Comparisons of efficacy and safety between Tenofovir and Entecavir drugs in chronic hepatitis B patients

Not Applicable

Completed

• Conditions: Infections and Infestations; Hepatitis B

• Registration Number: ISRCTN18291875
• Lead Sponsor: Kaohsiung Chang Gung Memorial Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2018-08-03
• Study Start: 2019-09-03
• Last Update Posted: 7 October 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 288

Inclusion Criteria

The inclusion criteria included three populations:
1. Chronic hepatitis B patients with hepatitis B virus surface antigen (HBsAg)
1.1 Positive status for more than 6 months
1.2 Elevated alanine transferase (ALT) levels = 5x ULN (200 IU/L) or ALT levels between 2x and 5x ULN combined HBV DNA =20000 IU/ml for HBeAg positive patients
1.2 ALT levels over 2x ULN combined HBV DNA =2000 IU/ml for HBeAg negative patients
2. Acute hepatic decompensated patient (prolong prothrombin time >3 sec and bilirubin>2 mg/dL) with positive for HBsAg
3. Clinical cirrhosis with HBV DNA =2000 IU/ml. The clinical evidence of cirrhosis was defined by one of the following
3.1 Ultrasound diagnosed liver cirrhosis with evidence of splenomegaly or esophageal or cardiac varices
3.2 Liver biopsy diagnosed liver cirrhosis
4. Aged 20 years or older.

Exclusion Criteria

1. Patients who had co-infection with human immunodeficiency virus, hepatitis C virus, hepatitis D virus or hepatitis E virus by serological assays
2. Patients who had a significant intake of alcohol (>20g/day for women; 30 g/day for men)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of patients with undetectable HBV DNA level at week 48, 96 and 144. Serum HBV DNA levels were analyzed using the Cobas AmpliPrep-Cobas TaqMan HBV test (CAP-CTM)(Roche Molecular System, Inc., Branchburg, NJ, USA), with a lower detection limit of 70 copies/ml

Secondary Outcome Measures

Name	Time	Method
<br> 1. Presence of HBsAg, HBeAg was assessed using electrochemiluinesence immunoassay (ECLIA) 3.0<br> 2. Renal function measured by the serum creatinine and estimated glomerular filtration rate (eGFR)<br> 3. Anti-HDV antibodies was assessed using radioimmunoassay (Abbott, North Chicago, IL, USA)<br>