Trial Outcomes & Findings for Effect of Entecavir in Blacks/African Americans and Hispanics With Chronic Hepatitis B Virus (HBV) Infection (NCT NCT00371150)
NCT ID: NCT00371150
Last Updated: 2012-04-16
Results Overview
HBV DNA assessments were performed using the Roche COBAS® TaqMan AmpliPrep assay. HBV DNA \< 50 IU/mL = approximately \<300 copies/mL.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
131 participants
Primary outcome timeframe
Week 48 of ETV treatment
Results posted on
2012-04-16
Participant Flow
A total of 131 participants were enrolled at 27 sites.
Of the 131 participants enrolled, 85 were never treated (82 no longer met study criteria, 2 withdrew consent, and 1 had other reason).
Participant milestones
| Measure |
Black/ African American
Entecavir (ETV) tablets, Oral, 0.5 mg, once daily, up to 52 weeks
|
Hispanic
ETV tablets, Oral, 0.5 mg, once daily, up to 52 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
40
|
6
|
|
Overall Study
Discontinued Prior to Week 48 Visit
|
1
|
1
|
|
Overall Study
Discontinued at or After Week 48 Visit
|
2
|
1
|
|
Overall Study
COMPLETED
|
37
|
4
|
|
Overall Study
NOT COMPLETED
|
3
|
2
|
Reasons for withdrawal
| Measure |
Black/ African American
Entecavir (ETV) tablets, Oral, 0.5 mg, once daily, up to 52 weeks
|
Hispanic
ETV tablets, Oral, 0.5 mg, once daily, up to 52 weeks
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
2
|
Baseline Characteristics
Effect of Entecavir in Blacks/African Americans and Hispanics With Chronic Hepatitis B Virus (HBV) Infection
Baseline characteristics by cohort
| Measure |
Black/ African American
n=40 Participants
Entecavir (ETV) tablets, Oral, 0.5 mg, once daily, up to 52 weeks
|
Hispanic
n=6 Participants
ETV tablets, Oral, 0.5 mg, once daily, up to 52 weeks
|
Total
n=46 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
39.0 years
n=5 Participants
|
48.0 years
n=7 Participants
|
40.0 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
31 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic / Latino
|
0 participants
n=5 Participants
|
6 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic / Latino
|
18 participants
n=5 Participants
|
0 participants
n=7 Participants
|
18 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Missing
|
22 participants
n=5 Participants
|
0 participants
n=7 Participants
|
22 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black/ African American
|
40 participants
n=5 Participants
|
0 participants
n=7 Participants
|
40 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
0 participants
n=5 Participants
|
6 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Region of Enrollment
Brazil
|
21 participants
n=5 Participants
|
0 participants
n=7 Participants
|
21 participants
n=5 Participants
|
|
Region of Enrollment
Mexico
|
0 participants
n=5 Participants
|
2 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Region of Enrollment
South Africa
|
3 participants
n=5 Participants
|
0 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
16 participants
n=5 Participants
|
4 participants
n=7 Participants
|
20 participants
n=5 Participants
|
|
Hepatitis B surface antigen (HBsAg) status at baseline
Positive
|
40 participants
n=5 Participants
|
4 participants
n=7 Participants
|
44 participants
n=5 Participants
|
|
Hepatitis B surface antigen (HBsAg) status at baseline
Negative
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Hepatitis B surface antigen (HBsAg) status at baseline
Missing
|
0 participants
n=5 Participants
|
2 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Hepatitis B e antigen (HBeAg) status at baseline
Positive
|
22 participants
n=5 Participants
|
4 participants
n=7 Participants
|
26 participants
n=5 Participants
|
|
Hepatitis B e antigen (HBeAg) status at baseline
Negative
|
18 participants
n=5 Participants
|
2 participants
n=7 Participants
|
20 participants
n=5 Participants
|
|
Hepatitis B e antibody (HBeAb) at baseline
Positive
|
19 participants
n=5 Participants
|
2 participants
n=7 Participants
|
21 participants
n=5 Participants
|
|
Hepatitis B e antibody (HBeAb) at baseline
Negative
|
21 participants
n=5 Participants
|
4 participants
n=7 Participants
|
25 participants
n=5 Participants
|
|
Alanine Aminotransferase (ALT)
|
106 U/L
n=5 Participants
|
113 U/L
n=7 Participants
|
107 U/L
n=5 Participants
|
|
Albumin
|
4.3 g/dL
n=5 Participants
|
4.3 g/dL
n=7 Participants
|
4.3 g/dL
n=5 Participants
|
|
Total Bilirubin
|
0.6 mg/dL
n=5 Participants
|
0.5 mg/dL
n=7 Participants
|
0.6 mg/dL
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 48 of ETV treatmentPopulation: All treated participants. If a participant is missing the efficacy assessments for a visit, this is considered a failure and is counted as evaluable.
