Clinical trial NCT01128686: Lamivudine(LAM) Good Responder Study
Official 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatitis B, Chronic
Keywords: retrospective
naïve Chronic Hepatitis B (CHB) patients
cohort study
lamivudine
Lead sponsor: ViiV Healthcare
Sponsor class: INDUSTRY
Collaborators: name: GlaxoSmithKline
First posted: 2010-05-24
Enrollment: 1
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: CHB patients who started LAM as an initial antiviral treatment at least 5 years prior to this investigation in General Hospital

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.

Eligibility criteria: Inclusion Criteria:

1. 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
2. HBsAg positive at least for 6 months at the beginning of observation
3. HBV DNA positive before LAM administration
4. 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:

1. Documented co-infection with HCV, HIV at the beginning of LAM treatment
2. Decompensated liver cirrhosis at the beginning of LAM treatment
3. HCC at the beginning of LAM treatment

Primary outcomes:
measure: Proportion of subjects showing HBV DNA negativity at 5 years of LAM treatment
timeFrame: 5years
Secondary outcomes:
measure: Proportion of subjects showing HBV DNA negativity during first 4 years of LAM treatment
timeFrame: 4 years
measure: Proportion of subjects showing HBV DNA less than 4 log copies per ml during 5 years of LAM treatment
timeFrame: 5 years
measure: Cumulative proportion of subjects showing HBeAg seroconversion during 5 years of LAM treatment
timeFrame: 5 years
measure: Cumulative proportion of subjects showing HBeAg loss during 5 years of LAM treatment
timeFrame: 5 years
measure: Proportion of subjects showing ALT normalization during 5 years of LAM treatment
timeFrame: 5 years
measure: Cumulative proportion of subjects showing resistant mutation during 5 years of LAM treatment
timeFrame: 5 years
Other outcomes:
Locations:
city: Kangwon-do
country: Korea, Republic of
facility: GSK Investigational Site
Study officials:
affiliation: ViiV Healthcare
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: