NCT00895596

Brief Summary

The purpose of the study is to investigate the safety and the antiviral activity of ascending multiple oral doses of LB80380 for 12 weeks in adults with lamivudine-refractory chronic hepatitis B infection.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
65

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Mar 2004

Typical duration for phase_1

Geographic Reach
2 countries

4 active sites

Status
completed

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

March 1, 2004

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2006

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

May 7, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 8, 2009

Completed
Last Updated

May 8, 2009

Status Verified

May 1, 2009

Enrollment Period

2.4 years

First QC Date

May 7, 2009

Last Update Submit

May 7, 2009

Conditions

Chronic Hepatitis B

Keywords

Chronic hepatitis BLamivudine resistantYMDD mutant type

Outcome Measures

Primary Outcomes (1)

  • Mean serum HBV DNA level (log10) reduction from the baseline at Week 12

    Week 12

Secondary Outcomes (1)

  • 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

    Week 12

Study Arms (5)

LB80380 30mg

EXPERIMENTAL

LB80380 30mg

Drug: LB80380

LB80380 60mg

EXPERIMENTAL

LB80380 60mg

Drug: LB80380

LB80380 90mg,

EXPERIMENTAL

LB80380 90mg

Drug: LB80380

LB80380 150mg

EXPERIMENTAL

LB80380 150mg

Drug: LB80380

LB80380 240mg

EXPERIMENTAL

LB80380 240mg

Drug: LB80380

Interventions

LB80380DRUG

Total treatment period: 12 weeks, followed by 24 weeks of treatment with adefovir dipivoxil 10mg

LB80380 150mgLB80380 240mgLB80380 30mgLB80380 60mgLB80380 90mg,

Eligibility Criteria

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

You may qualify if:

  • 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 Monitorâ„¢ assay)
  • Screening ALT value between 1.5 and 10 x ULN

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Queen Mary Hospital

Hong Kong, China

Location

Korea University Medical Center

Seoul, South Korea

Location

Severance Hospital of Yonsei University

Seoul, South Korea

Location

The Catholic University of Korea, Kangnam St. Mary's Hospital

Seoul, South Korea

Location

Related Publications (1)

  • 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: 20091678DERIVED

MeSH Terms

Conditions

Hepatitis B, Chronic

Interventions

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

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 Officials

  • Ching-Lung Lai, Dr

    Queen Mary Hospital, Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 7, 2009

First Posted

May 8, 2009

Study Start

March 1, 2004

Primary Completion

August 1, 2006

Study Completion

December 1, 2007

Last Updated

May 8, 2009

Record last verified: 2009-05

Locations

CN(1)KR(3)