Clinical trial NCT01607021: Pharmacogenomics Study on IL28B Genetic Variants in Chinese Children With Hepatitis C Virus Infection
Official title: Pharmacogenomics Study on IL28B Genetic Variants for Prediction of Drug Response in Chinese Children With HCV Infection.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Hepatitis C
Keywords: Chronic hepatitis C
interleukin 28
Children
Lead sponsor: Beijing 302 Hospital
Sponsor class: OTHER
First posted: 2012-05-28
Enrollment: 200
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 200 children with chronic HCV infection who were seen at beijing 302 hospital(Beijing China)between april 2012 and december 2012.

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing 302 Hospital
state: Beijing
Study officials:
affiliation: Beijing 302 Hospital
name: jin han, professor
role: PRINCIPAL_INVESTIGATOR
References: