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Design of the PEDS-C trial: pegylated interferon +/- ribavirin for children with chronic hepatitis C viral infection

Division of Gastroenterology and Nutrition, Department of Pediatrics, University of Washington, Children's Hospital and Regional Medical Center, Seattle, Washington, USA, Karen.murray{at}seattlechildrens.org

James R. Rodrigue

The Transplant Center, Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA

Regino P. González-Peralta

Section of Hepatology and Liver Transplantation, Department of Pediatrics, University of Florida, Gainesville, Florida, USA

John Shepherd

Department of Radiology, University of California, San Francisco, California, USA

Bruce A. Barton

Maryland Medical Research Institute, Baltimore, Maryland, USA

Patricia R. Robuck

Division of Digestive Diseases and Nutrition, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, Maryland, USA

Kathleen B. Schwarz

Division of Pediatric Gastroenterology and Nutrition, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA

for the PEDS-C Clinical Research Network

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. Clinical Trials 2007; 4: 661—673. http://ctj.sagepub.com

Clinical Trials, Vol. 4, No. 6, 661-673 (2007)
DOI: 10.1177/1740774507085445


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