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

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 ped...

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Published in:Clinical trials (London, England) England), 2007-01, Vol.4 (6), p.661-673
Main Authors: Murray, Karen F., Rodrigue, James R., González-Peralta, Regino P., Shepherd, John, Barton, Bruce A., Robuck, Patricia R., Schwarz, Kathleen B.
Format: Article
Language:English
Subjects:
Adolescent
Antiviral Agents - administration & dosage
Antiviral Agents - therapeutic use
Child
Child, Preschool
Clinical trials
Design of experiments
Drug therapy
Hepatitis
Hepatitis C virus
Hepatitis C, Chronic - drug therapy
Humans
Interferon-alpha - administration & dosage
Interferon-alpha - therapeutic use
Pediatrics
Placebos
Polyethylene Glycols - administration & dosage
Polyethylene Glycols - therapeutic use
Prospective Studies
Recombinant Proteins
Ribavirin - administration & dosage
Ribavirin - therapeutic use
Treatment Outcome
United States
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Summary: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
ISSN:1740-7745
1740-7753
DOI:10.1177/1740774507085445