Status:
UNKNOWN
Patterns of Early Hepatitis C Virus Decline Predict the Outcome of Interferon Therapy
Lead Sponsor:
The First Hospital of Jilin University
Collaborating Sponsors:
Chinese Academy of Sciences
Conditions:
Hepatitis
Eligibility:
All Genders
20-80 years
Brief Summary
The purpose of this study is to determine whether the outcome of interferon therapy on HCV infected patients can be early precisely predicted with a novel mathematic method with Chinese population.
Detailed Description
Hepatitis C virus (HCV) infection rate in China is about 3%, which means about 30 million patients. Combination therapy of ribavirin and interferons (IFN) is the standard clinical treatment of HCV chr...
Eligibility Criteria
Inclusion
- Serologic evidence of chronic hepatitis C infection by an anti-HCV antibody test
- Serum HCV-RNA \> 3 log IU/ml
- Has been infected by HCV for more than 6 months
- ALT,AST have been elevated continuously, inflammation and necrosis have been observed according to the histology diagnosis (G\>=2),modest liver fibrosis (S\>=2)
- For those patients whose ALT are normal,treatment accord to the liver biopsy. If obvious fibrosis has been detected (S2,S3),treatment should be done.For those S0,S1 stage patients, treatment could be delayed, but ALT/AST should be assayed every 3-6 months.
- Compensated liver disease
- Patients have never been treated with traditional interferon plus ribavirin or peginterferon plus ribavirin
Exclusion
- History:
- Has history of decompensated liver diseases
- Has been treated with other anti-virus drugs,or anti-tumor drugs,immuno-suppression drugs
- Has a history of autoimmune hepatitis
- History of a severe seizure disorder or current anticonvulsant use
- History or other evidence of a medical condition associated with chronic liver disease other than HCV which would make the patient, in the opinion of the investigator, unsuitable for the study (e.g., hemochromatosis, autoimmune hepatitis, metabolic liver disease, alcoholic liver disease, toxin exposures)
- Patients with documented or presumed coronary artery disease or cerebrovascular disease should not be enrolled if, in the judgment of the investigator, an acute decrease in hemoglobin by up to 4g/dL (as may be seen with ribavirin therapy) would not be well-tolerated
- History of thyroid disease poorly controlled on prescribed medications, elevated thyroid stimulating hormone (TSH) concentrations with elevation of antibodies to thyroid peroxidase and any clinical manifestations of thyroid disease
- Current condition:
- Pregnant women or women during the lactation period
- Co-infected with hepatitis b virus or human immunodeficiency virus
- Liver cancer or alpha-fetoprotein \> 100ng/ml
- Blood neutrophils count \< 1500/mm3, or platelets count \< 90000/mm3
- Female hemoglobin \<11.5g/dL, male hemoglobin \<12.5g/dL
- Blood creatinine \> 1.5 ULN
- Have severe mental diseases,especially depression
- Severe pulmonary dysfunction
- Severe cardiovascular disease
- Uncontrolled diabetes
- Uncontrolled thalassemia
- Evidence of alcohol abuse (alcohol consumption\>40 g/day)
- Unwillingness to provide informed consent or abide by the requirements of the study
- Local or System malignancy unstable status
Key Trial Info
Start Date :
May 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2011
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT01434212
Start Date
May 1 2010
End Date
December 1 2011
Last Update
October 28 2011
Active Locations (1)
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1
First Hospital Jilin University
Changchun, Jilin, China, 130061