Trial Outcomes & Findings for Antiviral Activity of Entecavir in Patients Receiving Liver Transplant Due to Chronic Hepatitis B Virus Infection (NCT NCT00395018)
NCT ID: NCT00395018
Last Updated: 2012-05-31
Results Overview
HBV DNA assessments were performed using the Roche COBAS® TaqMan High+Pure system (HPS) assay. HBV DNA =\> 50 IU/mL = approximately =\> 300 copies/mL.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
109 participants
Primary outcome timeframe
At 72 weeks
Results posted on
2012-05-31
Participant Flow
A total of 109 participants were enrolled at 27 investigative sites.
Of the 109 participants enrolled, 65 were treated and 61 received therapy for at least 1 month. Of the 44 participants who were never treated, 23 no longer met study criteria, 9 due to administrative reason by sponsor, 6 withdrew consent, 3 due to other reasons, 2 died, 1 due to poor/non-compliance.
Participant milestones
| Measure |
Entecavir (ETV)
ETV tablets, Oral, 1.0 mg, once daily, up to 72 weeks
|
|---|---|
|
On-Treatment
STARTED
|
65
|
|
On-Treatment
DISCONTINUED PRIOR TO WEEK 72 VISIT
|
10
|
|
On-Treatment
DISCONTINUED AT OR AFTER WEEK 72 VISIT
|
0
|
|
On-Treatment
COMPLETED
|
55
|
|
On-Treatment
NOT COMPLETED
|
10
|
|
Off-Treatment Follow-up
STARTED
|
5
|
|
Off-Treatment Follow-up
COMPLETED
|
1
|
|
Off-Treatment Follow-up
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
Entecavir (ETV)
ETV tablets, Oral, 1.0 mg, once daily, up to 72 weeks
|
|---|---|
|
On-Treatment
Death
|
4
|
|
On-Treatment
Other Reason
|
2
|
|
On-Treatment
Poor/non-compliance
|
2
|
|
On-Treatment
Subject no longer meets study criteria
|
2
|
|
Off-Treatment Follow-up
Followup no longer required per protocol
|
1
|
|
Off-Treatment Follow-up
Lost to Follow-up
|
2
|
|
Off-Treatment Follow-up
Poor/non-compliance
|
1
|
Baseline Characteristics
Antiviral Activity of Entecavir in Patients Receiving Liver Transplant Due to Chronic Hepatitis B Virus Infection
Baseline characteristics by cohort
| Measure |
Entecavir (ETV)
n=65 Participants
ETV tablets, Oral, 1.0 mg, once daily, up to 72 weeks
|
|---|---|
|
Age Continuous
|
51.0 years
n=5 Participants
|
|
Age, Customized
21-64 years
|
60 participants
n=5 Participants
|
|
Age, Customized
>=65 years
|
5 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
53 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
24 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black/African American
|
7 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian/Other Pacific Islander
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
25 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
8 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic/Latino
|
0 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic/Latino
|
14 participants
n=5 Participants
|
|
Region of Enrollment
Argentina
|
2 participants
n=5 Participants
|
|
Region of Enrollment
Australia
|
5 participants
n=5 Participants
|
|
Region of Enrollment
Brazil
|
12 participants
n=5 Participants
|
|
Region of Enrollment
France
|
12 participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
6 participants
n=5 Participants
|
|
Region of Enrollment
Korea, Republic of
|
7 participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
3 participants
n=5 Participants
|
|
Region of Enrollment
Taiwan
|
4 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
14 participants
n=5 Participants
|
|
HBV DNA by PCR
|
0.8 log10 IU/mL
n=5 Participants
|
|
Hepatitis B Surface Antigen
Positive
|
61 participants
n=5 Participants
|
|
Hepatitis B Surface Antigen
Negative
|
4 participants
n=5 Participants
|
|
Hepatitis B E Antigen (HBeAg)
Positive
|
7 participants
n=5 Participants
|
|
Hepatitis B E Antigen (HBeAg)
Negative
|
58 participants
n=5 Participants
|
|
Hepatitis B E Antibody (HBeAb)
Positive
|
48 participants
n=5 Participants
|
|
Hepatitis B E Antibody (HBeAb)
Negative
|
17 participants
n=5 Participants
|
|
International Normalized Ratio
|
1.51 ratio
n=5 Participants
|
|
Albumin
|
3.0 g/dL
n=5 Participants
|
|
Alanine Aminotransferase (ALT)
|
43 U/L
n=5 Participants
|
|
Total Bilirubin
|
2.4 mg/dL
n=5 Participants
|
PRIMARY outcome
Timeframe: At 72 weeksPopulation: Evaluable population: Treated participants who received at least 1 month of ETV therapy. Last observation carried forward (LOCF) approach was used for participants with no measurement in the specified visit window.
