Timing and Duration of Acute Hepatitis C Treatment

• Status: Completed
• Trial end date: 2006-01-01
• Target enrollment: 0
• Participant gender: All

Summary

Spontaneous resolution of acute hepatitis C infection cannot be predicted and the majority of cases persist and become chronic. This randomized trial assesses the efficacy and safety of peginterferon alfa-2b. The investigators hypothesize that therapy strategies could prevent the development of chronic hepatitis.

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

Details

• Lead Sponsor: Ain Shams University
• Collaborators: Alexander von Humboldt Association; Beth Israel Deaconess Medical Center; Fulbright; International Society for Infectious Diseases; National Institute of Allergy and Infectious Diseases (NIAID); TEMPUS; Tempus Labs; University Hospital Freiburg
• Treatments: Interferon alpha-2; Interferon-alpha; Interferons; Ribavirin

Criteria

Inclusion Criteria:

• Age: 18-50 years, with or without symptoms

• Diagnosis of acute hepatitis C: elevated serum alanine aminotransferase (ALT) > 10 times the upper limit of normal (ULN)

• Seroconversion from negative to positive anti-HCV antibody status (third-generation enzyme-linked immunosorbent assay)

• Conversion from negative to positive polymerase chain reaction (PCR) for HCV-RNA, ruling out other causes of hepatitis by history and appropriate serologic and virologic studies.

Exclusion Criteria:

• Decompensated liver disease

• Coinfection with human immunodeficiency virus (HIV) or Schistosoma mansoni

• Marked anemia (hemoglobin level ≤ 120 g/L in women and ≤ 130 g/L in men)

• Neutropenia (< 1,500/mm3)

• Thrombocytopenia (< 90,000/mm3)

• A creatinine concentration > 1.5 times ULN

• Serum alpha-fetoprotein > 25 ng/ml

• An organ transplant

• Neoplastic disease

• Severe cardiac or pulmonary disease

• Unstable thyroid dysfunction

• A psychiatric disorder

• Seizure disorder

• Severe retinopathy

• A current pregnancy or were breast feeding or unwillingness to practice contraception

• Therapy with immunomodulatory agents within the last 6 months

• Alcohol or drug dependence within 1 year of study entry.