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Emtricitabine for Naive Chinese Pregnant Chronic Hepatitis B Patients

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ClinicalTrials.gov Identifier: NCT02327702
Recruitment Status : Unknown
Verified December 2014 by 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):
Asian-Pacific Alliance of Liver Disease, Beijing

Brief Summary:
This study evaluates generic emtricitabine(FTC) efficacy and safety in Chinese naive pregnant chronic hepatitis B patients. Single group patients were enrolled to receive emtricitabine till 48 weeks after delivery.

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

Detailed Description:
Single group patients were enrolled to receive emtricitabine till 48 weeks after delivery, which include HBeAg positive and negative 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 Chinese Pregnant Chronic Hepatitis B Patients
Study Start Date : January 2015
Estimated Primary Completion Date : July 2015
Estimated Study Completion Date : July 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Chinese naive pregnant chronice hepatitis B
Chinese naive pregnant chronice hepatitis B were enrolled to take emtricitabine (200 mg one time per day) till 48 weeks after delivery.
Drug: Emtricitabine
emtricitabine were given to each patients at baseline till 48 weeks after delivery
Other Name: Brand name:Huierding




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


Secondary Outcome Measures :
  1. HBV DNA decrease level [ Time Frame: week 24 and 48 after delivery ]
    HBV DNA decrease compared with baseline(log10 copies/ml)

  2. virological response rate [ Time Frame: week 24 after delivery ]
    HBV DNA < 500 copies/ml

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

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

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

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

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

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

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

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

  11. birth defect in newborns [ Time Frame: 0 weeks, week24 and week48 after delivery ]
    birth defect in newborns

  12. HBsAg positive rate in newborns [ Time Frame: 0 weeks, week24 and week48 after delivery ]
    HBsAg positive rate in newborns



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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 patients
  • Diagnosed as ≥ 12 weeks pregnancy

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 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
  • Family history of genetic defects disease
  • Abnormal results in fatal defects screening
  • HBsAg positive sperm provider pregnancy

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): NCT02327702


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: Asian-Pacific Alliance of Liver Disease, Beijing
ClinicalTrials.gov Identifier: NCT02327702     History of Changes
Other Study ID Numbers: FTC-02-pregnant CHB patients
First Posted: December 30, 2014    Key Record Dates
Last Update Posted: December 30, 2014
Last Verified: December 2014
Keywords provided by Asian-Pacific Alliance of Liver Disease, Beijing:
Hepatitis B, chronic
Emtricitabine
Pregnancy
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