HBV DNA assessments were performed using the Roche COBAS® TaqMan High+Pure system (HPS) assay. HBV DNA =\> 50 IU/mL = approximately =\> 300 copies/mL.
Outcome measures
| Measure |
Entecavir (ETV)
n=61 Participants
ETV tablets, Oral, 1.0 mg, once daily, up to 72 weeks
|
|---|---|
|
Percentage of Participants With HBV Deoxyribonucleic Acid (DNA) => 50 IU/mL by Polymerase Chain Reaction (PCR) at Week 72
|
0 percentage of participants
Interval 0.0 to 5.9
|
PRIMARY outcome
Timeframe: At baseline (day 1), week 12, 24, 36, 48, 60, and 72Population: Evaluable population: Treated participants who received at least 1 month of ETV therapy. Non-Completer = Missing (NC = M) approach was used where participants who discontinued early or were missing the measurement were excluded from the specific analysis.
HBV DNA assessments were performed using the Roche COBAS® TaqMan High+Pure system (HPS) assay. HBV DNA =\> 50 IU/mL = approximately =\> 300 copies/mL.
Outcome measures
| Measure |
Entecavir (ETV)
n=61 Participants
ETV tablets, Oral, 1.0 mg, once daily, up to 72 weeks
|
|---|---|
|
Number of Participants With HBV DNA by PCR >= 50 IU/mL Through Week 72
Baseline
|
3 participants
Interval 1.0 to 13.7
|
|
Number of Participants With HBV DNA by PCR >= 50 IU/mL Through Week 72
Week 12 (n = 54)
|
0 participants
Interval 0.0 to 6.6
|
|
Number of Participants With HBV DNA by PCR >= 50 IU/mL Through Week 72
Week 24 (n = 58)
|
0 participants
Interval 0.0 to 6.2
|
|
Number of Participants With HBV DNA by PCR >= 50 IU/mL Through Week 72
Week 36 (n = 10)
|
0 participants
Interval 0.0 to 30.8
|
|
Number of Participants With HBV DNA by PCR >= 50 IU/mL Through Week 72
Week 48 (n = 49)
|
0 participants
Interval 0.0 to 7.3
|
|
Number of Participants With HBV DNA by PCR >= 50 IU/mL Through Week 72
Week 60 (n = 48)
|
0 participants
Interval 0.0 to 7.4
|
|
Number of Participants With HBV DNA by PCR >= 50 IU/mL Through Week 72
Week 72 (n = 49)
|
0 participants
Interval 0.0 to 7.3
|
SECONDARY outcome
Timeframe: On Day 1 (baseline) and at week 4, 12, 24, 36, 48, 60, 72Population: Evaluable population: Treated participants who received at least 1 month of ETV therapy.
ALT is an enzyme present in serum and various tissues of the body, associated commonly with the liver. Elevated levels of ALT often suggests existence of medical problems which includes viral hepatitis. Normal range varies from laboratory to laboratory. Values of 5-60 U/L is usually considered normal. ALT abnormality = \>1.25 x ULN (upper limit of normal).
Outcome measures
| Measure |
Entecavir (ETV)
n=61 Participants
ETV tablets, Oral, 1.0 mg, once daily, up to 72 weeks
|
|---|---|
|
Distribution of ALT Levels Through 72 Weeks: Overall
Week 72 (n=54)
|
26.9 U/L
Standard Error 2.81
|
|
Distribution of ALT Levels Through 72 Weeks: Overall
Baseline
|
158.7 U/L
Standard Error 36.20
|
|
Distribution of ALT Levels Through 72 Weeks: Overall
Week 4
|
61.2 U/L
Standard Error 10.12
|
|
Distribution of ALT Levels Through 72 Weeks: Overall
Week 12
|
28.4 U/L
Standard Error 2.66
|
|
Distribution of ALT Levels Through 72 Weeks: Overall
Week 24 (n=59)
|
28.4 U/L
Standard Error 3.37
|
|
Distribution of ALT Levels Through 72 Weeks: Overall
Week 36 (n=58)
|
41.2 U/L
Standard Error 8.20
|
|
Distribution of ALT Levels Through 72 Weeks: Overall
Week 48 (n=57)
|
24.9 U/L
Standard Error 1.91
|
|
Distribution of ALT Levels Through 72 Weeks: Overall
Week 60 (n=53)
|
30.6 U/L
Standard Error 4.04
|
SECONDARY outcome
Timeframe: At 72 weeks + 24 weeks follow-upPopulation: This analysis was planned if \> 10% of treated participants had HBV DNA measurements during the off-treatment follow-up period.
HBV DNA assessments were to be performed using the Roche COBAS® TaqMan AmpliPrep assay. HBV DNA \< 50 IU/mL = approximately 300 copies/mL.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At week 72Population: HBeAg positive participants at baseline who received at least 1 month of ETV therapy. LOCF approach was used for participants with no measurement in the specified visit window.
