Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Emtricitabine for Naive Chinese Chronic Hepatitis B Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02327663
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 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.

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. 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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2000 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Emtricitabine for Naive Chinese Chronic Hepatitis B Patients
Study Start Date : December 2014
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: HBeAg positive CHB group
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
Drug: Emtricitabine
emtricitabine were given to each patients at baseline and respoonse guided therapy was adopted according HBV DNA level at week 24
Other Name: Brand name:Huierding

Experimental: HBeAg negativie CHB group
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
Drug: Emtricitabine
emtricitabine were given to each patients at baseline and respoonse guided therapy was adopted according HBV DNA level at week 24
Other Name: Brand name:Huierding




Primary Outcome Measures :
  1. virological response rate [ Time Frame: week 96 ]
    HBV DNA < 500 copies/ml


Secondary Outcome Measures :
  1. HBV DNA decrease level [ Time Frame: week24, 48, 72 and 96 ]
    HBV DNA decrease compared with baseline(log10 copies/ml)

  2. HBV DNA negativity rate [ Time Frame: week 24, 48 and 72 ]
    HBV DNA < 500 copies/ml

  3. biochemical response [ Time Frame: week 24,48,72 and 96 ]
    ALT normalization

  4. HBeAg loss [ Time Frame: week 24,48,72 and 96 ]
    HBeAg loss in HBeAg positive group

  5. HBeAg seroconversion [ Time Frame: week 24,48,72 and 96 ]
    HBeAg seroconversion in HBeAg positive group

  6. HBeAg reversion [ Time Frame: week 24,48,72 and 96 ]
    HBeAg positive in Baseline HBeAg negativie group patients

  7. HBsAg loss [ Time Frame: week 24,48,72 and 96 ]
    HBsAg loss in both group

  8. HBsAg seroconversion [ Time Frame: week 24,48,72 and 96 ]
    HBsAg loss and anti-HBs positive

  9. adverse event [ Time Frame: week 24,48,72 and 96 ]
    type and rate of adverse events;type and rate of severe adverse event;

  10. HBV genetic resistance to emtricitabine and adefovir [ Time Frame: week 24,48,72 and 96 ]
    HBV genetic resistance to emtricitabine and adefovir



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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 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

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): NCT02327663


Contacts
Layout table for location 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
Layout table for investigator information
Principal Investigator: Jun Cheng, M.D. Asian Pacific Alliance of Liver Diseases, Beijing

Publications of Results:
Other Publications:
Layout table for additonal information
Responsible Party: Jun Cheng, chaireman of Asian-Pacific Alliance of Liver Diseas,Beijing, Asian-Pacific Alliance of Liver Disease, Beijing
ClinicalTrials.gov Identifier: NCT02327663     History of Changes
Other Study ID Numbers: FTC-01
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
Adefovir dipivixil
HBeAg
Additional relevant MeSH terms:
Layout table for MeSH terms
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
Adefovir
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