Pharmacogenomics Study on IL28B Genetic Variants in Chinese Children With Hepatitis C Virus Infection
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01607021|
Recruitment Status : Unknown
Verified August 2015 by Beijing 302 Hospital.
Recruitment status was: Recruiting
First Posted : May 28, 2012
Last Update Posted : August 17, 2015
|Condition or disease|
|Chronic Hepatitis C|
Hepatitis C affects thousands of children throughout the world. Most children acquire the virus through vertical transmission, although parenteral routes of acquisition are also common. Affected children are usually asymptomatic and histological findings are mild with a low risk of progression, about 5% develop significant liver disease in childhood.
The use of combination treatment with interferon-alpha and ribavirin were recommended in the treatment of chronic hepatitis C in children, SVR in children with genotype 1 ranged from 44% to 59%. SVR in children with genotype 2 and 3 was more than 90%. But both interferon and ribavirin have significant side effects which affect compliance, such as: repeated flu like symptoms, leukopenia and anemia, moderate weight loss, behavioural problems, thyroid dysfunction and transient deceleration of the growth rate. In addition, approximately 50% of children infected with genotype 1 do not respond to therapy.
Recent work has highlighted that single nucleotide polymorphisms (SNPs) around the IL28B gene have been identified as strong predictors of spontaneous and treatment-induced HCV clearance in adults, especially Rs 12979860 and Rs 8099917. A recent article in Hepatology also reported that interleukin (IL)-28B C/C genotype in the child was associated with spontaneous clearance of hepatitis C virus (HCV) genotype 1 infection. All this reports show that Genetic Variation in Interleukin-28B Locus is associated with the procession of CHC.
The aim of this study was to study the association between genetic variation in IL-28B and the development of CHC in Chinese children, such as: HCV viral load, serum alanine aminotransferase, histological change and the response to the treatment with interferon-alpha and ribavirin.
|Study Type :||Observational|
|Estimated Enrollment :||200 participants|
|Official Title:||Pharmacogenomics Study on IL28B Genetic Variants for Prediction of Drug Response in Chinese Children With HCV Infection.|
|Study Start Date :||April 2012|
|Estimated Primary Completion Date :||December 2015|
|Estimated Study Completion Date :||December 2015|
Chinese children with HCV RNA positive
A sample of 200 children with a recent confirmation of anti-HCV-antibody positive and HCV RNA positive. All the children were treated with antiviral therapy, and the course of treatment depend on HCV Viral genotyping(ie, genotype 1,2,3,4 subtypes).
Primary Outcome Measures:
Virologic response [ Time Frame: Weeks 2, 4, 6, 8, 10, and 12 ] Sustained virologic response (SVR, defined as plasma HCV RNA < lower limit of quantification [LLoQ] at 24 weeks after treatment cessation) following antiviral treatment.
Secondary Outcome Measures: Safety and tolerability of therapy. [ Time Frame: Up to 48 weeks ] measured by frequency of laboratory abnormalities , reported adverse events and discontinuations due to adverse events
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01607021
|Contact: rongrong wu||+8610-63879589 ext email@example.com|
|Beijing 302 Hospital||Recruiting|
|Beijing, Beijing, China, 100039|
|Contact: rongrong wu +8610-63879589 ext 2015.12 firstname.lastname@example.org|
|Principal Investigator:||jin han, professor||Beijing 302 Hospital|