Emtricitabine for Naive Chinese Chronic Hepatitis B Patients
NCT ID: NCT02327663
Last Updated: 2014-12-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
2000 participants
INTERVENTIONAL
2014-12-31
2017-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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
Emtricitabine
emtricitabine were given to each patients at baseline and respoonse guided therapy was adopted according HBV DNA level at week 24
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
Emtricitabine
emtricitabine were given to each patients at baseline and respoonse guided therapy was adopted according HBV DNA level at week 24
Interventions
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Emtricitabine
emtricitabine were given to each patients at baseline and respoonse guided therapy was adopted according HBV DNA level at week 24
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Beijing Ditan Hospital
OTHER
Hebei Medical University Pharmaceutical Factory
INDUSTRY
National Health and Family Planning Commission, P.R.China
OTHER_GOV
Asian-Pacific Alliance of Liver Disease, Beijing
OTHER
Responsible Party
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Jun Cheng
chaireman of Asian-Pacific Alliance of Liver Diseas,Beijing
Principal Investigators
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Jun Cheng, M.D.
Role: PRINCIPAL_INVESTIGATOR
Asian Pacific Alliance of Liver Diseases, Beijing
Central Contacts
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References
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Lim 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.
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.
Other Identifiers
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FTC-01
Identifier Type: -
Identifier Source: org_study_id