Trial reportClinical trials (London, England)2007
Design of the PEDS-C trial: pegylated interferon +/- ribavirin for children with chronic hepatitis C viral infection.
Trial report in Clinical trials (London, England), 2007. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00100659 (Pegylated Interferon +/- Ribavirin for Children With Hepatitis C), which is not on this map. Cited by 12 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Pegylated Interferon +/- Ribavirin for Children With Hepatitis C
Who cites it
12 citing papers in PubMed, 32 citations in OpenAlex.
- Autoantibodies and autoimmune disease during treatment of children with chronic hepatitis C.Journal of pediatric gastroenterology and nutrition · 2013Trial
- Pegylated interferon for chronic hepatitis C in children affects growth and body composition: results from the pediatric study of hepatitis C (PEDS-C) trial.Hepatology (Baltimore, Md.) · 2012Trial
- Peginterferon with or without ribavirin has minimal effect on quality of life, behavioral/emotional, and cognitive outcomes in children.Hepatology (Baltimore, Md.) · 2011Trial
- The combination of ribavirin and peginterferon is superior to peginterferon and placebo for children and adolescents with chronic hepatitis C.Gastroenterology · 2011Trial
- Impact of hepatitis C virus infection on children and their caregivers: quality of life, cognitive, and emotional outcomes.Journal of pediatric gastroenterology and nutrition · 2009Trial
- Treatment of Hepatitis C Virus Infection in Children Less than 12 Years of Age in Developing Countries.Journal of clinical and translational hepatology · 2014Review
- Evaluating progression of liver disease from repeat liver biopsies in children with chronic hepatitis C: a retrospective study.Hepatology (Baltimore, Md.) · 2013Article
- Treatment and follow up of children with chronic hepatitis C in Albania.Virology journal · 2012Article
- Salt-losing nephrogenic diabetes insipidus caused by fetal exposure to angiotensin receptor blocker.Pediatric nephrology (Berlin, Germany) · 2009Article
- Managing pediatric hepatitis C: current and emerging treatment options.Therapeutics and clinical risk management · 2009Article
- Recruitment and retention strategies in a clinical trial for children with chronic hepatitis C infection.Journal of pediatric nursingArticle
- Treatment of Hepatitis C in a Case of Pediatric B-Cell Acute Leukemia.Journal of global infectious diseasesArticle
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors at 7 institutions in 1 country.
Funding
Abstract
backgroundPEDS-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.
methodsEleven 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.
conclusionsIn 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.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.