Individualized Duration of Peg-interferon/Ribavirin Treatment of Hepatitis C

• Status: Completed
• Trial end date: 2011-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to investigate if the duration of treatment of hepatitis C with pegylated interferon and ribavirin can be individualized on the basis of how fast the hepatitis C virus concentration in the blood decreases, and if this is more cost-efficient than standard treatment.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Göteborg University
• Collaborators: Karolinska University Hospital; Lund University Hospital; Sahlgrenska University Hospital, Sweden; Skane University Hospital; Skaraborg Hospital; Sodra Alvsborgs Hospital; Uddevalla Hospital
• Treatments: Interferon alpha-2; Interferon-alpha; Interferons; Peginterferon alfa-2a; Ribavirin

Criteria

Inclusion Criteria:

• Anti-HCV positive for > 6 months

• Genotype 1

• Clinical indication for treatment, preferably a liver biopsy showing significant inflammation and/or fibrosis

• Negative pregnancy test (for fertile women)

Exclusion Criteria:

• Pregnancy or breast-feeding

• Antiviral or immune modulating treatment the last 6 months

• Hepatitis B or HIV infection (HBsAg, anti-HIV)

• Other significant chronic liver disease

• History of bleeding esophageal varices or other signs of decompensation

• Neutrophiles < 1.0 x 109/L or platelets < 50 x 109/L. S-creatinine > 2 x ULN

• History of severe psychiatric disorder

• Autoimmune disease, severe heart disease, previous organ or stem cell transplantation, malignancy, thyroid disease, severe retinopathy

• Drug abuse, current or during the last year