HBV DNA assessments were performed using the Roche COBAS® TaqMan AmpliPrep assay. HBV DNA \< 50 IU/mL = approximately \<300 copies/mL.
Outcome measures
| Measure |
Black / African American
n=40 Participants
ETV tablets, Oral, 0.5 mg, once daily, up to 52 weeks
|
Total
n=46 Participants
ETV tablets, Oral, 0.5 mg, once daily, up to 52 weeks (Includes 6 participants of the Hispanic cohort)
|
Total
Entecavir tablets, Oral, 0.5 mg, once daily, up to 52 weeks
|
|---|---|---|---|
|
Percentage of Participants With HBV Deoxyribonucleic Acid (DNA) < 50 IU/mL by Polymerase Chain Reaction (PCR) at Week 48
|
72.5 percentage of participants
Since enough participants could not be enrolled in the Hispanic cohort, 95% CI analysis was only performed on the overall population.
|
69.6 percentage of participants
Interval 56.3 to 82.9
|
—
|
SECONDARY outcome
Timeframe: Week 48Population: All treated participants. If a participant is missing the efficacy assessments for a visit, this is considered a failure and is counted as evaluable.
HBV DNA assessments were performed using the Roche COBAS® TaqMan AmpliPrep assay. LOQ is the level above which quantitative results may be obtained with a specified degree of confidence. The LOQ is mathematically defined as equal to 10 times the standard deviation of the results for a series of replicates used to determine a justifiable limit of detection.
Outcome measures
| Measure |
Black / African American
n=40 Participants
ETV tablets, Oral, 0.5 mg, once daily, up to 52 weeks
|
Total
n=46 Participants
ETV tablets, Oral, 0.5 mg, once daily, up to 52 weeks (Includes 6 participants of the Hispanic cohort)
|
Total
Entecavir tablets, Oral, 0.5 mg, once daily, up to 52 weeks
|
|---|---|---|---|
|
Percentage of Participants Who Achieve HBV DNA < Lower Limit of Quantitation (LOQ = 29 IU/mL [Approximately 169 Copies/mL]) at Week 48
|
12.5 percentage of participants
Since enough participants could not be enrolled in the Hispanic cohort, 95% CI analysis was only performed on the overall population.
|
13.0 percentage of participants
Interval 3.3 to 22.8
|
—
|
SECONDARY outcome
Timeframe: Week 48Population: All treated participants. If a participant is missing the efficacy assessments for a visit, this is considered a failure and is counted as evaluable.
HBV DNA assessments were performed using the Roche COBAS® TaqMan AmpliPrep assay.
