Pharmacogenomics Study on IL28B Genetic Variants in Chinese Children With Hepatitis C Virus Infection

Beijing 302 Hospital

Status: Unknown

Conditions: Chronic Hepatitis C

Study type: Observational

Funder types: Other

Identifiers

NCT01607021

beijing302-004

Details and patient eligibility

About

The aim of this study is to investigate the relationships between interleukin 28B genetic variants and the response to treatment of chronic hepatitis C in Chinese children.

Full description

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 1 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Aged 1-18 years
• Patients with chronic HCV infection

Exclusion criteria

• HCV infected patients previously treated with antiviral drugs
• Co-infected Patients with HIV or Hepatitis B virus (HBsAg positive)
• hepatocellular carcinoma or other malignancies
• anticipated with difficulty of follow-up observation

Trial design

200 participants in 1 patient group

Chinese children with HCV RNA positive

Description:

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