Protocol Number: 03-DK-0136
Patients 18 years of age and older with chronic hepatitis C genotype 2 or 3 may be eligible for this study. Each candidate will be screened with a medical history, physical examination, blood tests, and liver ultrasound. Patients who have not had a chest x-ray or electrocardiogram within a year of entering the study will have those tests as well. Additional tests, such as eye examination, hearing test, stress test, or others, will be done if deemed necessary because of the individual's particular medical condition or risk factors for side effects of therapy. Participants will be admitted to the NIH Clinical Center for 1 day for supervised administration of the first doses of peginterferon and ribavirin and 24-hour observation. The treatment regimen consists of two capsules of ribavirin twice a day every day and an injection of peginterferon under the skin once a week. Patients will return to the clinic at 2, 4, 8, 12, 16, 20 and 24 weeks after the first dose of therapy for a brief medical history and physical examination, blood test, and check on hepatitis symptoms and treatment side effects. Women capable of becoming pregnant will also have a pregnancy test at each visit. Patients will be tested for HCV levels after 12 weeks of therapy. Those who are negative for the virus at that time will continue therapy for another 12 weeks to insure that the response lasts. They will be monitored during that time and re-tested for the virus at the end of that period. Patients who do not respond to treatment after 12 weeks will stop low-dose therapy and be offered the higher-dose standard treatment for 48 weeks. Patients who responded after 12 weeks and completed 24 weeks of therapy but subsequently became positive after stopping treatment will also be offered standard high-dose treatment for the full 48-week regimen. Patients on high-dose therapy will return to the clinic every 4 weeks during the 48-week course for evaluation and blood tests. Patients who remain positive for HCV after 24 weeks of high-dose therapy will stop treatment, as a response is unlikely to occur beyond that time. After treatment, patients will return to the clinic at 4- to 8-week intervals for evaluations until 6 months. At 6 months, they will have a series of blood and urine tests and ultrasound of the liver.
Search The Studies | Help | Questions |
Warren Grant Magnuson Clinical Center (CC) |
||