HBeAg is a hepatitis B viral protein. HBeAg loss = HBeAg-negative at the specified analysis week.
Outcome measures
| Measure |
Entecavir (ETV)
n=7 Participants
ETV tablets, Oral, 1.0 mg, once daily, up to 72 weeks
|
|---|---|
|
Percentage of Participants With HBeAg Loss at Week 72 (for HBeAg-positive Participants)
|
100 percentage of participants
Interval 59.0 to 100.0
|
SECONDARY outcome
Timeframe: At week 72Population: HBeAg-positive participants at baseline who received at least 1 month of ETV therapy. LOCF approach was used for participants with no measurement in the specified visit window.
HBeAg is a hepatitis B viral protein. HBeAg Seroconversion = HBeAg Loss and Presence of Hepatitis B e Antibody (HBeAb).
Outcome measures
| Measure |
Entecavir (ETV)
n=7 Participants
ETV tablets, Oral, 1.0 mg, once daily, up to 72 weeks
|
|---|---|
|
Percentage of Participants With HBeAg Seroconversion at Week 72 (for HBeAg-positive Participants)
|
0 percentage of participants
Interval 0.0 to 41.0
|
SECONDARY outcome
Timeframe: At week 72Population: Evaluable participants: Treated participants who received at least 1 month of ETV therapy. LOCF approach was used for participants with no measurement in the specified visit window.
HBsAg = a part of the hepatitis B virus that, when in the blood, is an early marker of infection. HBsAg loss = HBsAg-negative at the specified analysis week.
Outcome measures
| Measure |
Entecavir (ETV)
n=61 Participants
ETV tablets, Oral, 1.0 mg, once daily, up to 72 weeks
|
|---|---|
|
Percentage of Participants With HBsAg Loss at Week 72
|
96.7 percentage of participants
Interval 88.7 to 99.6
|
SECONDARY outcome
Timeframe: At week 72Population: Evaluable participants: Treated participants who received at least 1 month of ETV therapy. LOCF approach was used for participants with no measurement in the specified visit window.
HBsAg = a part of the hepatitis B virus that, when in the blood, is an early marker of infection. HBs seroconversion is defined as HBsAg loss with positive HBsAb.
Outcome measures
| Measure |
Entecavir (ETV)
n=61 Participants
ETV tablets, Oral, 1.0 mg, once daily, up to 72 weeks
|
|---|---|
|
Percentage of Participants With HBsAg Seroconversion at Week 72
|
80.3 percentage of participants
Interval 68.2 to 89.4
|
SECONDARY outcome
Timeframe: At week 72Population: Evaluable participants: Treated participants who received at least 1 month of ETV therapy. LOCF approach was used for participants with no measurement in the specified visit window.
HBsAg = a part of the hepatitis B virus that, when in the blood, is an early marker of infection. HBsAg recurrence is defined as having detectable HBsAg among participants who have already experienced loss of HBsAg on-treatment. HBsAg recurrence = HBsAg-positive at the specified analysis week.
Outcome measures
| Measure |
Entecavir (ETV)
n=61 Participants
ETV tablets, Oral, 1.0 mg, once daily, up to 72 weeks
|
|---|---|
|
Percentage of Participants With HBsAg Recurrence At Week 72
|
3.3 percentage of participants
Interval 0.4 to 11.3
|
SECONDARY outcome
Timeframe: At week 72Population: Treated participants with measures available at week 72.
Bilirubin measures are used to diagnose or monitor liver functioning or diseases that include hepatitis. Viral hepatitis is one of the condition in which bilirubin levels are elevated. Normal range varies from laboratory to laboratory. Bilirubin abnormality : =\> 1.1 x ULN mg/dL.
Outcome measures
| Measure |
Entecavir (ETV)
n=54 Participants
ETV tablets, Oral, 1.0 mg, once daily, up to 72 weeks
|
|---|---|
|
Total Bilirubin at Week 72
|
0.79 mg/dL
Standard Error 0.079
|
SECONDARY outcome
Timeframe: At week 72Population: Treated participants with measures available at week 72.
Prothrombin, a liver protein, plays an important role in the extrinsic pathway of clotting. Increased prothrombin time indicates abnormal liver functioning. Normal prothrombin time varies from laboratory to laboratory. Generally, normal prothrombin time varies between 10 to 13.2 seconds. Abnormal PT: \> 1.01 x ULN.
Outcome measures
| Measure |
Entecavir (ETV)
n=53 Participants
ETV tablets, Oral, 1.0 mg, once daily, up to 72 weeks
|
|---|---|
|
Prothrombin Time (PT) at Week 72
|
13.32 seconds
Standard Error 0.305
|
SECONDARY outcome
Timeframe: Through week 72Population: Treated participants: Participants who received atleast 1 dose of study drug.
