Status:
COMPLETED
Individualized Duration of Peg-interferon/Ribavirin Treatment of Hepatitis C
Lead Sponsor:
Göteborg University
Collaborating Sponsors:
Sahlgrenska University Hospital
Sodra Alvsborgs Hospital
Conditions:
Chronic Hepatitis C, Genotype 1
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 conc...
Detailed Description
The current standard regimen for patients with chronic hepatitis C virus (HCV) infection, i.e., 48 weeks of pegylated interferon and ribavirin, needs to be further improved because of high costs and s...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2011
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00910975
Start Date
November 1 2007
End Date
September 1 2011
Last Update
September 5 2012
Active Locations (1)
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1
Sahlgrenska University Hospital
Gothenburg, Västra Götaland County, Sweden, 41346