Design of the PEDS-C trial: pegylated interferon +/- ribavirin for children with chronic hepatitis C viral infection
Year: 2007
Type: article
Abstract: BACKGROUND: PEDS-C is the first multicenter placebo-controlled trial for the treatment of chronic hepatitis C (HCV) in childhood that has ever been conducted in the United States (USA). Establishment of the research team, protocol, administrative infrastructure, and ancillary contributors for the pediatric trial took years of planning. PURPOSE: To study the safety and efficacy of pegylated-interferon alpha (PEG-2a) plus ribavirin (RV) with PEG-2a monotherapy in children aged 5 years through 18 years. To assess the health-related quality of life and growth and body composition in children with chronic hepatitis C infection, before, during, and after treatment. METHODS: Eleven centers of pediatric hepatobiliary clinical research were united in a National Institutes of Diabetes and Digestive and Kidney Diseases (NIDDK) funded grant with financial support from the Food and Drug Administration (FDA) and a corporate sponsor to conduct the treatment trial. LIMITATIONS: The most important initial limitation in the design of this complex study was securing the financial support and infrastructural organization, a process that took several years. Challenges faced by the study group included identifying the optimal study design given the limited study population, and determining what ancillary studies could be incorporated into the treatment trial. CONCLUSIONS: In this article the process taken to design the study and administrative infrastructure, the lessons learned, and the controversial issues deliberated during the planning process are discussed. The evolution of the study and the considerations taken in the development of the protocol are valuable tools which can be applied to pediatric clinical trials in general.
Source: Clinical Trials
Institutions: Seattle Children's Hospital, University of Washington, Beth Israel Deaconess Medical Center, University of Florida, University of California, San Francisco, Maryland Medical Research Institute, National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases, Johns Hopkins University, Johns Hopkins Medicine
Language: English
Topic: Hepatitis C virus research
Subfield: Hepatology
Field: Medicine
Domain: Health Sciences
Open Access status: green
Awards: G1122493539, General Clinical Research Center, G1325384987, G1359833195, G143835328, G14405488, G150447635, G1853449223, PEDIATRIC CLINICAL RESEARCH CENTER, G2078309758, G2623056496, G278975345, General Clinical Research Center, G3320014004, G386564605, General Clinical Research Center, G5362374264, Pegylated Interferon +/- Ribavirin for Children with HCV, General Clinical Research Center, G5642584813, G610945888, G6578036436, G936736366, G949340704
OpenAlex ID: W1970171323