Outcome measures
| Measure |
Entecavir (ETV)
n=65 Participants
ETV tablets, Oral, 1.0 mg, once daily, up to 72 weeks
|
|---|---|
|
Number of Participants With Liver Rejection Through Week 72
|
18 participants
|
SECONDARY outcome
Timeframe: Through week 72Population: Treated population: Participants who received atleast 1 dose of study drug.
Outcome measures
| Measure |
Entecavir (ETV)
n=65 Participants
ETV tablets, Oral, 1.0 mg, once daily, up to 72 weeks
|
|---|---|
|
Number of Participants With Re-transplantation Through Week 72
|
3 participants
|
SECONDARY outcome
Timeframe: OT:From start of dosing through Week 72 + 5 days; OF:End of OT through 24-weeks follow-upPopulation: Treated population: Participants who received atleast 1 dose of study drug.
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 an overdose. Toxicity grading by modified WHO grade system. Grade (GR) 2=moderate; GR3=severe; GR4=very severe. OT=from start of dosing to end of dosing+5 days; OF=from end of dosing+6 days to start of other anti-HBV therapy or end of follow-up.
Outcome measures
| Measure |
Entecavir (ETV)
n=65 Participants
ETV tablets, Oral, 1.0 mg, once daily, up to 72 weeks
|
|---|---|
|
Participants With Adverse Events (AE), Serious Adverse Events (SAE), and Discontinuations From Study Drug Due to AEs (On-treatment [OT] and Off-treatment Follow-up [OF])
Death-OT
|
4 participants
|
|
Participants With Adverse Events (AE), Serious Adverse Events (SAE), and Discontinuations From Study Drug Due to AEs (On-treatment [OT] and Off-treatment Follow-up [OF])
SAEs-OT
|
36 participants
|
|
Participants With Adverse Events (AE), Serious Adverse Events (SAE), and Discontinuations From Study Drug Due to AEs (On-treatment [OT] and Off-treatment Follow-up [OF])
SAEs-OF (n=5)
|
0 participants
|
|
Participants With Adverse Events (AE), Serious Adverse Events (SAE), and Discontinuations From Study Drug Due to AEs (On-treatment [OT] and Off-treatment Follow-up [OF])
Discontinuation due to AEs-OT
|
0 participants
|
|
Participants With Adverse Events (AE), Serious Adverse Events (SAE), and Discontinuations From Study Drug Due to AEs (On-treatment [OT] and Off-treatment Follow-up [OF])
Any AE-OT
|
62 participants
|
|
Participants With Adverse Events (AE), Serious Adverse Events (SAE), and Discontinuations From Study Drug Due to AEs (On-treatment [OT] and Off-treatment Follow-up [OF])
Any AE-OF (n=5)
|
0 participants
|
|
Participants With Adverse Events (AE), Serious Adverse Events (SAE), and Discontinuations From Study Drug Due to AEs (On-treatment [OT] and Off-treatment Follow-up [OF])
Related AEs-OT
|
11 participants
|
|
Participants With Adverse Events (AE), Serious Adverse Events (SAE), and Discontinuations From Study Drug Due to AEs (On-treatment [OT] and Off-treatment Follow-up [OF])
Grade 2 - 4 related AEs-OT
|
8 participants
|
|
Participants With Adverse Events (AE), Serious Adverse Events (SAE), and Discontinuations From Study Drug Due to AEs (On-treatment [OT] and Off-treatment Follow-up [OF])
Grade 3 - 4 AEs-OT
|
30 participants
|
SECONDARY outcome
Timeframe: OT:From start of dosing through Week 72 + 5 days; OF:End of OT through 24-weeks follow-upPopulation: Treated population: All subjects who received atleast 1 dose of study drug.
Criteria for hematology abnormalities were: Hemoglobin : \<11.0 g/dL; White Blood Cells : \<4000/mm\^3; Neutrophils : \<1500/mm\^3; Platelets : \< 99,000/mm\^3; International Normalized Ratio (INR) : increase \>= 0.5 from baseline.
