Conditions: Chronic Hepatitis c Cirrhosis, Liver Fibrosis, Liver Hepatic Cirrhosis
Keywords: liver disease hepatitis c virus antiviral agent cirrhosis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 1050
Healthy volunteers: no

Brief summary:
The HALT-C Trial is a National Institute of Diabetes and Digestive and Kidney Diseases sponsored, randomized clinical trial of long-term use of Peginterferon alfa-2a (pegylated interferon) in patients who failed to respond to prior interferon treatment. All patients who enter the trial will be treated for 6 months with Peginterferon alfa-2a and Ribavirin. Patients who respond to this 6 month treatment will continue to be treated for an additional 6 months.

Patients who do not respond to this treatment will be eligible for the long-term maintenance phase of this study where patients will be randomly selected to be treated with Peginterferon alfa-2a or to discontinue treatment for 3.5 years. Patients in both arms of this study will be followed closely with quarterly study visits.

The combination of peginterferon plus ribavirin has recently been approved by the FDA for treatment of chronic hepatitis C. Patients who remain HCV-RNA positive after being treated for at least 6 months with peginterferon and ribavirin outside of this study may be eligible to directly enter the randomized portion of the HALT-C Trial.

The HALT-C study is designed to determine if continuing interferon long-term over several years will suppress Hepatitis C virus, prevent progression to cirrhosis, prevent liver cancer and reduce the need for liver transplantation.

Detailed description:

Arms:
arm 1: Peg-interferon alfa-2a 90 mcg/week arm 2: Standard of care followup

Interventions: intervention 1: Peginterferon alfa-2a + Ribavirin intervention 2: Peginterferon alfa-2a
Intervention descriptions: intervention 1: Peginterferon alfa-2a 180 mcg/week injection, for 24 weeks, plus 1000-1200 mg Ribavirin oral (prescribed according to weight \<75 kg, \>75 kg) daily in two divided doses for 24 weeks intervention 2: 90 mcg/week injection, for 3.5 years

Protocol document: