Emtricitabine Plus Adefovir Dipivoxil for Naive Chinese HBV Related Cirrhosis Patients
1 other identifier
interventional
400
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Jan 2015
Typical duration for phase_4
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 23, 2014
CompletedFirst Posted
Study publicly available on registry
December 30, 2014
CompletedStudy Start
First participant enrolled
January 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2017
CompletedDecember 30, 2014
December 1, 2014
6 months
December 23, 2014
December 29, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
virological response rate
HBV DNA \< 500 copies/ml
week 96
Secondary Outcomes (12)
HBV DNA negativity rate
week 24, 48 and 72
HBV DNA decrease level
week24, 48, 72 and 96
biochemical response
week 24,48,72 and 96
HBeAg loss
week 24,48,72 and 96
HBeAg seroconversion
week 24,48,72 and 96
- +7 more secondary outcomes
Study Arms (2)
compensated HBV related cirrhosis patients
EXPERIMENTALChinese 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
decompensated HBV related cirrhosis patients
EXPERIMENTALChinese 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
Interventions
emtricitabine plus adefovir dipivoxil were given to each patients for 96 weeks
Eligibility Criteria
You may qualify if:
- Dignosed cirrhosis patients
- HBsAg positive for more than 6 months
- HBV DNA detectable
- Nucleoside/nucleotide naive patients
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (2)
Gish RG, Leung NW, Wright TL, Trinh H, Lang W, Kessler HA, Fang L, Wang LH, Delehanty J, Rigney A, Mondou E, Snow A, Rousseau F. Dose range study of pharmacokinetics, safety, and preliminary antiviral activity of emtricitabine in adults with hepatitis B virus infection. Antimicrob Agents Chemother. 2002 Jun;46(6):1734-40. doi: 10.1128/AAC.46.6.1734-1740.2002.
PMID: 12019083BACKGROUNDLim SG, Ng TM, Kung N, Krastev Z, Volfova M, Husa P, Lee SS, Chan S, Shiffman ML, Washington MK, Rigney A, Anderson J, Mondou E, Snow A, Sorbel J, Guan R, Rousseau F; Emtricitabine FTCB-301 Study Group. A double-blind placebo-controlled study of emtricitabine in chronic hepatitis B. Arch Intern Med. 2006 Jan 9;166(1):49-56. doi: 10.1001/archinte.166.1.49.
PMID: 16401810BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jun Cheng, M.D.
Asian Pacific Alliance of Liver Diseases, Beijing
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 23, 2014
First Posted
December 30, 2014
Study Start
January 1, 2015
Primary Completion
July 1, 2015
Study Completion
July 1, 2017
Last Updated
December 30, 2014
Record last verified: 2014-12