Trial Outcomes & Findings for An Open Label, Multi Centre Phase IV Study of Adefovir Dipivoxil in Korean Patients With Chronic Hepatitis B (CHB) (NCT NCT01205165)
NCT ID: NCT01205165
Last Updated: 2018-07-02
Results Overview
HBV DNA was tested with Roche Cobas Amplicor HBV monitor test, where the lower limit of detection was 300 copies/milliliter (mL), at baseline and other study visits. The mean log 10 reduction in serum HBV DNA level from baseline to week 12 was calculated as the week 12 value minus the baseline value. Baseline was the Day 1 for the study, when participant received study drug. Log 10 reduction implied reduced viral load.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
104 participants
Primary outcome timeframe
Baseline (Day 1) and Week 12
Results posted on
2018-07-02
Participant Flow
The study was conducted in participants with chronic hepatitis B and compensated liver disease, at 5 sites in Korea. It was conducted from 01 December 2004 to 28 April 2006.
Of the total 140 participants which were screened only 104 participants were randomized to the study.
Participant milestones
| Measure |
Adefovir Dipivoxil 10mg
The eligible participants received open label treatment of 10 milligram (mg) Adefovir dipivoxil, orally once daily for 52-weeks
|
|---|---|
|
Overall Study
STARTED
|
104
|
|
Overall Study
COMPLETED
|
102
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Adefovir Dipivoxil 10mg
The eligible participants received open label treatment of 10 milligram (mg) Adefovir dipivoxil, orally once daily for 52-weeks
|
|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
Baseline Characteristics
An Open Label, Multi Centre Phase IV Study of Adefovir Dipivoxil in Korean Patients With Chronic Hepatitis B (CHB)
Baseline characteristics by cohort
| Measure |
Adefovir Dipivoxil 10mg
n=104 Participants
The eligible participants received open label treatment of 10 mg Adefovir dipivoxil, orally once daily for 52-weeks
|
|---|---|
|
Age, Continuous
|
35.3 Years
STANDARD_DEVIATION 10.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
83 Participants
n=5 Participants
|
|
Region of Enrollment
Korea
|
104 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 1) and Week 12Population: Intent to treat (ITT). All participants regardless of whether or not the participant completed the planned duration of the study were analyzed with no data exclusions.
HBV DNA was tested with Roche Cobas Amplicor HBV monitor test, where the lower limit of detection was 300 copies/milliliter (mL), at baseline and other study visits. The mean log 10 reduction in serum HBV DNA level from baseline to week 12 was calculated as the week 12 value minus the baseline value. Baseline was the Day 1 for the study, when participant received study drug. Log 10 reduction implied reduced viral load.
Outcome measures
| Measure |
Adefovir Dipivoxil 10mg
n=104 Participants
The eligible participants received open label treatment of 10 mg Adefovir dipivoxil, orally once daily for 52-weeks.
|
|---|---|
|
Mean Log 10 Reduction in Serum Hepatitis B Virus (HBV), Deoxyribonucleic Acid (DNA) Level From Baseline to Week 12
|
-3.39 Log10 (copies/mL)
Standard Deviation 1.50
|
SECONDARY outcome
Timeframe: At week 52Population: ITT population
ALT normalization was defined as measurement less than or equal to the upper limit of the normal range. Only those set of participants with a baseline ALT value above the upper limit of the normal range was included in this analysis. The normal range for ALT is 7 to 43 Units/Liter.
Outcome measures
| Measure |
Adefovir Dipivoxil 10mg
n=104 Participants
The eligible participants received open label treatment of 10 mg Adefovir dipivoxil, orally once daily for 52-weeks.
|
|---|---|
|
Number of Participants Achieving Alanine Aminotransferase (ALT) Normalization at Week 52
|
83 Participants
|
SECONDARY outcome
Timeframe: At Week 52Population: ITT population.
Virological response was defined as HBV DNA level \< 300 copies/ml in serum. The number of participants achieving these DNA levels were reported.
Outcome measures
| Measure |
Adefovir Dipivoxil 10mg
n=104 Participants
The eligible participants received open label treatment of 10 mg Adefovir dipivoxil, orally once daily for 52-weeks.
|
|---|---|
|
Number of Participants Achieving Virological Response at Week 52
|
34 Participants
|
SECONDARY outcome
Timeframe: Week 4, week 8, week 12, week 20, week 28, week 36, week 44 and week 52Population: ITT population. Only those participants available at the specified timepoints were analyzed
Serum HBV DNA at different timepoints namely Baseline, Week 4, week 8, week 12, week 20, week 28, week 36, week 44 and week 52 were reported. The HBV DNA copies in the serum were reported in multiples of log 10 copies per mL, detected using Roche COBAS AMPLICOR HBV monitor.
Outcome measures
| Measure |
Adefovir Dipivoxil 10mg
n=104 Participants
The eligible participants received open label treatment of 10 mg Adefovir dipivoxil, orally once daily for 52-weeks.
|
|---|---|
|
HBV DNA Levels at Each Collection Timepoint Through Week 52
Week 4
|
5.59 log 10 copies/mL
Standard Deviation 0.83
|
|
HBV DNA Levels at Each Collection Timepoint Through Week 52
Week 8
|
4.96 log 10 copies/mL
Standard Deviation 0.99
|
|
HBV DNA Levels at Each Collection Timepoint Through Week 52
Week 12
|
4.56 log 10 copies/mL
Standard Deviation 1.13
|
|
HBV DNA Levels at Each Collection Timepoint Through Week 52
Week 20
|
3.97 log 10 copies/mL
Standard Deviation 1.13
|
|
HBV DNA Levels at Each Collection Timepoint Through Week 52
Week 28
|
3.92 log 10 copies/mL
Standard Deviation 1.14
|
|
HBV DNA Levels at Each Collection Timepoint Through Week 52
Week 36
|
3.78 log 10 copies/mL
Standard Deviation 1.15
|
|
HBV DNA Levels at Each Collection Timepoint Through Week 52
Week 44
|
3.63 log 10 copies/mL
Standard Deviation 1.13
|
|
HBV DNA Levels at Each Collection Timepoint Through Week 52
Week 52
|
3.66 log 10 copies/mL
Standard Deviation 1.18
|
SECONDARY outcome
Timeframe: Week 52Population: ITT population. Only the subset of participants with HBeAg and HBsAg positive at baseline (Day 1) was included in the analysis.
The HBeAg loss, defined as the number of participants with an undetectable level of serum HBeAg. The percentage of participants with a HBeAg seroconversion, defined as an undetectable level of serum HBeAg and a detectable level of serum hepatitis B e antibody (HBeAb) at Week 52. The number of participants with HBsAg loss was defined as an undetectable level of serum HBsAg; and those participants with HBsAg seroconversion were defined as an undetectable level of serum HBsAg and a detectable level of serum HBsAb. All these participant were reported at week 52. Only the subset of participants, with above parameters detectable at baseline were included and for participants with post-baseline values missing were considered as non-responders.
