Emtricitabine for Naive Child Chinese Chronic Hepatitis B Patients
NCT ID: NCT02327676
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
200 participants
INTERVENTIONAL
2015-01-31
2016-07-31
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
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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naive child CHB group
200 patients take generic emtricitabine capsule(200 mg one time per day) for 48 weeks
Emtricitabine
emtricitabine were given to each patients for 48 weeks
Interventions
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Emtricitabine
emtricitabine were given to each patients for 48 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* HBsAg positive for more than 6 months
* HBeAg positive patients: HBV DNA ≥ 5log10 copies/ml
* HBeAg positive 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 positive patients: ALT≥2×ULN;or liver biopsy G≥2;or liver biopsy S ≥2;or liver biopsy Knodell HAI ≥ 4
* Nucleoside/nucleotide naive patients
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 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
2 Years
17 Years
ALL
Yes
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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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-child patients
Identifier Type: -
Identifier Source: org_study_id