Trial record 227 of 511 for:    hepatitis b | Open Studies

Emtricitabine Plus Adefovir Dipivoxil for Naive Chinese HBV Related Cirrhosis 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:
NCT02327689
First received: December 23, 2014
Last updated: December 29, 2014
Last verified: December 2014
  Purpose
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 Intervention Phase
Hepatitis B, Chronic
Fibrosis
Drug: Emtricitabine plus adefovir dipivoxil
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Emtricitabine Plus Adefovir Dipivoxil for Naive Chinese HBV Related Cirrhosis 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 96 ] [ Designated as safety issue: No ]
    HBV DNA < 500 copies/ml


Secondary Outcome Measures:
  • HBV DNA negativity rate [ Time Frame: week 24, 48 and 72 ] [ Designated as safety issue: No ]
    HBV DNA < 500 copies/ml

  • HBV DNA decrease level [ Time Frame: week24, 48, 72 and 96 ] [ Designated as safety issue: No ]
    HBV DNA decrease compared with baseline(log10 copies/ml)

  • biochemical response [ Time Frame: week 24,48,72 and 96 ] [ Designated as safety issue: No ]
    ALT normalization

  • HBeAg loss [ Time Frame: week 24,48,72 and 96 ] [ Designated as safety issue: No ]
    HBeAg loss in HBeAg positive group

  • HBeAg seroconversion [ Time Frame: week 24,48,72 and 96 ] [ Designated as safety issue: No ]
    HBeAg seroconversion in HBeAg positive group

  • HBeAg reversion [ Time Frame: week 24,48,72 and 96 ] [ Designated as safety issue: No ]
    HBeAg positive in Baseline HBeAg negativie group patients

  • HBsAg loss [ Time Frame: week 24,48,72 and 96 ] [ Designated as safety issue: No ]
    HBsAg loss in both group

  • HBsAg seroconversion [ Time Frame: week 24,48,72 and 96 ] [ Designated as safety issue: No ]
    HBsAg loss and anti-HBs positive

  • HBV genetic resistance to emtricitabine and adefovir [ Time Frame: week 24,48,72 and 96 ] [ Designated as safety issue: No ]
    HBV genetic resistance to emtricitabine and adefovir

  • adverse event [ Time Frame: week 24,48,72 and 96 ] [ Designated as safety issue: Yes ]
    type and rate of adverse events;type and rate of severe adverse event

  • incidence of HCC [ Time Frame: week 24,48,72 and 96 ] [ Designated as safety issue: No ]
    incidence of HCC in both groups

  • change of MELD score and Child-Pugh score [ Time Frame: week 24,48,72 and 96 ] [ Designated as safety issue: No ]
    change of MELD score and Child-Pugh score in both groups


Estimated Enrollment: 400
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: 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

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.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
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
  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: NCT02327689

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: NCT02327689     History of Changes
Other Study ID Numbers: FTC-01-cirrhosis 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 virus
Cirrhosis
Emtricitabine
Adefovir dipivoxil

Additional relevant MeSH terms:
Hepatitis
Hepatitis B
Hepatitis B, Chronic
Hepatitis, Viral, Human
Hepatitis, Chronic
Fibrosis
Liver Cirrhosis
Liver Diseases
Digestive System Diseases
Hepadnaviridae Infections
DNA Virus Infections
Virus Diseases
Pathologic Processes
Emtricitabine
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

ClinicalTrials.gov processed this record on August 25, 2016