SNPMiner Trials by Shray Alag


SNPMiner Trials: Clinical Trial Report


Report for Clinical Trial NCT00857675

Developed by Shray Alag, 2019.
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 Hepatitis A Hepatitis, Chronic Hepatitis B Hepatitis B, 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
KRT8 ALMS1 C4B KRT18 AIRE
Chronic hepatitis
Genes 11
KRT8 ALMS1 RFXANK C4B KRT18 CIITA AIRE IL21R RFX5 RFXAP CD40LG
Hepatitis
Genes 74
TTC7A MST1 TRAF3IP2 TPP2 TBX19 IL12A MET IL12RB1 RASGRP1 TCF4 HSD3B7 KRT8 SERPINA1 TCF3 VIPAS39 ATP7A IGF2R MMEL1 ATP7B ALMS1 SPIB KRT18 VPS33B CIITA PDGFRL PIK3CA GPR35 CYP7A1 GUSB PIK3R1 AMACR RFXANK SHPK IGHM PIEZO1 SLC25A15 BTK IL21R CD40LG BLNK GLIS3 APC CLEC7A AIRE LRRC8A CASP8 POU2AF1 XIAP CASP10 C1S CYP7B1 PRKCD CD79A CD79B IRF5 C4B IL17RC IL17RA IGLL1 CTNNB1 FAS SKIV2L FASLG SH2D1A RFX5 IL17F RFXAP TNFSF15 TNPO3 PGM1 STAT1 TP53 AXIN1 FOXP3