Outcome measures
| Measure |
Adefovir Dipivoxil 10mg
n=104 Participants
The eligible participants received open label treatment of 10 mg Adefovir dipivoxil, orally once daily for 52-weeks.
|
|---|---|
|
Number of Participants With Hepatitis B e Viral Protein (HBeAg) Loss, HBeAg Seroconversion, Hepatitis B Virus Surface Antigen (HBsAg) Loss and HBsAg Seroconversion at Week 52
HbeAg loss
|
19 Participants
|
|
Number of Participants With Hepatitis B e Viral Protein (HBeAg) Loss, HBeAg Seroconversion, Hepatitis B Virus Surface Antigen (HBsAg) Loss and HBsAg Seroconversion at Week 52
HbeAg seroconversion
|
10 Participants
|
|
Number of Participants With Hepatitis B e Viral Protein (HBeAg) Loss, HBeAg Seroconversion, Hepatitis B Virus Surface Antigen (HBsAg) Loss and HBsAg Seroconversion at Week 52
HbsAg loss
|
0 Participants
|
|
Number of Participants With Hepatitis B e Viral Protein (HBeAg) Loss, HBeAg Seroconversion, Hepatitis B Virus Surface Antigen (HBsAg) Loss and HBsAg Seroconversion at Week 52
HbsAg seroconversion
|
0 Participants
|
SECONDARY outcome
Timeframe: at Week 12Population: ITT population
ALT normalization was defined as measurement less than or equal to the upper limit of the normal range. The normal range for ALT is 7-43 Units/Liter. Only those set of participants with a baseline ALT value above the upper limit of the normal range were included in this analysis, done at week 12.
Outcome measures
| Measure |
Adefovir Dipivoxil 10mg
n=104 Participants
The eligible participants received open label treatment of 10 mg Adefovir dipivoxil, orally once daily for 52-weeks.
|
|---|---|
|
Number of Participants Achieving ALT Normalization at Week 12
|
50 Participants
|
SECONDARY outcome
Timeframe: From treatment initiation (Week 0) to follow-up (up to 52 weeks)Population: ITT population.
AE is defined as, any untoward medical occurrence in a participant or clinical investigation, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that at any dose, results in death; is life threatening; requires hospitalization or prolongation of hospitalization; results in disability or incapacity, is a congenital anomaly/birth defect or requires medical intervention.
Outcome measures
| Measure |
Adefovir Dipivoxil 10mg
n=104 Participants
The eligible participants received open label treatment of 10 mg Adefovir dipivoxil, orally once daily for 52-weeks.
|
|---|---|
|
Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAEs)
All SAE's
|
2 Participants
|
|
Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAEs)
All AE's
|
43 Participants
|
|
Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAEs)
AEs related to study drug
|
6 Participants
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Week 12 and Week 52Population: ITT population.
The data for hematology parameters was summarized for Hemoglobin, Red blood cells (RBC), Platelets, Neutrophils, Lymphocytes, Monocytes, and Eosinophil as per the scheduled assessments and also according to maximum grade common terminology criteria (CTC) toxicity grade. The data for number of participants with shift in grade for hematology parameters at Week 12 and Week 52 were reported.
Outcome measures
| Measure |
Adefovir Dipivoxil 10mg
n=104 Participants
The eligible participants received open label treatment of 10 mg Adefovir dipivoxil, orally once daily for 52-weeks.
|
|---|---|
|
Number of Participants With Shift From Baseline Hematology Parameters at Week 12 and Week 52
Hemoglobin, Low to Normal, Week 12
|
0 Participants
|
|
Number of Participants With Shift From Baseline Hematology Parameters at Week 12 and Week 52
Hemoglobin, Low to High, Week 12
|
0 Participants
|
|
Number of Participants With Shift From Baseline Hematology Parameters at Week 12 and Week 52
Hemoglobin, High to Low, Week 12
|
0 Participants
|
|
Number of Participants With Shift From Baseline Hematology Parameters at Week 12 and Week 52
Hemoglobin, High to Normal, Week 12
|
3 Participants
|
|
Number of Participants With Shift From Baseline Hematology Parameters at Week 12 and Week 52
Hemoglobin, Normal to Low, Week 12
|
1 Participants
|
|
Number of Participants With Shift From Baseline Hematology Parameters at Week 12 and Week 52
Hemoglobin, Normal to High Week 12
|
3 Participants
|
|
Number of Participants With Shift From Baseline Hematology Parameters at Week 12 and Week 52
Hemoglobin, Low to Normal, Week 52
|
3 Participants
|
|
Number of Participants With Shift From Baseline Hematology Parameters at Week 12 and Week 52
Hemoglobin, Low to High, Week 52
|
0 Participants
|
|
Number of Participants With Shift From Baseline Hematology Parameters at Week 12 and Week 52
Hemoglobin, High to Low, Week 52
|
0 Participants
|
|
Number of Participants With Shift From Baseline Hematology Parameters at Week 12 and Week 52
Hemoglobin, High to Normal, Week 52
|
0 Participants
|
|
Number of Participants With Shift From Baseline Hematology Parameters at Week 12 and Week 52
Hemoglobin, Normal to Low, Week 52
|
1 Participants
|
|
Number of Participants With Shift From Baseline Hematology Parameters at Week 12 and Week 52
Hemoglobin, Normal to High Week 52
|
4 Participants
|
|
Number of Participants With Shift From Baseline Hematology Parameters at Week 12 and Week 52
RBC, Low to Normal, Week 12
|
4 Participants
|
|
Number of Participants With Shift From Baseline Hematology Parameters at Week 12 and Week 52
RBC, Low to High, Week 12
|
0 Participants
|
|
Number of Participants With Shift From Baseline Hematology Parameters at Week 12 and Week 52
RBC, High to Low, Week 12
|
0 Participants
|
|
Number of Participants With Shift From Baseline Hematology Parameters at Week 12 and Week 52
RBC, High to Normal, Week 12
|
0 Participants
|
|
Number of Participants With Shift From Baseline Hematology Parameters at Week 12 and Week 52
RBC, Normal to Low, Week 12
|
1 Participants
|
|
Number of Participants With Shift From Baseline Hematology Parameters at Week 12 and Week 52
RBC, Normal to High Week 12
|
2 Participants
|
|
Number of Participants With Shift From Baseline Hematology Parameters at Week 12 and Week 52
