Emtricitabine Plus Adefovir Dipivoxil for Naive Chinese HBV Related Cirrhosis Patients (NCT02327689) | Clinical Trial Compass
UnknownPhase 4
Emtricitabine Plus Adefovir Dipivoxil for Naive Chinese HBV Related Cirrhosis Patients
400 participantsStarted 2015-01
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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
What they're measuring
1
virological response rate
Timeframe: week 96
Trial details
NCT IDNCT02327689
SponsorAsian-Pacific Alliance of Liver Disease, Beijing