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

Hepatitis B, Chronic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02075294
• Other study ID #: YNKT201313
• Status: Completed
• Phase: N/A
• First received: February 27, 2014
• Last updated: October 26, 2014
• Start date: January 2010
• Est. completion date: October 2012

Study information

• Verified date: October 2014
• Source: Beijing 302 Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 242
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B, Chronic
• Hepatitis, Chronic

Intervention

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

Locations

Country	Name	City	State
China	302 military hospital of China	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Ying-Jie Ji

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the rates of serum HBVDNA undetectable and Renal dysfunction		3years	Yes
Secondary	the rate of normalisation of ALT		at week 2?4?12?24?36?48?60?72?84?96	Yes
Secondary	the rate of HBsAg negative		at week48?96?144	Yes
Secondary	the rate of HBeAg seroconversion		at week 24?48?72?96?120?144	Yes
Secondary	the rate of HBeAg negative		at week 24?48?72?96?120?144	Yes

External Links

•   Click here for more recruit information about this study
•   The introduction of the investigator affiliation