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Entecavir Plus Adefovir in Lamivudine-Resistant Chronic Hepatitis B Patients Who Fail Lamivudine Plus Adefovir (CAESAR)

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ClinicalTrials.gov Identifier: NCT01023217
Recruitment Status : Completed
First Posted : December 2, 2009
Results First Posted : January 13, 2014
Last Update Posted : February 10, 2014
Sponsor:
Information provided by (Responsible Party):
Young-Suk Lim, Asan Medical Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Hepatitis B, Chronic
Interventions Drug: Adefovir
Drug: Entecavir
Drug: Lamivudine
Enrollment 90
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Adefovir Plus Lamivudine Adefovir Plus Entecavir
Hide Arm/Group Description

Adefovir (10 mg/day) + Lamivudine (100 mg/day) for 52 weeks, and thereafter, Adefovir (10 mg/day) + Entecavir (1 mg/day) for 52 more weeks

Adefovir plus Lamivudine: Adefovir (10 mg/day) + Lamivudine (100 mg/day) for 52 weeks, and thereafter, Adefovir (10 mg/day) + Entecavir (1 mg/day) for 52 more weeks

Adefovir (10 mg/day) + Entecavir (1 mg/day) for 104 weeks

Adefovir plus Entecavir: Adefovir (10 mg/day) + Entecavir (1 mg/day) for 104 weeks

Period Title: Overall Study
Started 45 45
Completed 44 45
Not Completed 1 0
Reason Not Completed
Withdrawal by Subject             1             0
Arm/Group Title Adefovir Plus Entecavir Adefovir Plus Lamivudine Total
Hide Arm/Group Description

Adefovir (10 mg/day) + Entecavir (1 mg/day) for 104 weeks

Adefovir plus Entecavir: Adefovir (10 mg/day) + Entecavir (1 mg/day) for 104 weeks

Adefovir (10 mg/day) + Lamivudine (100 mg/day) for 52 weeks, and thereafter, Adefovir (10 mg/day) + Entecavir (1 mg/day) for 52 more weeks

Adefovir plus Lamivudine: Adefovir (10 mg/day) + Lamivudine (100 mg/day) for 52 weeks, and thereafter, Adefovir (10 mg/day) + Entecavir (1 mg/day) for 52 more weeks

Total of all reporting groups
Overall Number of Baseline Participants 45 45 90
Hide Baseline Analysis Population Description
Lamivudine-resistant CHB patients who had failed to respond to lamivudine plus adefovir combination therapy
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 45 participants 45 participants 90 participants
45  (11) 49  (11) 47  (11)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 45 participants 45 participants 90 participants
Female
12
  26.7%
11
  24.4%
23
  25.6%
Male
33
  73.3%
34
  75.6%
67
  74.4%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 45 participants 45 participants 90 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
45
 100.0%
45
 100.0%
90
 100.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
White
0
   0.0%
0
   0.0%
0
   0.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 45 participants 45 participants 90 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
45
 100.0%
45
 100.0%
90
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Korea, Republic of Number Analyzed 45 participants 45 participants 90 participants
45 45 90
Multiple-Drug-Refractory Chronic Hepatitis B Virus Patients  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 45 participants 45 participants 90 participants
45 45 90
1.Primary Outcome
Title Complete Virologic Response (CVR, Serum HBV DNA Undetectable by PCR or Less Than 60 IU/mL)
Hide Description [Not Specified]
Time Frame at week 52 from randomization
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Adefovir Plus Entecavir Adefovir Plus Lamivudine
Hide Arm/Group Description:

Adefovir (10 mg/day) + Entecavir (1 mg/day) for 104 weeks

Adefovir plus Entecavir: Adefovir (10 mg/day) + Entecavir (1 mg/day) for 104 weeks

Adefovir (10 mg/day) + Lamivudine (100 mg/day) for 52 weeks, and thereafter, Adefovir (10 mg/day) + Entecavir (1 mg/day) for 52 more weeks

Adefovir plus Lamivudine: Adefovir (10 mg/day) + Lamivudine (100 mg/day) for 52 weeks, and thereafter, Adefovir (10 mg/day) + Entecavir (1 mg/day) for 52 more weeks

Overall Number of Participants Analyzed 45 45
Measure Type: Number
Unit of Measure: participants
13 2
2.Secondary Outcome
Title Reduction in Serum HBV DNA Levels
Hide Description [Not Specified]
Time Frame at week 52 and at week 104 from randomization
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Genotypic Resistance to ADV or ETV
Hide Description [Not Specified]
Time Frame at week 52 and at week 104 from randomization
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Normalization of ALT Level
Hide Description [Not Specified]
Time Frame at week 52 and at week 104 from randomization
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Complete Virologic Response (CVR, Serum HBV DNA Undetectable by PCR or Less Than 60 IU/mL)
Hide Description [Not Specified]
Time Frame at week 104 from randomization
Outcome Measure Data Not Reported
Time Frame 1 year
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Adefovir Plus Entecavir Adefovir Plus Lamivudine
Hide Arm/Group Description

Adefovir (10 mg/day) + Entecavir (1 mg/day) for 104 weeks

Adefovir plus Entecavir: Adefovir (10 mg/day) + Entecavir (1 mg/day) for 104 weeks

Adefovir (10 mg/day) + Lamivudine (100 mg/day) for 52 weeks, and thereafter, Adefovir (10 mg/day) + Entecavir (1 mg/day) for 52 more weeks

Adefovir plus Lamivudine: Adefovir (10 mg/day) + Lamivudine (100 mg/day) for 52 weeks, and thereafter, Adefovir (10 mg/day) + Entecavir (1 mg/day) for 52 more weeks

All-Cause Mortality
Adefovir Plus Entecavir Adefovir Plus Lamivudine
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Adefovir Plus Entecavir Adefovir Plus Lamivudine
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/45 (4.44%)      2/45 (4.44%)    
Ear and labyrinth disorders     
Hearing loss *  1/45 (2.22%)  1 0/45 (0.00%)  0
Endocrine disorders     
Thyroid cancer *  1/45 (2.22%)  1 0/45 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Intervertebral disc herniation *  0/45 (0.00%)  0 1/45 (2.22%)  1
rib fracture *  0/45 (0.00%)  0 1/45 (2.22%)  1
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Adefovir Plus Entecavir Adefovir Plus Lamivudine
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/45 (11.11%)      5/45 (11.11%)    
Respiratory, thoracic and mediastinal disorders     
URI *  5/45 (11.11%)  5 5/45 (11.11%)  5
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Professor Young-Suk Lim
Organization: Asan Medical Center
Phone: +82-2-3010-5933
Responsible Party: Young-Suk Lim, Asan Medical Center
ClinicalTrials.gov Identifier: NCT01023217     History of Changes
Other Study ID Numbers: AMC-2009-0536
First Submitted: December 1, 2009
First Posted: December 2, 2009
Results First Submitted: November 23, 2013
Results First Posted: January 13, 2014
Last Update Posted: February 10, 2014