Status:
UNKNOWN
Micro RNA-122 and the Clinical Course of Patients With Chronic Hepatitis C
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
Brief Summary
Combination therapy with peginterferon plus ribavirin has become the current standard of care for chronic hepatitis C (CHC) patients, with an overall sustained virologic response (SVR) rate of 54-63%....
Detailed Description
Hepatitis C virus (HCV) infection, a leading cause of cirrhosis, hepatocellular carcinoma (HCC) and liver transplantation, affects approximately 170 million individuals worldwide. In Asian-Pacific reg...
Eligibility Criteria
Inclusion
- Treatment naïve
- Age 18 and older than 18 years old
- 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)
- Serum alanine aminotransferase levels above the upper limit of normal with 6 months of enrollment
- A liver biopsy consistent with the diagnosis of chronic hepatitis C
- Receive 24 or 48 weeks of PEG-IFN alfa plus ribavirin (1,000 mg/day for BW \< 75 kg; 1,200 mg/day for BW ≥ 75 kg for HCV genotype 1; 800 mg/day for HCV genotype 2)
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)
- Mixed HCV genotype 1 with other genotype infection
- 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
- Without definite viral information during the study period (sustained viral responders or viral relapsers)
Key Trial Info
Start Date :
September 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2010
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT00980161
Start Date
September 1 2009
End Date
December 1 2010
Last Update
March 26 2010
Active Locations (5)
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1
National Taiwan University Hospital, Yun-Lin Branch
Douliu, Taiwan
2
Kinmen Hospital
Kimmen, Taiwan
3
National Taiwan University Hospital
Taipei, Taiwan, 10002
4
Far Eastern Memorial Hospital
Taipei, Taiwan