- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT01607021
Pharmacogenomics Study on IL28B Genetic Variants in Chinese Children With Hepatitis C Virus Infection
Pharmacogenomics Study on IL28B Genetic Variants for Prediction of Drug Response in Chinese Children With HCV Infection.
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Anticipato)
Contatti e Sedi
Luoghi di studio
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Beijing
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Beijing, Beijing, Cina, 100039
- Reclutamento
- Beijing 302 Hospital
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Contatto:
- rongrong wu
- Numero di telefono: 2015.12 +8610-63879589
- Email: wrr302@163.com
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
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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 |
Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: jin han, professor, Beijing 302 Hospital
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Completamento primario (Anticipato)
Completamento dello studio (Anticipato)
Date di iscrizione allo studio
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Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Malattie dell'apparato digerente
- Infezioni da virus a RNA
- Malattie virali
- Infezioni
- Infezioni a trasmissione ematica
- Malattie trasmissibili
- Malattie del fegato
- Flaviviridae Infezioni
- Epatite, virale, umana
- Infezioni da enterovirus
- Infezioni da Picornaviridae
- Epatite
- Epatite A
- Epatite C
- Epatite cronica
- Epatite C, cronica
Altri numeri di identificazione dello studio
- beijing302-004
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .