Efficacy and Safety Study of Adefovir and Entecavir for Elderly With Chronic Hepatitis B

NCT ID: NCT02075294

Last Updated: 2014-10-28

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 242 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-01-31
• Study Completion Date: 2012-10-31

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.

Conditions

Hepatitis B, Chronic

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

youth

<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.

Adefovir dipivoxil or Entecavir

Intervention Type: DRUG

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

middle age

≥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.

Adefovir dipivoxil or Entecavir

Intervention Type: DRUG

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

elderly

≥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.

Adefovir dipivoxil or Entecavir

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

Other Intervention Names

ADV, Hepsera,; ETV, Baraclude

Eligibility Criteria

Inclusion Criteria

1. Age≥18 years

2. HBsAg positive for more than 6 months before enrollment

3. Serum HBVDNA >2×104IU/ml and serum ALT >80U/L or TBIL < 34 umol/L for chronic hepatitis B

4. Serum ALT < 80U/L, but hepatic inflammation scores ≥ G2 or hepatic fibrosis stage ≥ S2 for chronic hepatitis B

5. Serum HBVDNA >40 IU/ml for cirrhosis regardless of ALT and TBIL

Exclusion Criteria

1. Co-infected with HCV, HDV or HIV, or autoimmune liver diseases combined

2. received antiviral therapy or immunosuppressant drugs before 6 months prior to enrollment

3. Renal function: creatinine >1.5 ULN or eGFR< 50ml/min/1.73m2 before therapy

4. Combined with hepatocarcinoma before therapy

5. suspend therapy voluntarily

6. use other nephrotoxic drugs

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ying-Jie Ji

OTHER

Sponsor Role: lead

Responsible Party

Ying-Jie Ji

MD

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Ying-Jie Ji, MD.

Role: PRINCIPAL_INVESTIGATOR

Beijing 302 Hospital

Locations

302 military hospital of China

Beijing, Beijing Municipality, China

Countries

China

Related Links

http://www.302hospital.com/Html/Index.html

Click here for more recruit information about this study

Other Identifiers

YNKT201313

Identifier Type: -

Identifier Source: org_study_id