How Safe is Hepatitis C Treatment for Pregnant Women and their Babies?

This study wants to learn how treating Hepatitis C during pregnancy affects the health of pregnant women and their babies.


Why this Research Matters

Hepatitis C is an infection that affects the liver. It is a common illness that spreads through blood and other body fluids. We know that Hepatitis C treatment is safe and works well for children aged 3 and older, as well as for adults. However, there is not much information about how well these treatments work for pregnant women. This study wants to find out how safe Hepatitis C treatment is for pregnant women with Hepatitis C and their babies. You and your baby will have a visit to see if you can join the study. At this visit, the study team will review your medical history and take a blood sample from your arm. You will also have a physical exam, and you may have an ultrasound. If you qualify and choose to join, you will have your first of seven study visits. At the first study visit, the study team will show you how to take the study drugs. You will need to take the study drug once a day with food. You will take the study drug around the same time each day for eight weeks. During the visits, you will also have a physical exam and a blood sample taken from your arm. At two of the study visits, the study team will check the amount of study drug that is in your blood. To do this, they will take blood samples before and after you take the study drug. The study team will also check to see how you are doing during the weeks that you do not have a study visit. You will have three visits after you stop taking the study drugs. These visits will take place 12 weeks after you stop taking the study drugs, soon after you have your baby, and 2.5 months after you have your baby. At these visits, you and your baby’s medical history will be reviewed, and you both will have a physical exam. You and your baby will have a blood sample taken and you will provide a breast milk sample. You can earn up to $915 if you and your baby complete all study visits.


Who can Participate

All Ages

You may be able to join this study if you are 16 to 45 years old, are pregnant with one baby, and have Hepatitis C. You must be 14 to 32 weeks pregnant and not have problems with your pregnancy. You cannot join this study if you have been treated for Hepatitis C before with direct-acting antivirals, have another type of Hepatitis, have had a preterm birth before 34 weeks, or have a liver disease (like cirrhosis, which is scarring of the liver) or kidney problems.


Study ID

Protocol Number: 25-1102

More information available at ClinicalTrials.gov: NCT07040319


Compensation Information

Compensation
Study Payment: Compensation provided.

Meet the Team

Image of Principal Investigator

Elizabeth Mcfarland, MD

Principal Investigator