Lamivudine(LAM) Good Responder Study

Completed

• Conditions: Hepatitis B, Chronic
• Interventions: Other: No intervention

• Registration Number: NCT01128686
• Lead Sponsor: ViiV Healthcare

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 Timeline

• Study First Submitted: 2010-05-20
• Study First Submitted QC: 2010-05-21
• Study First Posted: 2010-05-24
• Study Start: 2010-08
• Primary Completion: 2011-06
• Study Completion: 2011-06
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-12
• Last Update Posted: 2016-09-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
CHB patients who started LAM as an initial antiviral treatment	No intervention	CHB patients who started LAM as an initial antiviral treatment at least 5 years prior to this investigation

Primary Outcome Measures

Name	Time	Method
Proportion of subjects showing HBV DNA negativity at 5 years of LAM treatment	5years

Secondary Outcome Measures

Name	Time	Method
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
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

Trial Locations

Locations (1)

GSK Investigational Site; 🇰🇷 Kangwon-do, Korea, Republic of