Trial Outcomes & Findings for Phase 3 Study of GSK548470 in Patients With Compensated Chronic Hepatitis B With Poor Response to Other Drugs (NCT NCT01475851)
NCT ID: NCT01475851
Last Updated: 2015-06-22
Results Overview
The number of participants with serum hepatitis B virus deoxyribonucleic acid (HBV DNA) level \< the lower limit of quantitation (2.1 log10 copies/millilitres\[copies/mL\]) (i.e., the rate of suppression) at Week 24 was summarized. Statistical analysis was not provided for the number of participants achieving HBV DNA \<2.1 log10 copies/mL (at Week 24). Missing values observed during the treatment period was imputed by the last observation carried forward (LOCF) method.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
34 participants
Primary outcome timeframe
Week 24
Results posted on
2015-06-22
Participant Flow
A total of 34 participants (13 participants in the Lamivudine \[LAM\]/ Tenofovir disoproxil fumarate \[TDF\] group and 21 participants in the Entecavir \[ETV\]/TDF group) were enrolled in the study
Participant milestones
| Measure |
LAM 100 mg/TDF 300 mg
Participants received a single, Open-Label (OL) Lamivudine (LAM) 100 milligram (mg) tablet once daily (OD) and a single, OL tenofovir disoproxil fumarate (TDF) 300 mg tablet OD for 96 weeks.
|
ETV 0.5 mg/TDF 300 mg
Participants received a single, OL entecavir (ETV) 0.5 mg tablet OD and a single, OL TDF 300 mg tablet OD for 96 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
13
|
21
|
|
Overall Study
COMPLETED
|
12
|
21
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
LAM 100 mg/TDF 300 mg
Participants received a single, Open-Label (OL) Lamivudine (LAM) 100 milligram (mg) tablet once daily (OD) and a single, OL tenofovir disoproxil fumarate (TDF) 300 mg tablet OD for 96 weeks.
|
ETV 0.5 mg/TDF 300 mg
Participants received a single, OL entecavir (ETV) 0.5 mg tablet OD and a single, OL TDF 300 mg tablet OD for 96 weeks.
|
|---|---|---|
|
Overall Study
Protocol defined stopping criteria
|
1
|
0
|
Baseline Characteristics
Phase 3 Study of GSK548470 in Patients With Compensated Chronic Hepatitis B With Poor Response to Other Drugs
Baseline characteristics by cohort
| Measure |
LAM 100 mg/TDF 300 mg
n=13 Participants
Participants received a single, Open-Label (OL) Lamivudine (LAM) 100 milligram (mg) tablet once daily (OD) and a single, OL tenofovir disoproxil fumarate (TDF) 300 mg tablet OD for 96 weeks.
|
ETV 0.5 mg/TDF 300 mg
n=21 Participants
Participants received a single, OL entecavir (ETV) 0.5 mg tablet OD and a single, OL TDF 300 mg tablet OD for 96 weeks.
|
Total
n=34 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
52.1 Years
STANDARD_DEVIATION 7.57 • n=5 Participants
|
50.3 Years
STANDARD_DEVIATION 9.18 • n=7 Participants
|
51.0 Years
STANDARD_DEVIATION 8.52 • n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian-Japanese Heritage
|
13 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 24Population: Full Analysis Set (FAS) Population: all participants who received at least one dose of investigational product (IP) and had at least one efficacy assessment after the start of study treatment.
The number of participants with serum hepatitis B virus deoxyribonucleic acid (HBV DNA) level \< the lower limit of quantitation (2.1 log10 copies/millilitres\[copies/mL\]) (i.e., the rate of suppression) at Week 24 was summarized. Statistical analysis was not provided for the number of participants achieving HBV DNA \<2.1 log10 copies/mL (at Week 24). Missing values observed during the treatment period was imputed by the last observation carried forward (LOCF) method.
Outcome measures
| Measure |
LAM 100 mg/TDF 300 mg
n=13 Participants
Participants received a single, Open-Label (OL) Lamivudine (LAM) 100 milligram (mg) tablet once daily (OD) and a single, OL tenofovir disoproxil fumarate (TDF) 300 mg tablet OD for 96 weeks.
|
ETV 0.5 mg/TDF 300 mg
n=21 Participants
Participants received a single, OL entecavir (ETV) 0.5 mg tablet OD and a single, OL TDF 300 mg tablet OD for 96 weeks.
|
|---|---|---|
|
Number of Participants With HBV DNA Level < 2.1 log10 Copies/mL at Week 24
|
8 participants
|
12 participants
|
SECONDARY outcome
Timeframe: Baseline and Week 24, Week 48 and Week 96Population: FAS Population
The mean change from Baseline in the hepatitis B virus deoxyribonucleic acid (HBV DNA) level at Week 24, Week 48 and Week 96 were assessed (HBV DNA values below the lower limit of quantitation \[i.e. 2.1 log10 copies/mL\] for the assay were set to the lower limit minus 0.1 \[i.e. 2.0 log10 copies/mL\]). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Last Observation Carried Forward (LOCF) method was applied for missing values.
