Chronic Hepatitis BPhase 2NCT01026610
Safety and Efficacy Study of LB80380 in the Treatment-naive Patients of Chronic Hepatitis B
A Phase 2 study testing LB80380 90 mg, LB80380 150 mg and entecavir 0.5 mg in people with Chronic Hepatitis B, run by LG Life Sciences at 10 sites in 2 countries.
Trial summary
The purpose of the study is to investigate the safety and the antiviral activity of two doses of LB80380 for 48 weeks in treatment-naive patients with chronic hepatitis B infection compared to entecavir 0.5 mg. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Hepatitis B
- What is being tested?
- LB80380 90 mg, LB80380 150 mg and entecavir 0.5 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 115 participants
- Where
- 10 sitesin 2 countries
- Study dates
- Aug 2009to May 2011
- Phase
- Phase 2
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female or male, 18 to 65 years of age, inclusive
- Chronic hepatitis B
- Not treated with anti-viral therapeutics including interferon or pegylated interferons for more than 12 weeks before Screening
- Not treated with anti-viral therapeutics including interferon or pegylated interferons 6 months within Screening
- Compensated chronic hepatitis B
- HBeAg positive or HBeAg negative
- Elevated serum ALT level (1.2-10 X ULN, inclusive)
Who cannot join
- Co-infection with hepatitis C or D virus (HCV or HDV) or HIV
- Decompensated liver disease
- Creatinine clearance (calculated by Cockroft-Gault formula) less than 50 ml/min
- Screening alpha-fetoprotein (AFP) value greater than or equal to 50 ng/mL, and a follow-up ultrasonography performed prior to baseline shows findings indicative of HCC
- Treatment with immunomodulatory agent or corticosteroids within 6 months prior to study entry.
- Pregnancy or breast-feeding
Show all 11Show fewer
- Patient is currently abusing alcohol or illicit drugs
- Significant systemic illnesses other than liver diseases
- Presence of other causes of liver disease
- A history of organ transplantation
- Presence of anti-HBs at screening
Trial locations and contacts
10 sites in 2 countries.
10 sites in 2 countries
South Korea9 sites
Kyungpook National University Hospital
Daegu
Hanyang University Guri Hospital
Guri-si, Gyeonggi-do
Inha University Hospital
Incheon, Inchen
Pusan National University Yangsan Hospital
Pusan
Kangnam Severance Hospital, Yonsei University
Seoul
Korea University Medical Center
Seoul
Severance Hospital of Yonsei University
Seoul
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul
Ulsan University Hospital
Ulsan
About this study
Official title: A Phase IIb, Open, Multinational, Multi-center, Randomised, Comparative, Parallel Study to Assess the Safety and Antiviral Activity of LB80380 Compared to Entecavir 0.5 mg in Chronic Hepatitis B Patients for 48 Weeks With a Planned Analysis of Efficacy and Safety at Week 24 of the Treatment for Selecting Optimal Dose
The purpose of the study is to investigate the safety and the antiviral activity of two doses of LB80380 for 48 weeks in treatment-naive patients with chronic hepatitis B infection compared to entecavir 0.5 mg.
Read the detailed description
LB80380, an oral prodrug, is a promising candidate nucleotide analogue with antiviral activity against wild-type HBV. LB80380 is undergoing clinical development by LG Life Sciences for use in the treatment of chronic HBV infection.
In this study, the treatment period is 48-week with 24-week of follow-up period.
- Conditions
- Chronic Hepatitis B
- Being tested
- LB80380 90 mg, LB80380 150 mg, entecavir 0.5 mg
- Keywords
- Chronic hepatitis B, LB80380, treatment-naive, 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.
LB80380 90 mgDrug
Also called LB80380
LB80380 90 mg + placebo tablets, once daily, for 48 weeks
LB80380 150 mgDrug
Also called LB80380
LB80380 60 mg + 90 mg tablets, once daily, for 48 weeks
entecavir 0.5 mgDrug
Also called Baraclude
entecavir 0.5 mg tablet, once daily, for 48 weeks
| Study group | Role | What they receive |
|---|---|---|
| LB80380 90 mg | Experimental | LB80380 90 mg (90 mg + placebo), once daily oral dose Receives: Drug: LB80380 90 mg |
| LB80380 150 mg | Experimental | LB80380 150 mg (60 mg + 90 mg), once daily oral dose Receives: Drug: LB80380 150 mg |
| entecavir 0.5 mg | Active comparator | entecavir 0.5 mg, once daily oral dose Receives: Drug: entecavir 0.5 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in HBV DNA level (log10) from baseline
Measured: At Week 24
Secondary outcomes (4)
Proportion of patients with undetectable serum HBV DNA
Measured: At Week 24 or Week 48
Proportion of patients with HBeAg seroconversion
Measured: At Week 24 or Week 48
Proportion of patients with ALT normalization
Measured: At Week 24 or Week 48
Safety assessment during the whole study period
Measured: At Week 24 or Week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2009 (estimated)
- Study startAug 2009
- Primary completionNov 2010
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Hepatitis BStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- LG Life Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01026610
- Sponsor's protocol ID
- BVCL007
- Status last verified
- Oct 2012
- First submitted
- 3 Dec 2009
- Last updated
- 5 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Fung J, Lai CL, Yuen MF. LB80380: a promising new drug for the treatment of chronic hepatitis B. Expert Opin Investig Drugs. 2008 Oct;17(10):1581-8. doi: 10.1517/13543784.17.10.1581.
