Status:
TERMINATED
Double Filtration Plasmapheresis for Hepatitis C Virus (HCV) Genotype 1 Patients With High Viral Load
Lead Sponsor:
National Taiwan University Hospital
Collaborating Sponsors:
National Science and Technology Council, Taiwan
Department of Health, Executive Yuan, R.O.C. (Taiwan)
Conditions:
Hepatitis C
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Hepatitis C virus (HCV) infection, a leading cause of cirrhosis, hepatocellular carcinoma (HCC) and liver transplantation, affects approximately 170 million individuals worldwide. The prevention of HC...
Detailed Description
Hepatitis C virus (HCV) infection, a leading cause of cirrhosis, hepatocellular carcinoma (HCC) and liver transplantation, affects approximately 170 million individuals worldwide. The prevention of HC...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
59 Patients enrolled
Trial Details
Trial ID
NCT00977054
Start Date
September 1 2009
End Date
December 1 2012
Last Update
December 20 2012
Active Locations (6)
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1
Buddhist Tzu Chi General Hospital
Chiayi City, Taiwan
2
Chiayi Christian Hospital
Chiayi City, Taiwan
3
National Taiwan University Hospital, Yun-Lin Branch
Douliu, Taiwan
4
Far Eastern Memorial Hospital
Taipei, Taiwan