Clinical trial NCT02327663: Emtricitabine for Naive Chinese Chronic Hepatitis B Patients
Official title: Emtricitabine for Naive Chinese Chronic Hepatitis B Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Hepatitis B, Chronic
Keywords: Hepatitis B, chronic
Emtricitabine
Adefovir dipivixil
HBeAg
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: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study evaluates generic emtricitabine(FTC) in Chinese naive chronic hepatitis B patients. Patients were divided into 2 groups: HBeAg positive Chronic hepatitis B(CHB)group and HBeAg 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. The investigators design this trial to test the effect of FTC in Chinese CHB which including naive HBeAg positive and Negative CHB patients. Response guided therapy strategy is adopted for patients who can not achieve HBV DNA negativity at week 24 FTC treatment, which means FTC and adefovir are combined for these patients.

Eligibility criteria: Inclusion Criteria:

* HBsAg positive for more than 6 months
* 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:

* 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 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

Primary outcomes:
measure: virological response rate
timeFrame: week 96
Secondary outcomes:
measure: HBV DNA decrease level
timeFrame: week24, 48, 72 and 96
measure: HBV DNA negativity rate
timeFrame: week 24, 48 and 72
measure: biochemical response
timeFrame: week 24,48,72 and 96
measure: HBeAg loss
timeFrame: week 24,48,72 and 96
measure: HBeAg seroconversion
timeFrame: week 24,48,72 and 96
measure: HBeAg reversion
timeFrame: week 24,48,72 and 96
measure: HBsAg loss
timeFrame: week 24,48,72 and 96
measure: HBsAg seroconversion
timeFrame: week 24,48,72 and 96
measure: adverse event
timeFrame: week 24,48,72 and 96
measure: HBV genetic resistance to emtricitabine and adefovir
timeFrame: week 24,48,72 and 96
Other outcomes:
Locations:
Study officials:
affiliation: Asian Pacific Alliance of Liver Diseases, Beijing
name: Jun Cheng, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.