NCT00857675

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
480

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Dec 2002

Longer than P75 for phase_3

Geographic Reach
1 country

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2002

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

March 5, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 9, 2009

Completed
Last Updated

April 3, 2009

Status Verified

April 1, 2009

Enrollment Period

5.3 years

First QC Date

March 5, 2009

Last Update Submit

April 2, 2009

Conditions

Chronic Hepatitis B

Keywords

HBV DNA suppressionALT normalisationViral resistanceHBeAg seroconversion

Outcome Measures

Primary Outcomes (1)

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

    Week 12

Secondary Outcomes (7)

  • The proportion of subjects with ALT normalisation

    Week 52, 104, 156, 208, 260

  • log10 reduction in serum HBV DNA

    Week 52, 104, 156, 208, 260

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

    Week 52, 104, 156, 208, 260

  • The proportion of subjects with HBeAg loss

    Week 52, 104, 156, 208, 260

  • The proportion of subjects with HBeAg seroconversion

    Week 52, 104, 156, 208, 260

  • +2 more secondary outcomes

Study Arms (2)

Adefovir Dipivoxil

EXPERIMENTAL

ADV 10mg tablets once daily

Drug: AAAADrug: AAPADrug: PAAA

Adefovir Dipivoxil matched placebo

PLACEBO COMPARATOR

Adefovir Dipivoxil matched placebo one tablet once daily

Drug: AAPADrug: PAAA

Interventions

AAAADRUG

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

Adefovir Dipivoxil
AAPADRUG

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

Adefovir DipivoxilAdefovir Dipivoxil matched placebo
PAAADRUG

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

Adefovir DipivoxilAdefovir Dipivoxil matched placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

GSK Investigational Site

Guangzhou, Guangdong, 510515, China

Location

GSK Investigational Site

Guangzhou, Guangdong, 510630, China

Location

GSK Investigational Site

Changchun, Jilin, 130021, China

Location

GSK Investigational Site

Jinan, Shandong, China

Location

GSK Investigational Site

Hangzhou, Zhejiang, 310003, China

Location

GSK Investigational Site

Beijing, 100011, China

Location

GSK Investigational Site

Beijing, 100044, China

Location

GSK Investigational Site

Chongqing, 400038, China

Location

GSK Investigational Site

Chongquin, 400038, China

Location

GSK Investigational Site

Shanghai, 200040, China

Location

MeSH Terms

Conditions

Hepatitis B, Chronic

Condition Hierarchy (Ancestors)

Hepatitis BBlood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitis, ChronicHepatitisLiver DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 5, 2009

First Posted

March 9, 2009

Study Start

December 1, 2002

Primary Completion

March 1, 2008

Study Completion

March 1, 2008

Last Updated

April 3, 2009

Record last verified: 2009-04

Locations

CN(10)