Kansas City,
01
October
2019
|
03:34 PM
Europe/Amsterdam

Hepatitis C Research Leads to Life-Changing Results

Pictured Left to Right: Heather Wasserkrug, BSN, RN, CPN, Clinical Research Coordinator, Trinity Fajen, James Daniel, MD, Lisa Harvey, Assistant Clinical Research Coordinator

Five-year-old Trinity Fajen has become accustomed to the two-hour trip from her home in Warsaw, Mo., to Children’s Mercy Adele Hall Campus. She doesn’t know why she and her mother Brandy make the sometimes monthly drives, only that they lead to her friends in the hospital’s GI/Liver Care Center clinical research study team – principal investigator James Daniel, MD; clinical research coordinator Heather Wasserkrug, RN; and assistant clinical research coordinator Lisa Harvey.

Brandy hopes that they lead to life-changing results.

“Trinity came to us (through adoption) when she was 2,” Brandy says. “After being placed in our home, we found out she had Hepatitis C. She got it in-utero from her mother (who was unaware that she had contracted it).

“She had a liver biopsy and numerous ultrasounds, and her liver blood levels were always elevated. They weren’t always high enough that it required immediate treatment, but it was high enough where Dr. Daniel felt, if they were to open this study and approve it… (that Trinity would be a good candidate).”

Children’s Mercy is among 27 locations invited to participate in the study, which focuses on treating pediatric Hepatitis C patients ages 3-18 years. It tests use of a drug approved for adults on children and adolescents.

According to the Centers for Disease Control and Prevention (CDC), many people with the Hepatitis C virus eventually develop chronic liver disease that can range from mild to severe, including cirrhosis and liver cancer. Brandy says Trinity also experienced sore and achy joints, had problems with her stool, and was always very tired.

“The purpose of the study was to offer children a drug to (potentially) cure their Hepatitis C well before the official FDA approval occurs,” Dr. Daniel says, noting that the disease carries both social and medical stigma.

Trinity’s Hepatitis C diagnosis elicited a range of emotions, Brandy says. She knew nothing about the disease and had lots of questions, but Dr. Daniel and the study team were always there with answers and comfort.

“I would say the first day we came, I was right on the verge of crying. As a mother, you don’t know what’s going to happen,” Brandy says. “You want them to get well. But by the same token, you’re scared to death. It’s a drug test study, you know.”

What stood out with the Children’s Mercy study team, she says, was “their kindness and them answering questions and going over everything with us. I mean … everything. Over and over. As a mother, it made me feel at peace, and I’m very grateful.”

Dr. Daniel has worked at Children’s Mercy for 20 years and been active in clinical research – including studies for children with Hepatitis C – for about 40 years. Until only a few years ago, he says, Hepatitis C was very difficult to cure. He tells his study team members that it’s a joy to be a part of work that’s producing medical advancements in his lifetime.

“We participate in research for two reasons,” Dr. Daniel says. “First, we aim to provide benefit to the patients. Next, we hope to learn scientifically more about a disease or treatment that could benefit others.”

When asked what Brandy would tell other families who are in a similar situation and grappling with the decision of whether to enroll a child in an experimental drug study, she says why not try it?

“I mean, what’s the alternative?” she says. “I feel like we should share this story because this is a scary adventure … (and) even though it’s scary, the outcome could potentially help all these other children.”

Study team members find reward in the connections they make with patients and their families and the opportunities to give them a new take on life. “You think about all these big institutes doing this type of research, and here we are being part of that,” Heather says. “I think that really makes a name for ourselves and really says something about Children’s Mercy.”

Trinity may not grasp the magnitude of her participation just yet. But she has her important takeaways from her visits to CM.

“When we’re at home,” Brandy says, “she’ll ask to come: ‘Can I go to see my friends at Children’s Mercy?’ Meaning Heather and Lisa.

“She doesn’t even know why she took this study. She just knows that she made a lot of new friends here.”

As of today, Trinity’s Hepatitis C is no longer detectible, but the study continues to monitor her.

 

Learn more about the Children's Research Institute at Children's Mercy.