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Lamivudine(LAM) Good Responder Study (LAMGR)

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01128686
First received: May 20, 2010
Last updated: June 9, 2011
Last verified: June 2011
History of Changes
  Purpose

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


Condition Intervention
Hepatitis B, Chronic
 Other: No intervention

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
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

Resource links provided by NLM:

Drug Information available for: Lamivudine
U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Proportion of subjects showing HBV DNA negativity at 5 years of LAM treatment [ Time Frame: 5years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of subjects showing HBV DNA negativity during first 4 years of LAM treatment [ Time Frame: 4 years ] [ Designated as safety issue: No ]
  • Proportion of subjects showing HBV DNA less than 4 log copies per ml during 5 years of LAM treatment [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Cumulative proportion of subjects showing HBeAg seroconversion during 5 years of LAM treatment [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Cumulative proportion of subjects showing HBeAg loss during 5 years of LAM treatment [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Proportion of subjects showing ALT normalization during 5 years of LAM treatment [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Cumulative proportion of subjects showing resistant mutation during 5 years of LAM treatment [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Enrollment: 1
Study Start Date: August 2010
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
CHB patients who started LAM as an initial antiviral treatment
CHB patients who started LAM as an initial antiviral treatment at least 5 years prior to this investigation
 Other: No intervention
This study is retrospective chart review

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

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01128686

Locations
Korea, Republic of
GSK Investigational Site
Kangwon-do, Korea, Republic of, 220-701
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT01128686     History of Changes
Other Study ID Numbers: 113973
Study First Received: May 20, 2010
Last Updated: June 9, 2011
Health Authority: Korea: Institutional Review Board

Keywords provided by GlaxoSmithKline:
A retrospective cohort study
naïve Chronic Hepatitis B (CHB) patients
good responses to lamivudine

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Hepatitis, Chronic
Hepatitis B, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
 DNA Virus Infections
Lamivudine
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Anti-HIV Agents

ClinicalTrials.gov processed this record on May 23, 2013