search
Back to results

Emtricitabine for Naive Child 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, Child

Eligibility Criteria

2 Years - 17 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Children with body weight ≥ 33 kg and who can swallow entire emtricitabine capsle(200mg)
  • HBsAg positive for more than 6 months
  • HBeAg positive patients: HBV DNA ≥ 5log10 copies/ml
  • HBeAg positive 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 positive patients: ALT≥2×ULN;or liver biopsy G≥2;or liver biopsy S ≥2;or liver biopsy Knodell HAI ≥ 4
  • 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
  • Neutrophils <1.5E+9/L
  • PLT<80E+9/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 Type

    Experimental

    Arm Label

    naive child CHB group

    Arm Description

    200 patients take generic emtricitabine capsule(200 mg one time per day) for 48 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
    HBsAg seroconversion
    HBsAg loss and anti-HBs positive
    HBV genetic resistance to emtricitabine
    HBV genetic resistance to emtricitabine
    adverse event
    type and rate of adverse events;type and rate of severe adverse event

    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
    NCT02327676
    Brief Title
    Emtricitabine for Naive Child Chinese Chronic Hepatitis B Patients
    Official Title
    Emtricitabine for Naive Child Chinese Chronic Hepatitis B 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 2016 (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 children chronic hepatitis B patients. Single group of child patients were enrolled, which include HBeAg positive and 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 in children paitients. The investigators design this trial to test the effect of FTC in Chinese children CHB which including naive HBeAg positive and Negative CHB 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, Child

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    naive child CHB group
    Arm Type
    Experimental
    Arm Description
    200 patients take generic emtricitabine capsule(200 mg one time per day) for 48 weeks
    Intervention Type
    Drug
    Intervention Name(s)
    Emtricitabine
    Other Intervention Name(s)
    Brand name：Huierding
    Intervention Description
    emtricitabine were given to each patients for 48 weeks
    Primary Outcome Measure Information:
    Title
    virological response rate
    Description
    HBV DNA < 500 copies/ml
    Time Frame
    week 48
    Secondary Outcome Measure Information:
    Title
    HBV DNA negativity rate
    Description
    HBV DNA < 500 copies/ml
    Time Frame
    week 24
    Title
    HBV DNA decrease level
    Description
    HBV DNA decrease compared with baseline（log10 copies/ml）
    Time Frame
    week24 and 48
    Title
    biochemical response
    Description
    ALT normalization
    Time Frame
    week 24 and 48
    Title
    HBeAg loss
    Description
    HBeAg loss in HBeAg positive group
    Time Frame
    week 24 and 48
    Title
    HBeAg seroconversion
    Description
    HBeAg seroconversion in HBeAg positive group
    Time Frame
    week 24 and 48
    Title
    HBeAg reversion
    Description
    HBeAg positive in Baseline HBeAg negativie group patients
    Time Frame
    week 24 and 48
    Title
    HBsAg loss
    Description
    HBsAg loss
    Time Frame
    week 24 and 48
    Title
    HBsAg seroconversion
    Description
    HBsAg loss and anti-HBs positive
    Time Frame
    week 24 and 48
    Title
    HBV genetic resistance to emtricitabine
    Description
    HBV genetic resistance to emtricitabine
    Time Frame
    week 24 and 48
    Title
    adverse event
    Description
    type and rate of adverse events;type and rate of severe adverse event
    Time Frame
    week 24 and 48

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    2 Years
    Maximum Age & Unit of Time
    17 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Children with body weight ≥ 33 kg and who can swallow entire emtricitabine capsle(200mg) HBsAg positive for more than 6 months HBeAg positive patients: HBV DNA ≥ 5log10 copies/ml HBeAg positive 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 positive patients: ALT≥2×ULN;or liver biopsy G≥2;or liver biopsy S ≥2;or liver biopsy Knodell HAI ≥ 4 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 Neutrophils <1.5E+9/L PLT<80E+9/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

    Learn more about this trial

    Emtricitabine for Naive Child Chinese Chronic Hepatitis B Patients

    We'll reach out to this number within 24 hrs