RBC, Low to Normal, Week 52
|
3 Participants
|
|
Number of Participants With Shift From Baseline Hematology Parameters at Week 12 and Week 52
RBC, Low to High, Week 52
|
0 Participants
|
|
Number of Participants With Shift From Baseline Hematology Parameters at Week 12 and Week 52
RBC, High to Low, Week 52
|
0 Participants
|
|
Number of Participants With Shift From Baseline Hematology Parameters at Week 12 and Week 52
RBC, High to Normal, Week 52
|
0 Participants
|
|
Number of Participants With Shift From Baseline Hematology Parameters at Week 12 and Week 52
RBC, Normal to Low, Week 52
|
1 Participants
|
|
Number of Participants With Shift From Baseline Hematology Parameters at Week 12 and Week 52
RBC, Normal to High Week 52
|
4 Participants
|
|
Number of Participants With Shift From Baseline Hematology Parameters at Week 12 and Week 52
Platelets, Low to Normal, Week 12
|
5 Participants
|
|
Number of Participants With Shift From Baseline Hematology Parameters at Week 12 and Week 52
Platelets, Low to High, Week 12
|
0 Participants
|
|
Number of Participants With Shift From Baseline Hematology Parameters at Week 12 and Week 52
Platelets, High to Low, Week 12
|
0 Participants
|
|
Number of Participants With Shift From Baseline Hematology Parameters at Week 12 and Week 52
Platelets, High to Normal, Week 12
|
0 Participants
|
|
Number of Participants With Shift From Baseline Hematology Parameters at Week 12 and Week 52
Platelets, Normal to Low, Week 12
|
2 Participants
|
|
Number of Participants With Shift From Baseline Hematology Parameters at Week 12 and Week 52
Platelet, Normal to High, Week 12
|
0 Participants
|
|
Number of Participants With Shift From Baseline Hematology Parameters at Week 12 and Week 52
Platelets, Low to Normal, Week 52
|
5 Participants
|
|
Number of Participants With Shift From Baseline Hematology Parameters at Week 12 and Week 52
Platelets, Low to High, Week 52
|
0 Participants
|
|
Number of Participants With Shift From Baseline Hematology Parameters at Week 12 and Week 52
Platelets, High to Low, Week 52
|
0 Participants
|
|
Number of Participants With Shift From Baseline Hematology Parameters at Week 12 and Week 52
Platelets, High to Normal, Week 52
|
0 Participants
|
|
Number of Participants With Shift From Baseline Hematology Parameters at Week 12 and Week 52
Platelet, Normal to Low, Week 52
|
0 Participants
|
|
Number of Participants With Shift From Baseline Hematology Parameters at Week 12 and Week 52
Platelets, Normal to High, Week 52
|
0 Participants
|
|
Number of Participants With Shift From Baseline Hematology Parameters at Week 12 and Week 52
Total WBC, Low to Normal, Week 12
|
10 Participants
|
|
Number of Participants With Shift From Baseline Hematology Parameters at Week 12 and Week 52
Total WBC, Low to High, Week 12
|
0 Participants
|
|
Number of Participants With Shift From Baseline Hematology Parameters at Week 12 and Week 52
Total WBC, High to Low, Week 12
|
0 Participants
|
|
Number of Participants With Shift From Baseline Hematology Parameters at Week 12 and Week 52
Total WBC, High to Normal, Week 12
|
0 Participants
|
|
Number of Participants With Shift From Baseline Hematology Parameters at Week 12 and Week 52
Total WBC, Normal to Low, Week 12
|
1 Participants
|
|
Number of Participants With Shift From Baseline Hematology Parameters at Week 12 and Week 52
Total WBC, Normal to High Week 12
|
1 Participants
|
|
Number of Participants With Shift From Baseline Hematology Parameters at Week 12 and Week 52
Total WBC, Low to Normal, Week 52
|
12 Participants
|
|
Number of Participants With Shift From Baseline Hematology Parameters at Week 12 and Week 52
Total WBC, Low to High, Week 52
|
0 Participants
|
|
Number of Participants With Shift From Baseline Hematology Parameters at Week 12 and Week 52
Total WBC, High to Low, Week 52
|
0 Participants
|
|
Number of Participants With Shift From Baseline Hematology Parameters at Week 12 and Week 52
Total WBC, High to Normal, Week 52
|
0 Participants
|
|
Number of Participants With Shift From Baseline Hematology Parameters at Week 12 and Week 52
Total WBC, Normal to Low, Week 52
|
3 Participants
|
|
Number of Participants With Shift From Baseline Hematology Parameters at Week 12 and Week 52
Total WBC, Normal to High, Week 52
|
3 Participants
|
|
Number of Participants With Shift From Baseline Hematology Parameters at Week 12 and Week 52
Neutrophils, Low to Normal, Week 12
|
11 Participants
|
|
Number of Participants With Shift From Baseline Hematology Parameters at Week 12 and Week 52
Neutrophils, Low to High, Week 12
|
0 Participants
|
|
Number of Participants With Shift From Baseline Hematology Parameters at Week 12 and Week 52
Neutrophils, High to Low, Week 12
|
0 Participants
|
|
Number of Participants With Shift From Baseline Hematology Parameters at Week 12 and Week 52
Neutrophils, High to Normal, Week 12
|
1 Participants
|
|
Number of Participants With Shift From Baseline Hematology Parameters at Week 12 and Week 52
Neutrophils, Normal to Low, Week 12
|
6 Participants
|
|
Number of Participants With Shift From Baseline Hematology Parameters at Week 12 and Week 52
Neutrophils, Normal to High, Week 12
|
0 Participants
|
|
Number of Participants With Shift From Baseline Hematology Parameters at Week 12 and Week 52
Neutrophils, Low to Normal, Week 52
|
14 Participants
|
|
Number of Participants With Shift From Baseline Hematology Parameters at Week 12 and Week 52
Neutrophils, Low to High, Week 52
|
0 Participants
|
|
Number of Participants With Shift From Baseline Hematology Parameters at Week 12 and Week 52
Neutrophils, High to Low, Week 52
|
0 Participants
|
|
Number of Participants With Shift From Baseline Hematology Parameters at Week 12 and Week 52
Neutrophils, High to Normal, Week 52
|
1 Participants
|
|
Number of Participants With Shift From Baseline Hematology Parameters at Week 12 and Week 52
Neutrophils, Normal to Low, Week 52
|
3 Participants
|
|
Number of Participants With Shift From Baseline Hematology Parameters at Week 12 and Week 52
Neutrophils, Normal to High, Week 52
