Clinical trial NCT02327689: Emtricitabine Plus Adefovir Dipivoxil for Naive Chinese HBV Related Cirrhosis Patients
Official title: Emtricitabine Plus Adefovir Dipivoxil for Naive Chinese HBV Related Cirrhosis Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Hepatitis B, Chronic
Fibrosis
Keywords: Hepatitis B virus
Cirrhosis
Emtricitabine
Adefovir dipivoxil
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: 400
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) 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.

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 plus adefovir dipivoxil in cirrhosis patients. The investigators design this trial to test the effect of FTC plus adefovir dipivoxil in Chinese naive compensated and decompensated HBV related cirrhosis patients.

Eligibility criteria: Inclusion Criteria:

* Dignosed cirrhosis patients
* HBsAg positive for more than 6 months
* HBV DNA detectable
* 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
* 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 96
Secondary outcomes:
measure: HBV DNA negativity rate
timeFrame: week 24, 48 and 72
measure: HBV DNA decrease level
timeFrame: week24, 48, 72 and 96
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: HBV genetic resistance to emtricitabine and adefovir
timeFrame: week 24,48,72 and 96
measure: adverse event
timeFrame: week 24,48,72 and 96
measure: incidence of HCC
timeFrame: week 24,48,72 and 96
measure: change of MELD score and Child-Pugh score
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: 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.
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.