Outcome measures
| Measure |
LAM 100 mg/TDF 300 mg
n=13 Participants
Participants received a single, Open-Label (OL) Lamivudine (LAM) 100 milligram (mg) tablet once daily (OD) and a single, OL tenofovir disoproxil fumarate (TDF) 300 mg tablet OD for 96 weeks.
|
ETV 0.5 mg/TDF 300 mg
n=21 Participants
Participants received a single, OL entecavir (ETV) 0.5 mg tablet OD and a single, OL TDF 300 mg tablet OD for 96 weeks.
|
|---|---|---|
|
Mean Change From Baseline in Serum HBV DNA Level at Week 24, Week 48 and Week 96
Week 24
|
-2.72 log10 copies/mL
Interval -3.5 to -1.93
|
-3.33 log10 copies/mL
Interval -4.01 to -2.65
|
|
Mean Change From Baseline in Serum HBV DNA Level at Week 24, Week 48 and Week 96
Week 48
|
-2.88 log10 copies/mL
Interval -3.7 to -2.06
|
-3.50 log10 copies/mL
Interval -4.28 to -2.73
|
|
Mean Change From Baseline in Serum HBV DNA Level at Week 24, Week 48 and Week 96
Week 96
|
-3.02 log10 copies/mL
Interval -3.84 to -2.21
|
-3.50 log10 copies/mL
Interval -4.35 to -2.66
|
SECONDARY outcome
Timeframe: Week 48 and Week 96Population: FAS Population.
The number of participants with serum HBV DNA level \< the lower limit of quantitation (2.1 log10 copies/mL) (i.e., the rate of suppression) at Week 48 and Week 96 were summarized. The LOCF method was applied for missing values.
Outcome measures
| Measure |
LAM 100 mg/TDF 300 mg
n=13 Participants
Participants received a single, Open-Label (OL) Lamivudine (LAM) 100 milligram (mg) tablet once daily (OD) and a single, OL tenofovir disoproxil fumarate (TDF) 300 mg tablet OD for 96 weeks.
|
ETV 0.5 mg/TDF 300 mg
n=21 Participants
Participants received a single, OL entecavir (ETV) 0.5 mg tablet OD and a single, OL TDF 300 mg tablet OD for 96 weeks.
|
|---|---|---|
|
Number of Participants With Serum HBV DNA < 2.1 log10 Copies/mL at Week 48 and Week 96
Week 48
|
9 participants
|
12 participants
|
|
Number of Participants With Serum HBV DNA < 2.1 log10 Copies/mL at Week 48 and Week 96
Week 96
|
10 participants
|
14 participants
|
SECONDARY outcome
Timeframe: Week 24, Week 48 and Week 96Population: Biochemically Evaluable Population (BEP): all participants who received at least one dose of investigational product and with an abnormal ALT at Baseline. The population for the analysis of ALT normalization was all participants with an ALT value \> ULN at Baseline.
The number of participants with alanine aminotransferase (ALT) normalization at Week 24, Week 48 and Week 96 were summarized. ALT normalization is defined as when an ALT value exceeds the upper limit of normal range (ULN) at Baseline and within the normal range at the end of treatment. The LOCF method was applied for missing values.
Outcome measures
| Measure |
LAM 100 mg/TDF 300 mg
n=5 Participants
Participants received a single, Open-Label (OL) Lamivudine (LAM) 100 milligram (mg) tablet once daily (OD) and a single, OL tenofovir disoproxil fumarate (TDF) 300 mg tablet OD for 96 weeks.
|
ETV 0.5 mg/TDF 300 mg
n=10 Participants
Participants received a single, OL entecavir (ETV) 0.5 mg tablet OD and a single, OL TDF 300 mg tablet OD for 96 weeks.
|
|---|---|---|
|
Number of Participants With Alanine Aminotransferase (ALT) Normalization at Week 24, Week 48 and Week 96
Week 24
|
3 participants
|
6 participants
|
|
Number of Participants With Alanine Aminotransferase (ALT) Normalization at Week 24, Week 48 and Week 96
Week 48
|
3 participants
|
5 participants
|
|
Number of Participants With Alanine Aminotransferase (ALT) Normalization at Week 24, Week 48 and Week 96
Week 96
|
3 participants
|
6 participants
|
SECONDARY outcome
Timeframe: Week 24, Week 48 and Week 96Population: FAS Population
The number of participants achieving hepatitis Be antigen (HBeAg) loss at Week 24, Week 48 and Week 96 in positive HBeAg participants at Baseline were summarized. Loss of HBeAg is defined as the change of detectable HBeAg from positive to negative. The LOCF method was applied for missing values.
