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Lamivudine(LAM) Good Responder Study (LAMGR)

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ClinicalTrials.gov Identifier: NCT01128686
Recruitment Status : Completed
First Posted : May 24, 2010
Last Update Posted : September 13, 2016
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
ViiV Healthcare

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

Condition or disease Intervention/treatment
Hepatitis B, Chronic Other: No intervention

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 Type : Observational
Actual Enrollment : 1 participants
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
Study Start Date : August 2010
Actual Primary Completion Date : June 2011
Actual Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Lamivudine

Group/Cohort Intervention/treatment
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




Primary Outcome Measures :
  1. Proportion of subjects showing HBV DNA negativity at 5 years of LAM treatment [ Time Frame: 5years ]

Secondary Outcome Measures :
  1. Proportion of subjects showing HBV DNA negativity during first 4 years of LAM treatment [ Time Frame: 4 years ]
  2. Proportion of subjects showing HBV DNA less than 4 log copies per ml during 5 years of LAM treatment [ Time Frame: 5 years ]
  3. Cumulative proportion of subjects showing HBeAg seroconversion during 5 years of LAM treatment [ Time Frame: 5 years ]
  4. Cumulative proportion of subjects showing HBeAg loss during 5 years of LAM treatment [ Time Frame: 5 years ]
  5. Proportion of subjects showing ALT normalization during 5 years of LAM treatment [ Time Frame: 5 years ]
  6. Cumulative proportion of subjects showing resistant mutation during 5 years of LAM treatment [ Time Frame: 5 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01128686


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

Responsible Party: ViiV Healthcare
ClinicalTrials.gov Identifier: NCT01128686     History of Changes
Other Study ID Numbers: 113973
First Posted: May 24, 2010    Key Record Dates
Last Update Posted: September 13, 2016
Last Verified: September 2016

Keywords provided by ViiV Healthcare:
retrospective
naïve Chronic Hepatitis B (CHB) patients
cohort study
lamivudine

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
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
Hepatitis, Chronic
Lamivudine
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Anti-HIV Agents