CHRONIC HEPATITIS BPhase 4NCT00354653
A Trial To Study The Effect Of Lamivudine In Adult Patients Who Suffer From Chronic Hepatitis B Alone
A Phase 4 study testing LAMIVUDINE in people with CHRONIC HEPATITIS B, run by ViiV Healthcare at 1 site in Iran.
Trial summary
The efficacy of lamivudine in Hepatitis Be Antigen (HBeAg) positive Asian patients of chronic hepatitis has been well established.The evidence in HBeAg negative patients is limited. Limited sustained response was observed post-treatment following a one year treatment period. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- CHRONIC HEPATITIS B
- What is being tested?
- LAMIVUDINE
- How many people
- 100 participants
- Where
- 1 siteIran
- Study dates
- 9 Feb 2002to 23 Jan 2007
- Phase
- Phase 4
- 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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Confirmed active liver disease due to Hepatitis B virus.
- Patients must have adequate blood \& liver functions.
- Female patients of child-bearing potential must be non pregnant and willing to abstain from intercourse from 2 weeks prior to administration of the first dose of study medication until 28 days after the final dose of study medication or be willing to consistently and correctly use an acceptable method of birth control.
- Patients who have serious concurrent illnesses other than hepatitis B like cancer, severe heart disease, uncontrolled diabetes mellitus or AIDS will not be eligible.
Who cannot join
- Persons allergic to lamivudine or suffering from hepatitis C, D or E infection or taking alcohol will not be eligible.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: AN OPEN STUDY OF LAMIVUDINE TREATMENT IN ADULT HBeAg NEGATIVE (Presumed Pre-core Mutant) CHRONIC HEPATITIS B PATIENTS IN IRAN.
The efficacy of lamivudine in Hepatitis Be Antigen (HBeAg) positive Asian patients of chronic hepatitis has been well established.The evidence in HBeAg negative patients is limited. Limited sustained response was observed post-treatment following a one year treatment period. Whether these results can be applied to patients in Iran is uncertain. This study is therefore intended to further assess the efficacy profile after two years of open treatment in the adult Iranian population.
- Conditions
- CHRONIC HEPATITIS B
- Being tested
- LAMIVUDINE
- Keywords
- HBeAg, HBV, CHRONIC HEPATITIS, lamivudine
- Medical subject headings
- Hepatitis B, Chronic, Hepatitis, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LAMIVUDINEDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete virologic response at Month 24 which is normalisation of alanine aminotransferase (ALT) and disappearance of HBV DNA by NAXCOR(brand name of a virus assay kit)
Secondary outcomes (1)
Partial response, histological improvement (at 24 months). Sustained complete response, sustained partial response at 30 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2006 (estimated)
- Study start9 Feb 2002
- Primary completion23 Jan 2007
- Study completion23 Jan 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CHRONIC HEPATITIS BStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants
Sponsor and investigators
- Lead sponsor
- ViiV Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, MD, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00354653
- Sponsor's protocol ID
- NUC 30956
- Status last verified
- Feb 2020
- First submitted
- 19 Jul 2006
- Last updated
- 3 Mar 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AN OPEN STUDY OF LAMIVUDINE TREATMENT IN ADULT HBeAg NEGATIVE (Presumed Pre-core Mutant) CHRONIC HEPATITIS B PATIENTS IN IRAN.
- ClinicalTrials.gov ID
- NCT00354653
- Acronym / sponsor ID
- NUC 30956
- Conditions
- CHRONIC HEPATITIS B
- Keywords
- HBeAg, HBV, CHRONIC HEPATITIS, lamivudine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants
- Lead sponsor
- ViiV HealthcareIndustry (pharma, biotech, devices)
- Study start
- 9 Feb 2002 (actual)
- Primary completion
- 23 Jan 2007 (actual)
- Study completion
- 23 Jan 2007 (actual)
- First posted
- 20 Jul 2006 (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.
The efficacy of lamivudine in Hepatitis Be Antigen (HBeAg) positive Asian patients of chronic hepatitis has been well established.The evidence in HBeAg negative patients is limited. Limited sustained response was observed post-treatment following a one year treatment period. Whether these results can be applied to patients in Iran is uncertain. This study is therefore intended to further assess the efficacy profile after two years of open treatment in the adult Iranian population.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Confirmed active liver disease due to Hepatitis B virus.
- Patients must have adequate blood \& liver functions.
- Female patients of child-bearing potential must be non pregnant and willing to abstain from intercourse from 2 weeks prior to administration of the first dose of study medication until 28 days after the final dose of study medication or be willing to consistently and correctly use an acceptable method of birth control.
- Patients who have serious concurrent illnesses other than hepatitis B like cancer, severe heart disease, uncontrolled diabetes mellitus or AIDS will not be eligible.
Key exclusion criteria (1 listed)
- Persons allergic to lamivudine or suffering from hepatitis C, D or E infection or taking alcohol will not be eligible.
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 |
|---|---|---|
| LAMIVUDINE | Drug | – |
Primary outcome
Complete virologic response at Month 24 which is normalisation of alanine aminotransferase (ALT) and disappearance of HBV DNA by NAXCOR(brand name of a virus assay kit)
1 secondary outcome
Partial response, histological improvement (at 24 months). Sustained complete response, sustained partial response at 30 months.
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 3 Mar 2020.
Related trials for CHRONIC HEPATITIS B
Active, not recruitingPhase 2
A Study of Sequential Therapy With Daplusiran/Tomligisiran (DAP/TOM) Followed by Bepirovirsen in Participants Living With Chronic Hepatitis B (CHB)
Chronic Hepatitis B Virus Infection, Hepatitis B
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Evaluation of Patients With Liver Disease
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Study of Bepirovirsen in Participants Living With Human Immunodeficiency Virus and Chronic Hepatitis B Virus Infection (B-Focus)
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Active, not recruitingPhase 2
Long-term Follow-up Study to Evaluate Durability of Treatment Response in Previous Bepirovirsen Study Participants (B-Sure)
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A Phase I Clinical Trial of CPU-YL01 Injection in Patients With Chronic Hepatitis B.
Chronic Hepatitis B
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, MD study director
GlaxoSmithKline
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing LAMIVUDINE in people with CHRONIC HEPATITIS B, run by ViiV Healthcare at 1 site in Iran.
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 1 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 3 Mar 2020. 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 Iran. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Complete virologic response at Month 24 which is normalisation of alanine aminotransferase (ALT) and disappearance of HBV DNA by NAXCOR(brand name of a virus assay kit). 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 3 Mar 2020.