Outcome measures
| Measure |
LAM 100 mg/TDF 300 mg
n=11 Participants
Participants received a single, Open-Label (OL) Lamivudine (LAM) 100 milligram (mg) tablet once daily (OD) and a single, OL tenofovir disoproxil fumarate (TDF) 300 mg tablet OD for 96 weeks.
|
ETV 0.5 mg/TDF 300 mg
n=17 Participants
Participants received a single, OL entecavir (ETV) 0.5 mg tablet OD and a single, OL TDF 300 mg tablet OD for 96 weeks.
|
|---|---|---|
|
Number of Participants With HBeAg Loss at Week 24, Week 48 and Week 96
Week 24
|
0 participants
|
0 participants
|
|
Number of Participants With HBeAg Loss at Week 24, Week 48 and Week 96
Week 48
|
1 participants
|
0 participants
|
|
Number of Participants With HBeAg Loss at Week 24, Week 48 and Week 96
Week 96
|
1 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Week 24, Week 48 and Week 96Population: FAS Population
The number of participants achieving hepatitis Be antigen (HBeAg)/hepatitis B e antibody (HBeAb) seroconversion at Week 24, Week 48 and Week 96 in positive HBeAg and negative HBeAb participants at Baseline were summarized. Seroconversion to HBeAg is defined as change of detectable antibody to HBeAg from negative to positive. The LOCF method was applied for missing values.
Outcome measures
| Measure |
LAM 100 mg/TDF 300 mg
n=11 Participants
Participants received a single, Open-Label (OL) Lamivudine (LAM) 100 milligram (mg) tablet once daily (OD) and a single, OL tenofovir disoproxil fumarate (TDF) 300 mg tablet OD for 96 weeks.
|
ETV 0.5 mg/TDF 300 mg
n=17 Participants
Participants received a single, OL entecavir (ETV) 0.5 mg tablet OD and a single, OL TDF 300 mg tablet OD for 96 weeks.
|
|---|---|---|
|
Number of Participants With HBeAg/HBeAb Seroconversion at Week 24, Week 48 and Week 96
Week 24
|
0 participants
|
0 participants
|
|
Number of Participants With HBeAg/HBeAb Seroconversion at Week 24, Week 48 and Week 96
Week 48
|
0 participants
|
0 participants
|
|
Number of Participants With HBeAg/HBeAb Seroconversion at Week 24, Week 48 and Week 96
Week 96
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Week 24, Week 48 and Week 96Population: FAS Population
The number of participants with hepatitis B surface antigen (HBsAg) loss at Week 24, Week 48 and Week 96 in positive HBsAg participants at Baseline were summarized. Loss of HBsAg is defined as change of detectable HBsAg from positive to negative. The LOCF method was applied for missing values.
Outcome measures
| Measure |
LAM 100 mg/TDF 300 mg
n=13 Participants
Participants received a single, Open-Label (OL) Lamivudine (LAM) 100 milligram (mg) tablet once daily (OD) and a single, OL tenofovir disoproxil fumarate (TDF) 300 mg tablet OD for 96 weeks.
|
ETV 0.5 mg/TDF 300 mg
n=21 Participants
Participants received a single, OL entecavir (ETV) 0.5 mg tablet OD and a single, OL TDF 300 mg tablet OD for 96 weeks.
|
|---|---|---|
|
Number of Participants Achieving HBsAg Loss at Week 24, Week 48 and Week 96
Week 24
|
0 participants
|
0 participants
|
|
Number of Participants Achieving HBsAg Loss at Week 24, Week 48 and Week 96
Week 48
|
0 participants
|
0 participants
|
|
Number of Participants Achieving HBsAg Loss at Week 24, Week 48 and Week 96
Week 96
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Week 24, Week 48 and Week 96Population: FAS Population
The number of participants with hepatitis B surface antigen (HBsAg)/hepatitis B surface antibody (HBsAb) seroconversion at Week 24, Week 48 and Week 96 in positive HBsAg and negative HBsAb participants at Baseline were summarized. HBsAg seroconversion was defined as change of detectable antibody to HBsAg from negative to positive. The LOCF method was applied for missing values.
