Double Filtration Plasmapheresis for Hepatitis C Virus (HCV) Genotype 1 Patients With High Viral Load
Hepatitis C
About this trial
This is an interventional treatment trial for Hepatitis C focused on measuring Hepatitis C, Peginterferon alfa-2a, Ribavirin, Plasmapheresis, Genotype 1
Eligibility Criteria
Inclusion Criteria:
- Treatment naïve
- Age 18 and older
- Anti-HCV (Abbott HCV EIA 2.0, Abbott Diagnostic, Chicago, IL) positive > 6 months
- Detectable serum quantitative HCV-RNA (Cobas Taqman v2.0, Roche Diagnostics) with HCV RNA > 800,000 IU/mL
- HCV genotype 1 (Inno-LiPA, Innogenetics)
- A liver biopsy consistent with the diagnosis of chronic hepatitis C
Exclusion Criteria:
- Anemia (hemoglobin < 13 gram per deciliter for men and < 12 gram per deciliter for women)
- Neutropenia (neutrophil count <1,500 per cubic milliliter)
- Thrombocytopenia (platelet <90,000 per cubic milliliter)
- Co-infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
- Chronic alcohol abuse (daily consumption > 20 gram per day)
- Decompensated liver disease (Child-Pugh class B or C)
- Serum creatinine level more than 1.5 times the upper limit of normal
- Autoimmune liver disease
- Neoplastic disease
- An organ transplant
- Immunosuppressive therapy
- Poorly controlled autoimmune diseases, pulmonary diseases, cardiac diseases, psychiatric diseases, neurological diseases, diabetes mellitus
- Evidence of drug abuse
- Unwilling to have contraception
Sites / Locations
- Buddhist Tzu Chi General Hospital
- Chiayi Christian Hospital
- National Taiwan University Hospital, Yun-Lin Branch
- Far Eastern Memorial Hospital
- National Taiwan University Hospital
- Taipei Municipal Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
DFPP and Peg-IFN + RBV
Peg-IFN + RBV
Double filtration plasmapheresis (Day 1, Day 2, Day 4, Day 8, and Day 9 from the onset of treatment; overall 5 session, each session for 4 hours) and weekly subcutaneous peginterferon alfa-2a 180 ug (week 1 to week 48) and daily oral ribavirin 1,000-1,200 mg (week 1 to week 48; body weight < 75 kg, 1,000 mg/day and body weight >= 75 kg, 1,200 mg/day)
Weekly subcutaneous peginterferon alfa-2a 180 ug (week 1 to week 48) and daily oral ribavirin 1,000-1,200 mg (week 1-48; body weight < 75 kg, 1,000 mg/day and body weight >=75 kg, 1,200 mg/day)