Efficacy and Safety Study of Adefovir and Entecavir for Elderly With Chronic Hepatitis B
- Registration Number
- NCT02075294
- Lead Sponsor
- Ying-Jie Ji
- Brief Summary
It is estimated that 350-400 million people have chronic infection with hepatitis B virus (HBV) all over the world. In china, 93 million individuals suffer from this chronic condition. Currently, seven medications are approved for the treatment of hepatitis B: two formulations of interferon and four nucleos(t)ide analogues. The Chinese population has one of the longer average life spans, and the size of the aged population has been increasing rapidly. As a result, the prevalence of elderly patients with HBV has increased, and the potential for development of cirrhosis or hepatocellular carcinoma in such patients is real. Hence, treatment of elderly patients with HBV is an important issue. However, ADV or ETV has become first choice due to the more side effect of INF and the resistant of LAM and LdT. But treatment outcomes with ADV and ETV in elderly are not known yet. In this study, we will evaluate and compare the efficacy and tolerability of ADV and ETV between younger and older patients with HBV. The aims of the present study are (1)to assess the benefits of ADV or ETV therapy for elderly patients with chronic hepatitis B, and (2)to determine differences in the emergence rate of side effect.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 242
- Age≥18 years
- HBsAg positive for more than 6 months before enrollment
- Serum HBVDNA >2×104IU/ml and serum ALT >80U/L or TBIL < 34 umol/L for chronic hepatitis B
- Serum ALT < 80U/L, but hepatic inflammation scores ≥ G2 or hepatic fibrosis stage ≥ S2 for chronic hepatitis B
- Serum HBVDNA >40 IU/ml for cirrhosis regardless of ALT and TBIL
- Co-infected with HCV, HDV or HIV, or autoimmune liver diseases combined
- received antiviral therapy or immunosuppressant drugs before 6 months prior to enrollment
- Renal function: creatinine >1.5 ULN or eGFR< 50ml/min/1.73m2 before therapy
- Combined with hepatocarcinoma before therapy
- suspend therapy voluntarily
- use other nephrotoxic drugs
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description youth Adefovir dipivoxil or Entecavir \<45years Adefovir dipivoxil or Entecavir Participants who received 10mg ADV more than 3 years or switch to other agent due to Renal dysfunction will be recruited. Participants who received 0.5mg ETV more than 3 years will be recruited. elderly Adefovir dipivoxil or Entecavir ≥65 years Adefovir dipivoxil or Entecavir Participants who received 10mg ADV more than 3 years or switch to other agent due to Renal dysfunction will be recruited. Participants who received 0.5mg ETV more than 3 years will be recruited. middle age Adefovir dipivoxil or Entecavir ≥45years and\<65years Adefovir dipivoxil or Entecavir Participants who received 10mg ADV more than 3 years or switch to other agent due to Renal dysfunction will be recruited. Participants who received 0.5mg ETV more than 3 years will be recruited.
- Primary Outcome Measures
Name Time Method the rates of serum HBVDNA undetectable and Renal dysfunction 3years
- Secondary Outcome Measures
Name Time Method the rate of HBeAg negative at week 24、48、72、96、120、144 the rate of normalisation of ALT at week 2、4、12、24、36、48、60、72、84、96 the rate of HBsAg negative at week48、96、144 the rate of HBeAg seroconversion at week 24、48、72、96、120、144
Trial Locations
- Locations (1)
302 military hospital of China
🇨🇳Beijing, Beijing, China