|
2 Participants
|
|
Number of Participants With Shift From Baseline Hematology Parameters at Week 12 and Week 52
Lymphocytes, Low to Normal, Week 12
|
1 Participants
|
|
Number of Participants With Shift From Baseline Hematology Parameters at Week 12 and Week 52
Lymphocytes, Low to High, Week 12
|
0 Participants
|
|
Number of Participants With Shift From Baseline Hematology Parameters at Week 12 and Week 52
Lymphocytes, High to Low, Week 12
|
0 Participants
|
|
Number of Participants With Shift From Baseline Hematology Parameters at Week 12 and Week 52
Lymphocytes, High to Normal, Week 12
|
9 Participants
|
|
Number of Participants With Shift From Baseline Hematology Parameters at Week 12 and Week 52
Lymphocytes, Normal to Low, Week 12
|
1 Participants
|
|
Number of Participants With Shift From Baseline Hematology Parameters at Week 12 and Week 52
Lymphocytes, Normal to High Week 12
|
6 Participants
|
|
Number of Participants With Shift From Baseline Hematology Parameters at Week 12 and Week 52
Lymphocytes, Low to Normal, Week 52
|
1 Participants
|
|
Number of Participants With Shift From Baseline Hematology Parameters at Week 12 and Week 52
Lymphocytes, Low to High, Week 52
|
0 Participants
|
|
Number of Participants With Shift From Baseline Hematology Parameters at Week 12 and Week 52
Lymphocytes, High to Low, Week 52
|
0 Participants
|
|
Number of Participants With Shift From Baseline Hematology Parameters at Week 12 and Week 52
Lymphocytes, High to Normal, Week 52
|
12 Participants
|
|
Number of Participants With Shift From Baseline Hematology Parameters at Week 12 and Week 52
Lymphocytes, Normal to Low, Week 52
|
4 Participants
|
|
Number of Participants With Shift From Baseline Hematology Parameters at Week 12 and Week 52
Lymphocytes, Normal to High, Week 52
|
1 Participants
|
|
Number of Participants With Shift From Baseline Hematology Parameters at Week 12 and Week 52
Monocytes, Low to Normal, Week 12
|
0 Participants
|
|
Number of Participants With Shift From Baseline Hematology Parameters at Week 12 and Week 52
Monocytes, Low to High, Week 12
|
0 Participants
|
|
Number of Participants With Shift From Baseline Hematology Parameters at Week 12 and Week 52
Monocytes, High to Low, Week 12
|
0 Participants
|
|
Number of Participants With Shift From Baseline Hematology Parameters at Week 12 and Week 52
Monocytes, High to Normal, Week 12
|
15 Participants
|
|
Number of Participants With Shift From Baseline Hematology Parameters at Week 12 and Week 52
Monocytes, Normal to Low, Week 12
|
0 Participants
|
|
Number of Participants With Shift From Baseline Hematology Parameters at Week 12 and Week 52
Monocytes, Normal to High, Week 12
|
1 Participants
|
|
Number of Participants With Shift From Baseline Hematology Parameters at Week 12 and Week 52
Monocytes, Low to Normal, Week 52
|
0 Participants
|
|
Number of Participants With Shift From Baseline Hematology Parameters at Week 12 and Week 52
Monocytes, Low to High, Week 52
|
0 Participants
|
|
Number of Participants With Shift From Baseline Hematology Parameters at Week 12 and Week 52
Monocytes, High to Low, Week 52
|
0 Participants
|
|
Number of Participants With Shift From Baseline Hematology Parameters at Week 12 and Week 52
Monocytes, High to Normal, Week 52
|
16 Participants
|
|
Number of Participants With Shift From Baseline Hematology Parameters at Week 12 and Week 52
Monocytes, Normal to Low, Week 52
|
0 Participants
|
|
Number of Participants With Shift From Baseline Hematology Parameters at Week 12 and Week 52
Monocytes, Normal to High, Week 52
|
1 Participants
|
|
Number of Participants With Shift From Baseline Hematology Parameters at Week 12 and Week 52
Eosinophils, Low to Normal, Week 12
|
2 Participants
|
|
Number of Participants With Shift From Baseline Hematology Parameters at Week 12 and Week 52
Eosinophils, Low to High, Week 12
|
0 Participants
|
|
Number of Participants With Shift From Baseline Hematology Parameters at Week 12 and Week 52
Eosinophils, High to Low, Week 12
|
0 Participants
|
|
Number of Participants With Shift From Baseline Hematology Parameters at Week 12 and Week 52
Eosinophils, High to Normal, Week 12
|
3 Participants
|
|
Number of Participants With Shift From Baseline Hematology Parameters at Week 12 and Week 52
Eosinophils, Normal to Low, Week 12
|
1 Participants
|
|
Number of Participants With Shift From Baseline Hematology Parameters at Week 12 and Week 52
Eosinophils, Normal to High Week 12
|
1 Participants
|
|
Number of Participants With Shift From Baseline Hematology Parameters at Week 12 and Week 52
Eosinophils, Low to Normal, Week 52
|
2 Participants
|
|
Number of Participants With Shift From Baseline Hematology Parameters at Week 12 and Week 52
Eosinophils, Low to High, Week 52
|
0 Participants
|
|
Number of Participants With Shift From Baseline Hematology Parameters at Week 12 and Week 52
Eosinophils, High to Normal, Week 52
|
5 Participants
|
|
Number of Participants With Shift From Baseline Hematology Parameters at Week 12 and Week 52
Eosinophils, High to Low, Week 52
|
0 Participants
|
|
Number of Participants With Shift From Baseline Hematology Parameters at Week 12 and Week 52
Eosinophils, Normal to High, Week 52
|
4 Participants
|
|
Number of Participants With Shift From Baseline Hematology Parameters at Week 12 and Week 52
Eosinophils, Normal to Low, Week 52
|
2 Participants
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Week 12 and Week 52Population: ITT population. Only those participants available at the specified time points were analyzed
The data for clinical chemical parameters namely sodium, potassium, calcium, phosphorus, total protein, albumin, amylase, creatinine phospho kinase, creatinine, blood urea nitrogen, total bilirubin, alkaline phosphatase, aspartate transaminase, alanine transaminase, and prothrombin time as per the scheduled assessments and also according to maximum CTC toxicity grade was reported. The data for number of participants with shift in grade for clinical chemistry parameters at Week 12 and Week 52 were reported.
