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

Verified siteInvestigationalNo 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 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.

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, 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.
Step 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.
Step 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.
Step 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.
Step 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 trial?

8 criteria

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 trial?

10 criteria

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.

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Verified sites

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

Azienda Ospedaliera Universitaria Citta' Della Salute E Della Scienza Di Torino
Verified
Turin, Italy
Azienda Ospedaliero Universitaria Careggi
Responsive
Florence, Italy
Azienda Ospedaliero-Universitaria Maggiore Della Carita
Verified
Novara, Italy

Trial locations

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Investigated drugs

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.

Human Normal Immunoglobulin (Iv)

What is already known about the treatment

Kedrion Intravenous Human Normal Immunoglobulin (IVIg) 10% – This medication is administered through an intravenous infusion, meaning it is given directly into a vein. It is currently being studied in clinical trials for its effectiveness and safety in treating adults with Chronic Immune Thrombocytopenia (ITP), a condition where the immune system mistakenly attacks and destroys platelets, leading to low platelet counts. The main therapeutic use of this medication is to increase platelet counts in patients with ITP. At the molecular level, it works by providing antibodies that help modulate the immune system, reducing the destruction of platelets. It is classified pharmacologically as an immunoglobulin, which is a type of protein used by the immune system to fight infections.

Investigated diseases

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.