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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
Group Labels: 1

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
Group Labels: 2

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
Group Labels: 2

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: