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Lamivudine(LAM) Good Responder Study | Clinical Trials | Clareo Health

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COMPLETEDNCT01128686

Lamivudine(LAM) Good Responder Study

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

Lead sponsor: ViiV Healthcare•1 locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

ViiV Healthcare

Collaborators

GlaxoSmithKline

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.

Age

20 - No limit years

Sex

ALL

Healthy Volunteers

No

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

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: September 13, 2016Terms

Trial snapshot

StatusCOMPLETED

Phase—

Enrollment1

Start dateAug 2010

Last updatedSep 13, 2016

Condition

Hepatitis B, Chronic

Locations shown

GSK Investigational Site

Kangwon-do

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 13, 2016Data synced to Clareo: May 25, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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