Outcome measures
| Measure |
Adefovir Dipivoxil 10mg
n=104 Participants
The eligible participants received open label treatment of 10 mg Adefovir dipivoxil, orally once daily for 52-weeks.
|
|---|---|
|
Number of Participants With Shift From Baseline Clinical Chemistry Parameters at Week 12 and Week 52
Phosphorus, High to Low, Week 52
|
0 Participants
|
|
Number of Participants With Shift From Baseline Clinical Chemistry Parameters at Week 12 and Week 52
Amylase, Normal to High, Week 12
|
3 Participants
|
|
Number of Participants With Shift From Baseline Clinical Chemistry Parameters at Week 12 and Week 52
Sodium, Low to Normal, Week 12
|
0 Participants
|
|
Number of Participants With Shift From Baseline Clinical Chemistry Parameters at Week 12 and Week 52
Sodium, Low to High, Week 12
|
0 Participants
|
|
Number of Participants With Shift From Baseline Clinical Chemistry Parameters at Week 12 and Week 52
Sodium, High to Low, Week 12
|
0 Participants
|
|
Number of Participants With Shift From Baseline Clinical Chemistry Parameters at Week 12 and Week 52
Sodium, Normal to Low, Week 12
|
2 Participants
|
|
Number of Participants With Shift From Baseline Clinical Chemistry Parameters at Week 12 and Week 52
Sodium, High to Normal, Week 12
|
0 Participants
|
|
Number of Participants With Shift From Baseline Clinical Chemistry Parameters at Week 12 and Week 52
Sodium, Normal to High, Week 12
|
1 Participants
|
|
Number of Participants With Shift From Baseline Clinical Chemistry Parameters at Week 12 and Week 52
Sodium, Low to Normal, Week 52
|
0 Participants
|
|
Number of Participants With Shift From Baseline Clinical Chemistry Parameters at Week 12 and Week 52
Sodium, Low to High, Week 52
|
0 Participants
|
|
Number of Participants With Shift From Baseline Clinical Chemistry Parameters at Week 12 and Week 52
Sodium, High to Low, Week 52
|
0 Participants
|
|
Number of Participants With Shift From Baseline Clinical Chemistry Parameters at Week 12 and Week 52
Sodium, High to Normal, Week 52
|
0 Participants
|
|
Number of Participants With Shift From Baseline Clinical Chemistry Parameters at Week 12 and Week 52
Sodium, Normal to Low, Week 52
|
0 Participants
|
|
Number of Participants With Shift From Baseline Clinical Chemistry Parameters at Week 12 and Week 52
Sodium, Normal to High, Week 52
|
2 Participants
|
|
Number of Participants With Shift From Baseline Clinical Chemistry Parameters at Week 12 and Week 52
Potassium, Low to Normal, Week 12
|
1 Participants
|
|
Number of Participants With Shift From Baseline Clinical Chemistry Parameters at Week 12 and Week 52
Potassium, Low to High, Week 12
|
0 Participants
|
|
Number of Participants With Shift From Baseline Clinical Chemistry Parameters at Week 12 and Week 52
Potassium, High to Low, Week 12
|
0 Participants
|
|
Number of Participants With Shift From Baseline Clinical Chemistry Parameters at Week 12 and Week 52
Potassium, High to Normal, Week 12
|
0 Participants
|
|
Number of Participants With Shift From Baseline Clinical Chemistry Parameters at Week 12 and Week 52
Potassium, Normal to Low, Week 12
|
0 Participants
|
|
Number of Participants With Shift From Baseline Clinical Chemistry Parameters at Week 12 and Week 52
Potassium, Normal to High, Week 12
|
1 Participants
|
|
Number of Participants With Shift From Baseline Clinical Chemistry Parameters at Week 12 and Week 52
Potassium, Low to Normal, Week 52
|
1 Participants
|
|
Number of Participants With Shift From Baseline Clinical Chemistry Parameters at Week 12 and Week 52
Potassium, Low to High, Week 52
|
0 Participants
|
|
Number of Participants With Shift From Baseline Clinical Chemistry Parameters at Week 12 and Week 52
Potassium, High to Low, Week 52
|
0 Participants
|
|
Number of Participants With Shift From Baseline Clinical Chemistry Parameters at Week 12 and Week 52
Potassium, High to Normal, Week 52
|
0 Participants
|
|
Number of Participants With Shift From Baseline Clinical Chemistry Parameters at Week 12 and Week 52
Potassium, Normal to Low, Week 52
|
1 Participants
|
|
Number of Participants With Shift From Baseline Clinical Chemistry Parameters at Week 12 and Week 52
Potassium, Normal to High, Week 52
|
0 Participants
|
|
Number of Participants With Shift From Baseline Clinical Chemistry Parameters at Week 12 and Week 52
Calcium, Low to Normal, Week 12
|
1 Participants
|
|
Number of Participants With Shift From Baseline Clinical Chemistry Parameters at Week 12 and Week 52
Calcium, Low to High, Week 12
|
0 Participants
|
|
Number of Participants With Shift From Baseline Clinical Chemistry Parameters at Week 12 and Week 52
Calcium, High to Low, Week 12
|
0 Participants
|
|
Number of Participants With Shift From Baseline Clinical Chemistry Parameters at Week 12 and Week 52
Calcium, High to Normal, Week 12
|
3 Participants
|
|
Number of Participants With Shift From Baseline Clinical Chemistry Parameters at Week 12 and Week 52
Calcium, Normal to Low, Week 12
|
1 Participants
|
|
Number of Participants With Shift From Baseline Clinical Chemistry Parameters at Week 12 and Week 52
Calcium, Normal to High, Week 12
|
2 Participants
|
|
Number of Participants With Shift From Baseline Clinical Chemistry Parameters at Week 12 and Week 52
Calcium, Low to Normal, Week 52
|
1 Participants
|
|
Number of Participants With Shift From Baseline Clinical Chemistry Parameters at Week 12 and Week 52
Calcium, Low to High, Week 52
|
0 Participants
|
|
Number of Participants With Shift From Baseline Clinical Chemistry Parameters at Week 12 and Week 52
Calcium, High to Low, Week 52
|
0 Participants
|
|
Number of Participants With Shift From Baseline Clinical Chemistry Parameters at Week 12 and Week 52
Calcium, High to Normal, Week 52
|
2 Participants
|
|
Number of Participants With Shift From Baseline Clinical Chemistry Parameters at Week 12 and Week 52
Calcium, Normal to Low, Week 52
|
2 Participants
|
|
Number of Participants With Shift From Baseline Clinical Chemistry Parameters at Week 12 and Week 52
Calcium, Normal to High, Week 52
|
0 Participants
|
|
Number of Participants With Shift From Baseline Clinical Chemistry Parameters at Week 12 and Week 52
Phosphorus, Low to Normal, Week 12
|
4 Participants
|
|
Number of Participants With Shift From Baseline Clinical Chemistry Parameters at Week 12 and Week 52
