Families were informed about the study by the site principal investigator and study coordinator. The majority of the study coordinators were experienced pediatric research nurses; there was also one pediatric nutritionist and one foreign medical graduate who served as coordinators. Parents and patients were able to ask questions and have them answered before they signed consent. No direct financial compensation was given to the research participants and families. The results of this trial were recently published (Schwarz et al., 2011).
The initial screening Visit for recruitment of children in our study lasted approximately 2-3 hours. Eligibility of research subjects was determined based on these inclusion criteria: age 5 to 17 years with CHC infection documented by the presence of the hepatitis C virus in plasma on two occasions at least 6months apart and chronic liver disease as indicated by inflammation and/or fibrosis consistent with CHC on a liver biopsy obtained within the past 24 months. Other details about inclusion and exclusion criteria are available at http:// www.ClinicalT rials. gov (PEDSC). Eligible research subjects were seen at the clinical site within 35 days of screening, for their baseline visit. This visit lasted approximately 2—3 hours and included detailed quality of life questionnaires, growth and body composition measurements, physical examination and venipuncture for laboratory assessment. Parental in- structions on giving injections and information on the study drugs were also provided during this visit.