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A Efficacy and Safety Study of Adefovir Dipivoxil to Treat Chinese Patients With HBeAg+ve Chronic Hepatitis B

Primary Purpose

Chronic Hepatitis B

Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
AAAA
AAPA
PAAA
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Hepatitis B focused on measuring HBV DNA suppression, ALT normalisation, Viral resistance, HBeAg seroconversion

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Aged 18-65 years
  • Presence of HBsAg and HBeAg at the time of screening and for at least 6 months prior to screening.
  • Positive HBV DNA plasma assay with screening value equal or more than 10 (6) copies/mL (Roche COBAS AMPLICORTM HBV MONITOR Test, LLOD less than 300 copies/mL) at the time of screening (within 4 weeks of randomisation).
  • Evidence of elevated serum ALT levels defined as serum ALT level greater than or equal to 2.0 times (inclusive) the upper limit of the normal range (ULN) in the previous 6 months, and serum ALT levels greater than 1.0 times the ULN at the time of screening.

Exclusion Criteria:

  • Evidence of hepatocellular carcinoma;
  • Clinical signs of liver decompensation;
  • Serum creatinine more than 1.5 mg/dL;
  • ALT more than 10 x ULN; seropositivity for hepatitis C or D virus or HIV;
  • Lamivudine therapy within 3 months prior to screening;
  • ADV therapy or any other anti-HBV therapy within the previous 6 months;
  • Use of systemic antiviral agents, immunomodulators, immunosuppressive therapy, Chinese Traditional Medicines or agents known to lower ALT levels during the study.

Sites / Locations

  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Adefovir Dipivoxil

Adefovir Dipivoxil matched placebo

Arm Description

ADV 10mg tablets once daily

Adefovir Dipivoxil matched placebo one tablet once daily

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

The proportion of subjects with ALT normalisation
log10 reduction in serum HBV DNA
The proportion of subjects with HBV DNA 10(5) copies/mL or a 2 log10 reduction from Baseline HBV DNA level
The proportion of subjects with HBeAg loss
The proportion of subjects with HBeAg seroconversion
The proportion of subjects developing N236T and A181V HBV DNA genotypic mutations associated with ADV resistance
The proportion of subjects with HBV DNA undetectable (<300 copies/mL)

Full Information

First Posted
March 5, 2009
Last Updated
April 2, 2009
Sponsor
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT00857675
Brief Title
A Efficacy and Safety Study of Adefovir Dipivoxil to Treat Chinese Patients With HBeAg+ve Chronic Hepatitis B
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2009
Overall Recruitment Status
Completed
Study Start Date
December 2002 (undefined)
Primary Completion Date
March 2008 (Actual)
Study Completion Date
March 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
GlaxoSmithKline

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hepatitis B
Keywords
HBV DNA suppression, ALT normalisation, Viral resistance, HBeAg seroconversion

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
480 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Adefovir Dipivoxil
Arm Type
Experimental
Arm Description
ADV 10mg tablets once daily
Arm Title
Adefovir Dipivoxil matched placebo
Arm Type
Placebo Comparator
Arm Description
Adefovir Dipivoxil matched placebo one tablet once daily
Intervention Type
Drug
Intervention Name(s)
AAAA
Intervention Description
Adefovir Dipivoxil (12 weeks) + open lable Adefovir Dipivoxil (28 weeks) + Adefovir Dipivoxil (12 weeks) + Open label Adefovir Dipivoxil (52-260weeks)
Intervention Type
Drug
Intervention Name(s)
AAPA
Intervention Description
Adefovir Dipivoxil (12 weeks) + Open label Adefovir Dipivoxil (28 weeks) + placebo (12 weeks) + open label-Adefovir Dipivoxil (52-260 weeks)
Intervention Type
Drug
Intervention Name(s)
PAAA
Intervention Description
Placebo (12 weeks) + Open label Adefovir Dipivoxil (28 weeks) + Adefovir Dipivoxil (12 weeks) + Open label Adefovir Dipivoxil (52-260 weeks)
Primary Outcome Measure Information:
Title
The log10 reduction in HBV DNA from baseline at week 12 between ADV 10mg and matching placebo
Time Frame
Week 12
Secondary Outcome Measure Information:
Title
The proportion of subjects with ALT normalisation
Time Frame
Week 52, 104, 156, 208, 260
Title
log10 reduction in serum HBV DNA
Time Frame
Week 52, 104, 156, 208, 260
Title
The proportion of subjects with HBV DNA 10(5) copies/mL or a 2 log10 reduction from Baseline HBV DNA level
Time Frame
Week 52, 104, 156, 208, 260
Title
The proportion of subjects with HBeAg loss
Time Frame
Week 52, 104, 156, 208, 260
Title
The proportion of subjects with HBeAg seroconversion
Time Frame
Week 52, 104, 156, 208, 260
Title
The proportion of subjects developing N236T and A181V HBV DNA genotypic mutations associated with ADV resistance
Time Frame
Week 52, 104, 156, 208, 260
Title
The proportion of subjects with HBV DNA undetectable (<300 copies/mL)
Time Frame
Week 52, 104, 156, 208, 260

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Aged 18-65 years Presence of HBsAg and HBeAg at the time of screening and for at least 6 months prior to screening. Positive HBV DNA plasma assay with screening value equal or more than 10 (6) copies/mL (Roche COBAS AMPLICORTM HBV MONITOR Test, LLOD less than 300 copies/mL) at the time of screening (within 4 weeks of randomisation). Evidence of elevated serum ALT levels defined as serum ALT level greater than or equal to 2.0 times (inclusive) the upper limit of the normal range (ULN) in the previous 6 months, and serum ALT levels greater than 1.0 times the ULN at the time of screening. Exclusion Criteria: Evidence of hepatocellular carcinoma; Clinical signs of liver decompensation; Serum creatinine more than 1.5 mg/dL; ALT more than 10 x ULN; seropositivity for hepatitis C or D virus or HIV; Lamivudine therapy within 3 months prior to screening; ADV therapy or any other anti-HBV therapy within the previous 6 months; Use of systemic antiviral agents, immunomodulators, immunosuppressive therapy, Chinese Traditional Medicines or agents known to lower ALT levels during the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510515
Country
China
Facility Name
GSK Investigational Site
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510630
Country
China
Facility Name
GSK Investigational Site
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130021
Country
China
Facility Name
GSK Investigational Site
City
Jinan
State/Province
Shandong
Country
China
Facility Name
GSK Investigational Site
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310003
Country
China
Facility Name
GSK Investigational Site
City
Beijing
ZIP/Postal Code
100011
Country
China
Facility Name
GSK Investigational Site
City
Beijing
ZIP/Postal Code
100044
Country
China
Facility Name
GSK Investigational Site
City
Chongqing
ZIP/Postal Code
400038
Country
China
Facility Name
GSK Investigational Site
City
Chongquin
ZIP/Postal Code
400038
Country
China
Facility Name
GSK Investigational Site
City
Shanghai
ZIP/Postal Code
200040
Country
China

12. IPD Sharing Statement

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A Efficacy and Safety Study of Adefovir Dipivoxil to Treat Chinese Patients With HBeAg+ve Chronic Hepatitis B

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