Hepatitis B, ChronicPhase 4NCT00625560
Continuing Lamivudine vs Switching to Entecavir in Patients With Detectable HBV DNA
A Phase 4 study testing Entecavir and Lamivudine in people with Hepatitis B, Chronic, run by Yonsei University at 2 sites in South Korea.
Trial summary
This is a randomized, open-labelled, prospective 96-week study comparing the antiviral efficacy and safety of switching to entecavir 1 mg QD from lamivudine versus maintaining lamivudine 100 mg QD treatment in HBV-infected subjects currently receiving lamivudine monotherapy. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hepatitis B, Chronic
- What is being tested?
- Entecavir and Lamivudine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 2 sitesSouth Korea
- Study dates
- Feb 2008to Nov 2010
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult subjects (18-70 years of age) currently taking lamivudine monotherapy for chronic HBV infection for at least 6 months with ≥ HBV DNA 60 IU/mL level and HBeAg positive at baseline.
Who cannot join
- All subjects will be tested for presence of M204V/I mutations in the YMDD motif at baseline. Subjects with M204V/I mutations in the YMDD motif at baseline are not eligible for the study.
- Subjects treated with other antiviral drugs (e.g. adefovir) in combination with lamivudine are not eligible for this study.
- Subjects should have ALT < 10 x ULN, and no evidence of hepatocellular carcinoma.
- Subjects should be without serological evidence of co-infection with HCV, HIV, or HDV.
- Subjects with decompensated liver disease, as well as pregnant or breast-feeding women, will not be eligible for the study.
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites
Pusan National University School of Medicine
Busan, Busan, 602-739
Severance Hospital
Seoul, Seoul, 120-752
About this study
Official title: Randomized, Open-Labelled Study Evaluating the Antiviral Efficacy, Safety, and Tolerability of Continuing Lamivudine Therapy or Switching to Entecavir in Subjects With Chronic Hepatitis B With Detectable HBV DNA
This is a randomized, open-labelled, prospective 96-week study comparing the antiviral efficacy and safety of switching to entecavir 1 mg QD from lamivudine versus maintaining lamivudine 100 mg QD treatment in HBV-infected subjects currently receiving lamivudine monotherapy.
Read the detailed description
Entecavir has a higher potent antiviral efficacy and a lower drug resistance rate than Lamivudine in nucleoside-naïve CHB patients. The prompt switch from Lamivudine to Entecavir in patients who have insufficient hepatitis B virus suppression (HBV DNA ≥ 60 IU/mL by PCR) may lead to full viral suppression to undetectable level by PCR method. The prompt switch from Lamivudine to Entecavir in patients who have insufficient hepatitis B virus suppression (HBV DNA ≥ 60 IU/mL) may preclude development of drug resistance. The results of this study will provide a rationale for switch treatment from one antiviral to another one, especially from LAM to ETV.
- Conditions
- Hepatitis B, Chronic
- Being tested
- Entecavir, Lamivudine
- Keywords
- Chronic hepatitis B, Lamivudine, Entecavir
- 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.
EntecavirDrug
Also called Baraclude 1.0mg
entecavir 1.0 mg QD
LamivudineDrug
Also called Zeffix 100mg
lamivudine 100 mg QD
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | entecavir 1.0 mg QD Receives: Drug: Entecavir |
| B | Active comparator | lamivudine 100 mg QD Receives: Drug: Lamivudine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage number of patients with HBV DNA < 60 IU/mL (Undetectable serum HBV DNA by PCR method) while on randomized therapy
Measured: at Week 96
Secondary outcomes (5)
Percentage number of patients with HBV DNA < 60 IU/mL while on randomized therapy
Measured: at Week 48
Percentage number of patients who developed drug resistant mutations while on randomized therapy
Measured: at Week 48 and Week 96
Change from baseline in mean HBV DNA
Measured: at Week 48 and 96
Percentage number of patients who achieved ALT normalization, HBeAg loss, HBe seroconversion, HBsAg loss and HBs seroconversion
Measured: at Week 48 and 96
Cumulative discontinuation rates due to lamivudine or entecavir resistance mutations and clinical breakthrough Safety assessment
Measured: Follow up period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2008 (estimated)
- Study startFeb 2008
- Primary completionNov 2009
- Study completionNov 2010
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 Yonsei UniversityThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Collaborators
- Pusan National University Hospital
- Responsible party
- Principal investigator, Sang Hoon Ahn, Yonsei University
- Investigators
- Sang Hoon Ahn, M.D.Ph.D, Study chair, Yonsei Univsersity College of MedicineDo Young Kim, M.D., Study director, Yonsei UniversityJun Yong Park, M.D, Principal investigator, Yonsei UniversityJeong Heo, M.D.Ph.D, Study director, Pusan National University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00625560
- Sponsor's protocol ID
- 4-2007-0351
- Status last verified
- May 2012
- First submitted
- 11 Feb 2008
- Last updated
- 8 May 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Open-Labelled Study Evaluating the Antiviral Efficacy, Safety, and Tolerability of Continuing Lamivudine Therapy or Switching to Entecavir in Subjects With Chronic Hepatitis B With Detectable HBV DNA
- ClinicalTrials.gov ID
- NCT00625560
- Acronym / sponsor ID
- 4-2007-0351
- Conditions
- Hepatitis B, Chronic
- Keywords
- Chronic hepatitis B, Lamivudine, Entecavir
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Collaborators
- Pusan National University Hospital
- Study start
- Feb 2008
- Primary completion
- Nov 2009 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 28 Feb 2008 (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 a randomized, open-labelled, prospective 96-week study comparing the antiviral efficacy and safety of switching to entecavir 1 mg QD from lamivudine versus maintaining lamivudine 100 mg QD treatment in HBV-infected subjects currently receiving lamivudine monotherapy.
