Continuing Lamivudine Versus Switching to Entecavir in Patients Who Achieved Undetectable HBV DNA - Full Text View

Sponsor:	Yonsei University
Collaborator:	Pusan National University Hospital
Information provided by:	Yonsei University
ClinicalTrials.gov Identifier:	NCT00625339

Purpose

This is a randomized, open-labelled, prospective 96-week study comparing the antiviral efficacy and safety of switching to entecavir 0.5mg QD from lamivudine versus maintaining lamivudine 100mg QD treatment in CHB patients currently receiving lamivudine monotherapy.

Condition	Intervention	Phase
Hepatitis B, Chronic	Drug: Entecavir Drug: Lamivudine	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Randomized, Open-Labeled Study Evaluating the Antiviral Efficacy, Safety, and Tolerability of Continuing Lamivudine Therapy or Switching to Entecavir in Subjects With Chronic Hepatitis B Who Achieved Undetectable HBV DNA

Resource links provided by NLM:

MedlinePlus related topics: Hepatitis Hepatitis B

Drug Information available for: Lamivudine Entecavir

U.S. FDA Resources

Further study details as provided by Yonsei University:

Primary Outcome Measures:

Percentage number of patients with HBV DNA < 60 IU/mL (Undetectable serum HBV DNA by PCR method) while on randomized therapy [ Time Frame: at Week 96 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Percentage number of patients with HBV DNA < 60 IU/mL (Undetectable serum HBV DNA by PCR method) while on randomized therapy [ Time Frame: at Week 48 ] [ Designated as safety issue: No ]
Percentage number of patients who achieved ALT normalization, HBeAg loss, HBe seroconversion, HBsAg loss and HBs seroconversion [ Time Frame: at Week 48 and 96 ] [ Designated as safety issue: No ]
Cumulative discontinuation rates due to lamivudine or entecavir resistance mutations and clinical breakthrough, Safety assessment [ Time Frame: Follow up period ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	200
Study Start Date:	February 2008
Estimated Study Completion Date:	November 2010
Estimated Primary Completion Date:	November 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental entecavir 0.5 mg QD	Drug: Entecavir entecavir 0.5 mg QD
B: Active Comparator lamivudine 100 mg QD	Drug: Lamivudine lamivudine 100 mg QD

Detailed Description:

Entecavir has a higher potent antiviral efficacy and a lower drug resistance rate than those of Lamivudine in nucleoside-naïve CHB patients. The switch from Lamivudine to Entecavir in patients who have undetectable hepatitis B virus DNA (HBV DNA < 60 IU/mL) may lead to more prolonged viral suppression to undetectable level by PCR method, compared to patients with continuous lamivudine treatment. The results of this study will provide a rationale for switch treatment from one antiviral to another one, especially from LAM to ETV.

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Adult subjects (18-70 years of age) currently taking lamivudine monotherapy for chronic HBV infection for at least 6 months with < HBV DNA 60 IU/mL level and HBeAg positive status.

Exclusion Criteria:

Subjects treated with other antiviral drugs (e.g. adefovir) in combination with lamivudine are not eligible for this study.
Subjects should have ALT ＜ 10 x ULN, and no evidence of hepatocellular carcinoma.
Subjects should be without serological evidence of co-infection with HCV, HIV, or HDV.
Subjects with decompensated liver disease, as well as pregnant or breast-feeding women, will not be eligible for the study.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00625339

Contacts

Contact: Jeong Heo, M.D.Ph.D	+82-51-240-7869	jheo@pusan.ac.kr
Contact: Jun Yong Park, M.D	+82-10-8353-0670	drpjy@yuhs.ac

Locations

Korea, Republic of
Pusan National University School of Medicine	Recruiting
Busan, Korea, Republic of, 602-739
Contact: Jeong Heo, M.D.Ph.D +82-51-240-7869 jheo@pusan.ac.kr
Principal Investigator: Jeong Heo, M.D.Ph.D
Severance Hospital	Recruiting
Seoul, Korea, Republic of, 120-752
Contact: Sang Hoon Ahn, M.D.Ph.D +82-11-419-8087 ahnsh@yuhs.ac
Contact: Jun Yong Park, M.D +82-10-8353-0670 drpjy@yuhs.ac
Principal Investigator: Jun Yong Park, M.D

Sponsors and Collaborators

Yonsei University

Pusan National University Hospital

Investigators

Study Chair:	Jeong Heo, M.D. Ph.D	Pusan National University School of Medicine
Study Director:	Sang Hoon Ahn, M.D.Ph.D	Yonsei Univsersity College of Medicine
Study Director:	Do Young Kim, M.D	Yonsei University College of Medicine
Principal Investigator:	Jun Yong Park, M.D	Yonsei University College of Medicine

More Information

No publications provided

Responsible Party:	Department of Internal Medicine, Pusan National University School of Medicine ( Jeong Heo )
Study ID Numbers:	4-2007-0367
Study First Received:	February 19, 2008
Last Updated:	September 17, 2008
ClinicalTrials.gov Identifier:	NCT00625339 History of Changes
Health Authority:	Korea: Food and Drug Administration

Keywords provided by Yonsei University:

Chronic hepatitis B
Lamivudine
Entecavir

Additional relevant MeSH terms:

Anti-Infective Agents
Liver Diseases
Anti-HIV Agents
Molecular Mechanisms of Pharmacological Action
Hepatitis, Chronic
Hepatitis, Viral, Human
Lamivudine
Enzyme Inhibitors
Antiviral Agents
Hepadnaviridae Infections
Pharmacologic Actions

Reverse Transcriptase Inhibitors
Hepatitis
Virus Diseases
Digestive System Diseases
Entecavir
Anti-Retroviral Agents
Therapeutic Uses
Hepatitis B, Chronic
Hepatitis B
DNA Virus Infections
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on February 08, 2010