Outcome measures
| Measure |
Black / African American
n=40 Participants
ETV tablets, Oral, 0.5 mg, once daily, up to 52 weeks
|
Total
n=46 Participants
ETV tablets, Oral, 0.5 mg, once daily, up to 52 weeks (Includes 6 participants of the Hispanic cohort)
|
Total
Entecavir tablets, Oral, 0.5 mg, once daily, up to 52 weeks
|
|---|---|---|---|
|
Percentage of Participants With HBV DNA by PCR Category at Week 48
<50 IU/mL (< 300 copies/mL)
|
72.5 percentage of participants
|
69.6 percentage of participants
|
—
|
|
Percentage of Participants With HBV DNA by PCR Category at Week 48
50 to <172 IU/mL (300 to < 103 copies/mL)
|
0 percentage of participants
|
0 percentage of participants
|
—
|
|
Percentage of Participants With HBV DNA by PCR Category at Week 48
172 to <1720 IU/mL (103 to < 104 copies/mL)
|
10.0 percentage of participants
|
10.9 percentage of participants
|
—
|
|
Percentage of Participants With HBV DNA by PCR Category at Week 48
1720 to <17200 IU/mL (104 to < 105 copies/mL)
|
5.0 percentage of participants
|
4.3 percentage of participants
|
—
|
|
Percentage of Participants With HBV DNA by PCR Category at Week 48
≥17,200 IU/mL (≥105 copies/mL)
|
0 percentage of participants
|
0 percentage of participants
|
—
|
|
Percentage of Participants With HBV DNA by PCR Category at Week 48
Missing
|
12.5 percentage of participants
|
15.2 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: through Week 48Population: All treated participants. The participants who discontinued prior to Week 48 were counted as failure.
Virologic rebound is defined as a confirmed increase of ≥ 1 log10 in HBV DNA from the participant's nadir value (2 sequential HBV DNA measurements or last on-treatment measurement)
Outcome measures
| Measure |
Black / African American
n=40 Participants
ETV tablets, Oral, 0.5 mg, once daily, up to 52 weeks
|
Total
n=46 Participants
ETV tablets, Oral, 0.5 mg, once daily, up to 52 weeks (Includes 6 participants of the Hispanic cohort)
|
Total
Entecavir tablets, Oral, 0.5 mg, once daily, up to 52 weeks
|
|---|---|---|---|
|
Percentage of Participants With Virologic Rebound Through Week 48 While on Continued Dosing With ETV
|
0 percentage of participants
|
0 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Week 48Population: All treated participants. If a participant is missing the efficacy assessments for a visit, this is considered a failure and is counted as evaluable.
ALT normalization=ALT level being less than or equal to 1 times the upper limit of normal (ULN). ULN for ALT is 37 U/L.
Outcome measures
| Measure |
Black / African American
n=40 Participants
ETV tablets, Oral, 0.5 mg, once daily, up to 52 weeks
|
Total
n=46 Participants
ETV tablets, Oral, 0.5 mg, once daily, up to 52 weeks (Includes 6 participants of the Hispanic cohort)
|
Total
Entecavir tablets, Oral, 0.5 mg, once daily, up to 52 weeks
|
|---|---|---|---|
|
Percentage of Participants With Alanine Aminotransferase (ALT) Normalization at Week 48
|
67.5 percentage of participants
|
67.4 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Week 48Population: Treated HBeAg-positive participants. If a participant was missing the efficacy assessments for a visit, this is considered a failure and was counted as evaluable.
HBeAg is a hepatitis B viral protein. HBeAg loss = HBeAg-negative at the specified analysis week
Outcome measures
| Measure |
Black / African American
n=22 Participants
ETV tablets, Oral, 0.5 mg, once daily, up to 52 weeks
|
Total
n=26 Participants
ETV tablets, Oral, 0.5 mg, once daily, up to 52 weeks (Includes 6 participants of the Hispanic cohort)
|
Total
Entecavir tablets, Oral, 0.5 mg, once daily, up to 52 weeks
|
|---|---|---|---|
|
Percentage of Participants With Confirmed HBeAg Loss at Week 48 (for HBeAg-positive Participants Only)
|
50.0 percentage of participants
|
53.8 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Week 48Population: Treated HBeAg-positive participants. If a participant was missing the efficacy assessments for a visit, this is considered a failure and was counted as evaluable.
HBeAg is a hepatitis B viral protein. HBeAg Seroconversion = HBeAg Loss and Presence of Hepatitis B e Antibody (HBeAb).
Outcome measures
| Measure |
Black / African American
n=22 Participants
ETV tablets, Oral, 0.5 mg, once daily, up to 52 weeks
|
Total
n=26 Participants
ETV tablets, Oral, 0.5 mg, once daily, up to 52 weeks (Includes 6 participants of the Hispanic cohort)
|
Total
Entecavir tablets, Oral, 0.5 mg, once daily, up to 52 weeks
|
|---|---|---|---|
|
Percentage of Participants With HBeAg Seroconversion at Week 48 (for HBeAg-positive Participants Only)
|
40.9 percentage of participants
|
46.2 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Week 48Population: All treated participants. If a participant was missing the efficacy assessments for a visit, this is considered a failure and was counted as evaluable.
