Hepatitis B, ChronicLAMGRNCT01128686
Lamivudine(LAM) Good Responder Study
An observational study of Hepatitis B, Chronic, run by ViiV Healthcare at 1 site in South Korea.
Trial summary
This is to evaluate the proportion of subjects who show good responses to LAM treatment in Korea. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Hepatitis B, Chronic
- How many people
- 1 participants
- Where
- 1 siteSouth Korea
- Study dates
- Aug 2010to Jun 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: CHB patients who started LAM as an initial antiviral treatment at least 5 years prior to this investigation in General Hospital
Who may be able to join
- 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
- HBsAg positive at least for 6 months at the beginning of observation
- HBV DNA positive before LAM administration
- 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
Who cannot join
- Documented co-infection with HCV, HIV at the beginning of LAM treatment
- Decompensated liver cirrhosis at the beginning of LAM treatment
- HCC at the beginning of LAM treatment
Trial locations and contacts
1 site in 1 country.
About this study
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
This is to evaluate the proportion of subjects who show good responses to LAM treatment in Korea.
Read the 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.
- Conditions
- Hepatitis B, Chronic
- Being tested
- No intervention
- Keywords
- retrospective, naïve Chronic Hepatitis B (CHB) patients, cohort study, lamivudine
- Medical subject headings
- Hepatitis B, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
This study is retrospective chart review
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects showing HBV DNA negativity at 5 years of LAM treatment
Measured: 5years
Secondary outcomes (6)
Proportion of subjects showing HBV DNA negativity during first 4 years of LAM treatment
Measured: 4 years
Proportion of subjects showing HBV DNA less than 4 log copies per ml during 5 years of LAM treatment
Measured: 5 years
Cumulative proportion of subjects showing HBeAg seroconversion during 5 years of LAM treatment
Measured: 5 years
Cumulative proportion of subjects showing HBeAg loss during 5 years of LAM treatment
Measured: 5 years
Proportion of subjects showing ALT normalization during 5 years of LAM treatment
Measured: 5 years
Cumulative proportion of subjects showing resistant mutation during 5 years of LAM treatment
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2010 (estimated)
- Study startAug 2010
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis B, ChronicStudies of the same condition, open and under way.
- More trials run by ViiV HealthcareThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- ViiV Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- GlaxoSmithKline
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, ViiV Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01128686
- Sponsor's protocol ID
- 113973
- Acronym
- LAMGR
- Status last verified
- Sep 2016
- First submitted
- 20 May 2010
- Last updated
- 13 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01128686
- Acronym / sponsor ID
- LAMGR / 113973
- Conditions
- Hepatitis B, Chronic
- Keywords
- retrospective, naïve Chronic Hepatitis B (CHB) patients, cohort study, lamivudine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- ViiV HealthcareIndustry (pharma, biotech, devices)
- Collaborators
- GlaxoSmithKline
- Study start
- Aug 2010
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 24 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CHB patients who started LAM as an initial antiviral treatment | – | Other: No interventionCHB patients who started LAM as an initial antiviral treatment at least 5 years prior to this investigation |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- CHB patients who started LAM as an initial antiviral treatment at least 5 years prior to this investigation in General Hospital
Key inclusion criteria (4 listed)
- 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
- HBsAg positive at least for 6 months at the beginning of observation
- HBV DNA positive before LAM administration
- 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
Key exclusion criteria (3 listed)
- Documented co-infection with HCV, HIV at the beginning of LAM treatment
- Decompensated liver cirrhosis at the beginning of LAM treatment
- HCC at the beginning of LAM treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionThis study is retrospective chart review | Other | CHB patients who started LAM as an initial antiviral treatment |
Primary outcome
Proportion of subjects showing HBV DNA negativity at 5 years of LAM treatment
Time frame: 5years
6 secondary outcomes
Proportion of subjects showing HBV DNA negativity during first 4 years of LAM treatment
Time frame: 4 years
Proportion of subjects showing HBV DNA less than 4 log copies per ml during 5 years of LAM treatment
Time frame: 5 years
Cumulative proportion of subjects showing HBeAg seroconversion during 5 years of LAM treatment
Time frame: 5 years
Cumulative proportion of subjects showing HBeAg loss during 5 years of LAM treatment
Time frame: 5 years
Proportion of subjects showing ALT normalization during 5 years of LAM treatment
Time frame: 5 years
Cumulative proportion of subjects showing resistant mutation during 5 years of LAM treatment
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
ViiV Healthcare
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatitis B, Chronic, run by ViiV Healthcare at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of subjects showing HBV DNA negativity at 5 years of LAM treatment (time frame: 5years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2016.