NCT00575627

Pegylated-Interferon and Ribavirin in Hepatitis C Patients With Persistently Normal Alanine Aminotransferase Levels

Treatment of Chronic Hepatitis C Patients With Persistently Normal Alanine Aminotransferase Levels With Peginterferon α-2a (40 kDa) Plus Ribavirin

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: University of Turin, Italy · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Patients with chronic hepatitis C with persistently normal alanine aminotransferase (ALT) levels have been generally excluded from treatment, because the strong conviction that normal ALT would be synonymous of absence of liver damage. However, recent studies have demonstrated marked liver fibrosis, including cirrhosis, in patients with HCV and persistently normal ALT levels. Up to now, just a sigle randomized, controlled, multicenter study was lead to evaluate the efficacy and safety of combined therapy in patients with chronic hepatitis C and persistently normal serum ALT levels. Aim of our study is evaluate the efficacy of treatment and the outcome of treated patients compared with a control group of untreated patients.

Conditions

• Chronic Hepatitis C

Interventions

Type	Name	Description
DRUG	Peg-Interferon alpha2a plus Ribavirin	Peg-Interferon alpha2a: 180 micrograms per week Ribavirin:100-1200 mg/daily

Timeline

• Start date: 2007-09-01
• Primary completion: 2009-09-01
• Completion: 2010-09-01
• First posted: 2007-12-18
• Last updated: 2008-06-04

Locations

1 site across 1 country: Italy