Long-term Safety and Efficacy Study of LB80380 in the Treatment-naive Patients of Chronic Hepatitis B

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by LG Life Sciences.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
LG Life Sciences
ClinicalTrials.gov Identifier:
NCT01242787
First received: November 12, 2010
Last updated: April 13, 2012
Last verified: April 2012
  Purpose

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.


Condition Intervention Phase
Chronic Hepatitis B
Drug: LB80380
Drug: Entecavir 0.5 mg
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multinational, Multi-center, Open, Comparative, Paralleled, Roll-over Study to Assess the Safety and Antiviral Activity of LB80380 Tablet Compared to Entecavir 0.5 mg After Additional 48 Weeks of Treatment in Chronic Hepatitis B Patients Who Have Completed LG-BVCL007 Study

Resource links provided by NLM:


Further study details as provided by LG Life Sciences:

Primary Outcome Measures:
  • Percentage of patients showing HBV DNA mutation [ Time Frame: at Week 48 ] [ Designated as safety issue: Yes ]
    Safety assessment including adverse events, laboratory abnormalities and DNA mutation


Secondary Outcome Measures:
  • Change of HBV DNA from Baseline of LG-BVCL007 study [ Time Frame: at Week 48 ] [ Designated as safety issue: No ]
    Efficacy assessment including normalization of ALT, HBsAg seroconversion, HBeAg seroconversion


Estimated Enrollment: 115
Study Start Date: August 2010
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Entecavir 0.5 mg
Entecavir 0.5 mg
Drug: Entecavir 0.5 mg
Entecavir 0.5 mg, by oral for 48 weeks
Experimental: LB80380
Optimal dose of LB80380 (optimal dose will be chosen early 2011 based on the results of LG-BVCL007 study)
Drug: LB80380
Optimal dose of LB80380, by oral for 48 weeks (optimal dose will be chosen early 2011 based on the results of LG-BVCL007 study)

Detailed Description:

LB80380, an oral prodrug, is a promising candidate nucleotide analogue with antiviral activity against wild-type hepatitis B virus (HBV). LB80380 is undergoing clinical development by LG Life Sciences for use in the treatment of chronic HBV infection.

This study is an extension study of the Phase IIb (Protocol No. LG-BVCL007), the treatment period of this study is 48-week with 24-week of follow-up period

  Eligibility

Ages Eligible for Study:   18 Years to 66 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01242787

Locations
China
Queen Mary Hospital
Hong Kong, China
Korea, Republic of
Severance Hospital of Yonsei University and other 8 sites in Korea
Seoul, Korea, Republic of
Sponsors and Collaborators
LG Life Sciences
  More Information

Publications:
Responsible Party: LG Life Sciences
ClinicalTrials.gov Identifier: NCT01242787     History of Changes
Other Study ID Numbers: BVCL008
Study First Received: November 12, 2010
Last Updated: April 13, 2012
Health Authority: United States: Food and Drug Administration
Hong Kong: Department of Health
South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by LG Life Sciences:
Chronic hepatitis B
LB80380
treatment-naive
entecavir
Extension

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Hepatitis, Chronic
Hepatitis B, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Entecavir
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 22, 2014