Phosphorus, Low to High, Week 12
|
0 Participants
|
|
Number of Participants With Shift From Baseline Clinical Chemistry Parameters at Week 12 and Week 52
Phosphorus, High to Low, Week 12
|
0 Participants
|
|
Number of Participants With Shift From Baseline Clinical Chemistry Parameters at Week 12 and Week 52
Phosphorus, High to Normal, Week 12
|
3 Participants
|
|
Number of Participants With Shift From Baseline Clinical Chemistry Parameters at Week 12 and Week 52
Phosphorus, Normal to Low, Week 12
|
0 Participants
|
|
Number of Participants With Shift From Baseline Clinical Chemistry Parameters at Week 12 and Week 52
Phosphorus, Normal to High, Week 12
|
3 Participants
|
|
Number of Participants With Shift From Baseline Clinical Chemistry Parameters at Week 12 and Week 52
Phosphorus, Low to Normal, Week 52
|
4 Participants
|
|
Number of Participants With Shift From Baseline Clinical Chemistry Parameters at Week 12 and Week 52
Phosphorus, Low to High, Week 52
|
0 Participants
|
|
Number of Participants With Shift From Baseline Clinical Chemistry Parameters at Week 12 and Week 52
Phosphorus, High to Normal, Week 52
|
1 Participants
|
|
Number of Participants With Shift From Baseline Clinical Chemistry Parameters at Week 12 and Week 52
Phosphorus, Normal to Low, Week 52
|
1 Participants
|
|
Number of Participants With Shift From Baseline Clinical Chemistry Parameters at Week 12 and Week 52
Phosphorus, Normal to High, Week 52
|
1 Participants
|
|
Number of Participants With Shift From Baseline Clinical Chemistry Parameters at Week 12 and Week 52
Total Protein, Low to Normal, Week 12
|
0 Participants
|
|
Number of Participants With Shift From Baseline Clinical Chemistry Parameters at Week 12 and Week 52
Total Protein, Low to High, Week 12
|
0 Participants
|
|
Number of Participants With Shift From Baseline Clinical Chemistry Parameters at Week 12 and Week 52
Total Protein, High to Low, Week 12
|
0 Participants
|
|
Number of Participants With Shift From Baseline Clinical Chemistry Parameters at Week 12 and Week 52
Total Protein, High to Normal, Week 12
|
1 Participants
|
|
Number of Participants With Shift From Baseline Clinical Chemistry Parameters at Week 12 and Week 52
Total Protein, Normal to Low, Week 12
|
0 Participants
|
|
Number of Participants With Shift From Baseline Clinical Chemistry Parameters at Week 12 and Week 52
Total Protein, Normal to High, Week 12
|
3 Participants
|
|
Number of Participants With Shift From Baseline Clinical Chemistry Parameters at Week 12 and Week 52
Total Protein, Low to Normal, Week 52
|
0 Participants
|
|
Number of Participants With Shift From Baseline Clinical Chemistry Parameters at Week 12 and Week 52
Total Protein, Low to High, Week 52
|
0 Participants
|
|
Number of Participants With Shift From Baseline Clinical Chemistry Parameters at Week 12 and Week 52
Total Protein, High to Low, Week 52
|
0 Participants
|
|
Number of Participants With Shift From Baseline Clinical Chemistry Parameters at Week 12 and Week 52
Total Protein, High to Normal, Week 52
|
0 Participants
|
|
Number of Participants With Shift From Baseline Clinical Chemistry Parameters at Week 12 and Week 52
Total Protein, Normal to Low, Week 52
|
0 Participants
|
|
Number of Participants With Shift From Baseline Clinical Chemistry Parameters at Week 12 and Week 52
Total Protein, Normal to High, Week 52
|
4 Participants
|
|
Number of Participants With Shift From Baseline Clinical Chemistry Parameters at Week 12 and Week 52
Amylase, Low to Normal, Week 12
|
0 Participants
|
|
Number of Participants With Shift From Baseline Clinical Chemistry Parameters at Week 12 and Week 52
Amylase, Low to High, Week 12
|
0 Participants
|
|
Number of Participants With Shift From Baseline Clinical Chemistry Parameters at Week 12 and Week 52
Amylase, High to Low, Week 12
|
0 Participants
|
|
Number of Participants With Shift From Baseline Clinical Chemistry Parameters at Week 12 and Week 52
Amylase, High to Normal, Week 12
|
6 Participants
|
|
Number of Participants With Shift From Baseline Clinical Chemistry Parameters at Week 12 and Week 52
Amylase, Normal to Low, Week 12
|
0 Participants
|
|
Number of Participants With Shift From Baseline Clinical Chemistry Parameters at Week 12 and Week 52
Amylase, Low to Normal, Week 52
|
0 Participants
|
|
Number of Participants With Shift From Baseline Clinical Chemistry Parameters at Week 12 and Week 52
Amylase, Low to High, Week 52
|
0 Participants
|
|
Number of Participants With Shift From Baseline Clinical Chemistry Parameters at Week 12 and Week 52
Amylase, High to Low, Week 52
|
0 Participants
|
|
Number of Participants With Shift From Baseline Clinical Chemistry Parameters at Week 12 and Week 52
Amylase, High to Normal, Week 52
|
6 Participants
|
|
Number of Participants With Shift From Baseline Clinical Chemistry Parameters at Week 12 and Week 52
Amylase, Normal to Low, Week 52
|
0 Participants
|
|
Number of Participants With Shift From Baseline Clinical Chemistry Parameters at Week 12 and Week 52
Amylase, Normal to High, Week 52
|
2 Participants
|
|
Number of Participants With Shift From Baseline Clinical Chemistry Parameters at Week 12 and Week 52
Creatinine phosphokinase, Low to Normal, Week 12
|
1 Participants
|
|
Number of Participants With Shift From Baseline Clinical Chemistry Parameters at Week 12 and Week 52
Creatinine phosphokinase, Low to High, Week 12
|
0 Participants
|
|
Number of Participants With Shift From Baseline Clinical Chemistry Parameters at Week 12 and Week 52
Creatinine phosphokinase, High to Low, Week 12
|
0 Participants
|
|
Number of Participants With Shift From Baseline Clinical Chemistry Parameters at Week 12 and Week 52
Creatinine phosphokinase, High to Normal, Week 12
|
5 Participants
|
|
Number of Participants With Shift From Baseline Clinical Chemistry Parameters at Week 12 and Week 52
Creatinine phosphokinase, Normal to Low, Week 12
|
0 Participants
|
|
Number of Participants With Shift From Baseline Clinical Chemistry Parameters at Week 12 and Week 52
Creatinine phosphokinase, Normal to High, Week 12
|
2 Participants
|
|
Number of Participants With Shift From Baseline Clinical Chemistry Parameters at Week 12 and Week 52
Creatinine phosphokinase, Low to Normal, Week 52
|
1 Participants
|
|
