- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00895596
Safety and Efficacy Study of LB80380 in the Patients With Lamivudine-Refractory Chronic Hepatitis B
A PhaseII, Open-Label, Multinational, Multi-Centre, Sequential Group, Dose-Escalation Study to Assess the Safety and Antiviral Activity of LB80380 for 12 Weeks in Patients With Lamivudine-Refractory Chronic Hepatitis B
Study Overview
Detailed Description
LB80380, an oral prodrug, is a promising candidate nucleoside 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 and for treatment of lamivudine-resistant disease.
In this study, the treatment period was divided into two parts: a 4-week treatment period with dose escalation assessment (Part 1), followed by an 8-week extension period (Part 2).
During Part 1, patients received LB80380 and LVD 100 mg once daily for 4 weeks. Each patient was then given only LB80380 for an additional 8 weeks (Part 2) unless dose-limiting toxicity (DLT) was observed during Part 1. At each dose level, all patients were to complete at least Part 1 of the treatment period before enrolment into the next Dose Group could commence. Dose escalation to the next group was not to be initiated if more than two patients experienced DLT during Part 1 in the previous Dose Group. Additionally, patients enrolled in LB80380 150mg and 240mg groups who agreed to participate in the pharmacokinetic (PK) analyses visited the study site the day before Week 12 for blood sampling. Follow-up period was 24 weeks, and patients were treated with adefovir dipivoxil during the follow-up period. During the study, patients were evaluated for changes from baseline in serum HBV DNA. Safety was evaluated on the basis of occurrence of AEs and changes from baseline in clinical laboratory parameters, physical examination findings, and vital signs.
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
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Hong Kong, China
- Queen Mary Hospital
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Seoul, Korea, Republic of
- Korea University Medical Center
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Seoul, Korea, Republic of
- Severance Hospital of Yonsei University
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Seoul, Korea, Republic of
- The Catholic University of Korea, Kangnam St. Mary's Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Compensated chronic hepatitis B patient
- Presence of serum HBsAg for more than 6 months.
- Presence of HBeAg for more than 1 month with compensated liver disease
- Confirmation of YMDD mutants (M552V, M552I and its related double mutant at L528M) by genotyping of the YMDD motif using line probe assay (INNO-LiPA HBV DR assay)
- Screening HBV DNA value higher than or equal to 1,000,000 copies/mL (measured by the COBAS Amplicor HBV Monitor™ assay)
- Screening ALT value between 1.5 and 10 x ULN
Exclusion Criteria:
- Co-infection with hepatitis C or D virus (HCV or HDV) or HIV
- Pregnancy or breast-feeding
- Previous treatment with nucleoside analogue or any other treatment for HBV except for lamivudine within 6 months prior to study entry
- Treatment with immunomodulatory agent or corticosteroids within 6 months prior to study entry.
- De-compensated liver disease
- Screening alpha-fetoprotein (AFP) value > 20 ng/mL, and a follow-up ultrasonography performed prior to baseline shows findings indicative of HCC.
- Presence of anti-HBs at screening
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: LB80380 30mg
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Total treatment period: 12 weeks, followed by 24 weeks of treatment with adefovir dipivoxil 10mg
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Experimental: LB80380 60mg
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Total treatment period: 12 weeks, followed by 24 weeks of treatment with adefovir dipivoxil 10mg
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Experimental: LB80380 90mg,
LB80380 90mg
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Total treatment period: 12 weeks, followed by 24 weeks of treatment with adefovir dipivoxil 10mg
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Experimental: LB80380 150mg
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Total treatment period: 12 weeks, followed by 24 weeks of treatment with adefovir dipivoxil 10mg
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Experimental: LB80380 240mg
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Total treatment period: 12 weeks, followed by 24 weeks of treatment with adefovir dipivoxil 10mg
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Mean serum HBV DNA level (log10) reduction from the baseline at Week 12
Time Frame: Week 12
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Week 12
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Proportion of patients with HBeAg seroconversion at 12 weeks Proportion of patients with HBsAg seroconversion at 12 weeks Proportion of patients with ALT normalization at 12 weeks Safety assessment during the whole study period
Time Frame: Week 12
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Week 12
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ching-Lung Lai, Dr, Queen Mary Hospital, Hong Kong
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Liver Diseases
- Hepatitis, Viral, Human
- Hepadnaviridae Infections
- DNA Virus Infections
- Enterovirus Infections
- Picornaviridae Infections
- Hepatitis B
- Hepatitis
- Hepatitis A
- Hepatitis B, Chronic
- Hepatitis, Chronic
Other Study ID Numbers
- BVCL004
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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