This trial is active, not recruiting.

Condition hepatitis
Treatment interferon alfa-2b, ribavirin
Sponsor First Hospital of Jilin University
Collaborator Chinese Academy of Sciences
Start date May 2010
End date December 2011
Trial size 40 participants
Trial identifier NCT01434212, 2008ZX10002-014-jida01, 2008ZX10004-002-jida01, 2009ZX10004-105-jida01


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
All the patients followed the standard treatment protocol.
interferon alfa-2b, ribavirin Generic: Recombinant Human Interferon alpha-2b,Ribavirin
Interferon:dosage,5 million units/person;frequency,every other day (qod);duration,48 weeks;Subcutaneous injection. Ribavirin: dosage,15mg/kg/day;frequency,three times a day (t.i.d);duration,48 weeks;take orally.

Primary Outcomes

Blood HCV RNA Copies
time frame: 0h,8h,10h,12h,18h,24h,37h,43h,3d,7d,2w,4w,6w,12w,24w,48w

Secondary Outcomes

IL-28B polymorphism
time frame: Baseline
Microarray Analysis of PBMC Gene Expression
time frame: Baseline,8h,18h,3d
HCV genotype
time frame: Baseline
Blood Anti-HCV,HBV Antibody
time frame: Baseline
HCV genome sequencing
time frame: 0h,8h,10h,12h,18h,24h,37h,43h,3d
Alanine Aminotransferase (ALT) and Aspartate transaminase (AST)
time frame: Baseline,4w,6w,12w,24w,48w
Fibrosis stage
time frame: Baseline,4w,12w,24w,48w
Regular blood test
time frame: Baseline,4w,12w,24w,48w
time frame: Baseline,4w,12w,24w,48w
Alcohol ,smoking condition
time frame: Baseline,4w,12w,24w,48w
Drug abuse history
time frame: Baseline

Eligibility Criteria

Male or female participants from 20 years up to 80 years old.

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

Additional Information

Official title Study of Parameters of Early Hepatitis C Virus Dynamics for Predicting the Outcome of Standard Interferon Therapy With Chinese Cohort
Principal investigator Bing Sun, PhD/MD
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 chronical infections. However, overall rate of sustained virological response (SVR) still do not exceed 60% even with ribavirin and peg-IFN. Due to several virus- and patient-related factors, treatment is even less successful in certain populations, especially in HCV genotype 1 infection. Thus the standard therapy duration is optimized according to the virus genotype in the clinical practice. Nowadays, two direct antiviral agents (DAAs) have been approved by Food and Drug Administration (FDA) of USA this year, which increases the SVR rate. However, high price, side effects and long duration render people to hesitate about the addition of the third drug in the traditional prescription. Predicting the outcome of traditional therapy is the cornerstone of the personalized therapy for HCV infected patients. In order to obtain an accurate prediction, different methods have been tried. Several indicators have been suggested to predict the final treatment outcomes. Rapid Virus Response (RVR), which indicates the non-detectable virus at the forth week since therapy starts, has been used to predict the final treatment outcome.Other indicators, including virus genotype, host genotype of IL-28B, human race and interferon stimulated genes (ISG) expression have also been shown to relate to and be able to predict the treatment outcomes to some extent. Here the investigators propose that the HCV virus dynamics analysis will give a more precise prediction for the therapy outcome. The general idea is that blood HCV titration data is obtained continuously in the early treatment period (first 6 weeks) of the patients who have strictly followed the therapy method. These titration data will be used to draw virus dynamics curve and calculate the corresponding parameters individually. The parameter(s) that can distinguish patients who reach the therapy evaluation standard from those who failed to reach the evaluation standard will be selected out, and such parameter(s) may be used to predict the therapy outcome of a new patient in the early stage of his/her treatment.
Trial information was received from ClinicalTrials.gov and was last updated in October 2011.
Information provided to ClinicalTrials.gov by First Hospital of Jilin University.