We’re on a mission to discover a new treatment option for post‑transplant CMV infections in children.

If your child has been diagnosed with cytomegalovirus (CMV) and has received a hematopoietic stem cell transplant (HSCT) or solid organ transplant (SOT), the Protego Study may interest you.

Find a participating site

We are currently enrolling children and adolescents who have been diagnosed with CMV to take part in a clinical research study.

Eligible participants must:

  • Be younger than 18 years of age
  • Have received an HSCT or SOT that is functioning
  • Have a documented CMV infection

There are additional eligibility criteria, which the study team will discuss with you.

About the Protego Study

The purpose of the Protego Study is to evaluate an investigational drug, maribavir, for the treatment of CMV infection in children and adolescents who have received an HSCT or SOT. The clinical research study is designed to help researchers understand how the body processes the investigational drug, how safe the investigational drug is, and the best dosage for treatment. Every participant in this study will receive the active investigational drug. The investigational drug, maribavir, is approved by the US Food and Drug Administration (FDA) for the treatment of post-transplant CMV in patients ages 12 and older in the US and in adult patients in multiple additional countries; it is now being studied for children and adolescents under the age of 18 with post-transplant CMV infection.

Participation in the Protego Study lasts approximately 22 weeks. During this time, your child will attend up to 17 study visits over three periods:

Screening period

This period can last up to two weeks and includes one study site visit. The purpose of this period is to evaluate all interested children and adolescents to see whether the study is a good match for them.

Study treatment period

This period lasts eight weeks and includes up to 10 study site visits or home health care visits. During this period, participants will take the investigational drug twice daily, and the study team will check on the participants’ health during regular study site visits.

Follow-up period

This period lasts 12 weeks and includes six study site visits or home health care visits. During this period, the study team will check on the participants’ health after stopping the investigational drug.

For more-detailed information on study participation, we encourage you to view the following informed consent videos.

For adults

Watch

For adolescents

Watch

For children

Watch

Find a Site

To learn more, and to see if your child may qualify, contact one of the following participating sites.

e.g., 12345

About Cytomegalovirus (CMV)

CMV is a widespread, common virus that rarely causes obvious illness in people with healthy immune systems. When symptoms do appear, they are most commonly fever, fatigue, sore throat, and swollen glands. These symptoms typically last just a few weeks and are not often a cause for concern on their own.1

For people with weakened immune systems, like those who have had organ transplants, a CMV infection can cause more serious problems.1   After a transplant surgery, the patient is given antirejection drugs to help prevent the body from rejecting the transplanted organ. The drugs also inhibit the immune system, which decreases the body’s ability to fight infection and make transplant recipients prone to infections like CMV.2

There is no cure for CMV. Once a person has been infected, the virus remains inactive and the person may have another CMV infection in the future.2   Treatment options for CMV are limited. Clinical research studies and the volunteers who participate are vital to the development of potential medications that can help address these types of unmet medical needs.

References:

  1. cdc.gov/cmv/overview.html
  2. my.clevelandclinic.org/health/diseases/21166-cytomegalovirus-cmv-in-transplant-patients

What You Should Know about Clinical Research Studies

Clinical research studies, also called clinical trials, research an investigational drug or medical device to see if it is safe, how it works in the body, and if it works to treat a specific disease. Clinical research studies are conducted by doctors who are responsible for the study participants’ study-related care.

In most countries, the regulatory health authority requires that several phases of clinical research be performed to better understand the safety and effectiveness of new investigational drugs and certain medical devices.

Clinical research studies must be approved by an institutional review board (IRB) or ethics committee (EC). An IRB/EC is a group that is responsible for helping to protect the rights and welfare of study participants. In addition, every study participant is monitored with study-related medical tests and exams before, during, and sometimes even after the study.

Participation in any clinical research study is completely voluntary, and you may choose to discontinue your child’s participation at any time for any reason. If you would like to withdraw your child from the study, you should discuss this with your child’s study doctor, who will give you information about how to do this safely.

Before your child can take part in the Protego Study, they will first need to attend the screening visit for initial tests and assessments to see whether they are eligible to participate. After all necessary tests and assessments have been completed, and if your child is eligible to participate, they may enter the clinical research study and receive the investigational drug.

Participation in the clinical research study lasts approximately 22 weeks.

Find a participating site