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Study on the Safety and Effects of NXT007 for Patients with Severe or Moderate Hemophilia A

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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 Hemophilia A, which is a bleeding disorder where blood doesn't clot properly. The study is specifically looking at people with severe or moderate forms of this condition, with or without inhibitors against a protein called factor VIII. The main purpose of the study is to evaluate the safety of a new treatment called NXT007. This treatment is a type of medication known as a humanized monoclonal modified IgG4 antibody, which is designed to help manage bleeding in people with Hemophilia A.

Participants in the study will receive NXT007 through a subcutaneous injection, which means it is injected under the skin. The study will also involve other treatments, including Coagulation Factor IX, II, VII, and X in Combination, Coagulation Factor VIII, and Eptacog Alfa (Activated), which are given through intravenous injection, meaning they are injected directly into a vein. Another treatment being studied is Damoctocog Alfa Pegol, also known by its code name BAY 94-9027, which is a modified version of factor VIII.

The study will monitor participants over time to assess the safety and effects of NXT007. This includes checking for any side effects, changes in laboratory test results, and vital signs. The study will also measure how the body processes the medication and whether participants develop any antibodies against the drug. Additionally, the study will track the number of bleeding events and the annualized bleeding rate, which is the average number of bleeding episodes per year. The goal is to gather information that could help improve treatment options for people with Hemophilia A.

The research process

The trial runs in 6 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, eligibility is confirmed based on specific criteria such as body weight, gender, and diagnosis of hemophilia A.
Participants must have a body weight of at least 40 kg and be male. The diagnosis should be severe or moderate hemophilia A, with or without inhibitors against factor VIII.
Step 2
Initial assessment
An initial assessment is conducted to establish baseline health data. This includes clinical laboratory tests, vital signs, and an electrocardiogram (ECG).
The purpose of this assessment is to gather data for comparison throughout the study.
Step 3
Medication administration
The medication NXT007 is administered through a subcutaneous injection. The dosage and frequency are determined by the study protocol.
The main objective is to evaluate the safety of multiple doses of NXT007.
Step 4
Monitoring and follow-up
Participants are monitored for any adverse events. The severity of these events is assessed using established criteria.
Regular follow-up visits are scheduled to track changes in clinical laboratory test results, vital signs, and ECG parameters.
Step 5
Evaluation of outcomes
The study evaluates the plasma concentration of NXT007 at specific time points and checks for the presence of anti-drug antibodies.
The number of bleeding events and the annualized bleeding rate are recorded to assess the efficacy of the treatment.
Step 6
Completion of the study
The study is estimated to conclude by June 16, 2032. Participants will have contributed valuable data on the safety and efficacy of NXT007 in treating hemophilia A.

Who can join the trial?

6 criteria

The patient must weigh at least 40 kilograms.
The patient must be male, based on sex at birth.
The patient must have a diagnosis of **severe** or **moderate Hemophilia A**. This means the patient has low levels of a blood clotting protein called **factor VIII**. Severe means less than 1 unit per deciliter, and moderate means between 1 and 5 units per deciliter.
If the patient has **factor VIII inhibitors** (which are substances that stop factor VIII from working), they must be using or willing to switch to a treatment called **recombinant activated factor VII (rFVIIa)** for managing bleeding, injuries, or medical procedures.
The patient must have past test results available to confirm any history of having factor VIII inhibitors and their current status.
If the patient has previously completed a treatment called **immune tolerance induction (ITI)**, it must have been finished at least 5 years before joining the study. There should be no signs of the inhibitors coming back. **Factor VIII tolerance** is defined as having less than 0.6 **Bethesda units (BU)** per milliliter, or less than 1.0 BU per milliliter for certain labs, and a recovery rate of more than 66% in the body.

Who cannot join the trial?

4 criteria

Patients who do not have Severe or Moderate Hemophilia A. Hemophilia A is a condition where the blood doesn't clot properly, leading to excessive bleeding.
Patients who are female. This study is only for male participants.
Patients who are not within the specified age range. The study is for certain age groups, so participants must fall within these age limits.
Patients who are part of a vulnerable population. This means people who might need special protection or care, such as those with certain disabilities or conditions.

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Verified sites

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Verified
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Milan, Italy
Responsive
Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Paz
Madrid, Spain
Verified
Hospital Sant Joan De Deu Barcelona
Esplugues De Llobregat, Spain

Trial locations

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Investigated drugs

NXT007 is a medication being studied for its safety, tolerability, and effectiveness in people with severe or moderate Hemophilia A. This trial aims to understand how the body processes the medication and its impact on the condition.

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What is already known about the treatment

NXT007 – NXT007 is administered through intravenous infusion, which means it is delivered directly into the bloodstream via a vein. Currently, it is being studied in clinical trials to assess its safety and effectiveness, particularly for individuals with severe or moderate Hemophilia A, with or without factor VIII inhibitors. The main therapeutic indication for NXT007 is to manage and treat Hemophilia A, a condition characterized by a deficiency in clotting factor VIII, leading to excessive bleeding. At the molecular level, NXT007 works by mimicking the activity of factor VIII, helping to promote blood clotting and reduce bleeding episodes. It is classified pharmacologically as a hemostatic agent, which is a type of medication used to stop bleeding.

Investigated diseases

Hemophilia A – Hemophilia A is a genetic disorder where the blood does not clot properly due to a deficiency of clotting factor VIII. This condition leads to prolonged bleeding after injuries, surgeries, or even spontaneously without any apparent cause. Individuals with severe or moderate forms may experience frequent bleeding episodes, particularly into joints and muscles, which can cause pain and swelling. Over time, repeated bleeding into joints can lead to chronic joint damage and reduced mobility. The severity of the condition is determined by the level of factor VIII activity in the blood, with lower levels indicating more severe disease. Hemophilia A can occur with or without the presence of inhibitors, which are antibodies that neutralize the activity of factor VIII, complicating the management of bleeding episodes.