Outcome measures
| Measure |
Entecavir (ETV)
n=65 Participants
ETV tablets, Oral, 1.0 mg, once daily, up to 72 weeks
|
|---|---|
|
Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment Follow-up(OF): Hematology (All Grades)
HEMOGLOBIN-OT
|
56 participants
|
|
Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment Follow-up(OF): Hematology (All Grades)
WHITE BLOOD CELLS-OT
|
50 participants
|
|
Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment Follow-up(OF): Hematology (All Grades)
PLATELETS-OT
|
40 participants
|
|
Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment Follow-up(OF): Hematology (All Grades)
HEMOGLOBIN-OF (n=5)
|
1 participants
|
|
Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment Follow-up(OF): Hematology (All Grades)
WHITE BLOOD CELLS-OF (n=5)
|
2 participants
|
|
Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment Follow-up(OF): Hematology (All Grades)
NEUTROPHILS (Includes absolute bands)-OT
|
24 participants
|
|
Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment Follow-up(OF): Hematology (All Grades)
NEUTROPHILS (Includes absolute bands)-OF (n=5)
|
1 participants
|
|
Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment Follow-up(OF): Hematology (All Grades)
PLATELETS-OF (n=5)
|
2 participants
|
|
Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment Follow-up(OF): Hematology (All Grades)
INR-OT (n=63)
|
30 participants
|
|
Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment Follow-up(OF): Hematology (All Grades)
INR-OF (n=4)
|
0 participants
|
SECONDARY outcome
Timeframe: OT:From start of dosing through Week 72 + 5 days; OF:End of OT through 24-weeks follow-upPopulation: Treated population: Participants who received atleast 1 dose of study drug.
Normal ranges are local lab data and vary according to the site. Criteria for laboratory abnormalities:ALT:\>1.25xULN;AST:\>1.25xULN;ALP:\>1.25xULN;Total Bilirubin:\>1.1xULN;Serum Lipase:\>1.10xULN;Creatinine:\>1.1xULN;Blood Urea Nitrogen:\>1.25xULN;Hyperglycemia:\>116mg/dL;Hypoglycemia:\<64mg/dL;Hyponatremia:\<132meq/L;Hypernatremia:\>148meq/L;Hypokalemia:\<3.4meq/L;hyperkalemia:\>5.6meq/L;Hypochloremia:\<93meq/L;Hyperchloremia:\>113meq/L;Albumin: Decrease \>= 1g/dL from baseline and \< 3 g/dL. HYPER=value\>ULN(upper limit of normal). HYPO=value\<LLN (lower limit of normal).
Outcome measures
| Measure |
Entecavir (ETV)
n=65 Participants
ETV tablets, Oral, 1.0 mg, once daily, up to 72 weeks
|
|---|---|
|
Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment (OF) Follow-up: Serum Chemistry (All Grades)
TOTAL BILIRUBIN-OF (n=4)
|
0 participants
|
|
Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment (OF) Follow-up: Serum Chemistry (All Grades)
ALANINE AMINOTRANSFERASE (ALT)-OT
|
54 participants
|
|
Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment (OF) Follow-up: Serum Chemistry (All Grades)
ALT-OF (n=4)
|
0 participants
|
|
Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment (OF) Follow-up: Serum Chemistry (All Grades)
ASPARTATE AMINOTRANSFERASE (AST)-OT
|
56 participants
|
|
Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment (OF) Follow-up: Serum Chemistry (All Grades)
AST-OF (n=4)
|
0 participants
|
|
Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment (OF) Follow-up: Serum Chemistry (All Grades)
ALKALINE PHOSPHATASE (ALP)-OT
|
34 participants
|
|
Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment (OF) Follow-up: Serum Chemistry (All Grades)
ALP-OF (n=4)
|
1 participants
|
|
Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment (OF) Follow-up: Serum Chemistry (All Grades)
ALBUMIN-OT (n=64)
|
51 participants
|
|
Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment (OF) Follow-up: Serum Chemistry (All Grades)
ALBUMIN-OF (n=3)
|
0 participants
|
|
Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment (OF) Follow-up: Serum Chemistry (All Grades)
TOTAL BILIRUBIN-OT
|
57 participants
|
|
Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment (OF) Follow-up: Serum Chemistry (All Grades)
SERUM LIPASE-OT (n=64)
|
37 participants
|
|
Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment (OF) Follow-up: Serum Chemistry (All Grades)
SERUM LIPASE-OF (n=3)
|
1 participants
|
|
Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment (OF) Follow-up: Serum Chemistry (All Grades)
CREATININE-OT
|
43 participants
|
|
Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment (OF) Follow-up: Serum Chemistry (All Grades)
CREATININE-OF (n=4)
|
0 participants
|
|
Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment (OF) Follow-up: Serum Chemistry (All Grades)
