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Completed

NCT Number: NCT01128686

Lamivudine(LAM) Good Responder Study

This is to evaluate the proportion of subjects who show good responses to LAM treatment in Korea.

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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

20 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

GSK Investigational Site

Kangwon-do, 220-701, South Korea

About this study

This is to evaluate the proportion of subjects who show good responses to LAM treatment such as HBV DNA negativity, HBV DNA less than 4 log, no resistant mutation, HBeAg seroconversion and normalization of ALT in naïve CHB patients with certain pre-treatment characteristics, i.e. HBV DNA less than 9log copies per ml and ALT more than 2 times ULN in HBeAg positive subjects, HBV DNA less than 7log copies per ml and elevated ALT in HBeAg negative subjects.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • CHB or liver cirrhosis due to Hepatitis B virus who had started LAM between Jan 1, 2003 and Dec 31, 2004 and maintained LAM at least 6 months
  • HBsAg positive at least for 6 months at the beginning of observation
  • HBV DNA positive before LAM administration
  • Subjects with certain pre-treatment laboratory findings as follows; HBV DNA less than 9log copies per ml and ALT more than 2 times ULN in HBeAg positive patients, HBV DNA less than 7log copies per ml and elevated ALT in HBeAg negative patients

Exclusion criteria

  • Documented co-infection with HCV, HIV at the beginning of LAM treatment
  • Decompensated liver cirrhosis at the beginning of LAM treatment
  • HCC at the beginning of LAM treatment

Treatment and study plan

No intervention

Other

This study is retrospective chart review

Primary outcomes

  1. Proportion of subjects showing HBV DNA negativity at 5 years of LAM treatment

    Time frame: 5years

Secondary outcomes

  1. Proportion of subjects showing HBV DNA negativity during first 4 years of LAM treatment

    Time frame: 4 years

  2. Proportion of subjects showing HBV DNA less than 4 log copies per ml during 5 years of LAM treatment

    Time frame: 5 years

  3. Cumulative proportion of subjects showing HBeAg seroconversion during 5 years of LAM treatment

    Time frame: 5 years

  4. Cumulative proportion of subjects showing HBeAg loss during 5 years of LAM treatment

    Time frame: 5 years

  5. Proportion of subjects showing ALT normalization during 5 years of LAM treatment

    Time frame: 5 years

  6. Cumulative proportion of subjects showing resistant mutation during 5 years of LAM treatment

    Time frame: 5 years

Sponsors and collaborators

Lead sponsor

ViiV Healthcare

Industry

Collaborators

  • GlaxoSmithKline

Registry information

Official study title

A Retrospective Cohort Study to Evaluate the Rate of Good Responses to Lamivudine (LAM) Treatment in naïve Chronic Hepatitis B (CHB) Patients With Certain Pre-treatment Characteristics

Acronym: LAMGR

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
May 24, 2010
Registry last updated
Sep 13, 2016

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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