RecruitingPHASE3INTERVENTIONAL

A Phase 3 Trial to Compare IV BCV Versus IV CDV for Treatment of Adenovirus Infection After Allo-HCT

This study is testing two different medicines, brincidofovir (BCV) and cidofovir (CDV), to treat adenovirus infections. These infections can happen in people who have recently had a special type of stem cell transplant called an allogeneic haematopoietic cell transplant (allo-HCT). Researchers want to find out which of these two drugs is more effective at getting rid of the adenovirus from the body. Patients in the study will be randomly given one of the two medicines and will be treated until the virus is gone or for a maximum of 12 weeks. The study will then follow them for 24 weeks to see how they are doing.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

SymBio Pharmaceuticals

Enrolment target

180

Start

17 Mar 2026

Estimated completion

30 Jun 2028

Adenovirus Infections

What is this study about?

This research study is looking at serious infections caused by a bug called adenovirus. These infections can sometimes be life-threatening for people who have recently had a stem cell transplant where they received cells from another person (called an allogeneic haematopoietic cell transplant, or allo-HCT). We want to find the best way to treat these infections. The study compares two medicines: brincidofovir (BCV) and cidofovir (CDV). Both are given into a vein (intravenously).

The main goal is to see which medicine is better at clearing the adenovirus from the body. Patients will be randomly assigned to receive either BCV or CDV. The treatment will continue until the adenovirus is no longer found in their blood or for up to 12 weeks, whichever comes first. After treatment, doctors will keep a close eye on patients for a total of 24 weeks to see how they are recovering and if the virus stays away.

Finding an effective treatment for adenovirus infections after a stem cell transplant is very important. This study helps doctors understand which medicine gives patients the best chance of getting well and staying well. It's a key step in improving care for people facing this challenging complication.

Key takeaways

This study compares two medicines for adenovirus infection after a stem cell transplant.
It aims to find which treatment, brincidofovir or cidofovir, works better.
Treatment can last up to 12 weeks, or until the virus is gone.
Patients are followed closely for 24 weeks after starting the study.
Participation involves regular visits and blood tests.
You can stop participating at any time.

Who may be eligible?

This study is looking for children and adults who have recently had a stem cell transplant from a donor (called an allogeneic transplant) within the last 180 days. They must be at least 2 months old. It's also important that their doctor believes they genuinely need treatment for an adenovirus infection, and their parents or guardians (if they are a child) are willing and able to give permission for them to take part.

To join, people must have an active adenovirus infection in their blood. This is usually confirmed by finding a certain amount of adenovirus DNA (the virus's genetic material) in their blood tests.

Some people can't join the study. For example, if you've had a stem cell transplant from a sibling donor, or if you've recently received a lot of the study drug cidofovir for another reason. You also can't take part if you are allergic to either of the study medicines or have recently participated in certain other research studies.

Quick self-check

Have I had an allogeneic stem cell transplant in the last 6 months?
Am I at least 2 months old?
Do I have an active adenovirus infection that needs treating?
Am I allergic to brincidofovir or cidofovir?
Have I received a sibling stem cell transplant?
Have I taken a lot of cidofovir recently for another reason?

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

What does participation involve?

If you join this study, you will be randomly assigned to receive one of two medicines, either brincidofovir (BCV) or cidofovir (CDV), both given into a vein. You won't get to choose which one you receive. The treatment will continue until tests show the adenovirus is gone from your blood, or for a maximum of 12 weeks. During this time, you'll have weekly visits and blood tests to check on the virus and your health.

After your treatment ends, you'll have specific follow-up visits. One visit will be about four weeks after your last dose to check if the treatment worked (this is called the 'test of cure' visit). You'll also have visits at 12 and 24 weeks after the start of your treatment. The study expects you to complete all these visits and checks, even if you stop treatment earlier. The total time you'll be involved in the study, including follow-up, is 24 weeks.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. A potential benefit of this study is receiving treatment for a serious adenovirus infection, which might improve your health compared to standard care or give you access to a new medicine. However, there's no guarantee the treatment will work for you. Potential risks include side effects from the medications, which your doctor will discuss with you. There might also be discomfort from blood tests and regular hospital visits. You have the right to leave the study at any time, for any reason, without it affecting your future medical care.

Locations (61)

Phoenix Children's Hospital
Phoenix, United States· Recruiting
City of Hope
Duarte, United States· Not yet recruiting
University of California Davis
Sacramento, United States· Not yet recruiting
Rady Children's Hospital
San Diego, United States· Not yet recruiting
Children's Hospital Colorado-Center for Cancer and Blood Disorders
Aurora, United States· Not yet recruiting
Children's National Hospital
Washington D.C., United States· Recruiting
Children's Healthcare of Atlanta/Emory
Atlanta, United States· Not yet recruiting
Ann and Robert H Lurie Children's Hospital
Chicago, United States· Recruiting
University of Chicago
Chicago, United States· Not yet recruiting
Dana-Farber Cancer Institute-Brighman and Women's
Boston, United States· Not yet recruiting
Dana-Farber/Boston Children's Cancer and Blood Disorders Center
Boston, United States· Not yet recruiting
Helen Devos Children's Hospital / Michigan State University
Grand Rapids, United States· Not yet recruiting

+49 more sites — see the official record for the full list.

Common questions

What is an adenovirus infection?

Adenovirus is a common virus, but it can cause serious problems, like infections, in people whose immune systems are weakened, such as after a stem cell transplant.

What is a stem cell transplant?

It's a medical procedure where healthy blood-forming cells are given to a patient to replace unhealthy ones, often used to treat certain cancers or blood disorders.

Why are two different medicines being tested?

Researchers want to compare brincidofovir and cidofovir to determine which one is more effective and safer for treating adenovirus infections after a stem cell transplant.

How long will I be on treatment?

You will receive treatment until the virus can no longer be detected in your blood, or for a maximum of 12 weeks, whichever happens first.

Can I choose which medicine I get?

No, you will be randomly assigned to receive either brincidofovir or cidofovir. This is a common way to ensure study results are fair and unbiased.

How to find out more

Rochelle Maher

MedInfo@symbiopharma.com +1-917-656-6951 Official trial record

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