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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by Beijing 302 Hospital
Sponsor:
Information provided by (Responsible Party):
Beijing 302 Hospital
ClinicalTrials.gov Identifier:
NCT01607021
First received: May 24, 2012
Last updated: June 10, 2013
Last verified: June 2013
  Purpose

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.


Condition
Chronic Hepatitis C

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Pharmacogenomics Study on IL28B Genetic Variants for Prediction of Drug Response in Chinese Children With HCV Infection.

Resource links provided by NLM:


Further study details as provided by Beijing 302 Hospital:

Estimated Enrollment: 200
Study Start Date: April 2012
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
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


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

Ages Eligible for Study:   1 Year to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01607021

Contacts
Contact: rongrong wu +8610-63879589 ext 2015.12 wrr302@163.com

Locations
China, Beijing
Beijing 302 Hospital Recruiting
Beijing, Beijing, China, 100039
Contact: rongrong wu    +8610-63879589 ext 2015.12    wrr302@163.com   
Sponsors and Collaborators
Beijing 302 Hospital
Investigators
Principal Investigator: jin han, professor Beijing 302 Hospital
  More Information

No publications provided

Responsible Party: Beijing 302 Hospital
ClinicalTrials.gov Identifier: NCT01607021     History of Changes
Other Study ID Numbers: beijing302-004
Study First Received: May 24, 2012
Last Updated: June 10, 2013
Health Authority: China: Ministry of Health

Keywords provided by Beijing 302 Hospital:
Chronic hepatitis C
interleukin 28
Children

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections

ClinicalTrials.gov processed this record on September 16, 2014