RecruitingPHASE3INTERVENTIONAL

Efficacy of Atenativ in Patients With Congenital Antithrombin Deficiency Undergoing Surgery or Delivery

This study, called "Efficacy of Atenativ in Patients With Congenital Antithrombin Deficiency Undergoing Surgery or Delivery," is testing a medication called Atenativ. It's for individuals born with a rare condition called congenital antithrombin deficiency, which increases their risk of blood clots. The main goal is to find out how often serious blood clots (thrombotic or thromboembolic events) occur in patients taking Atenativ when they are having surgery or giving birth. By understanding this, doctors can better manage the care of people with this condition during high-risk times, aiming to improve safety and health outcomes.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Octapharma

Enrolment target

Start

01 Jul 2022

Estimated completion

01 Dec 2026

Congenital Antithrombin Deficiency

What is this study about?

This research study is investigating a medication called Atenativ. It's designed for people who have a condition known as congenital antithrombin deficiency. This is a rare, inherited condition where the body doesn't produce enough antithrombin, a natural protein that helps prevent blood from clotting too much. Without enough antithrombin, individuals are at a higher risk of developing dangerous blood clots, particularly during stressful times for the body like surgery or childbirth.

The main purpose of this study is to see how effective Atenativ is at stopping these serious blood clots from forming during and after surgical procedures or during and after delivery for pregnant individuals. Researchers will carefully track how many participants experience blood clots while receiving Atenativ for these events. The information gathered will help doctors understand the best ways to protect patients with this condition during times of increased risk.

Ultimately, this study aims to enhance our understanding of how to safely manage congenital antithrombin deficiency, especially when patients undergo high-risk medical procedures. The insights gained could lead to better treatment strategies and improved safety for individuals living with this rare condition in the future.

Key takeaways

This study is for people born with a rare condition that increases their risk of blood clots.
It's testing a medication called Atenativ to prevent blood clots during surgery or delivery.
The study focuses on common blood clot risks and how Atenativ can help manage them.
Eligibility depends on your specific health details, planned procedures, and age.
Participation involves clinic visits, medication administration, and health monitoring.
You can stop participating at any time without affecting your medical care.

Who may be eligible?

To be considered for this study, you would generally need to be an adult between 18 and 80 years old, with a confirmed diagnosis of congenital antithrombin deficiency. For the main treatment part of the study, you would either need to be having a planned major surgery that carries a high risk of blood clots, or be at least 27 weeks pregnant and scheduled for a C-section or delivery. There's also a small group of younger participants, aged 12 to 17, being included to understand how their bodies process the medication.

However, some factors might mean you can't join. For instance, if you require emergency surgery or an emergency C-section, or if you've recently had surgery within the last six weeks. You also wouldn't be able to participate if you have other blood clotting disorders, certain severe health issues like liver or kidney problems, or if you've had allergic reactions to similar medications or blood products in the past. There are also restrictions based on body specific measurements for non-pregnant patients, and a requirement to not refuse blood transfusions.

Quick self-check

Are you an adult aged between 18 and 80? (Or 12-17 for a specific part of the study)
Do you have a confirmed diagnosis of congenital antithrombin deficiency?
Are you scheduled for a planned surgery that carries a high risk of blood clots, or are you at least 27 weeks pregnant and planning a C-section or delivery?
Do you have any other significant health conditions, like severe kidney/liver disease or other severe clotting disorders?
Have you had recent surgery (within the last 6 weeks) or do you need emergency surgery/delivery?
Are you able to agree to receive blood-derived products if needed?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

Taking part in this study would involve several visits to a clinic. You would receive the study medication, Atenativ, as needed for your surgery or delivery. Researchers would perform regular checks to monitor your health, take blood samples to see how you're responding to the treatment, and ask about any new symptoms. The exact number of visits, assessments, and the overall duration of your involvement would depend on your individual circumstances, such as whether you are having surgery or delivering a baby, and how long you are followed up afterwards. All procedures and timelines would be fully explained before you agree to participate.

Potential risks and benefits

Like all medical studies, there are potential benefits and risks. A potential benefit of taking part could be receiving a specific treatment, Atenativ, which is designed to reduce your risk of serious blood clots during a high-risk time. This could improve your safety and health outcomes. However, there are also potential risks, such as side effects from the medication, which would be fully discussed with you by the study team. You would also need to attend clinic appointments and have blood tests. It's very important to remember that participating is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (30)

Georgetown University
Washington D.C., United States· Recruiting
University of Miami
Miami, United States· Recruiting
Bleeding and Clotting Disorders Institute
Peoria, United States· Recruiting
Weill Cornell Medicine
New York, United States· Recruiting
Duke University
Durham, United States· Recruiting
Yeolyan Hematology and Oncology Centre
Yerevan, Armenia· Recruiting
Universitätsklinik für Innere Medizin Klinische Abteilung für Hämatologie und Hämostaseologie
Vienna, Austria· Recruiting
Centre for Thrombosis and Haemaostasis
Nymburk, Czechia· Recruiting
Centre de Référence de l'Hémophilie Unité d'Hémostase Clinique Hôpital Cardiologique Louis Pradel
Bron, France· Recruiting
University Hospital of Reims
Reims, France· Recruiting
Centre Hospitalier Universitaire de Rouen (CHU de Rouen) - Centre de Traitement des Maladies Hemorragiques (CRTH) (Centre d'Hemophiles)
Rouen, France· Recruiting
Aversi Clinic
Tbilisi, Georgia· Recruiting

+18 more sites — see the official record for the full list.

Common questions

What is congenital antithrombin deficiency?

It's a rare inherited condition where your body doesn't make enough antithrombin, a natural protein that helps stop your blood from clotting too much. This means you have a higher risk of developing dangerous blood clots.

What is Atenativ?

Atenativ is the medication being tested in this study. It's designed to provide the antithrombin that your body might be lacking, especially during times of increased risk like surgery or childbirth, to help prevent blood clots.

Why is this study important for me if I have this condition?

This study aims to understand how well Atenativ can protect people with congenital antithrombin deficiency from serious blood clots during surgery or delivery. The results could lead to safer care for you and others with this condition.

Will I receive Atenativ if I join the study?

If you are eligible and join the treatment phase of the study, you will receive Atenativ when you are having a planned surgery or delivering a baby, as part of the study protocol.

Can I leave the study if I change my mind?

Yes, taking part is completely voluntary. You have the right to withdraw from the study at any time, for any reason, and it will not affect the medical care you receive.

How to find out more

Sigurd Knaub

Sigurd.Knaub@octapharma.com +41554512141 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.