BLOOD UREA NITROGEN-OT
|
43 participants
|
|
Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment (OF) Follow-up: Serum Chemistry (All Grades)
BLOOD UREA NITROGEN-OF (n=4)
|
0 participants
|
|
Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment (OF) Follow-up: Serum Chemistry (All Grades)
HYPERGLYCEMIA-OT (n=64)
|
52 participants
|
|
Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment (OF) Follow-up: Serum Chemistry (All Grades)
HYPERGLYCEMIA-OF (n=3)
|
0 participants
|
|
Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment (OF) Follow-up: Serum Chemistry (All Grades)
HYPOGLYCEMIA-OT (n=64)
|
15 participants
|
|
Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment (OF) Follow-up: Serum Chemistry (All Grades)
HYPOGLYCEMIA-OF (n=3)
|
0 participants
|
|
Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment (OF) Follow-up: Serum Chemistry (All Grades)
HYPERNATREMIA-OT
|
7 participants
|
|
Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment (OF) Follow-up: Serum Chemistry (All Grades)
HYPERNATREMIA-OF (n=4)
|
0 participants
|
|
Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment (OF) Follow-up: Serum Chemistry (All Grades)
HYPONATREMIA-OT
|
14 participants
|
|
Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment (OF) Follow-up: Serum Chemistry (All Grades)
HYPONATREMIA-OF (n=4)
|
0 participants
|
|
Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment (OF) Follow-up: Serum Chemistry (All Grades)
HYPERKALEMIA-OT
|
15 participants
|
|
Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment (OF) Follow-up: Serum Chemistry (All Grades)
HYPERKALEMIA-OF (n=4)
|
0 participants
|
|
Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment (OF) Follow-up: Serum Chemistry (All Grades)
HYPOKALEMIA-OT
|
22 participants
|
|
Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment (OF) Follow-up: Serum Chemistry (All Grades)
HYPOKALEMIA-OF (n=4)
|
0 participants
|
|
Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment (OF) Follow-up: Serum Chemistry (All Grades)
HYPERCHLOREMIA-OT
|
11 participants
|
|
Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment (OF) Follow-up: Serum Chemistry (All Grades)
HYPERCHLOREMIA-OF (n=4)
|
0 participants
|
|
Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment (OF) Follow-up: Serum Chemistry (All Grades)
HYPOCHLOREMIA-OT
|
7 participants
|
|
Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment (OF) Follow-up: Serum Chemistry (All Grades)
HYPOCHLOREMIA-OF (n=4)
|
0 participants
|
Adverse Events
Entecavir (ETV)
Serious events: 36 serious events
Other events: 58 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Entecavir (ETV)
n=65 participants at risk
ETV tablets, Oral, 1.0 mg, once daily, up to 72 weeks
|
|---|---|
|
Investigations
Aspartate aminotransferase increased
|
3.1%
2/65 • From start of dosing through Week 72 + 5 days
|
|
Injury, poisoning and procedural complications
Biliary anastomosis complication
|
1.5%
1/65 • From start of dosing through Week 72 + 5 days
|
|
Hepatobiliary disorders
Biliary dilatation
|
1.5%
1/65 • From start of dosing through Week 72 + 5 days
|
|
Gastrointestinal disorders
Diarrhoea
|
3.1%
2/65 • From start of dosing through Week 72 + 5 days
|
|
Infections and infestations
Haematoma infection
|
1.5%
1/65 • From start of dosing through Week 72 + 5 days
|
|
Renal and urinary disorders
Renal failure acute
|
4.6%
3/65 • From start of dosing through Week 72 + 5 days
|
|
Infections and infestations
Septic shock
|
1.5%
1/65 • From start of dosing through Week 72 + 5 days
|
|
Vascular disorders
Shock haemorrhagic
|
1.5%
1/65 • From start of dosing through Week 72 + 5 days
|
|
Hepatobiliary disorders
Bile duct stenosis
|
3.1%
2/65 • From start of dosing through Week 72 + 5 days
|
|
Hepatobiliary disorders
Biliary fistula
|
1.5%
1/65 • From start of dosing through Week 72 + 5 days
|
|
Cardiac disorders
Cardiac arrest
|
1.5%
1/65 • From start of dosing through Week 72 + 5 days
|
|
Injury, poisoning and procedural complications
Compression fracture
|
1.5%
1/65 • From start of dosing through Week 72 + 5 days
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
1.5%
1/65 • From start of dosing through Week 72 + 5 days
|
|
Vascular disorders
Intra-abdominal haemorrhage
|
1.5%
1/65 • From start of dosing through Week 72 + 5 days
|
|
Immune system disorders
Liver transplant rejection
|
1.5%
1/65 • From start of dosing through Week 72 + 5 days
|
|
Renal and urinary disorders
Renal failure
|
1.5%
1/65 • From start of dosing through Week 72 + 5 days
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis
|
1.5%
