Treatment of acute hepatitis C infection: immediate therapy of all patients with peg-interferon alpha-2b alone versus delayed therapy of patients not eliminating hepatitis C virus (HCV) spontaneously with peg-interferon alpha-2b plus ribaviri

Completed

Conditions: Acute hepatitis C
Infections and Infestations
Hepatitis

Registration Number: ISRCTN88729946

Lead Sponsor: Hannover Medical School (Medizinische Hochschule Hannover) (Germany)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 135

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

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
HCV virological response (HCV RNA negative) 84 weeks after randomisation or 24 weeks after the end of treatment

Secondary Outcome Measures

Name	Time	Method
1. Biochemical response (alanine aminotransferase [ALT] and aspartate aminotransferase [AST] levels)<br>2. Severity and frequency of adverse events<br>3. Rate of spontaneous clearance of HCV<br>4. Quality of life during acute HCV infection and during treatment<br>5. Evaluation of HCV-specific CD4+ and CD8+ T cell responses and humoral immune responses