RecruitingPHASE3INTERVENTIONAL

Phase 3 Study of Fibrinogen Concentrate (CSL511) in Subjects With Pseudomyxoma Peritonei Undergoing Cytoreductive Surgery

This research study, called a Phase 3 trial, is looking at a new medicine called CSL511. It's designed for people who have a rare cancer-like condition called pseudomyxoma peritonei (PMP) and who need a big operation called cytoreductive surgery, often with heated chemotherapy. This surgery can sometimes cause significant blood loss. The study aims to find out if CSL511 is a safe and effective way to help manage severe bleeding during this surgery compared to a common treatment called cryoprecipitate. Patients who are expected to lose a lot of blood during their operation will be randomly given either CSL511 or cryoprecipitate to see which works best.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

CSL Behring

Enrolment target

Start

01 Oct 2024

Estimated completion

29 Oct 2027

Acquired Fibrinogen Deficiency

What is this study about?

This clinical trial is focused on people undergoing a significant operation for a rare condition called pseudomyxoma peritonei (PMP). PMP is a jelly-like substance that builds up inside the tummy, often linked to certain types of cancer. The main treatment is a major surgery to remove as much of it as possible, sometimes followed by chemotherapy that's heated and directly put into the tummy.

During such a complex surgery, there's a risk of losing a lot of blood. When this happens, a substance in the blood called fibrinogen is very important for clotting and stopping bleeding. Sometimes, people can run low on fibrinogen, a condition known as acquired fibrinogen deficiency. This study is testing a new medicine, CSL511, which is a concentrated form of fibrinogen.

We want to see if CSL511 can effectively and safely help control bleeding during this type of surgery, especially when a lot of blood loss is expected. It will be compared to cryoprecipitate, which is a standard treatment containing fibrinogen already used to help with bleeding. This research is important to find better ways to keep patients safe during very challenging surgeries.

Key takeaways

This study is for adults with pseudomyxoma peritonei (PMP) undergoing a specific major surgery.
It aims to find a better way to manage significant bleeding during this complex operation.
A new medicine, CSL511, is being compared to a standard treatment called cryoprecipitate.
Participants will be randomly assigned to one of the two treatments.
Your safety and wellbeing will be closely monitored throughout the study.
You can stop participating at any time without affecting your medical care.

Who may be eligible?

To join this study, you need to be an adult, aged 18 or older. You must have been diagnosed with pseudomyxoma peritonei (PMP) and be scheduled for the specific type of surgery (cytoreductive surgery with heated chemotherapy) that this study is focusing on. Doctors must also believe you are likely to lose two litres or more of blood during your operation, which is a significant amount.

There are also some reasons why you might not be able to join. These include having certain blood clotting problems (either present from birth or developed later), or if you've had a heart attack or stroke in the last two months. You also can't take part if you have a history of chronic hepatitis or if you've recently taken certain blood-thinning medications within a specific timeframe before your surgery.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Have you been diagnosed with pseudomyxoma peritonei (PMP) and scheduled for cytoreductive surgery with HIPEC?
Are your doctors predicting you might lose 2 litres or more of blood during your surgery?
Have you *not* had a heart attack or stroke in the last two months?
Are you *not* currently taking certain types of blood-thinning medications (your doctor can confirm this)?
Do you *not* have a known chronic liver condition (hepatitis) or certain blood clotting disorders?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, the first step is to give your informed consent, meaning you understand and agree to participate. You will then be randomly assigned, like flipping a coin, to receive either the study medicine (CSL511) or the standard treatment (cryoprecipitate) during your surgery. Neither you nor your doctors will know which treatment you are receiving until after the surgery.

During and after your surgery, the medical team will carefully monitor your bleeding, blood test results, and overall health. They will collect information about how well your bleeding is controlled and if you experience any side effects. There might be additional blood tests or checks during your hospital stay. The total duration of your participation will depend on your hospital stay and recovery, but the main part of the study involves your surgery and immediate post-operative period.

Potential risks and benefits

Participating in this study might offer the benefit of receiving a new treatment that could potentially be more effective at managing bleeding during your surgery. However, like all medical treatments, there are potential risks. These could include side effects from the study medication or the standard treatment, although both are carefully monitored. There's also a chance the new treatment might not work better than the usual care. You will be closely monitored by a medical team and you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Basingstoke and North Hampshire Hospital
Verified postcode
Basingstoke, United Kingdom· Recruiting

Common questions

What is pseudomyxoma peritonei (PMP)?

It's a rare condition where a jelly-like substance (mucus) builds up inside your tummy, often caused by certain types of cancer cells.

What is 'cytoreductive surgery with HIPEC'?

It's a major operation to remove as much of the PMP as possible, often followed by heated chemotherapy washed directly inside your tummy to kill remaining cells.

Why is blood loss a concern in this surgery?

This is a very complex and long surgery, which can sometimes lead to significant blood loss. Managing this blood loss is vital for your safety.

What is CSL511?

CSL511 is a new medicine being tested. It's a special type of human protein called fibrinogen, which helps your blood to clot.

Will I know if I'm getting CSL511 or the standard treatment?

No, you will be randomly assigned to one or the other, and neither you nor your doctors will know which one until after the surgery. This helps ensure fair results.

How to find out more

Trial Registration Coordinator

clinicaltrials@cslbehring.com +1 610-878-4697 Official trial record

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