HBsAg = a part of the hepatitis B virus that, when in the blood, is a marker of infection. HBsAg loss = HBsAg-negative at the specified analysis week.
Outcome measures
| Measure |
Black / African American
n=40 Participants
ETV tablets, Oral, 0.5 mg, once daily, up to 52 weeks
|
Total
n=46 Participants
ETV tablets, Oral, 0.5 mg, once daily, up to 52 weeks (Includes 6 participants of the Hispanic cohort)
|
Total
Entecavir tablets, Oral, 0.5 mg, once daily, up to 52 weeks
|
|---|---|---|---|
|
Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at Week 48
|
5.0 percentage of participants
|
6.5 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Week 48Population: All treated participants. If a participant was missing the efficacy assessments for a visit, this is considered a failure and was counted as evaluable.
HBsAg = a part of the hepatitis B virus that, when in the blood, is a of infection. HBs seroconversion is defined as HBsAg loss with positive HBsAb.
Outcome measures
| Measure |
Black / African American
n=40 Participants
ETV tablets, Oral, 0.5 mg, once daily, up to 52 weeks
|
Total
n=46 Participants
ETV tablets, Oral, 0.5 mg, once daily, up to 52 weeks (Includes 6 participants of the Hispanic cohort)
|
Total
Entecavir tablets, Oral, 0.5 mg, once daily, up to 52 weeks
|
|---|---|---|---|
|
Percentage of Participants With HBsAg Seroconversion at Week 48
|
2.5 percentage of participants
|
4.3 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: baseline, Week 48Population: All treated participants. The participants who discontinued prior to Week 48 were counted as failure.
HBV DNA was analyzed by PCR, using the Roche COBAS®TaqMan TaqMan AmpliPrep assay. Reduction in log10 HBV count=reduced viral load.
Outcome measures
| Measure |
Black / African American
n=35 Participants
ETV tablets, Oral, 0.5 mg, once daily, up to 52 weeks
|
Total
n=39 Participants
ETV tablets, Oral, 0.5 mg, once daily, up to 52 weeks (Includes 6 participants of the Hispanic cohort)
|
Total
Entecavir tablets, Oral, 0.5 mg, once daily, up to 52 weeks
|
|---|---|---|---|
|
Mean log10 Reduction From Baseline in HBV DNA at Week 48
Baseline
|
7.1 log10 IU/mL
Standard Error 0.26
|
7.0 log10 IU/mL
Standard Error 0.25
|
—
|
|
Mean log10 Reduction From Baseline in HBV DNA at Week 48
HBV DNA at Week 48
|
1.88 log10 IU/mL
Standard Error 0.100
|
1.87 log10 IU/mL
Standard Error 0.091
|
—
|
|
Mean log10 Reduction From Baseline in HBV DNA at Week 48
Change from baseline
|
-5.22 log10 IU/mL
Standard Error 0.249
|
-5.18 log10 IU/mL
Standard Error 0.231
|
—
|
SECONDARY outcome
Timeframe: Week 48Population: Since there were no other cut-off points other than those at the time of data analysis, this outcome was not analysed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From enrollment through Week 52 + 5 daysPopulation: All treated participants.
AE: any new untoward medical occurrence/worsening of pre-existing medical condition, whether or not related to study drug. SAE: any AE that resulted in death; was life threatening; resulted in persistent/significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; or was an overdose. Participants who discontinued the study due to any AEs were recorded.
