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Emtricitabine Plus Adefovir Dipivoxil for Naive Chinese HBV Related Cirrhosis Patients

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ClinicalTrials.gov Identifier: NCT02327689
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) plus adefovir dipivoxil in Chinese naive HBV related cirrhosis patients. Patients were divided into 2 groups: compensated HBV related cirrhosis patients and decompensated HBV related cirrhosis patients.

Condition or disease Intervention/treatment Phase
Hepatitis B, Chronic Fibrosis Drug: Emtricitabine plus adefovir dipivoxil 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 plus adefovir dipivoxil in cirrhosis patients. The investigators design this trial to test the effect of FTC plus adefovir dipivoxil in Chinese naive compensated and decompensated HBV related cirrhosis patients.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Emtricitabine Plus Adefovir Dipivoxil for Naive Chinese HBV Related Cirrhosis Patients
Study Start Date : January 2015
Estimated Primary Completion Date : July 2015
Estimated Study Completion Date : July 2017


Arm Intervention/treatment
Experimental: compensated HBV related cirrhosis patients
Chinese naive compensated HBV related cirrhosis patients were treated with generic emtricitabine capsule(200 mg one time per day) plus adefovir dipivoxil(10 mg one time per day) for 96 weeks
Drug: Emtricitabine plus adefovir dipivoxil
emtricitabine plus adefovir dipivoxil were given to each patients for 96 weeks
Other Name: Brand name of emtricitabine:Huierding

Experimental: decompensated HBV related cirrhosis patients
Chinese naive decompensated HBV related cirrhosis patients were treated with generic emtricitabine capsule(200 mg one time per day) plus adefovir dipivoxil(10 mg one time per day) for 96 weeks
Drug: Emtricitabine plus adefovir dipivoxil
emtricitabine plus adefovir dipivoxil were given to each patients for 96 weeks
Other Name: Brand name of emtricitabine:Huierding




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


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

  2. HBV DNA decrease level [ Time Frame: week24, 48, 72 and 96 ]
    HBV DNA decrease compared with baseline(log10 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. HBV genetic resistance to emtricitabine and adefovir [ Time Frame: week 24,48,72 and 96 ]
    HBV genetic resistance to emtricitabine and adefovir

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

  11. incidence of HCC [ Time Frame: week 24,48,72 and 96 ]
    incidence of HCC in both groups

  12. change of MELD score and Child-Pugh score [ Time Frame: week 24,48,72 and 96 ]
    change of MELD score and Child-Pugh score in both groups



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Dignosed cirrhosis patients
  • HBsAg positive for more than 6 months
  • HBV DNA detectable
  • 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
  • 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): NCT02327689


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: NCT02327689     History of Changes
Other Study ID Numbers: FTC-01-cirrhosis 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 virus
Cirrhosis
Emtricitabine
Adefovir dipivoxil
Additional relevant MeSH terms:
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Liver Cirrhosis
Emtricitabine
Hepatitis B
Hepatitis B, Chronic
Hepatitis
Fibrosis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Pathologic Processes
Hepadnaviridae Infections
DNA Virus Infections
Hepatitis, Chronic
Adefovir
Adefovir dipivoxil
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