RecruitingRare disease

Study on the Effectiveness of Atenativ for Patients with Congenital Antithrombin Deficiency Undergoing Surgery or Childbirth

Verified siteRegistered drugNo 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 the effectiveness and safety of a treatment called Atenativ in patients with a condition known as congenital antithrombin deficiency. This condition is a rare genetic disorder where the body does not produce enough of a protein called antithrombin, which helps prevent blood clots. The study aims to understand how well Atenativ works in preventing blood clots in patients with this deficiency who are undergoing surgery or childbirth.

The treatment being tested, Atenativ, is a solution that is given through an intravenous infusion, which means it is administered directly into the bloodstream through a vein. The study will observe patients over a period of time to see if Atenativ can effectively reduce the risk of blood clots during and after surgical procedures or delivery. The study will also monitor the safety of the treatment by checking for any side effects or adverse reactions.

Participants in the study will receive Atenativ and will be closely monitored by healthcare professionals. The study will track the occurrence of any blood clotting events and assess various health parameters to ensure the treatment is safe and effective. The goal is to gather information that could help improve the management of congenital antithrombin deficiency in patients undergoing surgery or childbirth.

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
Enrollment and consent
Upon joining the study, you will be required to provide informed consent. This means you agree to participate after understanding the study's purpose, procedures, and potential risks and benefits.
Step 2
Initial assessment
An initial assessment will be conducted to confirm your eligibility. This includes verifying your age, medical history, and confirming a diagnosis of congenital antithrombin deficiency through a blood test showing antithrombin levels of 60% or less.
Step 3
Treatment phase
If eligible, you will enter the treatment phase. This involves receiving the medication Atenativ, which is a solution for infusion administered through an intravenous infusion. The dosage and frequency will be determined by the medical team based on your specific needs, particularly if you are undergoing surgery or delivery.
Step 4
Monitoring and follow-up
Throughout the treatment, your health will be closely monitored. This includes checking for any thrombotic events (blood clots) and measuring the levels of antithrombin in your blood. Regular blood tests and health assessments will be conducted to ensure your safety and the effectiveness of the treatment.
Step 5
Post-treatment evaluation
After the treatment phase, a follow-up period of up to 30 days will occur. During this time, you will continue to be monitored for any adverse effects or complications. This includes checking vital signs, conducting physical examinations, and performing additional blood tests if necessary.

Who can join the trial?

7 criteria

Adult male or female patients aged between 18 and 80 years. In the US, 4 male or female patients aged between 12 and less than 17 years can also participate in a specific phase of the study.
Must have a documented case of congenital antithrombin deficiency, which means having a plasma level of antithrombin that is 60% or less.
Must have a personal or family history of Thrombotic Events (TEs) or Thromboembolic Events (TEEs). These are conditions where blood clots form in blood vessels.
For the Treatment Phase:
- Non-pregnant patients scheduled for elective surgical procedures that have a high risk of TEs or TEEs.
- Pregnant patients who are at least 27 weeks into their pregnancy and are scheduled for a caesarean section or delivery.
- For female patients who can become pregnant and are entering the PK Phase or the Treatment Phase for any procedure other than caesarean section or delivery, a negative urine pregnancy test is required at screening and at the start of the study.
- Must have provided informed consent, which means agreeing to participate in the study after understanding all the details and risks involved.

Who cannot join the trial?

4 criteria

Patients who do not have **congenital antithrombin deficiency** cannot participate. This is a condition where a person is born with lower levels of a protein called antithrombin, which helps prevent blood clots.
Patients who are not within the specified age range for the study cannot participate. The study includes certain age groups only.
Patients who are not undergoing surgical procedures or childbirth (parturition) cannot participate. The study is focused on these specific situations.
Patients who are not covered by **Atenativ** during their procedure cannot participate. Atenativ is a medication used to manage antithrombin deficiency.

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Verified sites

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Azienda Ospedaliera Papa Giovanni XXIII
Verified
Bergamo, Italy
Azienda Ospedaliera di Padova
Verified
Padua, Italy
Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Paz
Responsive
Madrid, Spain

Trial locations

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Investigated drugs

Atenativ is a medication used in this clinical trial to help patients who have a condition called congenital antithrombin deficiency. This condition means that their blood does not have enough of a protein called antithrombin, which helps prevent blood clots. When people with this deficiency undergo surgery or give birth, they are at a higher risk of developing blood clots. Atenativ is given to these patients to increase the levels of antithrombin in their blood, which helps reduce the risk of blood clots forming during these procedures. The trial is studying how well Atenativ works in preventing these clotting events and ensuring it is safe for the patients to use.

What is already known about the treatment

Atenativ – Atenativ is administered through an intravenous injection, meaning it is delivered directly into a vein. It is currently being studied in a Phase 3 clinical trial to evaluate its effectiveness and safety for patients with congenital antithrombin deficiency who are undergoing surgery or childbirth. This medication is primarily used to prevent blood clots in individuals with this rare genetic condition. At the molecular level, Atenativ works by supplementing the body with antithrombin, a protein that helps regulate blood clotting. It is classified as an anticoagulant, which is a type of medication that helps prevent the formation of harmful blood clots.

Investigated diseases

Congenital antithrombin deficiency – Congenital antithrombin deficiency is a genetic disorder characterized by a reduced level of antithrombin, a protein that helps regulate blood clotting. This deficiency leads to an increased risk of developing abnormal blood clots, known as thrombotic events, which can occur in veins or arteries. The condition is present from birth and can vary in severity among individuals. As the deficiency progresses, individuals may experience recurrent clotting episodes, especially during situations that increase clotting risk, such as surgery or childbirth. The disorder is typically inherited in an autosomal dominant pattern, meaning one copy of the altered gene in each cell is sufficient to cause the condition. Over time, the risk of clot formation can lead to complications if not managed properly.