Clinical Trials / Research Studies
Chronic Hepatitis B Research Study for Children
Why are we doing this research?
Cincinnati Children’s is conducting a research study, sometimes known as a clinical trial or clinical study, to help us evaluate if the study drug tenofovir DF is effective and safe in the treatment of hepatitis B virus in children 2 to 11 years old. We also hope to learn about how kids’ bodies handle the study drug.
Who can participate?
Children 2 to 11 years old who have been diagnosed with chronic hepatitis B may be eligible to participate.
Conditions
- Gastroenterology, Hepatology and Nutrition
What will happen in the study?
The study lasts for about 3 ½ to 4 years and includes 23 study visits and 1 follow-up visit.Eligible children will be randomized (like drawing numbers from a hat) into 1 of 2 study groups. Most of the children will receive the study drug, but some of the children will receive placebo (a pill with no medication, e.g., sugar pill). If your child is not able to swallow a tablet, he/she will receive the study drug or placebo as an oral powder.
Parents interested in having their child participate will be given a consent form that thoroughly explains all of the details of the study, including any potential harms, issues or concerns. A member of the study staff will review the consent form with you and will be sure that you understand why the study is being conducted, how your child will be treated and help answer all of your questions.
What are the good things that can happen from this research?
Being in the study may not help your child. However, your child will have close medical monitoring of his/her health condition. When we complete the study, we hope to know if the study drug tenofovir DF is effective in treating Hepatitis B in children 2 to 11 years old.
What are the bad things that can happen from this research?
Possible serious risks and discomforts to the child will be discussed with parents or guardians as part of the consenting process.
Will you/your child be paid to be in this research study?
Families may receive up to $1,200 for time and effort. If eligible, families may receive travel reimbursement.
Contact
Tracie Horning
513-636-7511
tracie.horning@cchmc.org
Gastroenterology, Hepatology & Nutrition
Cincinnati Children’s Hospital Medical Center, MLC
3333 Burnet Ave.
Cincinnati, OH 45229-3039
Study Doctor
Jorge A. Bezerra, MD
Gastroenterology, Hepatology, & Nutrition
Cincinnati Children’s Hospital Medical Center
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3333 Burnet Avenue, Cincinnati, Ohio 45229-3026
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