Hepatitis C
Conditions
Keywords
Clinical trial, Randomized, Treatment, Prospective, Parallel Assignment, Efficacy Safety Study
Brief 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.
Detailed description
With nearly 4 million people in the United States, and an estimated 170-200 million people worldwide, the hepatitis C virus (HCV) represents a clear and significant public health issue. Unfortunately, for most people infected with HCV (70%-85%) spontaneous resolution is uncommon and 60% to 80% of patients with acute hepatitis C infection develop chronic hepatitis. This randomized trial focuses on defining the effect of treatment of acute HCV on prevention of chronic hepatitis in addition to optimization of the treatment regimen, onset and the length of peginterferon alpha therapy in acute hepatitis C infections. This randomized, multi-center prospective study assesses the efficacy of peginterferon in acute hepatitis. We will also compare differences in sustained viral response rates in patients with acute hepatitis C starting treatment at 8, 12, or 24 weeks. We will also compare the efficacy of 8, 12 or 24 weeks therapy with PEG-IFN-alpha. All eligible patients are enrolled and screened for an initial observation period starting from the time of their first positive HCV-RNA-PCR, during which bi-weekly serum ALT and HCV-RNA subjects were performed. Patients who did not resolve spontaneously (loss of HCV-RNA without treatment) by the end of the observation period were randomly assigned to receive PEG-IFN-alpha at the assigned onset and/or duration. Patients who do not consent to therapy at enrollment are included as a non-randomized comparison group. All subjects with SVR were followed for 48 weeks after the follow-up at 24 weeks when SVR was determined.
Interventions
DRUGPegylated interferon alpha 2
DRUGRibavirin
Sponsors
University Hospital Freiburg
Beth Israel Deaconess Medical Center
Alexander von Humboldt Association
Fulbright
National Institute of Allergy and Infectious Diseases (NIAID)
Tempus AI
International Society for Infectious Diseases
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sustained viral response rate in treatment group versus control | — |
Secondary
| Measure | Time frame |
|---|---|
| End of treatment virologic response | — |
| Early virologic response at week 4 | — |
| Quality of life | — |
Countries
Egypt
Outcome results
None listed