Patterns of Early Hepatitis C Virus Decline Predict the Outcome of Interferon Therapy (sIFN-pred2)

• Status: Unknown status
• Trial end date: 2014-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to validate the first round HCV early dynamics discovery within a larger population.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Junqi Niu
• Collaborator: Chinese Academy of Sciences
• Treatments: Interferon alpha-2; Interferon-alpha; Interferons; Ribavirin

Criteria

Inclusion Criteria:

• 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 Criteria:

-

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