Compare Continuing Lamivudine Plus Adefovir or Adefovir Versus Switching to Entecavir Plus Adefovir in Patients With LAM-resistant Chronic Hepatitis B
Primary Purpose
Hepatitis B, Chronic
Status
Unknown status
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Lamivudine
Adefovir
Entecavir
Sponsored by
About this trial
This is an interventional treatment trial for Hepatitis B, Chronic
Eligibility Criteria
Inclusion Criteria:
- Chronic hepatitis B
- Age ≥ 20 year old
- Currently taking Lamivudine and Adefovir combination therapy or Adefovir monotherapy for chronic HBV infection for 24 weeks
- Proven Lamivudine resistant mutation
- HBV DNA levels at screening ≥ 15 IU/mL
- Females must be post-menopausal, unable to conceive, or test negative for pregnancy via urine test
- Patient is able to give written informed consent prior to study start and to comply with the study requirements
Exclusion Criteria:
- A history or current of decompensated cirrhosis or hepatocellular carcinoma
- Currently receiving antiviral, immunomodulatory, cytotoxic or corticosteroid therapy
- Co-infected with HCV or HIV
- A history of organ transplantation
- Pregnant or breast-feeding
- Current clinically relevant of abuse of alcohol or drugs.
- Significant immunocompromised, gastrointestinal, renal(serum creatinine ≥ 1.5 mg/dL), hematological, psychiatric, bronchopulmonary, biliary diseases excluding asymptomatic GB stone, neurological, cardiac, oncologic, allergic disease or medical illness that in the investigator's opinion might interfere with therapy
- malignancy in previous 5 years
Sites / Locations
- Asan Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Lamivudine plus Adefovir or Adefovir
Entecavir plus Adefovir
Arm Description
Lamivudine+Adefovir or Adefovir for 48 weeks
Entecavir+Adefovir for 48 weeks
Outcomes
Primary Outcome Measures
Proportion of patients with HBV DNA<15IU/mL
Secondary Outcome Measures
Proportion of patients with HBV DNA<15IU/mL
The change of HBV DNA from the baseline
Proportion of patients with ALT normalization
Proportion of patients with HBeAg loss and/or seroconversion
The change of HBsAg from the baseline
Proportion of patients with HBsAg loss and/or seroconversion
Proportion of patients who experienced virologic breakthrough
Assessment the safety in all patients (composite measure of AE, labs, phys. exam, vital signs)
Composite outcome measure consisting of multiple measures, including:
Number of patients with Adverse events( including SAEs)
Frequency and severity of Abnormalities in laboratory examinations; BUN, Albumin, AST, ALT,GGT, Creatinine, Hemoglobin, Hematocrit, Platelet Count, Prothrombin time
Number of patients with Abnormalities in physical examinations; Eyes/Ears/Nose/Throat, Respiratory, Cardiovascular, Dermatological, Abdominal, Musculoskeletal, Other
Number of patients with Abnormalities in vital signs ; pulse rate( beats per minute), Blood pressure(mmHg), Height(cm), weight(kg)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02482272
Brief Title
Compare Continuing Lamivudine Plus Adefovir or Adefovir Versus Switching to Entecavir Plus Adefovir in Patients With LAM-resistant Chronic Hepatitis B
Official Title
Efficacy and Safety of Continuing Lamivudine Plus Adefovir or Adefovir Versus Switching to Entecavir Plus Adefovir in Patients With Chronic Hepatitis B Who Have Resistant Mutants to Lamivudine and Show Suboptimal Response to Combination of Lamivudine Plus Adefovir or Adefovir Monotherapy
Study Type
Interventional
2. Study Status
Record Verification Date
December 2015
Overall Recruitment Status
Unknown status
Study Start Date
May 2015 (undefined)
Primary Completion Date
January 2017 (Anticipated)
Study Completion Date
May 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Asan Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to compare efficacy and safety of continuing Lamivudine plus Adefovir or Adefovir versus switching to Entecavir plus Adefovir in patients with LAM-resistant chronic hepatitis B who have suboptimal response to Lamivudine plus Adefovir or Adefovir
