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Emtricitabine for Naive Chinese Chronic Hepatitis B Patients

Primary Purpose

Hepatitis B, Chronic

Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Emtricitabine
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, chronic, Emtricitabine, Adefovir dipivixil, HBeAg

Eligibility Criteria

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

Inclusion Criteria:

  • HBsAg positive for more than 6 months
  • HBeAg positive patients: HBV DNA ≥ 5log10 copies/ml
  • HBeAg postive patients: ALT≥2×ULN;or liver biopsy G≥2;or liver biopsy S ≥2;or liver biopsy Knodell HAI ≥ 4
  • HBeAg negative patients: HBV DNA ≥ 4log10 copies/ml
  • HBeAg postive patients: ALT≥2×ULN;or liver biopsy G≥2;or liver biopsy S ≥2;or liver biopsy Knodell HAI ≥ 4
  • nucleoside/nucleotide naive paitents

Exclusion Criteria:

  • Diagnosed HCC with AFP and ultrasound, CT or MRI
  • Creatine >130μmol/L or Ccr < 70mL/min
  • Hemoglobin <100g/L
  • Neutrophils <1.5E+9/L
  • PLT<80E+9/L
  • Coinfected with HAV,HEV,HCV,HDV or HIV
  • ANA > 1:100
  • Uncontrolled cardiovascluar diseases, kidney diseases,lung diseases, neurological diseases, digestive diseases,metabolic disorders, immune-compromised diseases or cancer
  • Drug abuse or alcohal 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
  • Preganency or in breastfeeding

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    HBeAg positive CHB group

    HBeAg negativie CHB group

    Arm Description

    1000 patients take generic emtricitabine capsule(200 mg one time per day) for 96 weeks,and for patients who have HBV DNA > 500 copies/ml, adefovir dipivoxil were combined

    1000 patients take generic emtricitabine capsule(200 mg one time per day) for 96 weeks,and for patients who have HBV DNA > 500 copies/ml, adefovir dipivoxil were combined

    Outcomes

    Primary Outcome Measures

    virological response rate
    HBV DNA < 500 copies/ml

    Secondary Outcome Measures

    HBV DNA decrease level
    HBV DNA decrease compared with baseline（log10 copies/ml）
    HBV DNA negativity rate
    HBV DNA < 500 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
    adverse event
    type and rate of adverse events;type and rate of severe adverse event;
    HBV genetic resistance to emtricitabine and adefovir
    HBV genetic resistance to emtricitabine and adefovir

    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
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02327663
    Brief Title
    Emtricitabine for Naive Chinese Chronic Hepatitis B Patients
    Official Title
    Emtricitabine for Naive Chinese Chronic Hepatitis B Patients
    Study Type
    Interventional

    2. Study Status

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

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    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) in Chinese naive chronic hepatitis B patients. Patients were divided into 2 groups: HBeAg positive Chronic hepatitis B(CHB)group and HBeAg negative Chronic hepatitis B(CHB)group.
    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. The investigators design this trial to test the effect of FTC in Chinese CHB which including naive HBeAg positive and Negative CHB patients. Response guided therapy strategy is adopted for patients who can not achieve HBV DNA negativity at week 24 FTC treatment, which means FTC and adefovir are combined for these patients.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hepatitis B, Chronic
    Keywords
    Hepatitis B, chronic, Emtricitabine, Adefovir dipivixil, HBeAg

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    2000 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    HBeAg positive CHB group
    Arm Type
    Experimental
    Arm Description
    1000 patients take generic emtricitabine capsule(200 mg one time per day) for 96 weeks,and for patients who have HBV DNA > 500 copies/ml, adefovir dipivoxil were combined
    Arm Title
    HBeAg negativie CHB group
    Arm Type
    Experimental
    Arm Description
    1000 patients take generic emtricitabine capsule(200 mg one time per day) for 96 weeks,and for patients who have HBV DNA > 500 copies/ml, adefovir dipivoxil were combined
    Intervention Type
    Drug
    Intervention Name(s)
    Emtricitabine
    Other Intervention Name(s)
    Brand name：Huierding
    Intervention Description
    emtricitabine were given to each patients at baseline and respoonse guided therapy was adopted according HBV DNA level at week 24
    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 decrease level
    Description
    HBV DNA decrease compared with baseline（log10 copies/ml）
    Time Frame
    week24, 48, 72 and 96
    Title
    HBV DNA negativity rate
    Description
    HBV DNA < 500 copies/ml
    Time Frame
    week 24, 48 and 72
    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
    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
    HBV genetic resistance to emtricitabine and adefovir
    Description
    HBV genetic resistance to emtricitabine and adefovir
    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: HBsAg positive for more than 6 months HBeAg positive patients: HBV DNA ≥ 5log10 copies/ml HBeAg postive patients: ALT≥2×ULN;or liver biopsy G≥2;or liver biopsy S ≥2;or liver biopsy Knodell HAI ≥ 4 HBeAg negative patients: HBV DNA ≥ 4log10 copies/ml HBeAg postive patients: ALT≥2×ULN;or liver biopsy G≥2;or liver biopsy S ≥2;or liver biopsy Knodell HAI ≥ 4 nucleoside/nucleotide naive paitents Exclusion Criteria: Diagnosed HCC with AFP and ultrasound, CT or MRI Creatine >130μmol/L or Ccr < 70mL/min Hemoglobin <100g/L Neutrophils <1.5E+9/L PLT<80E+9/L Coinfected with HAV,HEV,HCV,HDV or HIV ANA > 1:100 Uncontrolled cardiovascluar diseases, kidney diseases,lung diseases, neurological diseases, digestive diseases,metabolic disorders, immune-compromised diseases or cancer Drug abuse or alcohal 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 Preganency 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
    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
    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
    result

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    Emtricitabine for Naive Chinese Chronic Hepatitis B Patients

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