High-Dose Ribavirin and Peginterferon to Treat Chronic Hepatitis C Genotype 1
Status:
Completed
Trial end date:
2013-06-01
Target enrollment:
Participant gender:
Summary
This study will evaluate the effectiveness of an experimental treatment regimen for hepatitis
C (HCV). Standard treatment consists of combination therapy with ribavirin, taken by mouth
twice a day, and Peginterferon, injected under the skin once a week. Hepatitis C genotypes 2
and 3 have a high success rate with this regimen, while genotype 1 is more difficult to
treat. This study will determine if patients with genotype 1 respond better to treatment that
uses a higher dose of ribavirin than the standard approved dose of 1,000 to 1,200 mg daily.
Patients 18 years of age and older with chronic hepatitis C genotype 1 who have not been
successfully treated with a standard course of Peginterferon and ribavirin may be eligible
for this study. Participants eligible will receive Peginterferon plus twice the standard dose
of ribavirin (2,000 to 2,400 mg daily) for 48 weeks. In addition to treatment, all patients
receive undergo the following:
Before Treatment:
- Medical history and physical examination, symptom questionnaires, blood tests, urine
collection, chest x-ray, electrocardiogram, liver ultrasound, Fibroscan (ultrasound to
measure stiffness of the liver) and pregnancy test for women who are able to have
children.
- Patients with other medical conditions or special risk factors may have further
evaluations before starting treatment. These may include, for example, eye evaluation
for patients with diabetes, exercise stress test for people over age 40 or who have risk
factors for heart disease and psychiatric evaluation for people who have depression or
anxiety disorder.
During Treatment
- Periodic blood tests to monitor blood counts and viral levels.
- Outpatient clinic visits every 4 weeks for the duration of the study for laboratory
tests and review of symptoms and treatment side effects. Physical examinations and urine
tests are done every 12 weeks.
Following Completion of Treatment
About 1 1/2 years after starting treatment, subjects are re-evaluated as they were at the
start of treatment.
...
Phase:
Phase 2
Details
Lead Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)