search
Back to results

Emtricitabine Plus Adefovir Dipivoxil for Naive Chinese HBV Related Cirrhosis Patients

Primary Purpose

Hepatitis B, Chronic, Fibrosis

Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Emtricitabine plus adefovir dipivoxil
Sponsored by
Asian-Pacific Alliance of Liver Disease, Beijing
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatitis B, Chronic focused on measuring Hepatitis B virus, Cirrhosis, Emtricitabine, Adefovir dipivoxil

Eligibility Criteria

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

Inclusion Criteria:

  • Dignosed cirrhosis patients
  • HBsAg positive for more than 6 months
  • HBV DNA detectable
  • Nucleoside/nucleotide naive patients

Exclusion Criteria:

  • Diagnosed HCC with AFP and ultrasound, CT or MRI
  • Creatine >130μmol/L or Ccr < 70mL/min
  • Hemoglobin <100g/L
  • Coinfected with HAV,HEV,HCV,HDV or HIV
  • ANA > 1:100
  • Uncontrolled cardiovascular diseases, kidney diseases,lung diseases, neurological diseases, digestive diseases,metabolic disorders, immune-compromised diseases or cancer;
  • Drug abuse or alcohol addiction
  • Previous history of taking agents of lamivudine, adefovir, tenofovir entecavir or telbivudine
  • Long-term use of immunosuppressor or immunomodulator 6 months before enrollment to this trial
  • Underwent liver transplantation or liver transplantation in schedule
  • Allergic to nucleoside or nucleotide analogues
  • Pregnancy or in breastfeeding

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    compensated HBV related cirrhosis patients

    decompensated HBV related cirrhosis patients

    Arm Description

    Chinese naive compensated HBV related cirrhosis patients were treated with generic emtricitabine capsule(200 mg one time per day) plus adefovir dipivoxil(10 mg one time per day) for 96 weeks

    Chinese naive decompensated HBV related cirrhosis patients were treated with generic emtricitabine capsule(200 mg one time per day) plus adefovir dipivoxil(10 mg one time per day) for 96 weeks

    Outcomes

    Primary Outcome Measures

    virological response rate
    HBV DNA < 500 copies/ml

    Secondary Outcome Measures

    HBV DNA negativity rate
    HBV DNA < 500 copies/ml
    HBV DNA decrease level
    HBV DNA decrease compared with baseline（log10 copies/ml）
    biochemical response
    ALT normalization
    HBeAg loss
    HBeAg loss in HBeAg positive group
    HBeAg seroconversion
    HBeAg seroconversion in HBeAg positive group
    HBeAg reversion
    HBeAg positive in Baseline HBeAg negativie group patients
    HBsAg loss
    HBsAg loss in both group
    HBsAg seroconversion
    HBsAg loss and anti-HBs positive
    HBV genetic resistance to emtricitabine and adefovir
    HBV genetic resistance to emtricitabine and adefovir
    adverse event
    type and rate of adverse events;type and rate of severe adverse event
    incidence of HCC
    incidence of HCC in both groups
    change of MELD score and Child-Pugh score
    change of MELD score and Child-Pugh score in both groups

    Full Information

    First Posted
    December 23, 2014
    Last Updated
    December 29, 2014
    Sponsor
    Asian-Pacific Alliance of Liver Disease, Beijing
    Collaborators
    Beijing Ditan Hospital, Hebei Medical University Pharmaceutical Factory, National Health and Family Planning Commission, P.R.China
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT02327689
    Brief Title
    Emtricitabine Plus Adefovir Dipivoxil for Naive Chinese HBV Related Cirrhosis Patients
    Official Title
    Emtricitabine Plus Adefovir Dipivoxil for Naive Chinese HBV Related Cirrhosis Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2014
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 2015 (undefined)
    Primary Completion Date
    July 2015 (Anticipated)
    Study Completion Date
    July 2017 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Asian-Pacific Alliance of Liver Disease, Beijing
    Collaborators
    Beijing Ditan Hospital, Hebei Medical University Pharmaceutical Factory, National Health and Family Planning Commission, P.R.China

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    This study evaluates generic emtricitabine(FTC) plus adefovir dipivoxil in Chinese naive HBV related cirrhosis patients. Patients were divided into 2 groups: compensated HBV related cirrhosis patients and decompensated HBV related cirrhosis patients.
    Detailed Description
    Generic emtricitabine(FTC) has been approved for treatment of naive chronic hepatitis B(CHB) patients in China. Yet data are limited for this agent plus adefovir dipivoxil in cirrhosis patients. The investigators design this trial to test the effect of FTC plus adefovir dipivoxil in Chinese naive compensated and decompensated HBV related cirrhosis patients.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hepatitis B, Chronic, Fibrosis
    Keywords
    Hepatitis B virus, Cirrhosis, Emtricitabine, Adefovir dipivoxil