PubMed 18808318Yuen MF, Lee SH, Kang HM, Kim CR, Kim J, Ngai V, Lai CL. Pharmacokinetics of LB80331 and LB80317 following oral administration of LB80380, a new antiviral agent for chronic hepatitis B (CHB), in healthy adult subjects, CHB patients, and mice. Antimicrob Agents Chemother. 2009 May;53(5):1779-85. doi: 10.1128/AAC.01290-08. Epub 2009 Feb 17.
PubMed 19223649
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IIb, Open, Multinational, Multi-center, Randomised, Comparative, Parallel Study to Assess the Safety and Antiviral Activity of LB80380 Compared to Entecavir 0.5 mg in Chronic Hepatitis B Patients for 48 Weeks With a Planned Analysis of Efficacy and Safety at Week 24 of the Treatment for Selecting Optimal Dose
- ClinicalTrials.gov ID
- NCT01026610
- Acronym / sponsor ID
- BVCL007
- Conditions
- Chronic Hepatitis B
- Keywords
- Chronic hepatitis B, LB80380, treatment-naive, entecavir
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- LG Life SciencesIndustry (pharma, biotech, devices)
- Study start
- Aug 2009
- Primary completion
- Nov 2010 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 4 Dec 2009 (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 purpose of the study is to investigate the safety and the antiviral activity of two doses of LB80380 for 48 weeks in treatment-naive patients with chronic hepatitis B infection compared to entecavir 0.5 mg.
Detailed description
LB80380, an oral prodrug, is a promising candidate nucleotide analogue with antiviral activity against wild-type HBV. LB80380 is undergoing clinical development by LG Life Sciences for use in the treatment of chronic HBV infection.
In this study, the treatment period is 48-week with 24-week of follow-up period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| LB80380 90 mg | Experimental | Drug: LB80380 90 mgLB80380 90 mg (90 mg + placebo), once daily oral dose |
| LB80380 150 mg | Experimental | Drug: LB80380 150 mgLB80380 150 mg (60 mg + 90 mg), once daily oral dose |
| entecavir 0.5 mg | Active comparator | Drug: entecavir 0.5 mgentecavir 0.5 mg, once daily oral dose |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Female or male, 18 to 65 years of age, inclusive
- Chronic hepatitis B
- Not treated with anti-viral therapeutics including interferon or pegylated interferons for more than 12 weeks before Screening
- Not treated with anti-viral therapeutics including interferon or pegylated interferons 6 months within Screening
- Compensated chronic hepatitis B
Key exclusion criteria (11 listed)
- Co-infection with hepatitis C or D virus (HCV or HDV) or HIV
- Decompensated liver disease
- Creatinine clearance (calculated by Cockroft-Gault formula) less than 50 ml/min
- Screening alpha-fetoprotein (AFP) value greater than or equal to 50 ng/mL, and a follow-up ultrasonography performed prior to baseline shows findings indicative of HCC
- Treatment with immunomodulatory agent or corticosteroids within 6 months prior to study entry.
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 |
|---|---|---|
| LB80380 90 mgAlso: LB80380LB80380 90 mg + placebo tablets, once daily, for 48 weeks | Drug | LB80380 90 mg |
| LB80380 150 mgAlso: LB80380LB80380 60 mg + 90 mg tablets, once daily, for 48 weeks | Drug | LB80380 150 mg |
| entecavir 0.5 mgAlso: Baracludeentecavir 0.5 mg tablet, once daily, for 48 weeks | Drug | entecavir 0.5 mg |
Primary outcome
Changes in HBV DNA level (log10) from baseline
Time frame: At Week 24
4 secondary outcomes
Proportion of patients with undetectable serum HBV DNA
Time frame: At Week 24 or Week 48
Proportion of patients with HBeAg seroconversion
Time frame: At Week 24 or Week 48
Proportion of patients with ALT normalization
Time frame: At Week 24 or Week 48
Safety assessment during the whole study period
Time frame: At Week 24 or Week 48
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 5 Oct 2012.
- Background: PubMed 18808318Fung J, Lai CL, Yuen MF. LB80380: a promising new drug for the treatment of chronic hepatitis B. Expert Opin Investig Drugs. 2008 Oct;17(10):1581-8. doi: 10.1517/13543784.17.10.1581.
- Background: PubMed 19223649Yuen MF, Lee SH, Kang HM, Kim CR, Kim J, Ngai V, Lai CL. Pharmacokinetics of LB80331 and LB80317 following oral administration of LB80380, a new antiviral agent for chronic hepatitis B (CHB), in healthy adult subjects, CHB patients, and mice. Antimicrob Agents Chemother. 2009 May;53(5):1779-85. doi: 10.1128/AAC.01290-08. Epub 2009 Feb 17.
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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.
The record lists no contact. Use the official record to reach the sponsor.
10 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing LB80380 90 mg, LB80380 150 mg and entecavir 0.5 mg in people with Chronic Hepatitis B, run by LG Life Sciences at 10 sites in 2 countries.
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 7 inclusion and 11 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 5 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in South Korea, China. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Changes in HBV DNA level (log10) from baseline (time frame: At Week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01026610, which also lists 2 linked publications.
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 5 Oct 2012.