| A clinical trial for 112 children (ages 2-17) infected with hepatitis C begins in December 2004 at 11 medical centers across the United States.
The randomized clinical trial, which will treat and then monitor children for five years, compares two drug treatments. One group will be treated with only pegylated interferon, and the second group will be treated with a combination of pegylated interferon and ribavirin.
Currently, adults with hepatitis C are treated with both the antiviral ribavirin and pegylated interferon, which requires one injection of the immune system-enhancing drug each week.
This trial will compare the effectiveness of treating a child with just pegylated interferon, against the combination of pegylated interferon and ribavirin. In a recent pediatric clinical trial that used only pegylated interferon in 16 children infected with HCV, 43 percent of the children cleared their infection.
To participate in this trial, children must test positive for HCV-RNA. They do not need to have elevated ALT (liver enzymes.) Each participant must have had a liver biopsy within the last two years. They must not have cirrhosis or any other significant medical problem, nor should they suffer from depression, because interferon can exacerbate depression.
The trial is funded by a cooperative grant from the National Institute of Diabetes & Digestive & Kidney Diseases with co-funding from the U.S. Food and Drug Administration and Roche, the pharmaceutical company that makes the pegylated interferon drug Pegasys.
Screening of potential participants begins in December. The participating doctors and medical centers are listed below:
- Kathleen B. Schwarz, M.D., Johns Hopkins University School of Medicine, Baltimore. Dr. Schwarz is the lead doctor in the trial. Phone 410-955-8769.
- Zachary D. Goodman, M.D., Armed Forces Institute of Pathology, Washington D.C.
- William Balistreri, M.D., Children’s Hospital Medical Center, Cincinnati, Ohio
- Regino P. Gonzalez-Peralta, M.D. Shands Children’s Hospital, University of Florida, Jacksonville, Florida
- Barbara Haber, M.D., Children’s Hospital of Philadelphia, Penn.
- Maureen Jonas, M.D., Children’s Hospital Boston, Mass.
- Parvathi Mohan, M.D., George Washington University, Washington D.C.
- Jean P. Molleston, M.D., Indiana University Medical School, Indianapolis, Ind.
- Karen F. Murray, M.D., Children’s Hospital and Regional Medical Center, Seattle, Wash.
- Michael R. Narkewicz, M.D., The Children’s Hospital Denver, Denver, Colorado
- James Rodrigue, Ph.D., University of Florida, Jacksonville, Florida
- Philip Rosenthal, M.D., University of California, San Francisco
- John Shepherd, M.D., University of California, San Francisco
- Lesley J. Smith, M.D., and William Treem, M.D., Columbia University, New York City
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