Last updated: 11/04/2018 04:32:40

A efficacy and safety study of adefovir dipivoxil to treat Chinese patients with HBeAg+ve Chronic Hepatitis B

GSK study ID
ADF30001
See study documents
Clinicaltrials.gov ID
NCT00857675
See results summary
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

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)
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:

Change from Baseline to Week 12 in log10 reduction in hepatitis B virus deoxyribonucleic acid (HBV DNA)

Timeframe: Baseline (Week 0) and Week 12

Secondary outcomes:

Number of participants with alanine aminotransferase (ALT) normalization

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

Change from Baseline in log10 reduction in serum HBV DNA

Timeframe: Baseline (Week 0) and Weeks 52, 104, 156, 208 and 260

Number of participants with HBV DNA 10^5 copies per mL or a 2 log10 reduction from Baseline HBV DNA level

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

Number of participants with HBeAg loss

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

Number of participants with HBeAg seroconversion

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

Number of participants developing N236T and A181V HBV DNA genotypic mutations associated with ADV resistance

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

Number of participants with HBV DNA undetectable (<300 copies/mL)

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

Interventions:
  • Drug: AAAA
  • Drug: AAPA
  • Drug: PAAA
    • Enrollment:
    480
    Primary completion date:
    2008-17-03
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    MD Zeng, YM Mao, GB Yao et al. Efficacy and safety of two years adefovir dipivoxil (ADV) in Chinese patients with HBeAg positive chronic hepatitis B (CHB). Journal of Hepatology 2006;44 (Suppl. 2): Abstract 496, S185.
    MinDe Zeng, YiMin Mao, GuangBi Yao et al. A double blind randomised trial of adefovir dipivoxil in Chinese subjects with HBeAg positive chronic hepatitis B. Hepatology 2006; 44: 108-116.
    MinDe Zeng, YiMin Mao, GuangBi Yao et al. Efficacy of two years therapy with adefovir dipivoxil (ADV) in Chinese patients with HBeAg positive chronic hepatitis B (CHB). Journal of Gastroenterology and Hepatology 2006;21 (Suppl. 2): Abstract 3, A71.
    MinDe Zeng, YiMin Mao, WeiLun Lu et al. Safety of two years therapy with adefovir dipivoxil (ADV) in Chinese patients with HBeAg positive chronic hepatitis B (CHB). Journal of Gastroenterology and Hepatology 2006;21 (Suppl. 2): Abstract 102, A105.
    YiMin Mao, MinDe Zeng, XiaQiu Zhou et al. Lack of impact of YMDD mutants on efficacy or safety of two years therapy with adefovir dipivoxil (ADV) in Chinese HBeAg positive chronic hepatitis B (CHB) patients. Journal of Gastroenterology and Hepatology 2006;21 (Suppl. 2): Abstract 103, A106.
    Yiming Mao, MindeZeng, Guangbi Yao et al. Efficacy and safety of two years therapy with adefovir dipivoxil (ADV) in Chinese patients with HBeAg positive chronic hepatitis B (CHB). Journal of Gastroenterology and Hepatology 2006;21 (Suppl.): Abstract 42, A14.
    Chin J Infect Dis, December 2005, Vol 23, No. 6
    Hepatology 2006; 44: 108-116
    Hepatology 2006; Vol. 44, No. 4, Suppl. 1: 164A, poster LB21
    Hepatology International Volume 1, Number 1 March, 2007
    Hepatology International Volume 2, Number 1 March, 2008
    Hepatology International Volume 2, Supplement 2, June 2008
    Hepatology International Volume 3 Number 1, March 2009
    Jinlin Hou, etc. Adefovir Dipivoxil (ADV) Resistance during 3 yrs ADV In Chinese HBeAg+ve Chronic Hepatitis B (CHB).Hepatology International Volume 1, Number 1 March, 2007
    Journal of Gastroenterology and Hepatology 2006; 21 (Suppl. 2): Abstract 102, A105
    Journal of Gastroenterology and Hepatology 2006; 21 (Suppl. 2): Abstract 103, A106
    Journal of Gastroenterology and Hepatology 2006; 21 (Suppl. 2): Abstract 3, A71
    Journal of Gastroenterology and Hepatology 2006; 21 (Suppl.): Abstract 42, A14
    Journal of Hepatology 2006;44 (Suppl. 2): Abstract 496, S185