Outcome measures
| Measure |
Black / African American
n=40 Participants
ETV tablets, Oral, 0.5 mg, once daily, up to 52 weeks
|
Total
n=6 Participants
ETV tablets, Oral, 0.5 mg, once daily, up to 52 weeks (Includes 6 participants of the Hispanic cohort)
|
Total
n=46 Participants
Entecavir tablets, Oral, 0.5 mg, once daily, up to 52 weeks
|
|---|---|---|---|
|
Number of Participants With Adverse Events (AE), Serious Adverse Events (SAE), and Discontinuations From Study Drug Due to Adverse Events
Deaths
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Adverse Events (AE), Serious Adverse Events (SAE), and Discontinuations From Study Drug Due to Adverse Events
SAEs
|
3 participants
|
1 participants
|
4 participants
|
|
Number of Participants With Adverse Events (AE), Serious Adverse Events (SAE), and Discontinuations From Study Drug Due to Adverse Events
Discontinuations Due to AEs
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Adverse Events (AE), Serious Adverse Events (SAE), and Discontinuations From Study Drug Due to Adverse Events
Any AE
|
33 participants
|
5 participants
|
38 participants
|
|
Number of Participants With Adverse Events (AE), Serious Adverse Events (SAE), and Discontinuations From Study Drug Due to Adverse Events
Grade 3 - 4 AEs
|
5 participants
|
1 participants
|
6 participants
|
|
Number of Participants With Adverse Events (AE), Serious Adverse Events (SAE), and Discontinuations From Study Drug Due to Adverse Events
Related AEs
|
16 participants
|
0 participants
|
16 participants
|
|
Number of Participants With Adverse Events (AE), Serious Adverse Events (SAE), and Discontinuations From Study Drug Due to Adverse Events
Grade 2 - 4 Related AEs
|
5 participants
|
0 participants
|
5 participants
|
SECONDARY outcome
Timeframe: OT: From start of study therapy through Week 52 + 5 days; OF= End of OT period + 24-week follow-upPopulation: All treated participants. n = number of participants in the OF period.
Criteria for hematology abnormalities were graded using the modified WHO grading system. Hemoglobin: \<=11.0 g/dL; White Blood Cells: \<4000/mm\^3; Absolute Neutrophils (includes absolute bands): \<1500/mm\^3; Platelets: \<=99,000/mm\^3; International Normalized Ratio: ≥ 1.5 and ≥ 0.5 from baseline.
Outcome measures
| Measure |
Black / African American
n=40 Participants
ETV tablets, Oral, 0.5 mg, once daily, up to 52 weeks
|
Total
n=46 Participants
ETV tablets, Oral, 0.5 mg, once daily, up to 52 weeks (Includes 6 participants of the Hispanic cohort)
|
Total
Entecavir tablets, Oral, 0.5 mg, once daily, up to 52 weeks
|
|---|---|---|---|
|
Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment (OF): Hematology
Hemoglobin-OT
|
1 participants
|
2 participants
|
—
|
|
Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment (OF): Hematology
Hemoglobin-OF; n=26 , 29
|
0 participants
|
0 participants
|
—
|
|
Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment (OF): Hematology
White Blood Cells-OT
|
15 participants
|
18 participants
|
—
|
|
Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment (OF): Hematology
White Blood Cells-OF; n=26 , 29
|
7 participants
|
8 participants
|
—
|
|
Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment (OF): Hematology
Neutrophils -OT
|
13 participants
|
13 participants
|
—
|
|
Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment (OF): Hematology
Neutrophils-OF; n=26 , 26
|
4 participants
|
4 participants
|
—
|
|
Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment (OF): Hematology
Platelets-OT
|
4 participants
|
4 participants
|
—
|
|
Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment (OF): Hematology
Platelets-OF; n=26 , 29
|
0 participants
|
0 participants
|
—
|
|
Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment (OF): Hematology
International Normalized Ratio-OT
|
18 participants
|
23 participants
|
—
|
|
Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment (OF): Hematology
International Normalized Ratio-OF; n=26 , 29
|
4 participants
|
4 participants
|
—
|
SECONDARY outcome
Timeframe: OT: From start of study therapy through Week 52 + 5 days; OF= End of OT period + 24-week follow-upPopulation: All treated participants. n = number of participants in the OF period.
