Status:
COMPLETED
Timing and Duration of Acute Hepatitis C Treatment
Lead Sponsor:
Ain Shams University
Collaborating Sponsors:
University Hospital Freiburg
Beth Israel Deaconess Medical Center
Conditions:
Hepatitis C
Eligibility:
All Genders
18-50 years
Phase:
PHASE4
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 ...
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,...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2002
Trial Type :
INTERVENTIONAL
End Date :
January 1 2006
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT00241618
Start Date
January 1 2002
End Date
January 1 2006
Last Update
September 11 2006
Active Locations (3)
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1
ASU Specialized Hospital
Cairo, Cairo Governorate, Egypt, 11351
2
ASU
Cairo, Egypt, 03316
3
Shebin Liver Center
Cairo, Egypt, 11351