Hepatitis C antiviral long-term treatment against cirrhosis (Halt-C)
Timothy Morgan, MD
General Clinical Research Center at UC Irvine Medical Center in Orange and VA Medical Center, 5901 E. 7th Street - 111G, Bldg. 122, Ward C-2, Long Beach, CA 90822
This study is designed to determine whether long-term pegylated-interferon treatment will reduce progression of liver disease to cirrhosis, prevent progression to liver cancer and reduce the need for liver transplantation.
Men and women, 18 years and older, who have been treated with either interferon or interferon and ribavirin for at least 3 months and have failed to respond to treatment. Volunteers must have significant scarring of the liver as demonstrated by a liver biopsy, have no other liver diseases or other unstable medical diseases or conditions and have and have not recently abused alcohol or illicit drugs.
During this 4 year study, the following tests will be performed to monitor the progression of chronic hepatitis C and the liver disease it may cause:
- A physical examination and blood tests every 1-3 months
- A liver biopsy at the start of the study, if not recently performed, and then at 2 and 4 years
Additional procedures that will be performed if not completed recently include:
- An ultrasound to monitor for liver cancer at screening
- An endoscopy (upper GI) to assess the risk of internal bleeding at Week 24
No guarantees can be provided that any subject will benefit by participating in this study. Many patients treated with interferon with or without ribavirin fail to respond. They remain infected with the Hepatitis virus and this virus continues to cause liver damage. However, recent studies suggest that continuing interferon long-term in patients who remain infected with HCV may prevent progressive liver damage.
Trial medication, physician visits, viral testing, and research required procedures are provided at no cost to candidates accepted to participate in this study.
Julia Rich, VA Medical Center