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Completed

NCT Number: NCT02075294

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

302 military hospital of China

Beijing, Beijing Municipality, 100039, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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

Other names: ADV, Hepsera,, ETV, Baraclude

Primary outcomes

  1. the rates of serum HBVDNA undetectable and Renal dysfunction

    Time frame: 3years

Secondary outcomes

  1. the rate of normalisation of ALT

    Time frame: at week 2、4、12、24、36、48、60、72、84、96

  2. the rate of HBsAg negative

    Time frame: at week48、96、144

  3. the rate of HBeAg seroconversion

    Time frame: at week 24、48、72、96、120、144

  4. the rate of HBeAg negative

    Time frame: at week 24、48、72、96、120、144

Sponsors and collaborators

Lead sponsor

Ying-Jie Ji

Other

Registry information

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Mar 3, 2014
Registry last updated
Oct 28, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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