Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 5:02 AM
Ignite Modification Date:
2025-12-25 @ 5:02 AM
NCT ID:
NCT00241618
Eligibility 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT00241618
Study Brief:
Protocol Section:
NCT00241618