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Valganciclovir for Cytomegalovirus-Related Hearing Loss (ValEAR Trial)
ValEAR Trial Summary
This trial will determine whether hearing-impaired infants with asymptomatic cCMV have better hearing and language outcomes if they receive valganciclovir antiviral treatment.
ValEAR Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowValEAR Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2015 Phase 4 trial • 40 Patients • NCT01509404ValEAR Trial Design
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- You have signs of hydrocephalus (a condition where fluid builds up in the brain).My parent or guardian does not speak English or Spanish.I am between 1 month and 12 months old.My liver enzyme levels are high, or I have liver enlargement or serious gut issues.I was born before reaching 32 weeks of pregnancy.You are expected to pass away soon.You have slow growth inside the womb.I have permanent hearing loss that is not solely due to nerve issues.I have low blood counts or a significant blood disorder.My kidney function is reduced or I have a significant kidney disorder.I am currently taking antiviral medications or receiving immune globulin therapy.You are allergic to valganciclovir or ganciclovir.My baby tested positive for CMV through specific tests.My birth weight was less than 1800 grams.There are signs of calcium deposits in the brain.I have severe hearing loss in both ears.You have a smaller than average head size.I have been diagnosed with hearing loss through ABR testing.I have small red or purple spots on my skin.I have eye conditions like inflammation, optic nerve damage, or pale optic nerves.My hearing loss is not due to meningitis or medication damage.You are a mother who has HIV and may have a weakened immune system.I am breastfeeding and taking antiviral or immunosuppressive medication.I am not taking any medications that are not allowed in this study.I am mostly exposed to a language other than English or Spanish.
- Group 1: Arm A
- Group 2: Arm B
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Would this particular test be appropriate for patients who are octogenarians?
"To be eligible for this clinical trial, patients must between the ages of 1 month to 12 months old. There are a total of 66 studies currently ongoing for children under 18 and 160 for adults over 65 years old."
Are there any dangerous side effects associated with Valganciclovir?
"While there is some data supporting Valganciclovir's safety, it did not receive a higher score because efficacy has yet to be demonstrated in clinical trials."
Could I qualify to take part in this research?
"To qualify for this study, infants between the ages of 1 month and 12 months must have cmv. This trial has space for around 52 participants."
Are there still positions available in this clinical trial?
"As of right now, this study is not looking for any more participants. However, it's important to note that this could change in the future as the study was last edited on February 22nd, 2022. If you're interested in participating in other studies, there are 176 trials involving cmv and 28 Valganciclovir trials that are currently enrolling patients."
How many participants will this research project be able to accommodate?
"At the moment, this clinical trial is not enrolling patients. The date of the original posting was August 31st, 2018 and February 22nd, 2020 marks the most recent update. There are 28 other trials recruiting participants who have cmv and Valganciclovir respectively."
Are there other areas of research in which Valganciclovir has been used?
"Valganciclovir was first trialled in 2004 at the National Institutes of Health Clinical Center. In the 16 years since, there have been 101 completed clinical trials with valganciclovir. Right now, 28 different medical studies are using this medication with a large portion taking place in Ottawa and California."
How many different hospitals are participating in this trial?
"In addition to other sites, this trial is accepting patients from Children's Hospital of Eastern Ontario in Ottawa, California, Hospital for Sick Children in Toronto, Michigan and McMaster University in Hamilton."
What are Valganciclovir's common applications in medication?
"Valganciclovir is often given to patients with AIDS, however it can also help those with cytomegalovirus retinitis, kidney transplants, and lung transplants."
Who else is applying?
What state do they live in?
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