1/65 • From start of dosing through Week 72 + 5 days
|
|
Cardiac disorders
Ventricular tachycardia
|
1.5%
1/65 • From start of dosing through Week 72 + 5 days
|
|
Investigations
Alanine aminotransferase increased
|
3.1%
2/65 • From start of dosing through Week 72 + 5 days
|
|
Infections and infestations
Device related infection
|
1.5%
1/65 • From start of dosing through Week 72 + 5 days
|
|
Hepatobiliary disorders
Hepatic artery thrombosis
|
4.6%
3/65 • From start of dosing through Week 72 + 5 days
|
|
Infections and infestations
Meningitis aseptic
|
1.5%
1/65 • From start of dosing through Week 72 + 5 days
|
|
Injury, poisoning and procedural complications
Overdose
|
1.5%
1/65 • From start of dosing through Week 72 + 5 days
|
|
Infections and infestations
Wound infection
|
1.5%
1/65 • From start of dosing through Week 72 + 5 days
|
|
Investigations
Blood bilirubin increased
|
1.5%
1/65 • From start of dosing through Week 72 + 5 days
|
|
Infections and infestations
Cytomegalovirus infection
|
1.5%
1/65 • From start of dosing through Week 72 + 5 days
|
|
Infections and infestations
Eye infection toxoplasmal
|
1.5%
1/65 • From start of dosing through Week 72 + 5 days
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
1.5%
1/65 • From start of dosing through Week 72 + 5 days
|
|
Infections and infestations
Pneumocystis jiroveci pneumonia
|
1.5%
1/65 • From start of dosing through Week 72 + 5 days
|
|
Infections and infestations
Pneumonia
|
1.5%
1/65 • From start of dosing through Week 72 + 5 days
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.5%
1/65 • From start of dosing through Week 72 + 5 days
|
|
Eye disorders
Vision blurred
|
1.5%
1/65 • From start of dosing through Week 72 + 5 days
|
|
Gastrointestinal disorders
Vomiting
|
3.1%
2/65 • From start of dosing through Week 72 + 5 days
|
|
Vascular disorders
Arterial rupture
|
1.5%
1/65 • From start of dosing through Week 72 + 5 days
|
|
Hepatobiliary disorders
Cholangitis
|
3.1%
2/65 • From start of dosing through Week 72 + 5 days
|
|
Hepatobiliary disorders
Hepatic artery stenosis
|
1.5%
1/65 • From start of dosing through Week 72 + 5 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic neoplasm malignant
|
1.5%
1/65 • From start of dosing through Week 72 + 5 days
|
|
Investigations
Hepatitis B virus test
|
1.5%
1/65 • From start of dosing through Week 72 + 5 days
|
|
Infections and infestations
Peritonitis bacterial
|
1.5%
1/65 • From start of dosing through Week 72 + 5 days
|
|
Infections and infestations
Pyelonephritis
|
1.5%
1/65 • From start of dosing through Week 72 + 5 days
|
|
General disorders
Pyrexia
|
3.1%
2/65 • From start of dosing through Week 72 + 5 days
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
1.5%
1/65 • From start of dosing through Week 72 + 5 days
|
|
Vascular disorders
Vein disorder
|
1.5%
1/65 • From start of dosing through Week 72 + 5 days
|
|
Gastrointestinal disorders
Ascites
|
1.5%
1/65 • From start of dosing through Week 72 + 5 days
|
|
Hepatobiliary disorders
Bile duct obstruction
|
1.5%
1/65 • From start of dosing through Week 72 + 5 days
|
|
Nervous system disorders
Cerebral haematoma
|
1.5%
1/65 • From start of dosing through Week 72 + 5 days
|
|
Gastrointestinal disorders
Inguinal hernia
|
1.5%
1/65 • From start of dosing through Week 72 + 5 days
|
|
Gastrointestinal disorders
Nausea
|
3.1%
2/65 • From start of dosing through Week 72 + 5 days
|
|
Infections and infestations
Urinary tract infection
|
1.5%
1/65 • From start of dosing through Week 72 + 5 days
|
|
Infections and infestations
Anal abscess
|
1.5%
1/65 • From start of dosing through Week 72 + 5 days
|
|
Hepatobiliary disorders
Biliary tract disorder
|
1.5%
1/65 • From start of dosing through Week 72 + 5 days
|
|
Gastrointestinal disorders
Hernial eventration
|
1.5%
1/65 • From start of dosing through Week 72 + 5 days
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.5%
1/65 • From start of dosing through Week 72 + 5 days
|
|
Immune system disorders
Transplant rejection
|
1.5%
1/65 • From start of dosing through Week 72 + 5 days
|
|
Gastrointestinal disorders
Umbilical hernia
|
1.5%
1/65 • From start of dosing through Week 72 + 5 days
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
1.5%
1/65 • From start of dosing through Week 72 + 5 days
|
|
Infections and infestations
Gastroenteritis
|
1.5%
1/65 • From start of dosing through Week 72 + 5 days
|
|
General disorders
Multi-organ failure
|
1.5%
1/65 • From start of dosing through Week 72 + 5 days
|
|
Gastrointestinal disorders
Peritoneal haemorrhage
|
1.5%
1/65 • From start of dosing through Week 72 + 5 days
|
|
