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Emtricitabine for Naive Child Chinese Chronic Hepatitis B Patients

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ClinicalTrials.gov Identifier: NCT02327676
Recruitment Status : Unknown
Verified December 2014 by Jun Cheng, Asian-Pacific Alliance of Liver Disease, Beijing.
Recruitment status was:  Not yet recruiting
First Posted : December 30, 2014
Last Update Posted : December 30, 2014
Sponsor:
Collaborators:
Beijing Ditan Hospital
Hebei Medical University Pharmaceutical Factory
National Health and Family Planning Commission, P.R.China
Information provided by (Responsible Party):
Jun Cheng, Asian-Pacific Alliance of Liver Disease, Beijing

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.

Condition or disease Intervention/treatment Phase
Hepatitis B, Chronic Drug: Emtricitabine Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Emtricitabine for Naive Child Chinese Chronic Hepatitis B Patients
Study Start Date : January 2015
Estimated Primary Completion Date : July 2015
Estimated Study Completion Date : July 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: naive child CHB group
200 patients take generic emtricitabine capsule(200 mg one time per day) for 48 weeks
Drug: Emtricitabine
emtricitabine were given to each patients for 48 weeks
Other Name: Brand name:Huierding




Primary Outcome Measures :
  1. virological response rate [ Time Frame: week 48 ]
    HBV DNA < 500 copies/ml


Secondary Outcome Measures :
  1. HBV DNA negativity rate [ Time Frame: week 24 ]
    HBV DNA < 500 copies/ml

  2. HBV DNA decrease level [ Time Frame: week24 and 48 ]
    HBV DNA decrease compared with baseline(log10 copies/ml)

  3. biochemical response [ Time Frame: week 24 and 48 ]
    ALT normalization

  4. HBeAg loss [ Time Frame: week 24 and 48 ]
    HBeAg loss in HBeAg positive group

  5. HBeAg seroconversion [ Time Frame: week 24 and 48 ]
    HBeAg seroconversion in HBeAg positive group

  6. HBeAg reversion [ Time Frame: week 24 and 48 ]
    HBeAg positive in Baseline HBeAg negativie group patients

  7. HBsAg loss [ Time Frame: week 24 and 48 ]
    HBsAg loss

  8. HBsAg seroconversion [ Time Frame: week 24 and 48 ]
    HBsAg loss and anti-HBs positive

  9. HBV genetic resistance to emtricitabine [ Time Frame: week 24 and 48 ]
    HBV genetic resistance to emtricitabine

  10. adverse event [ Time Frame: week 24 and 48 ]
    type and rate of adverse events;type and rate of severe adverse event



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Ages Eligible for Study:   2 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02327676


Contacts
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Contact: Jun Cheng, M.D. +86 10 84322116 jun.cheng.ditan@gmail.com
Contact: Song Yang, M.D. +86 15011210692 sduyangsong@163.com

Sponsors and Collaborators
Asian-Pacific Alliance of Liver Disease, Beijing
Beijing Ditan Hospital
Hebei Medical University Pharmaceutical Factory
National Health and Family Planning Commission, P.R.China
Investigators
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Principal Investigator: Jun Cheng, M.D. Asian Pacific Alliance of Liver Diseases, Beijing

Publications:
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Responsible Party: Jun Cheng, chaireman of Asian-Pacific Alliance of Liver Diseas,Beijing, Asian-Pacific Alliance of Liver Disease, Beijing
ClinicalTrials.gov Identifier: NCT02327676     History of Changes
Other Study ID Numbers: FTC-01-child patients
First Posted: December 30, 2014    Key Record Dates
Last Update Posted: December 30, 2014
Last Verified: December 2014
Keywords provided by Jun Cheng, Asian-Pacific Alliance of Liver Disease, Beijing:
Hepatitis B, chronic
Emtricitabine
Child
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis B
Hepatitis B, Chronic
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Hepatitis, Chronic
Emtricitabine
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Anti-HIV Agents