Trial Outcomes & Findings for Entecavir Plus Adefovir in Lamivudine-Resistant Chronic Hepatitis B Patients Who Fail Lamivudine Plus Adefovir (NCT NCT01023217)

NCT ID: NCT01023217

Last Updated: 2014-02-10

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 90 participants
• Primary outcome timeframe: at week 52 from randomization
• Results posted on: 2014-02-10

Participant Flow

Participant milestones

Measure	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
Overall Study STARTED	45	45
Overall Study COMPLETED	44	45
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Measure	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
Overall Study Withdrawal by Subject	1	0

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Adefovir Plus Entecavir n=45 Participants 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 n=45 Participants 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 n=90 Participants Total of all reporting groups
Age, Continuous	45 years STANDARD_DEVIATION 11 • n=5 Participants	49 years STANDARD_DEVIATION 11 • n=7 Participants	47 years STANDARD_DEVIATION 11 • n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants	11 Participants n=7 Participants	23 Participants n=5 Participants
Sex: Female, Male Male	33 Participants n=5 Participants	34 Participants n=7 Participants	67 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	45 Participants n=5 Participants	45 Participants n=7 Participants	90 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	45 Participants n=5 Participants	45 Participants n=7 Participants	90 Participants n=5 Participants
Region of Enrollment Korea, Republic of	45 participants n=5 Participants	45 participants n=7 Participants	90 participants n=5 Participants
Multiple-Drug-Refractory Chronic Hepatitis B Virus Patients	45 participants n=5 Participants	45 participants n=7 Participants	90 participants n=5 Participants

PRIMARY outcome

Timeframe: at week 52 from randomization

Outcome measures

Measure	Adefovir Plus Entecavir n=45 Participants 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 n=45 Participants 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
Complete Virologic Response (CVR, Serum HBV DNA Undetectable by PCR or Less Than 60 IU/mL)	13 participants	2 participants

SECONDARY outcome

Timeframe: at week 52 and at week 104 from randomization

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: at week 52 and at week 104 from randomization

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: at week 52 and at week 104 from randomization

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: at week 104 from randomization

Outcome measures

Outcome data not reported

Adverse Events

Adefovir Plus Entecavir

Serious events: 2 serious events

Other events: 5 other events

Deaths: 0 deaths

Adefovir Plus Lamivudine

Serious events: 2 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Measure	Adefovir Plus Entecavir n=45 participants at risk 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 n=45 participants at risk 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
Ear and labyrinth disorders Hearing loss	2.2% 1/45 • Number of events 1 • 1 year	0.00% 0/45 • 1 year
Endocrine disorders Thyroid cancer	2.2% 1/45 • Number of events 1 • 1 year	0.00% 0/45 • 1 year
Musculoskeletal and connective tissue disorders Intervertebral disc herniation	0.00% 0/45 • 1 year	2.2% 1/45 • Number of events 1 • 1 year
Musculoskeletal and connective tissue disorders rib fracture	0.00% 0/45 • 1 year	2.2% 1/45 • Number of events 1 • 1 year

Other adverse events

Measure	Adefovir Plus Entecavir n=45 participants at risk 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 n=45 participants at risk 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
Respiratory, thoracic and mediastinal disorders URI	11.1% 5/45 • Number of events 5 • 1 year	11.1% 5/45 • Number of events 5 • 1 year

Additional Information

Professor Young-Suk Lim

Asan Medical Center

Phone: +82-2-3010-5933

Email: limys@amc.seoul.kr

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place