Clinical trial NCT02075294: Efficacy and Safety Study of Adefovir and Entecavir for Elderly With Chronic Hepatitis B
Official title: Efficacy and Safety Study of Adefovir and Entecavir for Elderly With Chronic Hepatitis B
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatitis B, Chronic
Keywords: Aged
Hepatitis B, Chronic
Antiviral Agents
Lead sponsor: Beijing 302 Hospital
Sponsor class: OTHER
First posted: 2014-03-03
Enrollment: 242
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

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.


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

Primary outcomes:
measure: the rates of serum HBVDNA undetectable and Renal dysfunction
timeFrame: 3years
Secondary outcomes:
measure: the rate of normalisation of ALT
timeFrame: at week 2、4、12、24、36、48、60、72、84、96
measure: the rate of HBsAg negative
timeFrame: at week48、96、144
measure: the rate of HBeAg seroconversion
timeFrame: at week 24、48、72、96、120、144
measure: the rate of HBeAg negative
timeFrame: at week 24、48、72、96、120、144
Other outcomes:
Locations:
city: Beijing
country: China
facility: 302 military hospital of China
state: Beijing
Study officials:
affiliation: Beijing 302 Hospital
name: Ying-Jie Ji, MD.
role: PRINCIPAL_INVESTIGATOR
References: