Study of VGA039 in Healthy Volunteers and Patients With Von Willebrand Disease (VIVID)
The VIVID study is exploring a new medicine, VGA039, for Von Willebrand Disease (VWD) and other bleeding disorders. It's being tested in different groups: healthy volunteers and individuals with VWD. The study will try out the medicine given either into a vein (IV) or under the skin (SC). The main aim is to see how safe the medicine is and how the body handles it at different doses. Later parts of the study will look at giving multiple doses and using it before minor surgery. Participants will be monitored closely for several weeks, depending on how they receive the medicine. This research is important for finding new ways to manage bleeding conditions.
At a glance
What is this study about?
This study, called VIVID, is designed to understand a new medicine named VGA039. It's being developed for people with Von Willebrand Disease (VWD), which is a common inherited bleeding disorder, and potentially for other similar conditions where blood doesn't clot properly. The study is split into several parts, acting like steps to learn more about the medicine safely and effectively.
The first step involves testing VGA039 in healthy volunteers to understand how it behaves in the body and to check its safety at different doses. After that, the study will move on to people who have been diagnosed with VWD. Here, researchers will continue to assess its safety and also begin to explore if it has any helpful effects. They'll also try different ways of giving the medicine – either directly into a vein or via an injection under the skin, which could be more convenient for patients.
Later stages of the study will involve giving the medicine multiple times to see if it's effective for ongoing treatment, and even trying it before minor surgical procedures to see if it can help prevent bleeding. It’s a thorough approach to ensure the medicine is well-understood before it can potentially become available to a wider group of patients. This type of research is crucial for advancing treatment options for bleeding disorders.
Key takeaways
- The VIVID study is testing a new medicine (VGA039) for Von Willebrand Disease.
- It involves both healthy volunteers and people with VWD.
- The medicine will be given either through a vein or under the skin.
- The study aims to understand the medicine's safety and effectiveness.
- Participants will have regular check-ups and follow-up for several weeks.
- It's a step-by-step trial, moving from safety in healthy people to effectiveness in patients.
Who may be eligible?
To join this study, you generally need to be between 18 and 60 years old for the first parts, or between 12 and 60 years old for later parts. You'll need to be in good overall health, without any significant issues with your blood tests, heart readings (ECG), or blood pressure.
If you have Von Willebrand Disease, the study is looking for people who experience symptoms like bleeding or bruising. Your blood counts for haemoglobin (which carries oxygen) and platelets (which help blood clot) would also need to be within a healthy range.
However, there are reasons why you might not be able to join. For example, if you've recently used hormonal contraceptives, or if you have certain blood clotting disorders or a history of blood clots. People with serious kidney, liver, heart, or other major health conditions would also not be able to participate. The study also checks for specific levels of a clotting factor called FVIII; if your levels are too high, you might not be eligible.
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 between 12 and 60 years old?
- Do you have Von Willebrand Disease and experience symptoms like bleeding or bruising?
- Are you generally in good health, with normal blood test results?
- Do you have any history of blood clots or other serious health conditions like kidney or heart disease?
- Have you used hormonal contraceptives within the last 56 days?
What does participation involve?
If you take part in this study, you'll join one of several groups. For some groups, you might stay in the study for about 8 weeks, and for others, it could be up to 15 weeks. You will receive the study medicine, VGA039, either through a drip into a vein (IV) or as an injection under the skin (SC). Depending on the part of the study, you might receive a single dose, or multiple doses. Some participants might receive a placebo, which looks like the study medicine but contains no active drug.
Throughout the study, you'll have regular visits to the clinic for various assessments. These will include blood tests to check how the medicine is affecting you and to monitor your overall health. There will also be other checks like your blood pressure, pulse, and possibly ECGs to check your heart. After you receive the medicine, there will be follow-up appointments to make sure you are well and to collect all the necessary information about the treatment's effects. The total duration of your involvement will depend on the specific part of the study you are in, but generally involves close monitoring for several weeks after receiving any study medicine.
Potential risks and benefits
Locations (25)
- Orthopedic Institute for Children (UCLA)Verified postcodeLos Angeles, United States· Recruiting
- UC Davis Medical CenterVerified postcodeSacramento, United States· Recruiting
- University of Colorado School of MedicineVerified postcodeAurora, United States· Recruiting
- Hemophilia of Georgia Center for Bleeding & Clotting Disorders of EmoryVerified postcodeAtlanta, United States· Recruiting
- Science 37, Inc.Verified postcodeMorrisville, United States· Recruiting
- Hemophilia Center of Western PAVerified postcodePittsburgh, United States· Recruiting
- Vanderbilt University Medical CenterVerified postcodeNashville, United States· Recruiting
- University of Texas SouthwesternVerified postcodeDallas, United States· Recruiting
- Washington Center for Bleeding DisordersVerified postcodeSeattle, United States· Recruiting
- Versiti Comprehensive Center for Bleeding DisordersVerified postcodeMilwaukee, United States· Recruiting
- Royal Brisbane & Women's Hospital, Queensland Haemophilia CentreVerified postcodeHerston, Australia· Recruiting
- Medical University of ViennaVerified postcodeVienna, Austria· Completed
Common questions
What is Von Willebrand Disease?
Von Willebrand Disease is a common inherited condition where your blood doesn't clot properly, leading to easier bruising and bleeding.
What does 'placebo' mean in this study?
A placebo is a substance that looks exactly like the study medicine but doesn't contain any active drug. It helps researchers compare the real medicine's effects.
Will I know if I'm getting the active medicine or a placebo?
For some parts of the study, neither you nor the study doctors will know if you're receiving the active medicine or the placebo (this is called 'double-blind'). This helps ensure unbiased results.
How will the medicine be given?
The medicine can be given in two ways: either directly into a vein through a drip (intravenous) or as an injection just under the skin (subcutaneous).
What is the main goal of this study?
The main goal is to check how safe VGA039 is, how the body handles it, and if it could be an effective new treatment for Von Willebrand Disease and other bleeding disorders.
How to find out more
Clinical Trials
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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