The modified World Health Oranization(WHO)grading system was used to grade the abnormalities. ULN=upper limit of normal. Alanine aminotransferase:\>1.25xULN, Aspartate aminotransferase:\>1.25xULN, Alkaline Phosphatase:\>1.25xULN, Total Bilirubin:\>1.1xULN, Serum Lipase:\>1.10xULN, Creatinine:\>1.1xULN, Blood Urea Nitrogen:1.25xULN, Hyperglycemia:\>116 mg/dL, Hypoglycemia:\<64 mg/dL, Hyponatremia:\<132meq/L, Hypokalemia:\<3.4 meq/L, Albumin:≥1g/dL decrease from baseline, \<3 g/dL; Hypernatremia:\>148 meq/L, Hyperkalemia:\>5.6 meq/L, Hypokalemia:\<3.4 meq/L, Hyperchloremia:\>113 meq/L, Hypochloremia:\<93 meq/L
Outcome measures
| Measure |
Black / African American
n=40 Participants
ETV tablets, Oral, 0.5 mg, once daily, up to 52 weeks
|
Total
n=46 Participants
ETV tablets, Oral, 0.5 mg, once daily, up to 52 weeks (Includes 6 participants of the Hispanic cohort)
|
Total
Entecavir tablets, Oral, 0.5 mg, once daily, up to 52 weeks
|
|---|---|---|---|
|
Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment (OF) : Serum Chemistry
Alanine aminotransferase-OF; n=26 , 29
|
3 participants
|
4 participants
|
—
|
|
Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment (OF) : Serum Chemistry
Alkaline Phosphatase-OF; n=26 , 29
|
1 participants
|
1 participants
|
—
|
|
Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment (OF) : Serum Chemistry
Hyponatremia-OF; n=26 , 29
|
0 participants
|
1 participants
|
—
|
|
Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment (OF) : Serum Chemistry
Hyperkalemia-OT
|
0 participants
|
0 participants
|
—
|
|
Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment (OF) : Serum Chemistry
Blood Urea Nitrogen-OT
|
2 participants
|
2 participants
|
—
|
|
Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment (OF) : Serum Chemistry
Blood Urea Nitrogen-OF; n=26 , 29
|
0 participants
|
0 participants
|
—
|
|
Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment (OF) : Serum Chemistry
Hyperglycemia-OT
|
14 participants
|
15 participants
|
—
|
|
Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment (OF) : Serum Chemistry
Hyperglycemia-OF; n=26 , 29
|
5 participants
|
5 participants
|
—
|
|
Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment (OF) : Serum Chemistry
Hypoglycemia-OT
|
5 participants
|
5 participants
|
—
|
|
Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment (OF) : Serum Chemistry
Hypoglycemia-OF; n=26 , 29
|
1 participants
|
1 participants
|
—
|
|
Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment (OF) : Serum Chemistry
Hypernatremia-OT
|
0 participants
|
0 participants
|
—
|
|
Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment (OF) : Serum Chemistry
Hypernatremia-OF; n=26 , 29
|
0 participants
|
0 participants
|
—
|
|
Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment (OF) : Serum Chemistry
Hyponatremia-OT
|
3 participants
|
3 participants
|
—
|
|
Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment (OF) : Serum Chemistry
Hyperkalemia-OF; n=26 , 29
|
0 participants
|
0 participants
|
—
|
|
Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment (OF) : Serum Chemistry
Hypokalemia-OT
|
3 participants
|
3 participants
|
—
|
|
Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment (OF) : Serum Chemistry
Hypokalemia-OF; n=26 , 29
|
0 participants
|
0 participants
|
—
|
|
Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment (OF) : Serum Chemistry
Hyperchloremia-OT
|
0 participants
|
0 participants
|
—
|
|
Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment (OF) : Serum Chemistry
Hyperchloremia-OF; n=26 , 29
|
0 participants
|
0 participants
|
—
|
|
Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment (OF) : Serum Chemistry
Hypochloremia-OT
|
0 participants
|
0 participants
|
—
|
|
Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment (OF) : Serum Chemistry
Hypochloremia-OF; n=26 , 29
|
0 participants
|
