Chronic Hepatitis CNCT01607021
Pharmacogenomics Study on IL28B Genetic Variants in Chinese Children With Hepatitis C Virus Infection
An observational study of Chronic Hepatitis C, run by Beijing 302 Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Chronic Hepatitis C
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- Apr 2012to Dec 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: 200 children with chronic HCV infection who were seen at beijing 302 hospital(Beijing China)between april 2012 and december 2012.
Who may be able to join
- Aged 1-18 years
- Patients with chronic HCV infection
Who cannot join
- 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 locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing 302 Hospital
Beijing, Beijing Municipality, 100039
rongrong wu, +8610-63879589 ext. 2015.12, wrr302@163.com
About this study
Official title: Pharmacogenomics Study on IL28B Genetic Variants for Prediction of Drug Response in Chinese Children With HCV Infection.
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.
Read the 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.
- Conditions
- Chronic Hepatitis C
- Keywords
- Chronic hepatitis C, interleukin 28, Children
- Medical subject headings
- Hepatitis C, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2012 (estimated)
- Study startApr 2012
- Primary completionDec 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hepatitis CStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing 302 Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- jin han, professor, Principal investigator, Beijing 302 Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01607021
- Sponsor's protocol ID
- beijing302-004
- Status last verified
- Aug 2015
- First submitted
- 24 May 2012
- Last updated
- 17 Aug 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacogenomics Study on IL28B Genetic Variants for Prediction of Drug Response in Chinese Children With HCV Infection.
- ClinicalTrials.gov ID
- NCT01607021
- Acronym / sponsor ID
- beijing302-004
- Conditions
- Chronic Hepatitis C
- Keywords
- Chronic hepatitis C, interleukin 28, Children
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Beijing 302 HospitalUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 28 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- 200 children with chronic HCV infection who were seen at beijing 302 hospital(Beijing China)between april 2012 and december 2012.
Key inclusion criteria (2 listed)
- Aged 1-18 years
- Patients with chronic HCV infection
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
jin han, professor principal investigator
Beijing 302 Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Hepatitis C, run by Beijing 302 Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact rongrong wu (+8610-63879589 ext. 2015.12, wrr302@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2015.