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis B, Chronic
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Lamivudine plus Adefovir or Adefovir
Arm Type
Active Comparator
Arm Description
Lamivudine+Adefovir or Adefovir for 48 weeks
Arm Title
Entecavir plus Adefovir
Arm Type
Experimental
Arm Description
Entecavir+Adefovir for 48 weeks
Intervention Type
Drug
Intervention Name(s)
Lamivudine
Intervention Description
Lamivudine 100mg/day orally
Intervention Type
Drug
Intervention Name(s)
Adefovir
Intervention Description
Adefovir 10mg/day orally
Intervention Type
Drug
Intervention Name(s)
Entecavir
Intervention Description
Entecavir 1mg/day orally
Primary Outcome Measure Information:
Title
Proportion of patients with HBV DNA<15IU/mL
Time Frame
week 48
Secondary Outcome Measure Information:
Title
Proportion of patients with HBV DNA<15IU/mL
Time Frame
Day1, week12, week 24, week 36, week 48
Title
The change of HBV DNA from the baseline
Time Frame
week 48
Title
Proportion of patients with ALT normalization
Time Frame
Day1, week12, week 24, week 36, week 48
Title
Proportion of patients with HBeAg loss and/or seroconversion
Time Frame
Day1, week12, week 24, week 36, week 48
Title
The change of HBsAg from the baseline
Time Frame
week 48
Title
Proportion of patients with HBsAg loss and/or seroconversion
Time Frame
week 24, week 48
Title
Proportion of patients who experienced virologic breakthrough
Time Frame
week 48
Title
Assessment the safety in all patients (composite measure of AE, labs, phys. exam, vital signs)
Description
Composite outcome measure consisting of multiple measures, including:
Number of patients with Adverse events( including SAEs)
Frequency and severity of Abnormalities in laboratory examinations; BUN, Albumin, AST, ALT,GGT, Creatinine, Hemoglobin, Hematocrit, Platelet Count, Prothrombin time
Number of patients with Abnormalities in physical examinations; Eyes/Ears/Nose/Throat, Respiratory, Cardiovascular, Dermatological, Abdominal, Musculoskeletal, Other
Number of patients with Abnormalities in vital signs ; pulse rate( beats per minute), Blood pressure(mmHg), Height(cm), weight(kg)
Time Frame
week 48
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Chronic hepatitis B
Age ≥ 20 year old
Currently taking Lamivudine and Adefovir combination therapy or Adefovir monotherapy for chronic HBV infection for 24 weeks
Proven Lamivudine resistant mutation
HBV DNA levels at screening ≥ 15 IU/mL
Females must be post-menopausal, unable to conceive, or test negative for pregnancy via urine test
Patient is able to give written informed consent prior to study start and to comply with the study requirements
Exclusion Criteria:
A history or current of decompensated cirrhosis or hepatocellular carcinoma
Currently receiving antiviral, immunomodulatory, cytotoxic or corticosteroid therapy
Co-infected with HCV or HIV
A history of organ transplantation
Pregnant or breast-feeding
Current clinically relevant of abuse of alcohol or drugs.
Significant immunocompromised, gastrointestinal, renal(serum creatinine ≥ 1.5 mg/dL), hematological, psychiatric, bronchopulmonary, biliary diseases excluding asymptomatic GB stone, neurological, cardiac, oncologic, allergic disease or medical illness that in the investigator's opinion might interfere with therapy
malignancy in previous 5 years
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Danbi Lee
Phone
82)2-3010-3907
Email
leighdb@hanmail.net
Facility Information:
Facility Name
Asan Medical Center
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Young Hwa Chung
12. IPD Sharing Statement
Learn more about this trial
Compare Continuing Lamivudine Plus Adefovir or Adefovir Versus Switching to Entecavir Plus Adefovir in Patients With LAM-resistant Chronic Hepatitis B
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