RecruitingPHASE3INTERVENTIONAL

A Pilot Crossover Trial of Prophylactic Wilate Compared to Placebo for Heavy Menstrual Bleeding in Patients with VWD

This research is looking for women aged 18 and over who have von Willebrand Disease (VWD) and very heavy periods. The study aims to see if a medicine called Wilate, which contains important clotting factors, can help reduce heavy menstrual bleeding. It's a pilot study, meaning it's a smaller, early trial designed to figure out if a bigger study would be practical and effective. Participants will either receive Wilate or a placebo (a dummy treatment like saline) for a few months, then switch to the other treatment. Doctors and patients won't know who is getting which treatment. The main goal is to test the study design and see if the methods used can properly measure how well the treatment works.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Unity Health Toronto

Enrolment target

Start

21 Oct 2024

Estimated completion

01 Sep 2026

Von Willebrand Diseases

What is this study about?

If you experience heavy periods and have a condition called von Willebrand Disease (VWD), you might be interested in this study. VWD is a lifelong condition where your blood doesn't clot as well as it should because you don't have enough of certain proteins, called clotting factors. This can lead to heavy bleeding, especially during your period.

This study is testing a treatment called Wilate. Wilate is a medicine that provides the missing clotting factors to help your blood clot better. The main aim of this particular study, called the EMPOWER trial, is a 'pilot' study. This means it's a smaller trial to check if a larger, more detailed study would be possible and well-designed. It will help us understand if the way we measure how well the treatment works is effective.

Participants will receive either Wilate or a 'placebo' (a treatment that looks the same but contains no active medicine) for a period, and then swap over to the other treatment. This helps researchers compare the treatments fairly. We hope to see if Wilate can make a real difference in reducing heavy periods for women with VWD.

Key takeaways

This study is for women over 18 with von Willebrand Disease and heavy periods.
It tests a medicine called Wilate against a placebo to see if it reduces heavy bleeding.
It's a 'pilot' study to check if a larger trial would be viable.
You'll receive both Wilate and placebo at different times over two years.
Neither you nor your doctor will know which treatment you are getting at any time.
Participation involves regular clinic visits and infusions by a nurse.

Who may be eligible?

This study is looking for women aged 18 or older who have been diagnosed with von Willebrand Disease (any type) and experience very heavy periods. To qualify, your doctor must believe that treatment with Wilate is a good option for you, based on your bleeding history. We'll also check if your usual treatments for heavy periods and iron deficiency have been stable for the last three months, and are expected to stay the same throughout the study.

You would need to be comfortable with a nurse giving you infusions (medicine through a drip) during the study. Also, you'd need to agree to use specific feminine hygiene products provided by the study organisers. This is to help us accurately measure any changes in your bleeding.

However, some things would mean you couldn't take part. For example, if you have another known bleeding disorder, are pregnant, planning to become pregnant, or breastfeeding. If you've had certain allergic reactions to similar medicines in the past, or if you have severe liver disease, you wouldn't be able to join. Additionally, if you have a high risk of blood clots, are already taking a specific medicine called desmopressin (unless for emergencies), or are planning to start certain hormone-based treatments, you would also be excluded.

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 a woman aged 18 or over?
Do you have a diagnosis of von Willebrand Disease?
Do you experience very heavy menstrual bleeding?
Are you NOT pregnant, planning to be, or breastfeeding?
Have your heavy period treatments been stable for the last 3 months?
Are you comfortable receiving IV infusions from a nurse?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, it will last for about two years. You'll be asked to visit your doctor or clinic regularly. For the first part of the study, you'll either receive Wilate (the active treatment) or a placebo (a dummy treatment) through an infusion given by a nurse. This will be for four monthly periods. Neither you nor your doctor will know which one you're receiving – this is to make sure the results are as fair as possible.

After these four cycles, you'll have a one-month break where you won't receive either study treatment. Then, for the second part of the study, you'll switch over to the other treatment (so if you had Wilate first, you'll get the placebo, and vice-versa) for another four monthly periods. Throughout the study, you'll continue your usual care for heavy periods. You'll also be asked to use specific feminine hygiene products provided by the study, and your bleeding will be carefully monitored. The main goal is to see how the study itself works.

Potential risks and benefits

Participating in this trial might offer you a potential benefit by helping to reduce your heavy periods. You would also be contributing valuable information that could help other women with VWD in the future. However, like all medicines, Wilate can have side effects, and some people may have allergic reactions. There's also a chance you might receive the placebo and not the active drug during one part of the study. You're free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

St. Michael's Hospital
Verified postcode
Toronto, Canada· Recruiting

Common questions

What is von Willebrand Disease (VWD)?

VWD is a common bleeding disorder where your blood doesn't clot properly due to a lack of a certain protein, which can cause heavy or prolonged bleeding.

What is Wilate?

Wilate is a medicine that contains the clotting factors that people with VWD may be missing. It's given through an infusion (a drip).

What is a 'placebo'?

A placebo is a substance or treatment that looks exactly like the real medicine but contains no active drug. It helps researchers compare results fairly.

Will I know if I'm getting Wilate or the placebo?

No, neither you nor your doctor will know which treatment you are receiving until after the study is completed. This is called 'double-blind'.

How long will I be in the study?

The study will last for approximately two years, including the treatment periods and follow-up.

How to find out more

St. Michael's Hospital

empower@unityhealth.to 4168646060 Official trial record

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