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Trial record 13 of 349 for:    hepatitis b | Open Studies

Emtricitabine for Naive Chinese Pregnant Chronic Hepatitis B Patients

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified December 2014 by Asian-Pacific Alliance of Liver Disease, Beijing
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
ClinicalTrials.gov Identifier:
NCT02327702
First received: December 23, 2014
Last updated: December 29, 2014
Last verified: December 2014
  Purpose
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 Intervention Phase
Hepatitis B, Chronic
Pregnancy
Drug: Emtricitabine
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Emtricitabine for Naive Chinese Pregnant Chronic Hepatitis B Patients

Resource links provided by NLM:


Further study details as provided by Asian-Pacific Alliance of Liver Disease, Beijing:

Primary Outcome Measures:
  • virological response rate [ Time Frame: week 48 after delivery ] [ Designated as safety issue: No ]
    HBV DNA < 500 copies/ml


Secondary Outcome Measures:
  • HBV DNA decrease level [ Time Frame: week 24 and 48 after delivery ] [ Designated as safety issue: No ]
    HBV DNA decrease compared with baseline(log10 copies/ml)

  • virological response rate [ Time Frame: week 24 after delivery ] [ Designated as safety issue: No ]
    HBV DNA < 500 copies/ml

  • biochemical response [ Time Frame: week 24 and 48 after delivery ] [ Designated as safety issue: No ]
    ALT normalization

  • HBeAg loss [ Time Frame: week 24 and 48 after delivery ] [ Designated as safety issue: No ]
    HBeAg loss in HBeAg positive group

  • HBeAg seroconversion [ Time Frame: week 24 and 48 after delivery ] [ Designated as safety issue: No ]
    HBeAg seroconversion in HBeAg positive group

  • HBeAg reversion [ Time Frame: week 24 and 48 after delivery ] [ Designated as safety issue: No ]
    HBeAg positive in Baseline HBeAg negativie group patients

  • HBsAg loss [ Time Frame: week 24 and 48 after delivery ] [ Designated as safety issue: No ]
    HBsAg loss

  • HBsAg seroconversion [ Time Frame: week 24 and 48 after delivery ] [ Designated as safety issue: No ]
    HBsAg loss and anti-HBs positive

  • HBV genetic resistance to emtricitabine [ Time Frame: week 24 and 48 after delivery ] [ Designated as safety issue: No ]
    HBV genetic resistance to emtricitabine

  • adverse event [ Time Frame: week 24 and 48 after delivery ] [ Designated as safety issue: Yes ]
    type and rate of adverse events;type and rate of severe adverse event;

  • birth defect in newborns [ Time Frame: 0 weeks, week24 and week48 after delivery ] [ Designated as safety issue: Yes ]
    birth defect in newborns

  • HBsAg positive rate in newborns [ Time Frame: 0 weeks, week24 and week48 after delivery ] [ Designated as safety issue: No ]
    HBsAg positive rate in newborns


Estimated Enrollment: 200
Study Start Date: January 2015
Estimated Study Completion Date: July 2017
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:
Single group patients were enrolled to receive emtricitabine till 48 weeks after delivery, which include HBeAg positive and negative patients.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02327702

Contacts
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
Principal Investigator: Jun Cheng, M.D. Asian Pacific Alliance of Liver Diseases, Beijing
  More Information

Publications:
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 
Study First Received: December 23, 2014
Last Updated: December 29, 2014
Health Authority: China: Ethics Committee

Keywords provided by Asian-Pacific Alliance of Liver Disease, Beijing:
Hepatitis B, chronic
Emtricitabine
Pregnancy

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis B
Hepatitis B, Chronic
Hepatitis, Viral, Human
Liver Diseases
Digestive System Diseases
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
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

ClinicalTrials.gov processed this record on December 02, 2016