Outcome measures
| Measure |
LAM 100 mg/TDF 300 mg
n=13 Participants
Participants received a single, Open-Label (OL) Lamivudine (LAM) 100 milligram (mg) tablet once daily (OD) and a single, OL tenofovir disoproxil fumarate (TDF) 300 mg tablet OD for 96 weeks.
|
ETV 0.5 mg/TDF 300 mg
n=21 Participants
Participants received a single, OL entecavir (ETV) 0.5 mg tablet OD and a single, OL TDF 300 mg tablet OD for 96 weeks.
|
|---|---|---|
|
Number of Participants Achieving HBsAg/HBsAb Seroconversion at Week 24, Week 48 and Week 96
Week 24
|
0 participants
|
0 participants
|
|
Number of Participants Achieving HBsAg/HBsAb Seroconversion at Week 24, Week 48 and Week 96
Week 48
|
0 participants
|
0 participants
|
|
Number of Participants Achieving HBsAg/HBsAb Seroconversion at Week 24, Week 48 and Week 96
Week 96
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Screening, Week 24, Week 48, Week 96 and Virological BreakthroughPopulation: FAS Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
The number of participants who harbored resistance-related mutations and developed virological breakthrough was summarized. Virological breakthrough defined as HBV DNA level increase \>=1 log10 copies/mL above the treatment nadir were analyzed through end of treatment. Subjects who achieved the HBV-DNA values below lower limit of quantification (LLQ) (\< 2.1 log10 copies/mL) in quantitative analysis at Week 96 were also considered "negative" in drug-resistance without implementation of genotypic analysis. Lamivudine (LAM), adefovir pivoxil (ADV), and entecavir hydrate (ETV) resistance-related mutations were analyzed at Screening (i.e. Baseline), Week 24, Week 48 and Week 96 in participants with HBV DNA level above the lower limit of detection. Virologic breakthrough was defined as 1.0 log10 or greater increases in serum HBV DNA levels from on-treatment nadir. The LOCF method was applied for missing values.
Outcome measures
| Measure |
LAM 100 mg/TDF 300 mg
n=13 Participants
Participants received a single, Open-Label (OL) Lamivudine (LAM) 100 milligram (mg) tablet once daily (OD) and a single, OL tenofovir disoproxil fumarate (TDF) 300 mg tablet OD for 96 weeks.
|
ETV 0.5 mg/TDF 300 mg
n=21 Participants
Participants received a single, OL entecavir (ETV) 0.5 mg tablet OD and a single, OL TDF 300 mg tablet OD for 96 weeks.
|
|---|---|---|
|
Number of Participants With Virological Breakthrough and Resistance-related Mutations
Virological breakthrough, through end of study n=0
|
0 participants
|
1 participants
|
|
Number of Participants With Virological Breakthrough and Resistance-related Mutations
LAM resistance-related mutations,Screening,n=13,21
|
11 participants
|
17 participants
|
|
Number of Participants With Virological Breakthrough and Resistance-related Mutations
ADV resistance-related mutations,Screening,n=13,21
|
4 participants
|
0 participants
|
|
Number of Participants With Virological Breakthrough and Resistance-related Mutations
ETV resistance-related mutations,Screening,n=13,21
|
6 participants
|
16 participants
|
|
Number of Participants With Virological Breakthrough and Resistance-related Mutations
LAM resistance-related mutations, Week 24, n=5, 9
|
4 participants
|
8 participants
|
|
Number of Participants With Virological Breakthrough and Resistance-related Mutations
ADV resistance-related mutations, Week 24, n=5, 9
|
2 participants
|
0 participants
|
|
Number of Participants With Virological Breakthrough and Resistance-related Mutations
ETV resistance-related mutations, Week 24, n=5, 9
|
1 participants
|
8 participants
|
|
Number of Participants With Virological Breakthrough and Resistance-related Mutations
LAM resistance-related mutations, Week 48, n= 3, 9
|
2 participants
|
7 participants
|
|
Number of Participants With Virological Breakthrough and Resistance-related Mutations
ADV resistance-related mutations, Week 48, n= 3, 9
|
1 participants
|
0 participants
|
|
Number of Participants With Virological Breakthrough and Resistance-related Mutations
ETV resistance-related mutations, Week 48, n= 3, 9
|
1 participants
|
7 participants
|
|
Number of Participants With Virological Breakthrough and Resistance-related Mutations
LAM resistance-related mutations, Week 96, n= 2, 7
|
2 participants
|
6 participants
|
|
Number of Participants With Virological Breakthrough and Resistance-related Mutations
ADV resistance-related mutations, Week 96, n= 2, 7
|
1 participants
|
0 participants
|
|
Number of Participants With Virological Breakthrough and Resistance-related Mutations
ETV resistance-related mutations, Week 96, n= 2, 7
|
2 participants
|
6 participants
|
|
Number of Participants With Virological Breakthrough and Resistance-related Mutations
LAM resistance-related mutations, VB, n=0,1
|
0 participants
|
1 participants
|
|
Number of Participants With Virological Breakthrough and Resistance-related Mutations
ADV resistance-related mutations, VB, n=0,1
|
0 participants
|
0 participants
|
|
Number of Participants With Virological Breakthrough and Resistance-related Mutations
ETV resistance-related mutations, VB, n=0,1
|
0 participants
|
1 participants
|
SECONDARY outcome
Timeframe: Baseline, Week 24, Week 48 and Week 96Population: FAS Population
The number of participants achieving each indicated hepatitis B surface antigen (HBsAg) category (HBsAg \<80, 80 to 800, 800 to 8000, 8000 to 80000, \>=80000) (kilo international unit per liter \[KIU/L\]) by study visit was summarized.