Detailed description
Entecavir has a higher potent antiviral efficacy and a lower drug resistance rate than Lamivudine in nucleoside-naïve CHB patients. The prompt switch from Lamivudine to Entecavir in patients who have insufficient hepatitis B virus suppression (HBV DNA ≥ 60 IU/mL by PCR) may lead to full viral suppression to undetectable level by PCR method. The prompt switch from Lamivudine to Entecavir in patients who have insufficient hepatitis B virus suppression (HBV DNA ≥ 60 IU/mL) may preclude development of drug resistance. The results of this study will provide a rationale for switch treatment from one antiviral to another one, especially from LAM to ETV.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: Entecavirentecavir 1.0 mg QD |
| B | Active comparator | Drug: Lamivudinelamivudine 100 mg QD |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult subjects (18-70 years of age) currently taking lamivudine monotherapy for chronic HBV infection for at least 6 months with ≥ HBV DNA 60 IU/mL level and HBeAg positive at baseline.
Key exclusion criteria (5 listed)
- All subjects will be tested for presence of M204V/I mutations in the YMDD motif at baseline. Subjects with M204V/I mutations in the YMDD motif at baseline are not eligible for the study.
- Subjects treated with other antiviral drugs (e.g. adefovir) in combination with lamivudine are not eligible for this study.
- Subjects should have ALT < 10 x ULN, and no evidence of hepatocellular carcinoma.
- Subjects should be without serological evidence of co-infection with HCV, HIV, or HDV.
- Subjects with decompensated liver disease, as well as pregnant or breast-feeding women, will not be eligible for the study.
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 |
|---|---|---|
| EntecavirAlso: Baraclude 1.0mgentecavir 1.0 mg QD | Drug | A |
| LamivudineAlso: Zeffix 100mglamivudine 100 mg QD | Drug | B |
Primary outcome
Percentage number of patients with HBV DNA < 60 IU/mL (Undetectable serum HBV DNA by PCR method) while on randomized therapy
Time frame: at Week 96
5 secondary outcomes
Percentage number of patients with HBV DNA < 60 IU/mL while on randomized therapy
Time frame: at Week 48
Percentage number of patients who developed drug resistant mutations while on randomized therapy
Time frame: at Week 48 and Week 96
Change from baseline in mean HBV DNA
Time frame: at Week 48 and 96
Percentage number of patients who achieved ALT normalization, HBeAg loss, HBe seroconversion, HBsAg loss and HBs seroconversion
Time frame: at Week 48 and 96
Cumulative discontinuation rates due to lamivudine or entecavir resistance mutations and clinical breakthrough Safety assessment
Time frame: Follow up period
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 8 May 2012.
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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.
Sang Hoon Ahn, M.D.Ph.D study chair
Yonsei Univsersity College of Medicine
Do Young Kim, M.D. study director
Yonsei University
Jun Yong Park, M.D principal investigator
Yonsei University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Entecavir and Lamivudine in people with Hepatitis B, Chronic, run by Yonsei University at 2 sites 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 1 inclusion and 5 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 8 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
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?
Percentage number of patients with HBV DNA < 60 IU/mL (Undetectable serum HBV DNA by PCR method) while on randomized therapy (time frame: at Week 96). 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 8 May 2012.