Number of Participants With Shift From Baseline Clinical Chemistry Parameters at Week 12 and Week 52
Creatinine phosphokinase, Low to High, Week 52
|
0 Participants
|
|
Number of Participants With Shift From Baseline Clinical Chemistry Parameters at Week 12 and Week 52
Creatinine phosphokinase, High to Low, Week 52
|
0 Participants
|
|
Number of Participants With Shift From Baseline Clinical Chemistry Parameters at Week 12 and Week 52
Creatinine phosphokinase, High to Normal, Week 52
|
5 Participants
|
|
Number of Participants With Shift From Baseline Clinical Chemistry Parameters at Week 12 and Week 52
Creatinine phosphokinase, Normal to Low, Week 52
|
0 Participants
|
|
Number of Participants With Shift From Baseline Clinical Chemistry Parameters at Week 12 and Week 52
Creatinine phosphokinase, Normal to High, Week 52
|
3 Participants
|
|
Number of Participants With Shift From Baseline Clinical Chemistry Parameters at Week 12 and Week 52
Creatinine, Low to Normal, Week 12
|
0 Participants
|
|
Number of Participants With Shift From Baseline Clinical Chemistry Parameters at Week 12 and Week 52
Creatinine, Low to High, Week 12
|
0 Participants
|
|
Number of Participants With Shift From Baseline Clinical Chemistry Parameters at Week 12 and Week 52
Creatinine, High to Low, Week 12
|
0 Participants
|
|
Number of Participants With Shift From Baseline Clinical Chemistry Parameters at Week 12 and Week 52
Creatinine, High to Normal, Week 12
|
0 Participants
|
|
Number of Participants With Shift From Baseline Clinical Chemistry Parameters at Week 12 and Week 52
Creatinine, Normal to Low, Week 12
|
0 Participants
|
|
Number of Participants With Shift From Baseline Clinical Chemistry Parameters at Week 12 and Week 52
Creatinine, Normal to High, Week 12
|
2 Participants
|
|
Number of Participants With Shift From Baseline Clinical Chemistry Parameters at Week 12 and Week 52
Creatinine, Low to Normal, Week 52
|
0 Participants
|
|
Number of Participants With Shift From Baseline Clinical Chemistry Parameters at Week 12 and Week 52
Creatinine, Low to High, Week 52
|
0 Participants
|
|
Number of Participants With Shift From Baseline Clinical Chemistry Parameters at Week 12 and Week 52
Creatinine, High to Low, Week 52
|
0 Participants
|
|
Number of Participants With Shift From Baseline Clinical Chemistry Parameters at Week 12 and Week 52
Creatinine, High to Normal, Week 52
|
0 Participants
|
|
Number of Participants With Shift From Baseline Clinical Chemistry Parameters at Week 12 and Week 52
Creatinine, Normal to Low, Week 52
|
0 Participants
|
|
Number of Participants With Shift From Baseline Clinical Chemistry Parameters at Week 12 and Week 52
Creatinine, Normal to High, Week 52
|
3 Participants
|
|
Number of Participants With Shift From Baseline Clinical Chemistry Parameters at Week 12 and Week 52
Blood urea nitrogen, Low to Normal, Week 12
|
7 Participants
|
|
Number of Participants With Shift From Baseline Clinical Chemistry Parameters at Week 12 and Week 52
Blood urea nitrogen, Low to High, Week 12
|
0 Participants
|
|
Number of Participants With Shift From Baseline Clinical Chemistry Parameters at Week 12 and Week 52
Blood urea nitrogen, High to Low, Week 12
|
0 Participants
|
|
Number of Participants With Shift From Baseline Clinical Chemistry Parameters at Week 12 and Week 52
Blood urea nitrogen, High to Normal, Week 12
|
1 Participants
|
|
Number of Participants With Shift From Baseline Clinical Chemistry Parameters at Week 12 and Week 52
Blood urea nitrogen, Normal to Low, Week 12
|
1 Participants
|
|
Number of Participants With Shift From Baseline Clinical Chemistry Parameters at Week 12 and Week 52
Blood urea nitrogen, Normal to High, Week 12
|
0 Participants
|
|
Number of Participants With Shift From Baseline Clinical Chemistry Parameters at Week 12 and Week 52
Blood urea nitrogen, Low to Normal, Week 52
|
10 Participants
|
|
Number of Participants With Shift From Baseline Clinical Chemistry Parameters at Week 12 and Week 52
Blood urea nitrogen, Low to High, Week 52
|
0 Participants
|
|
Number of Participants With Shift From Baseline Clinical Chemistry Parameters at Week 12 and Week 52
Blood urea nitrogen, High to Low, Week 52
|
0 Participants
|
|
Number of Participants With Shift From Baseline Clinical Chemistry Parameters at Week 12 and Week 52
Blood urea nitrogen, High to Normal, Week 52
|
1 Participants
|
|
Number of Participants With Shift From Baseline Clinical Chemistry Parameters at Week 12 and Week 52
Blood urea nitrogen, Normal to Low, Week 52
|
3 Participants
|
|
Number of Participants With Shift From Baseline Clinical Chemistry Parameters at Week 12 and Week 52
Blood urea nitrogen, Normal to High, Week 52
|
0 Participants
|
|
Number of Participants With Shift From Baseline Clinical Chemistry Parameters at Week 12 and Week 52
Total bilirubin, Low to Normal, Week 12
|
0 Participants
|
|
Number of Participants With Shift From Baseline Clinical Chemistry Parameters at Week 12 and Week 52
Total bilirubin, Low to High, Week 12
|
0 Participants
|
|
Number of Participants With Shift From Baseline Clinical Chemistry Parameters at Week 12 and Week 52
Total bilirubin, High to Low, Week 12
|
0 Participants
|
|
Number of Participants With Shift From Baseline Clinical Chemistry Parameters at Week 12 and Week 52
Total bilirubin, High to Normal, Week 12
|
7 Participants
|
|
Number of Participants With Shift From Baseline Clinical Chemistry Parameters at Week 12 and Week 52
Total bilirubin, Normal to Low, Week 12
|
0 Participants
|
|
Number of Participants With Shift From Baseline Clinical Chemistry Parameters at Week 12 and Week 52
Total bilirubin, Low to Normal, Week 52
|
0 Participants
|
|
Number of Participants With Shift From Baseline Clinical Chemistry Parameters at Week 12 and Week 52
Total bilirubin, Low to High, Week 52
|
0 Participants
|
|
Number of Participants With Shift From Baseline Clinical Chemistry Parameters at Week 12 and Week 52
Total bilirubin, High to Low, Week 52
|
0 Participants
|
|
Number of Participants With Shift From Baseline Clinical Chemistry Parameters at Week 12 and Week 52
Total bilirubin, High to Normal, Week 52
|
5 Participants
|
|
Number of Participants With Shift From Baseline Clinical Chemistry Parameters at Week 12 and Week 52
Total bilirubin, Normal to Low, Week 52
|
0 Participants
|
|
