S-Adenosyl Methionine (SAMe) to Treat Patients With Chronic Hepatitis C
Status:
Completed
Trial end date:
2011-05-01
Target enrollment:
Participant gender:
Summary
This study will examine the effectiveness of S-adenosyl methionine (SAMe) in combination with
peginterferon and ribavirin for treating hepatitis C virus. One out of three patients with
hepatitis C develops cirrhosis of the liver, which can lead to liver failure or liver cancer.
SAMe is a nutritional supplement that is made naturally in all cells of the body and acts to
improve how the body handles stress. In laboratory experiments with liver cells, SAMe
decreases the injury caused by liver toxins and improves the ability of interferon to block
hepatitis C virus.
Patients 18 years of age and older with hepatitis C infection who did not respond
successfully to prior treatment with interferon and ribavirin or peginterferon and ribavirin
may be eligible for this study.
Participants receive the following treatment:
- Peginterferon (given by injection) and ribavirin (taken by mouth) for 2 weeks
- Washout period (no medications) for 4 weeks
- SAMe (taken by mouth) for 2 weeks
- Peginterferon, ribavirin and SAMe for 12-48 weeks, depending on patient response to
treatment.
Participants have a thorough physical evaluation before beginning treatment and again at the
study's end. After starting treatment, patients return for clinic visits and blood tests
weekly for the first several weeks, then less frequently (at 2-week, then 4-week and 8-week
intervals until up to 72 weeks) to monitor symptoms, drug side effects, hepatitis C virus
levels, liver enzyme levels and immune responses to hepatitis C.
...
Phase:
Phase 2
Details
Lead Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)