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

NCT02075294 | Completed DMC

• 1 other identifier: YNKT201313
• Study Type: observational
• Target: 242
• Locations: 1 country
• Sites: 1

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

Keywords

Aged; Hepatitis B, Chronic; Antiviral Agents

Outcome Measures

Primary Outcomes (1)

• the rates of serum HBVDNA undetectable and Renal dysfunction

  3years

Secondary Outcomes (4)

• the rate of normalisation of ALT

  at week 2、4、12、24、36、48、60、72、84、96

• the rate of HBsAg negative

  at week48、96、144

• the rate of HBeAg seroconversion

  at week 24、48、72、96、120、144

• the rate of HBeAg negative

  at week 24、48、72、96、120、144

Study Arms (3)

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.

Drug: Adefovir dipivoxil or Entecavir

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.

Drug: Adefovir dipivoxil or Entecavir

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.

Drug: Adefovir dipivoxil or Entecavir

Interventions

Adefovir dipivoxil or Entecavir 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

Also known as: ADV, Hepsera,, ETV, Baraclude

elderly; middle age; youth

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Age≥18 years
• HBsAg positive for more than 6 months before enrollment
• Serum HBVDNA \>2×104IU/ml and serum ALT \>80U/L or TBIL \< 34 umol/L for chronic hepatitis B
• Serum ALT \< 80U/L, but hepatic inflammation scores ≥ G2 or hepatic fibrosis stage ≥ S2 for chronic hepatitis B
• Serum HBVDNA \>40 IU/ml for cirrhosis regardless of ALT and TBIL

You may not qualify if:

• Co-infected with HCV, HDV or HIV, or autoimmune liver diseases combined
• received antiviral therapy or immunosuppressant drugs before 6 months prior to enrollment
• Renal function: creatinine \>1.5 ULN or eGFR\< 50ml/min/1.73m2 before therapy
• Combined with hepatocarcinoma before therapy
• suspend therapy voluntarily
• use other nephrotoxic drugs

Sponsors & Collaborators

• Ying-Jie Ji: lead

Study Sites (1)

302 military hospital of China

Beijing, Beijing Municipality, 100039, China

Location

Related Links

• Click here for more recruit information about this study

MeSH Terms

Conditions

Hepatitis B, Chronic

Interventions

adefovir dipivoxil; entecavir

Condition Hierarchy (Ancestors)

Hepatitis B; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ying-Jie Ji, MD.

  Beijing 302 Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: February 27, 2014
• First Posted: March 3, 2014
• Study Start: January 1, 2010
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: October 28, 2014

Record last verified: 2014-10

Locations

CN (1)