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    400 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    compensated HBV related cirrhosis patients
    Arm Type
    Experimental
    Arm Description
    Chinese naive compensated HBV related cirrhosis patients were treated with generic emtricitabine capsule(200 mg one time per day) plus adefovir dipivoxil(10 mg one time per day) for 96 weeks
    Arm Title
    decompensated HBV related cirrhosis patients
    Arm Type
    Experimental
    Arm Description
    Chinese naive decompensated HBV related cirrhosis patients were treated with generic emtricitabine capsule(200 mg one time per day) plus adefovir dipivoxil(10 mg one time per day) for 96 weeks
    Intervention Type
    Drug
    Intervention Name(s)
    Emtricitabine plus adefovir dipivoxil
    Other Intervention Name(s)
    Brand name of emtricitabine：Huierding
    Intervention Description
    emtricitabine plus adefovir dipivoxil were given to each patients for 96 weeks
    Primary Outcome Measure Information:
    Title
    virological response rate
    Description
    HBV DNA < 500 copies/ml
    Time Frame
    week 96
    Secondary Outcome Measure Information:
    Title
    HBV DNA negativity rate
    Description
    HBV DNA < 500 copies/ml
    Time Frame
    week 24, 48 and 72
    Title
    HBV DNA decrease level
    Description
    HBV DNA decrease compared with baseline（log10 copies/ml）
    Time Frame
    week24, 48, 72 and 96
    Title
    biochemical response
    Description
    ALT normalization
    Time Frame
    week 24,48,72 and 96
    Title
    HBeAg loss
    Description
    HBeAg loss in HBeAg positive group
    Time Frame
    week 24,48,72 and 96
    Title
    HBeAg seroconversion
    Description
    HBeAg seroconversion in HBeAg positive group
    Time Frame
    week 24,48,72 and 96
    Title
    HBeAg reversion
    Description
    HBeAg positive in Baseline HBeAg negativie group patients
    Time Frame
    week 24,48,72 and 96
    Title
    HBsAg loss
    Description
    HBsAg loss in both group
    Time Frame
    week 24,48,72 and 96
    Title
    HBsAg seroconversion
    Description
    HBsAg loss and anti-HBs positive
    Time Frame
    week 24,48,72 and 96
    Title
    HBV genetic resistance to emtricitabine and adefovir
    Description
    HBV genetic resistance to emtricitabine and adefovir
    Time Frame
    week 24,48,72 and 96
    Title
    adverse event
    Description
    type and rate of adverse events;type and rate of severe adverse event
    Time Frame
    week 24,48,72 and 96
    Title
    incidence of HCC
    Description
    incidence of HCC in both groups
    Time Frame
    week 24,48,72 and 96
    Title
    change of MELD score and Child-Pugh score
    Description
    change of MELD score and Child-Pugh score in both groups
    Time Frame
    week 24,48,72 and 96

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Dignosed cirrhosis patients HBsAg positive for more than 6 months HBV DNA detectable Nucleoside/nucleotide naive patients Exclusion Criteria: Diagnosed HCC with AFP and ultrasound, CT or MRI Creatine >130μmol/L or Ccr < 70mL/min Hemoglobin <100g/L Coinfected with HAV,HEV,HCV,HDV or HIV ANA > 1:100 Uncontrolled cardiovascular diseases, kidney diseases,lung diseases, neurological diseases, digestive diseases,metabolic disorders, immune-compromised diseases or cancer; Drug abuse or alcohol addiction Previous history of taking agents of lamivudine, adefovir, tenofovir entecavir or telbivudine Long-term use of immunosuppressor or immunomodulator 6 months before enrollment to this trial Underwent liver transplantation or liver transplantation in schedule Allergic to nucleoside or nucleotide analogues Pregnancy or in breastfeeding
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Jun Cheng, M.D.
    Phone
    +86 10 84322116
    Email
    jun.cheng.ditan@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Song Yang, M.D.
    Phone
    +86 15011210692
    Email
    sduyangsong@163.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jun Cheng, M.D.
    Organizational Affiliation
    Asian Pacific Alliance of Liver Diseases, Beijing
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    12019083
    Citation
    Gish RG, Leung NW, Wright TL, Trinh H, Lang W, Kessler HA, Fang L, Wang LH, Delehanty J, Rigney A, Mondou E, Snow A, Rousseau F. Dose range study of pharmacokinetics, safety, and preliminary antiviral activity of emtricitabine in adults with hepatitis B virus infection. Antimicrob Agents Chemother. 2002 Jun;46(6):1734-40. doi: 10.1128/AAC.46.6.1734-1740.2002.
    Results Reference
    background
    PubMed Identifier
    16401810
    Citation
    Lim SG, Ng TM, Kung N, Krastev Z, Volfova M, Husa P, Lee SS, Chan S, Shiffman ML, Washington MK, Rigney A, Anderson J, Mondou E, Snow A, Sorbel J, Guan R, Rousseau F; Emtricitabine FTCB-301 Study Group. A double-blind placebo-controlled study of emtricitabine in chronic hepatitis B. Arch Intern Med. 2006 Jan 9;166(1):49-56. doi: 10.1001/archinte.166.1.49.
    Results Reference
    background

    Learn more about this trial

    Emtricitabine Plus Adefovir Dipivoxil for Naive Chinese HBV Related Cirrhosis Patients

    We'll reach out to this number within 24 hrs