An observational study in Hepatitis B, Chronic, sponsored by Ying-Jie Ji. Completed at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-10-28.
Sponsored by Ying-Jie Ji · Observational
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.
2,710 studies on the registry are indexed under Hepatitis A; 142 are open to participants now.
This study's enrollment of 242 is close to the median of 250 across 687 observational studies indexed under Hepatitis A.
Browse Hepatitis A studies →This is the only study on the registry with Ying-Jie Ji as lead sponsor.
Counted across the registry records on this site, refreshed daily.
We retrospectively analyzed a consecutive cohort of chronic hepatitis B patients treated with ADV, 10mg, daily, or with ETV，0.5mg，daily between January 2010 and December 2013 in a single tererral referral hospital in Beijing. Data were retrieved from a prospectively maintined database.
Exclusion Criteria:
\<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.
Drug: 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.
Drug: 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.
Drug: Adefovir dipivoxil or Entecavir
Adefovir tablet, 10mg, take orally, once per day, more than 3years, exact duration depend on specific conditions and guidelines. Entecavir tablet, 0.5mg, take orally, once per day, more than 3years, exact duration depend on specific conditions and guidelines
Also known as: ADV, Hepsera,, ETV, Baraclude
the rates of serum HBVDNA undetectable and Renal dysfunction
Time frame: 3years
the rate of normalisation of ALT
Time frame: at week 2、4、12、24、36、48、60、72、84、96
the rate of HBsAg negative
Time frame: at week48、96、144
the rate of HBeAg seroconversion
Time frame: at week 24、48、72、96、120、144
the rate of HBeAg negative
Time frame: at week 24、48、72、96、120、144
This study is completed, as verified in Oct 2014. You cannot join it, but the record below documents what was studied.
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