Trials / Completed
CompletedNCT02075294
Efficacy and Safety Study of Adefovir and Entecavir for Elderly With Chronic Hepatitis B
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 242 (actual)
- Sponsor
- Ying-Jie Ji · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2010-01-01
- Primary completion
- 2012-10-01
- Completion
- 2012-10-01
- First posted
- 2014-03-03
- Last updated
- 2014-10-28
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT02075294. Inclusion in this directory is not an endorsement.