A 24-week, parallel-group, open-label, randomized trial comparing Telbivudine with Entecavir treatment in HBeAg-positive chronic hepatitis B patients

Authors
Category Primary study
Registry of TrialsChinese Clinical Trial Register
Year 2009
INTERVENTION: Telbivudine Group:received Telbivudine alone;Entecavir Group:received Entecavir alone; CONDITION: Chronic hepatitis B PRIMARY OUTCOME: HBV‐DNA;HBV‐M;serum liver function; SECONDARY OUTCOME: Blood routine;serum kidney function; INCLUSION CRITERIA: 1. Men and women patients are adults aged 16 to 65 years with chronic hepatitis B: (1) HBeAg positive; (2) HBV‐DNA >= 100,0000 copies/ml and ALT levels 2‐10 times the upper limit of normal(ULN). 2. Patients have compensated liver function with total serum bilirubin <=2ULN; prothrombin time <=3 seconds; serum albumin and creatinine within the normal range; 3. alpha‐fetoprotein (AFP) <100ng/mL, when the level of AFP is during 50‐100ng/mL, ultrasound examination should be taken to exclude HCC; 4. The patients are voluntary to sign the informed consents, good compliance for treatment and interview; 5. Patients including the female and the chaperon of men during the child‐bearing period should take contraception in the trial.
Epistemonikos ID: 3bca0e9d5083a031a6058afa2d18b60f33c9cf02
First added on: Aug 22, 2024