Lamivudine(LAM) Good Responder Study

Hepatitis B, Chronic Clinical Trial

— LAMGR  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01128686
• Other study ID #: 113973
• Status: Completed
• Phase: N/A
• First received: May 20, 2010
• Last updated: September 12, 2016
• Start date: August 2010
• Est. completion date: June 2011

Study information

• Verified date: September 2016
• Source: ViiV Healthcare
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B, Chronic

Intervention

Other:
• No intervention
This study is retrospective chart review

Locations

Country	Name	City	State
Korea, Republic of	GSK Investigational Site	Kangwon-do

Sponsors (2)

Lead Sponsor	Collaborator
ViiV Healthcare	GlaxoSmithKline

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of subjects showing HBV DNA negativity at 5 years of LAM treatment		5years	No
Secondary	Proportion of subjects showing HBV DNA negativity during first 4 years of LAM treatment		4 years	No
Secondary	Proportion of subjects showing HBV DNA less than 4 log copies per ml during 5 years of LAM treatment		5 years	No
Secondary	Cumulative proportion of subjects showing HBeAg seroconversion during 5 years of LAM treatment		5 years	No
Secondary	Cumulative proportion of subjects showing HBeAg loss during 5 years of LAM treatment		5 years	No
Secondary	Proportion of subjects showing ALT normalization during 5 years of LAM treatment		5 years	No
Secondary	Cumulative proportion of subjects showing resistant mutation during 5 years of LAM treatment		5 years	No