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Report for Clinical Trial NCT01434212

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

Study of Parameters of Early Hepatitis C Virus Dynamics for Predicting the Outcome of Standard Interferon Therapy With Chinese Cohort

The purpose of this study is to determine whether the outcome of interferon therapy on HCV infected patients can be early precisely predicted with a novel mathematic method with Chinese population.

NCT01434212 Hepatitis
MeSH: Hepatitis A Hepatitis C Hepatitis
HPO: Hepatitis

1 Interventions

Name: Interferon Alfa-2b, Ribavirin

Description: Interferon:dosage,5 million units/person;frequency,every other day (qod);duration,48 weeks;Subcutaneous injection. Ribavirin: dosage,15mg/kg/day;frequency,three times a day (t.i.d);duration,48 weeks;take orally.

Type: Drug

Interferon and ribavirin


Primary Outcomes

Description: Blood HCV RNA copies were assayed with Roche - COBAS® AmpliPrep/COBAS® TaqMan® HCV Test.

Measure: Blood HCV RNA Copies

Time: 0h,8h,10h,12h,18h,24h,37h,43h,3d,7d,2w,4w,6w,12w,24w,48w

Secondary Outcomes

Description: IL28 gene polymorphism,rs8099917,rs12979860,etc

Measure: IL-28B polymorphism

Time: Baseline

Description: During the first 3 days, blood samples are collected for PBMC separation and microarray analysis.

Measure: Microarray Analysis of PBMC Gene Expression

Time: Baseline,8h,18h,3d

Description: HCV NS5A is cloned into T vector and sequenced for evolutionary analysis.

Measure: HCV genotype

Time: Baseline

Description: Co-infection status are analyzed.

Measure: Blood Anti-HCV,HBV Antibody

Time: Baseline

Description: Deep sequencing is used for blood serum HCV genome analysis.

Measure: HCV genome sequencing

Time: 0h,8h,10h,12h,18h,24h,37h,43h,3d

Description: ALT AST are assayed to detect the hepatic function.

Measure: Alanine Aminotransferase (ALT) and Aspartate transaminase (AST)

Time: Baseline,4w,6w,12w,24w,48w

Description: Fibrosis is analyzed with Fibroscan.

Measure: Fibrosis stage

Time: Baseline,4w,12w,24w,48w

Description: The distribution and absolute count of the different types of blood cells are assayed.

Measure: Regular blood test

Time: Baseline,4w,12w,24w,48w

Description: Electrocardiography is taken to avoid severe side effects.

Measure: Electrocardiography

Time: Baseline,4w,12w,24w,48w

Description: Patients are asked whether they take alcohol or smoke cigarettes during the therapy period.

Measure: Alcohol ,smoking condition

Time: Baseline,4w,12w,24w,48w

Description: Patients will be asked about their drug usage history.

Measure: Drug abuse history

Time: Baseline

Time Perspective: Prospective

Cohort


There are 2 SNPs

SNPs


1 rs12979860

IL28 gene polymorphism,rs8099917,rs12979860,etc.


2 rs8099917

IL28 gene polymorphism,rs8099917,rs12979860,etc.



HPO Nodes


HPO:
Hepatitis
Genes 90
CD247 CTNNB1 ATP7B CASP10 PIEZO1 GUSB BLNK SHPK CYP7A1 IL17RA IGF2R CASP8 SH2D1A SLC25A15 BTK BTK C4B CD79B VPS33B XIAP SERPINA1 PIK3R1 GLIS3 POU2AF1 CIITA FOXP3 TPP2 RFX5 CIITA RASGRP1 RFXANK SLC25A15 AXIN1 TCF4 CD3D TP53 IL12A PRKCD CD40LG BTK IGHM IL17RC ALMS1 TRAF3IP2 KRT8 FAS LRRC8A FAS IL17F XIAP SPIB C1S RFX5 RFXAP MST1 TTC7A COG8 SKIV2L VIPAS39 IGLL1 PDGFRL TNFSF15 HSD3B7 CD3E AMACR ATP7B FASLG RFXANK IL12RB1 TCF3 CD79A KRT18 IRF5 MET PIK3CA MMEL1 ITCH TBX19 IL21R AIRE RFXAP TTC7A CLEC7A GPR35 ATP7A CYP7B1 STAT1 PGM1 APC TNPO3