Nonalcoholic Fatty Liver/Steatohepatitis (NAFL/NASH) Observational Study

A 5-year Longitudinal Observational Study of Patients with Nonalcoholic Fatty Liver or Nonalcoholic Steatohepatitis

Protocol Description

The purpose of this multi-center observational investigation is to study the natural course of nonalcoholic fatty liver (NAFL) disease with a goal of identifying whether certain changes in lifestyle, diet, or other treatments can affect its progression. NAFL is the storage of fat in the liver, and there are presently are no approved drugs for treatment of this condition. A potentially serious form of the disease, nonalcoholic steatohepatitis (NASH), includes irritation or inflammation of the liver due to fat. This research study collects information and medical samples and is not prescriptive.

Eligibility Criteria

Patients of both genders, ages 6 and older, who are being managed or treated for NAFL or NASH are eligible.
Males and Females: Ages 6 and older

Requirements

Participants’ past and future medical record information, including test results, information about their NAFL/NASH progression and any other health conditions, will be collected and sent to the study sponsor to be added to the database with identification redacted to maintain confidentiality. Over the course of the study, participants will complete questionnaires during annual clinic visits for management of their liver disease at Children’s Hospital of Pittsburgh of UPMC. Optionally, participants may elect to have blood samples added to the study biorepository for analysis.
Visits: Annually
Duration: Up to 5 years

Status: Open to Enrollment

Source(s) of Support

TARGET PharmaSolutions, Inc.

Primary Investigator

Patrick McKiernan, MD

Contact Information

For more information about the study or enrollment, please contact:
Clinical Research Nurse Coordinator Lori Haberstroh, RN, BSN
412-692-5811