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Report for Clinical Trial NCT00857675

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

A Multi-Centre, Double-Blind , Randomized, Placebo-Controlled Phase II/III Study of Adefovir Dipivoxil for the Treatment of Chinese Patients With HBeAg Positive Chronic Hepatitis B Followed by Long-Term (5 Years Total) Adefovir Dipivoxil Treatment. (Report on Year 1 and Year 2 Data)

The purpose of this study is to determine whether Adefovir Dipivoxil is effective and safe in treatment of Chinese Patients with HBeAg positive Chronic Hepatitis B for 5 years.

NCT00857675 Chronic Hepatitis B
MeSH: Hepatitis A Hepatitis B Hepatitis B, Chronic Hepatitis Hepatitis, Chronic
HPO: Chronic active hepatitis Chronic hepatitis Hepatitis

3 Interventions

Name: AAAA

Description: Adefovir Dipivoxil (12 weeks) + open lable Adefovir Dipivoxil (28 weeks) + Adefovir Dipivoxil (12 weeks) + Open label Adefovir Dipivoxil (52-260weeks)

Type: Drug

Adefovir Dipivoxil

Name: AAPA

Description: Adefovir Dipivoxil (12 weeks) + Open label Adefovir Dipivoxil (28 weeks) + placebo (12 weeks) + open label-Adefovir Dipivoxil (52-260 weeks)

Type: Drug

Adefovir Dipivoxil Adefovir Dipivoxil matched placebo

Name: PAAA

Description: Placebo (12 weeks) + Open label Adefovir Dipivoxil (28 weeks) + Adefovir Dipivoxil (12 weeks) + Open label Adefovir Dipivoxil (52-260 weeks)

Type: Drug

Adefovir Dipivoxil Adefovir Dipivoxil matched placebo


Primary Outcomes

Measure: The log10 reduction in HBV DNA from baseline at week 12 between ADV 10mg and matching placebo

Time: Week 12

Secondary Outcomes

Measure: The proportion of subjects with ALT normalisation

Time: Week 52, 104, 156, 208, 260

Measure: log10 reduction in serum HBV DNA

Time: Week 52, 104, 156, 208, 260

Measure: The proportion of subjects with HBV DNA 10(5) copies/mL or a 2 log10 reduction from Baseline HBV DNA level

Time: Week 52, 104, 156, 208, 260

Measure: The proportion of subjects with HBeAg loss

Time: Week 52, 104, 156, 208, 260

Measure: The proportion of subjects with HBeAg seroconversion

Time: Week 52, 104, 156, 208, 260

Measure: The proportion of subjects developing N236T and A181V HBV DNA genotypic mutations associated with ADV resistance

Time: Week 52, 104, 156, 208, 260

Measure: The proportion of subjects with HBV DNA undetectable (<300 copies/mL)

Time: Week 52, 104, 156, 208, 260

Purpose: Treatment

Allocation: Randomized

Parallel Assignment


There are 2 SNPs

SNPs


1 A181V

The proportion of subjects developing N236T and A181V HBV DNA genotypic mutations associated with ADV resistance. --- N236T --- --- A181V ---


2 N236T

The proportion of subjects developing N236T and A181V HBV DNA genotypic mutations associated with ADV resistance. --- N236T ---



HPO Nodes


HPO:
Chronic active hepatitis
Genes 5
ALMS1 KRT8 AIRE C4B KRT18
Chronic hepatitis
Genes 11
ALMS1 KRT8 IL21R AIRE RFXAP C4B RFXANK CD40LG KRT18 RFX5 CIITA
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