Clinical trial NCT02327676: Emtricitabine for Naive Child Chinese Chronic Hepatitis B Patients
Official title: Emtricitabine for Naive Child Chinese Chronic Hepatitis B Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Hepatitis B, Chronic
Keywords: Hepatitis B, chronic
Emtricitabine
Child
Lead sponsor: Asian-Pacific Alliance of Liver Disease, Beijing
Sponsor class: OTHER
Collaborators: name: Beijing Ditan Hospital
name: Hebei Medical University Pharmaceutical Factory
name: National Health and Family Planning Commission, P.R.China
First posted: 2014-12-30
Enrollment: 200
Sex: ALL
Minimum age (years): 2
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study evaluates generic emtricitabine(FTC) in Chinese naive children chronic hepatitis B patients. Single group of child patients were enrolled, which include HBeAg positive and negative Chronic hepatitis B(CHB)group.

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 in children paitients. The investigators design this trial to test the effect of FTC in Chinese children CHB which including naive HBeAg positive and Negative CHB patients.

Eligibility criteria: Inclusion Criteria:

* Children with body weight ≥ 33 kg and who can swallow entire emtricitabine capsle(200mg)
* 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:

* - Diagnosed HCC with AFP and ultrasound, CT or MRI
* 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

Primary outcomes:
measure: virological response rate
timeFrame: week 48
Secondary outcomes:
measure: HBV DNA negativity rate
timeFrame: week 24
measure: HBV DNA decrease level
timeFrame: week24 and 48
measure: biochemical response
timeFrame: week 24 and 48
measure: HBeAg loss
timeFrame: week 24 and 48
measure: HBeAg seroconversion
timeFrame: week 24 and 48
measure: HBeAg reversion
timeFrame: week 24 and 48
measure: HBsAg loss
timeFrame: week 24 and 48
measure: HBsAg seroconversion
timeFrame: week 24 and 48
measure: HBV genetic resistance to emtricitabine
timeFrame: week 24 and 48
measure: adverse event
timeFrame: week 24 and 48
Other outcomes:
Locations:
Study officials:
affiliation: Asian Pacific Alliance of Liver Diseases, Beijing
name: Jun Cheng, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.