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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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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 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 Plus Entecavir

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


Participant Flow:   Overall Study
    Adefovir Plus Lamivudine   Adefovir Plus Entecavir
STARTED   45   45 
COMPLETED   44   45 
NOT COMPLETED   1   0 
Withdrawal by Subject                1                0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Lamivudine-resistant CHB patients who had failed to respond to lamivudine plus adefovir combination therapy

Reporting Groups
  Description
Adefovir Plus Entecavir

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 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 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 Total of all reporting groups

Baseline Measures
   Adefovir Plus Entecavir   Adefovir Plus Lamivudine   Total 
Overall Participants Analyzed 
[Units: Participants]
 45   45   90 
Age 
[Units: Years]
Mean (Standard Deviation)
 45  (11)   49  (11)   47  (11) 
Gender 
[Units: Participants]
     
Female   12   11   23 
Male   33   34   67 
Race (NIH/OMB) 
[Units: Participants]
     
American Indian or Alaska Native   0   0   0 
Asian   45   45   90 
Native Hawaiian or Other Pacific Islander   0   0   0 
Black or African American   0   0   0 
White   0   0   0 
More than one race   0   0   0 
Unknown or Not Reported   0   0   0 
Ethnicity (NIH/OMB) 
[Units: Participants]
     
Hispanic or Latino   0   0   0 
Not Hispanic or Latino   0   0   0 
Unknown or Not Reported   45   45   90 
Region of Enrollment 
[Units: Participants]
     
Korea, Republic of   45   45   90 
Multiple-Drug-Refractory Chronic Hepatitis B Virus Patients 
[Units: Participants]
 45   45   90 


  Outcome Measures

1.  Primary:   Complete Virologic Response (CVR, Serum HBV DNA Undetectable by PCR or Less Than 60 IU/mL)   [ Time Frame: at week 52 from randomization ]

2.  Secondary:   Reduction in Serum HBV DNA Levels   [ Time Frame: at week 52 and at week 104 from randomization ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

3.  Secondary:   Genotypic Resistance to ADV or ETV   [ Time Frame: at week 52 and at week 104 from randomization ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

4.  Secondary:   Normalization of ALT Level   [ Time Frame: at week 52 and at week 104 from randomization ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

5.  Secondary:   Complete Virologic Response (CVR, Serum HBV DNA Undetectable by PCR or Less Than 60 IU/mL)   [ Time Frame: at week 104 from randomization ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

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
e-mail: limys@amc.seoul.kr


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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