    M. Zeng, Y.Mao, G. Yao et al. Efficacy, safety and low resistance of three years therapy with adefovir dipivoxil. Hepatology 2006; Vol. 44, No. 4, Suppl. 1: 164A, poster LB21
    MD Zeng, YM Mao, GB Yao et al. Efficacy and safety of two years adefovir dipivoxil (ADV) in Chinese patients with HBeAg positive chronic hepatitis B (CHB). Journal of Hepatology 2006;44 (Suppl. 2): Abstract 496, S185
    MinDe Zeng, YiMin Mao, GuangBi Yao et al. A double blind randomised trial of adefovir dipivoxil in Chinese subjects with HBeAg positive chronic hepatitis B. Hepatology 2006; 44: 108-116
    MinDe Zeng, YiMin Mao, GuangBi Yao et al. Efficacy of two years therapy with adefovir dipivoxil (ADV) in Chinese patients with HBeAg positive chronic hepatitis B (CHB). Journal of Gastroenterology and Hepatology 2006;21 (Suppl. 2): Abstract 3, A71
    MinDe Zeng, YiMin Mao, GuangBi Yao et al.. A 52-week multi-center trial of adefovir dipivoxil in Chinese subjects with HBeAg positive chronic hepatitis B. Chin J Infect Dis, December 2005, Vol 23, No. 6
    MinDe Zeng, YiMin Mao, WeiLun Lu et al. Safety of two years therapy with adefovir dipivoxil (ADV) in Chinese patients with HBeAg positive chronic hepatitis B (CHB). Journal of Gastroenterology and Hepatology 2006;21 (Suppl. 2): Abstract 102, A105
    Yimin Mao, etc. Efficacy And Safety Of 3yrs Adefovir Dipivoxil (ADV) In Chinese HBeAg+ve Chronic Hepatitis B (CHB).Hepatology International Volume 1, Number 1 March, 2007
    YiMin Mao, MinDe Zeng, XiaQiu Zhou et al. Lack of impact of YMDD mutants on efficacy or safety of two years therapy with adefovir dipivoxil (ADV) in Chinese HBeAg positive chronic hepatitis B (CHB) patients. Journal of Gastroenterology and Hepatology 2006
    Yiming Mao, MindeZeng, Guangbi Yao et al. Efficacy and safety of two years therapy with adefovir dipivoxil (ADV) in Chinese patients with HBeAg positive chronic hepatitis B (CHB). Journal of Gastroenterology and Hepatology 2006;21 (Suppl.): Abstract 42, A
    Medical condition
    Hepatitis B, Chronic
    Product
    adefovir
    Collaborators
    GSK
    Study date(s)
    December 2002 to March 2008
    Type
    Interventional
    Phase
    3

    Participation criteria

    Sex
    Female & Male
    Age
    18 - 65 years
    Accepts healthy volunteers
    No
    • Aged 18-65 years
    • Presence of HBsAg and HBeAg at the time of screening and for at least 6 months prior to screening.
    • Evidence of hepatocellular carcinoma;
    • Clinical signs of liver decompensation;
    Inclusion and exclusion 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.

    Trial location(s)

    Location
    Status
    Contact us
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    Location
    GSK Investigational Site
    Changchun, Jilin, China, 130021
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Shanghai, China, 200040
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Beijing, China, 100044
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Chongquin, China, 400038
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Jinan, Shandong, China
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Guangzhou, Guangdong, China, 510515
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Guangzhou, Guangdong, China, 510630
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Chongqing, China, 400038
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Beijing, China, 100015
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Shanghai, China, 200025
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Shanghai, China, 200001
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Hangzhou, Zhejiang, China, 310003
    Status
    Study Complete
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    Study documents

    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Results posted on ClinicalTrials.gov

    Recruitment status
    Study complete
    Actual primary completion date
    2008-17-03
    Actual study completion date
    2008-17-03

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

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    Additional information
    Results for study ADF30001 can be found on the GSK Clinical Study Register.
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