Number of Participants With Shift From Baseline Clinical Chemistry Parameters at Week 12 and Week 52
Total bilirubin, Normal to High, Week 52
|
9 Participants
|
|
Number of Participants With Shift From Baseline Clinical Chemistry Parameters at Week 12 and Week 52
Alkaline phosphatase, Low to Normal, Week 12
|
0 Participants
|
|
Number of Participants With Shift From Baseline Clinical Chemistry Parameters at Week 12 and Week 52
Alkaline phosphatase, Low to High, Week 12
|
0 Participants
|
|
Number of Participants With Shift From Baseline Clinical Chemistry Parameters at Week 12 and Week 52
Alkaline phosphatase, High to Low, Week 12
|
0 Participants
|
|
Number of Participants With Shift From Baseline Clinical Chemistry Parameters at Week 12 and Week 52
Alkaline phosphatase, High to Normal, Week 12
|
5 Participants
|
|
Number of Participants With Shift From Baseline Clinical Chemistry Parameters at Week 12 and Week 52
Alkaline phosphatase, Normal to Low, Week 12
|
3 Participants
|
|
Number of Participants With Shift From Baseline Clinical Chemistry Parameters at Week 12 and Week 52
Alkaline phosphatase, Normal to High, Week 12
|
2 Participants
|
|
Number of Participants With Shift From Baseline Clinical Chemistry Parameters at Week 12 and Week 52
Alkaline phosphatase, Low to Normal, Week 52
|
0 Participants
|
|
Number of Participants With Shift From Baseline Clinical Chemistry Parameters at Week 12 and Week 52
Alkaline phosphatase, Low to High, Week 52
|
0 Participants
|
|
Number of Participants With Shift From Baseline Clinical Chemistry Parameters at Week 12 and Week 52
Alkaline phosphatase, High to Low, Week 52
|
0 Participants
|
|
Number of Participants With Shift From Baseline Clinical Chemistry Parameters at Week 12 and Week 52
Alkaline phosphatase, High to Normal, Week 52
|
8 Participants
|
|
Number of Participants With Shift From Baseline Clinical Chemistry Parameters at Week 12 and Week 52
Alkaline phosphatase, Normal to Low, Week 52
|
2 Participants
|
|
Number of Participants With Shift From Baseline Clinical Chemistry Parameters at Week 12 and Week 52
Alkaline phosphatase, Normal to High, Week 52
|
1 Participants
|
|
Number of Participants With Shift From Baseline Clinical Chemistry Parameters at Week 12 and Week 52
Prothrombin Time, Low to Normal, Week 12
|
1 Participants
|
|
Number of Participants With Shift From Baseline Clinical Chemistry Parameters at Week 12 and Week 52
Prothrombin Time, Low to High, Week 12
|
0 Participants
|
|
Number of Participants With Shift From Baseline Clinical Chemistry Parameters at Week 12 and Week 52
Prothrombin Time, High to Low, Week 12
|
0 Participants
|
|
Number of Participants With Shift From Baseline Clinical Chemistry Parameters at Week 12 and Week 52
Prothrombin Time, High to Normal, Week 12
|
5 Participants
|
|
Number of Participants With Shift From Baseline Clinical Chemistry Parameters at Week 12 and Week 52
Prothrombin Time, Normal to Low, Week 12
|
1 Participants
|
|
Number of Participants With Shift From Baseline Clinical Chemistry Parameters at Week 12 and Week 52
Prothrombin Time, Normal to High, Week 12
|
6 Participants
|
|
Number of Participants With Shift From Baseline Clinical Chemistry Parameters at Week 12 and Week 52
Prothrombin Time, Low to Normal, Week 52
|
2 Participants
|
|
Number of Participants With Shift From Baseline Clinical Chemistry Parameters at Week 12 and Week 52
Prothrombin Time, Low to High, Week 52
|
0 Participants
|
|
Number of Participants With Shift From Baseline Clinical Chemistry Parameters at Week 12 and Week 52
Prothrombin Time, High to Low, Week 52
|
0 Participants
|
|
Number of Participants With Shift From Baseline Clinical Chemistry Parameters at Week 12 and Week 52
Prothrombin Time, High to Normal, Week 52
|
6 Participants
|
|
Number of Participants With Shift From Baseline Clinical Chemistry Parameters at Week 12 and Week 52
Prothrombin Time, Normal to Low, Week 52
|
6 Participants
|
|
Number of Participants With Shift From Baseline Clinical Chemistry Parameters at Week 12 and Week 52
Prothrombin Time, Normal to High, Week 52
|
2 Participants
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Week 52Population: ITT population
HBV DNA was tested with Roche Cobas Amplicor HBV monitor test, HBV DNA was tested with Roche Cobas Amplicor HBV monitor test, Lower Limit of Detection 300 copies/mL), at baseline and other study visits. The mean log 10 reduction in serum HBV DNA level from baseline to Week 52 was calculated as the Week 52 value minus the baseline value. Baseline was the Day 1 for the study when participant received study drug. Log 10 reduction implied reduced viral load
Outcome measures
| Measure |
Adefovir Dipivoxil 10mg
n=104 Participants
The eligible participants received open label treatment of 10 mg Adefovir dipivoxil, orally once daily for 52-weeks.
|
|---|---|
|
Mean Log 10 Reduction in Serum HBV DNA Level From Baseline to Week 52
|
-4.32 Log10 (copies/mL)
Standard Deviation 1.56
|
Adverse Events
Adefovir Dipivoxil 10mg
Serious events: 2 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Adefovir Dipivoxil 10mg
n=104 participants at risk
The eligible participants received open label treatment of 10 mg Adefovir dipivoxil, orally once daily for 52-weeks
|
|---|---|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.96%
1/104 • From treatment initiation (Week 0) to follow-up (up to 52 weeks)
ITT population
|
|
Hepatobiliary disorders
Ascites
|
0.96%
1/104 • From treatment initiation (Week 0) to follow-up (up to 52 weeks)
ITT population
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.96%
1/104 • From treatment initiation (Week 0) to follow-up (up to 52 weeks)
ITT population
|
Other adverse events
| Measure |
Adefovir Dipivoxil 10mg
n=104 participants at risk
The eligible participants received open label treatment of 10 mg Adefovir dipivoxil, orally once daily for 52-weeks
|
|---|---|
|
General disorders
Fatigue
|
8.7%
9/104 • From treatment initiation (Week 0) to follow-up (up to 52 weeks)
ITT population
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract infection
|
6.7%
7/104 • From treatment initiation (Week 0) to follow-up (up to 52 weeks)
ITT population
|
Additional Information
GSK Response Center
GlaxoSmithKline
Phone: 866-435-7343
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER