NCT01242787

Brief Summary

The purpose of the study is to investigate the long-term safety and the antiviral activity of the optimal doses of LB80380 for additional 48 weeks in treatment-naive patients with chronic hepatitis B infection compared to entecavir 0.5 mg.

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
115

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Aug 2010

Geographic Reach
2 countries

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2010

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 12, 2010

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 17, 2010

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

April 16, 2012

Status Verified

April 1, 2012

Enrollment Period

2.1 years

First QC Date

November 12, 2010

Last Update Submit

April 13, 2012

Conditions

Chronic Hepatitis B

Keywords

Chronic hepatitis BLB80380treatment-naiveentecavirExtension

Outcome Measures

Primary Outcomes (1)

  • Percentage of patients showing HBV DNA mutation

    Safety assessment including adverse events, laboratory abnormalities and DNA mutation

    at Week 48

Secondary Outcomes (1)

  • Change of HBV DNA from Baseline of LG-BVCL007 study

    at Week 48

Study Arms (2)

Entecavir 0.5 mg

ACTIVE COMPARATOR

Entecavir 0.5 mg

Drug: Entecavir 0.5 mg

LB80380

EXPERIMENTAL

Optimal dose of LB80380 (optimal dose will be chosen early 2011 based on the results of LG-BVCL007 study)

Drug: LB80380

Interventions

LB80380DRUG

Optimal dose of LB80380, by oral for 48 weeks (optimal dose will be chosen early 2011 based on the results of LG-BVCL007 study)

LB80380
Entecavir 0.5 mgDRUG

Entecavir 0.5 mg, by oral for 48 weeks

Entecavir 0.5 mg

Eligibility Criteria

Age18 Years - 66 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The patients who are able to participate in this expanded study without any interruption after completing 48 weeks treatment of LG-BVCL007 study

You may not qualify if:

  • Co-infection with hepatitis C or D virus (HCV or HDV) or HIV
  • Decompensated liver disease
  • ALT \> 10 x ULN
  • Creatinine clearance (calculated by cockcroft-gault formula) less than 50 ml/min
  • 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
  • Patient is currently abusing alcohol or illicit drugs
  • Significant systemic illnesses other than liver diseases
  • Presence of other causes of liver disease
  • Plan for liver transplantation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Queen Mary Hospital

Hong Kong, China

Location

Severance Hospital of Yonsei University and other 8 sites in Korea

Seoul, South Korea

Location

Related Publications (4)

  • 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.

    PMID: 18808318RESULT

  • Yuen 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.

    PMID: 19223649RESULT

  • Yuen MF, Han KH, Um SH, Yoon SK, Kim HR, Kim J, Kim CR, Lai CL. Antiviral activity and safety of LB80380 in hepatitis B e antigen-positive chronic hepatitis B patients with lamivudine-resistant disease. Hepatology. 2010 Mar;51(3):767-76. doi: 10.1002/hep.23462.

    PMID: 20091678RESULT

  • Yuen MF, Kim J, Kim CR, Ngai V, Yuen JC, Min C, Kang HM, Shin BS, Yoo SD, Lai CL. A randomized placebo-controlled, dose-finding study of oral LB80380 in HBeAg-positive patients with chronic hepatitis B. Antivir Ther. 2006;11(8):977-83.

    PMID: 17302367RESULT

MeSH Terms

Conditions

Hepatitis B, Chronic

Interventions

((1-((2-amino-9H-purin-9-yl)methyl)cyclopropyl)oxy)methylphosphonic acid dipivoxylentecavir

Condition Hierarchy (Ancestors)

Hepatitis BBlood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitis, ChronicHepatitisLiver DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 12, 2010

First Posted

November 17, 2010

Study Start

August 1, 2010

Primary Completion

September 1, 2012

Study Completion

September 1, 2012

Last Updated

April 16, 2012

Record last verified: 2012-04

Locations

CN(1)KR(1)