Acute hepatitis C Infections and Infestations Hepatitis
Conditions
Interventions
Please note that as of 08/11/10 the end date of this trial has been extended from 31/12/10 to 31/12/11. Recruitment finished in 09/09/10
Administration of peg-interferon alpha-2b subcutaneously (sc)v
Sponsors
Hannover Medical School (Medizinische Hochschule Hannover) (Germany)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with acute HCV infection and detectable HCV RNA 2. More than 18 years 3. Compensated liver disease 4. Negative urine or blood pregnancy test 5. Willingness to give written informed consent
Exclusion criteria
Exclusion criteria: 1. Other possible reasons for acute HCV infection 2. Liver cirrhosis 3. Pregnancy or breast feeding 4. Previous antiviral therapy with interferon or ribavirin 5. Positive test results for anti hepatitis A virus (HAV) IgM antib., HBsAg, anti-HBc IgM antib., HBeAg, anti human immunodeficiency virus (HIV) 6. History or evidence for chronic liver disease 7. History of severe psychiatric disease, thyroid dysfunction poorly controlled 8. History or evidence for severe illness 9. Drug use within 6 mionths prior to first dose of study drug
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HCV virological response (HCV RNA negative) 84 weeks after randomisation or 24 weeks after the end of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Biochemical response (alanine aminotransferase [ALT] and aspartate aminotransferase [AST] levels) 2. Severity and frequency of adverse events 3. Rate of spontaneous clearance of HCV 4. Quality of life during acute HCV infection and during treatment 5. Evaluation of HCV-specific CD4+ and CD8+ T cell responses and humoral immune responses | — |
Countries
Germany
Outcome results
None listed