects or bleeding episodes during the treatment period.

Participants will be involved in the study for a period of time, during which they will receive the treatment and have regular check-ups to monitor their health and response to the treatment. The study aims to gather information on how quickly and effectively the treatment works, how long the effects last, and any changes in bleeding symptoms. This information will help determine the potential benefits of KIg10 for people with chronic ITP.

1 joining the study

Upon joining the study, you will be required to sign an informed consent form. This document confirms your understanding of the study and your agreement to participate.

You will need to provide authorization to access your personal health information.

2 screening and baseline assessment

A screening process will be conducted to confirm your eligibility. This includes verifying your age, diagnosis of chronic immune thrombocytopenia (ITP), and platelet count.

A urine pregnancy test will be conducted for women of childbearing potential.

Your platelet count will be measured twice, at least one day apart, to ensure it is below 30 × 10⁹/L.

3 treatment administration

You will receive the medication KIg10, which is a solution for infusion containing human normal immunoglobulin.

The medication will be administered intravenously, meaning it will be given through a vein.

The dosage and frequency of administration will be determined by the study protocol and your healthcare provider.

4 evaluation period

During the evaluation period, your platelet count will be monitored to assess the response to the treatment.

A response is defined as a platelet count greater than 30 × 10⁹/L and at least a two-fold increase from the baseline count, confirmed on at least two separate occasions at least seven days apart.

The absence of bleeding during this period is also a criterion for response.

5 follow-up and monitoring

Regular follow-up visits will be scheduled to monitor your health and the effectiveness of the treatment.

Your healthcare provider will assess the duration of the response, any changes in platelet count, and any bleeding events.

The study aims to evaluate the maximum platelet count achieved and the time taken to reach this count.

Who Can Join the Study?

Must be a male or female between 18 and 70 years old.
Must have signed the Informed Consent Form (ICF), which means you agree to participate in the study.
Must have a diagnosis of chronic Immune Thrombocytopenia (ITP) for more than 12 months.
Must have a low platelet count (less than 30 x 10⁹/L) from two tests taken at least one day apart. One test can be from the past 14 days before the first treatment.
Must have a low platelet count (less than 30 x 10⁹/L) at the start of the study.
Must be willing to follow all the study requirements.
Women who can have children must have a negative pregnancy test at the start and agree to use effective birth control during the study.
Must give permission to access your personal health information.

Who Cannot Join the Study?

Patients with any other serious health condition that might interfere with the study.
Patients who are pregnant or breastfeeding.
Patients who have had a recent major surgery or are planning to have surgery during the study period.
Patients who are currently participating in another clinical trial.
Patients with a history of substance abuse or alcohol dependency.
Patients who have received any investigational drug within the last 30 days.
Patients with known allergies to the study medication or its ingredients.
Patients with uncontrolled high blood pressure or other uncontrolled medical conditions.
Patients with a history of cancer within the last 5 years, except for certain types of skin cancer.
Patients with active infections that require treatment.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Azienda Ospedaliero Universitaria Careggi	Florence	Italy

Other Sites

Site Name	City	Country
Azienda Sanitaria Universitaria Giuliano Isontina	Trieste	Italy
Hospital General Universitario Gregorio Maranon	Madrid	Spain
Azienda Unita Locale Socio Sanitaria N 8 Berica	Vicenza	Italy
Spitalul Clinic Coltea	Bucharest	Romania
Fakultni Nemocnice Brno	Brno	Czechia
Hospital Ruber Juan Bravo	Madrid	Spain
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca	Cluj Napoca	Romania
Azienda Ospedaliero-Universitaria Maggiore Della Carita	Novara	Italy
Vseobecna Fakultni Nemocnice V Praze	Prague	Czechia
Stzzmfwn Cmbedn Mrkgnwsoo Fnetbjurzza Cequoep	Craiova	Romania
Akdbuvm Oqmoxeryhys Uangkchjulvqb Cyixibovmspv Ddfze Smtuwm E Dvwzx Syphbvc Dm Tcwdsc	Turin	Italy
Gwfazz Ufxetfvycm Fjnwduodj	Frankfurt	Germany
Hlrxfyjl Uhwfvzjxkfjjr do A Clrleu	A Coruna Galicia	Spain

Trial status

Country	Status	Recruitment Start
Czechia	Not yet recruiting	14.04.2025
Germany	Not yet recruiting	14.04.2025
Italy	Not yet recruiting	14.04.2025
Romania	Recruiting	14.04.2025
Spain	Recruiting	14.04.2025

Trial locations

Investigated drugs:

Human Normal Immunoglobulin (Iv)

Kedrion Intravenous Human Normal Immunoglobulin (IVIg) 10% is a medication used in this clinical trial to help treat adults with a condition called chronic immune thrombocytopenia (ITP). ITP is a disorder where the immune system mistakenly attacks and destroys the body’s own platelets, which are cells that help blood to clot. This can lead to easy bruising and bleeding. The medication is given through a vein, and it works by providing the body with antibodies that can help regulate the immune system and increase the number of platelets in the blood. The goal of using this medication in the trial is to see if it can effectively increase platelet counts in patients with ITP, helping to reduce symptoms and improve their condition.

Investigated diseases:

Thrombocytopenia

Chronic Immune Thrombocytopenia (ITP) – Chronic Immune Thrombocytopenia is a disorder characterized by a persistently low number of platelets, which are cells in the blood that help with clotting. In this condition, the immune system mistakenly attacks and destroys platelets, leading to a reduced ability to form blood clots. As the disease progresses, individuals may experience easy or excessive bruising and bleeding, such as nosebleeds or bleeding gums. The condition can also cause small red or purple spots on the skin, known as petechiae, due to minor bleeding from capillaries. Over time, the low platelet count can lead to more significant bleeding issues, especially after injuries or surgeries. The progression of the disease can vary, with some individuals experiencing stable symptoms and others having fluctuating platelet levels.

Trial ID:

2023-507115-35-00

Protocol code:

KB072

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on the Effectiveness and Safety of Human Normal Immunoglobulin (IV) for Adults with Chronic Immune Thrombocytopenia

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