NCT01128686CompletedNot Applicable
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
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- ViiV Healthcare
- Enrollment
- 1
- Locations
- 1
- Primary Endpoint
- Proportion of subjects showing HBV DNA negativity at 5 years of LAM treatment
Study Overview
Brief Summary
This is to evaluate the proportion of subjects who show good responses to LAM treatment in Korea.
Detailed Description
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 20 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Proportion of subjects showing HBV DNA negativity at 5 years of LAM treatment
Time Frame: 5years
Secondary Outcomes
- 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)
- Proportion of subjects showing HBV DNA negativity during first 4 years of LAM treatment(4 years)
- Proportion of subjects showing ALT normalization during 5 years of LAM treatment(5 years)
- Cumulative proportion of subjects showing resistant mutation during 5 years of LAM treatment(5 years)
- Cumulative proportion of subjects showing HBeAg loss during 5 years of LAM treatment(5 years)
Investigators
Study Sites (1)
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