Respiratory, thoracic and mediastinal disorders
Pleural haemorrhage
|
1.5%
1/65 • From start of dosing through Week 72 + 5 days
|
|
Infections and infestations
Sepsis
|
3.1%
2/65 • From start of dosing through Week 72 + 5 days
|
Other adverse events
| Measure |
Entecavir (ETV)
n=65 participants at risk
ETV tablets, Oral, 1.0 mg, once daily, up to 72 weeks
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.7%
5/65 • From start of dosing through Week 72 + 5 days
|
|
Gastrointestinal disorders
Diarrhoea
|
27.7%
18/65 • From start of dosing through Week 72 + 5 days
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
23.1%
15/65 • From start of dosing through Week 72 + 5 days
|
|
Nervous system disorders
Hypoaesthesia
|
6.2%
4/65 • From start of dosing through Week 72 + 5 days
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
6.2%
4/65 • From start of dosing through Week 72 + 5 days
|
|
Hepatobiliary disorders
Bile duct stenosis
|
7.7%
5/65 • From start of dosing through Week 72 + 5 days
|
|
Gastrointestinal disorders
Constipation
|
18.5%
12/65 • From start of dosing through Week 72 + 5 days
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
12.3%
8/65 • From start of dosing through Week 72 + 5 days
|
|
Nervous system disorders
Headache
|
20.0%
13/65 • From start of dosing through Week 72 + 5 days
|
|
Investigations
Liver function test abnormal
|
9.2%
6/65 • From start of dosing through Week 72 + 5 days
|
|
Metabolism and nutrition disorders
Overweight
|
6.2%
4/65 • From start of dosing through Week 72 + 5 days
|
|
Gastrointestinal disorders
Abdominal distension
|
6.2%
4/65 • From start of dosing through Week 72 + 5 days
|
|
Psychiatric disorders
Depression
|
6.2%
4/65 • From start of dosing through Week 72 + 5 days
|
|
Renal and urinary disorders
Renal impairment
|
6.2%
4/65 • From start of dosing through Week 72 + 5 days
|
|
Nervous system disorders
Tremor
|
12.3%
8/65 • From start of dosing through Week 72 + 5 days
|
|
Infections and infestations
Upper respiratory tract infection
|
6.2%
4/65 • From start of dosing through Week 72 + 5 days
|
|
Gastrointestinal disorders
Vomiting
|
13.8%
9/65 • From start of dosing through Week 72 + 5 days
|
|
Blood and lymphatic system disorders
Anaemia
|
12.3%
8/65 • From start of dosing through Week 72 + 5 days
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.2%
4/65 • From start of dosing through Week 72 + 5 days
|
|
General disorders
Catheter site discharge
|
7.7%
5/65 • From start of dosing through Week 72 + 5 days
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
6.2%
4/65 • From start of dosing through Week 72 + 5 days
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
6.2%
4/65 • From start of dosing through Week 72 + 5 days
|
|
Gastrointestinal disorders
Abdominal pain upper
|
10.8%
7/65 • From start of dosing through Week 72 + 5 days
|
|
Gastrointestinal disorders
Ascites
|
20.0%
13/65 • From start of dosing through Week 72 + 5 days
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
18.5%
12/65 • From start of dosing through Week 72 + 5 days
|
|
Gastrointestinal disorders
Dyspepsia
|
6.2%
4/65 • From start of dosing through Week 72 + 5 days
|
|
Injury, poisoning and procedural complications
Incision site pain
|
6.2%
4/65 • From start of dosing through Week 72 + 5 days
|
|
Gastrointestinal disorders
Nausea
|
12.3%
8/65 • From start of dosing through Week 72 + 5 days
|
|
Injury, poisoning and procedural complications
Procedural pain
|
7.7%
5/65 • From start of dosing through Week 72 + 5 days
|
|
Skin and subcutaneous tissue disorders
Rash
|
6.2%
4/65 • From start of dosing through Week 72 + 5 days
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
15.4%
10/65 • From start of dosing through Week 72 + 5 days
|
|
Vascular disorders
Hypertension
|
33.8%
22/65 • From start of dosing through Week 72 + 5 days
|
|
Psychiatric disorders
Insomnia
|
20.0%
13/65 • From start of dosing through Week 72 + 5 days
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
16.9%
11/65 • From start of dosing through Week 72 + 5 days
|
|
Gastrointestinal disorders
Abdominal pain
|
26.2%
17/65 • From start of dosing through Week 72 + 5 days
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
6.2%
4/65 • From start of dosing through Week 72 + 5 days
|
|
General disorders
Oedema peripheral
|
10.8%
7/65 • From start of dosing through Week 72 + 5 days
|
|
General disorders
Pain
|
6.2%
4/65 • From start of dosing through Week 72 + 5 days
|
|
Infections and infestations
Sepsis
|
6.2%
4/65 • From start of dosing through Week 72 + 5 days
|
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