0 participants
|
—
|
|
Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment (OF) : Serum Chemistry
Alanine aminotransferase-OT
|
37 participants
|
43 participants
|
—
|
|
Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment (OF) : Serum Chemistry
Aspartate aminotransferase-OT
|
33 participants
|
38 participants
|
—
|
|
Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment (OF) : Serum Chemistry
Aspartate aminotransferase-OF; n=26 , 29
|
2 participants
|
3 participants
|
—
|
|
Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment (OF) : Serum Chemistry
Alkaline Phosphatase-OT
|
3 participants
|
3 participants
|
—
|
|
Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment (OF) : Serum Chemistry
Albumin-OT
|
3 participants
|
5 participants
|
—
|
|
Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment (OF) : Serum Chemistry
Albumin-OF; n=26 , 29
|
0 participants
|
0 participants
|
—
|
|
Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment (OF) : Serum Chemistry
Total Bilirubin-OT
|
7 participants
|
7 participants
|
—
|
|
Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment (OF) : Serum Chemistry
Total Bilirubin-OF; n=26 , 29
|
3 participants
|
4 participants
|
—
|
|
Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment (OF) : Serum Chemistry
Serum Lipase-OT
|
12 participants
|
14 participants
|
—
|
|
Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment (OF) : Serum Chemistry
Serum Lipase-OF; n=26 , 29
|
1 participants
|
1 participants
|
—
|
|
Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment (OF) : Serum Chemistry
Creatinine-OT
|
3 participants
|
3 participants
|
—
|
|
Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment (OF) : Serum Chemistry
Creatinine-OF; n=26 , 29
|
0 participants
|
0 participants
|
—
|
Adverse Events
Entecavir (ETV)
Serious events: 4 serious events
Other events: 21 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Entecavir (ETV)
n=46 participants at risk
Entecavir tablets, Oral, 0.5 mg, once daily, up to 48 weeks (Includes 6 participants of the Hispanic cohort)
|
|---|---|
|
Investigations
ALANINE AMINOTRANSFERASE INCREASED
|
2.2%
1/46 • 52 Weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
RENAL CELL CARCINOMA
|
2.2%
1/46 • 52 Weeks
|
|
General disorders
PYREXIA
|
2.2%
1/46 • 52 Weeks
|
|
Cardiac disorders
ANGINA PECTORIS
|
2.2%
1/46 • 52 Weeks
|
|
Gastrointestinal disorders
ASCITES
|
2.2%
1/46 • 52 Weeks
|
|
Investigations
BLOOD GLUCOSE ABNORMAL
|
2.2%
1/46 • 52 Weeks
|
|
Nervous system disorders
HEADACHE
|
2.2%
1/46 • 52 Weeks
|
|
Blood and lymphatic system disorders
LEUKOCYTOSIS
|
2.2%
1/46 • 52 Weeks
|
|
Infections and infestations
LOBAR PNEUMONIA
|
2.2%
1/46 • 52 Weeks
|
|
Infections and infestations
PNEUMONIA
|
2.2%
1/46 • 52 Weeks
|
Other adverse events
| Measure |
Entecavir (ETV)
n=46 participants at risk
Entecavir tablets, Oral, 0.5 mg, once daily, up to 48 weeks (Includes 6 participants of the Hispanic cohort)
|
|---|---|
|
Nervous system disorders
SOMNOLENCE
|
6.5%
3/46 • 52 Weeks
|
|
General disorders
PYREXIA
|
8.7%
4/46 • 52 Weeks
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
8.7%
4/46 • 52 Weeks
|
|
Nervous system disorders
HEADACHE
|
17.4%
8/46 • 52 Weeks
|
|
Infections and infestations
URINARY TRACT INFECTION
|
6.5%
3/46 • 52 Weeks
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
13.0%
6/46 • 52 Weeks
|
|
Gastrointestinal disorders
DIARRHOEA
|
10.9%
5/46 • 52 Weeks
|
|
General disorders
FATIGUE
|
8.7%
4/46 • 52 Weeks
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
6.5%
3/46 • 52 Weeks
|
|
Infections and infestations
NASOPHARYNGITIS
|
6.5%
3/46 • 52 Weeks
|
|
Infections and infestations
INFLUENZA
|
8.7%
4/46 • 52 Weeks
|
|
Gastrointestinal disorders
NAUSEA
|
8.7%
4/46 • 52 Weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication
- Publication restrictions are in place
Restriction type: OTHER