Lamivudine(LAM) Good Responder Study
LAMGR
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
1 other identifier
observational
1
1 country
1
Brief Summary
This is to evaluate the proportion of subjects who show good responses to LAM treatment in Korea.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Aug 2010
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 20, 2010
CompletedFirst Posted
Study publicly available on registry
May 24, 2010
CompletedStudy Start
First participant enrolled
August 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2011
CompletedSeptember 13, 2016
September 1, 2016
10 months
May 20, 2010
September 12, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Proportion of subjects showing HBV DNA negativity at 5 years of LAM treatment
5years
Secondary Outcomes (6)
Proportion of subjects showing HBV DNA negativity during first 4 years of LAM treatment
4 years
Proportion of subjects showing HBV DNA less than 4 log copies per ml during 5 years of LAM treatment
5 years
Cumulative proportion of subjects showing HBeAg seroconversion during 5 years of LAM treatment
5 years
Cumulative proportion of subjects showing HBeAg loss during 5 years of LAM treatment
5 years
Proportion of subjects showing ALT normalization during 5 years of LAM treatment
5 years
- +1 more secondary outcomes
Study Arms (1)
CHB patients who started LAM as an initial antiviral treatment
CHB patients who started LAM as an initial antiviral treatment at least 5 years prior to this investigation
Interventions
This study is retrospective chart review
Eligibility Criteria
CHB patients who started LAM as an initial antiviral treatment at least 5 years prior to this investigation in General Hospital
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- ViiV Healthcarelead
- GlaxoSmithKlinecollaborator
Study Sites (1)
GSK Investigational Site
Kangwon-do, 220-701, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
ViiV Healthcare
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 20, 2010
First Posted
May 24, 2010
Study Start
August 1, 2010
Primary Completion
June 1, 2011
Study Completion
June 1, 2011
Last Updated
September 13, 2016
Record last verified: 2016-09