- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00625560
Continuing Lamivudine vs Switching to Entecavir in Patients With Detectable HBV DNA
May 7, 2012 updated by: Sang Hoon Ahn, Yonsei University
Randomized, Open-Labelled Study Evaluating the Antiviral Efficacy, Safety, and Tolerability of Continuing Lamivudine Therapy or Switching to Entecavir in Subjects With Chronic Hepatitis B With Detectable HBV DNA
This is a randomized, open-labelled, prospective 96-week study comparing the antiviral efficacy and safety of switching to entecavir 1 mg QD from lamivudine versus maintaining lamivudine 100 mg QD treatment in HBV-infected subjects currently receiving lamivudine monotherapy.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Entecavir has a higher potent antiviral efficacy and a lower drug resistance rate than Lamivudine in nucleoside-naïve CHB patients.
The prompt switch from Lamivudine to Entecavir in patients who have insufficient hepatitis B virus suppression (HBV DNA ≥ 60 IU/mL by PCR) may lead to full viral suppression to undetectable level by PCR method.
The prompt switch from Lamivudine to Entecavir in patients who have insufficient hepatitis B virus suppression (HBV DNA ≥ 60 IU/mL) may preclude development of drug resistance.
The results of this study will provide a rationale for switch treatment from one antiviral to another one, especially from LAM to ETV.
Study Type
Interventional
Enrollment (Actual)
72
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Busan, Korea, Republic of, 602-739
- Pusan National University School of Medicine
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Seoul, Korea, Republic of, 120-752
- Severance Hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 at baseline.
Exclusion Criteria:
- All subjects will be tested for presence of M204V/I mutations in the YMDD motif at baseline. Subjects with M204V/I mutations in the YMDD motif at baseline are not eligible for the study.
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: B
lamivudine 100 mg QD
|
lamivudine 100 mg QD
Other Names:
|
Experimental: A
entecavir 1.0 mg QD
|
entecavir 1.0 mg QD
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
at Week 96
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Percentage number of patients who achieved ALT normalization, HBeAg loss, HBe seroconversion, HBsAg loss and HBs seroconversion
Time Frame: at Week 48 and 96
|
at Week 48 and 96
|
Percentage number of patients with HBV DNA < 60 IU/mL while on randomized therapy
Time Frame: at Week 48
|
at Week 48
|
Percentage number of patients who developed drug resistant mutations while on randomized therapy
Time Frame: at Week 48 and Week 96
|
at Week 48 and Week 96
|
Change from baseline in mean HBV DNA
Time Frame: at Week 48 and 96
|
at Week 48 and 96
|
Cumulative discontinuation rates due to lamivudine or entecavir resistance mutations and clinical breakthrough Safety assessment
Time Frame: Follow up period
|
Follow up period
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Jun Yong Park, M.D, Yonsei University
- Study Chair: Sang Hoon Ahn, M.D.Ph.D, Yonsei Univsersity College of Medicine
- Study Director: Do Young Kim, M.D., Yonsei University
- Study Director: Jeong Heo, M.D.Ph.D, Pusan National University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2008
Primary Completion (Actual)
November 1, 2009
Study Completion (Actual)
November 1, 2010
Study Registration Dates
First Submitted
February 11, 2008
First Submitted That Met QC Criteria
February 19, 2008
First Posted (Estimate)
February 28, 2008
Study Record Updates
Last Update Posted (Estimate)
May 8, 2012
Last Update Submitted That Met QC Criteria
May 7, 2012
Last Verified
May 1, 2012
More Information
Terms related to this study
Keywords
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, Chronic
- Hepatitis B
- Hepatitis
- Hepatitis A
- Hepatitis B, Chronic
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Reverse Transcriptase Inhibitors
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Anti-HIV Agents
- Anti-Retroviral Agents
- Entecavir
- Lamivudine
Other Study ID Numbers
- 4-2007-0351
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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