Outcome measures
| Measure |
LAM 100 mg/TDF 300 mg
n=13 Participants
Participants received a single, Open-Label (OL) Lamivudine (LAM) 100 milligram (mg) tablet once daily (OD) and a single, OL tenofovir disoproxil fumarate (TDF) 300 mg tablet OD for 96 weeks.
|
ETV 0.5 mg/TDF 300 mg
n=21 Participants
Participants received a single, OL entecavir (ETV) 0.5 mg tablet OD and a single, OL TDF 300 mg tablet OD for 96 weeks.
|
|---|---|---|
|
Number of Participants Achieving Each Indicated HBsAg Category at Baseline, Week 24, Week 48 and Week 96
HBsAg 800-8000 KIU/L, Week 24
|
5 participants
|
15 participants
|
|
Number of Participants Achieving Each Indicated HBsAg Category at Baseline, Week 24, Week 48 and Week 96
HBsAg 8000-80,000 KIU/L, Week 24
|
5 participants
|
6 participants
|
|
Number of Participants Achieving Each Indicated HBsAg Category at Baseline, Week 24, Week 48 and Week 96
HBsAg >=80,000 KIU/L, Week 24
|
0 participants
|
0 participants
|
|
Number of Participants Achieving Each Indicated HBsAg Category at Baseline, Week 24, Week 48 and Week 96
HBsAg <80 KIU/L, Week 48
|
0 participants
|
0 participants
|
|
Number of Participants Achieving Each Indicated HBsAg Category at Baseline, Week 24, Week 48 and Week 96
HBsAg 80-800 KIU/L, Week 48
|
3 participants
|
1 participants
|
|
Number of Participants Achieving Each Indicated HBsAg Category at Baseline, Week 24, Week 48 and Week 96
HBsAg 800-8000 KIU/L, Week 48
|
5 participants
|
14 participants
|
|
Number of Participants Achieving Each Indicated HBsAg Category at Baseline, Week 24, Week 48 and Week 96
HBsAg 8000-80,000 KIU/L, Week 48
|
5 participants
|
6 participants
|
|
Number of Participants Achieving Each Indicated HBsAg Category at Baseline, Week 24, Week 48 and Week 96
HBsAg >=80,000 KIU/L, Week 48
|
0 participants
|
0 participants
|
|
Number of Participants Achieving Each Indicated HBsAg Category at Baseline, Week 24, Week 48 and Week 96
HBsAg <80 KIU/L, Week 96
|
0 participants
|
0 participants
|
|
Number of Participants Achieving Each Indicated HBsAg Category at Baseline, Week 24, Week 48 and Week 96
HBsAg 80-800 KIU/L, Week 96
|
4 participants
|
3 participants
|
|
Number of Participants Achieving Each Indicated HBsAg Category at Baseline, Week 24, Week 48 and Week 96
HBsAg 800-8000 KIU/L, Week 96
|
6 participants
|
13 participants
|
|
Number of Participants Achieving Each Indicated HBsAg Category at Baseline, Week 24, Week 48 and Week 96
HBsAg 8000-80,000 KIU/L, Week 96
|
3 participants
|
5 participants
|
|
Number of Participants Achieving Each Indicated HBsAg Category at Baseline, Week 24, Week 48 and Week 96
HBsAg >=80,000 KIU/L, Week 96
|
0 participants
|
0 participants
|
|
Number of Participants Achieving Each Indicated HBsAg Category at Baseline, Week 24, Week 48 and Week 96
HBsAg <80 KIU/L, Baseline
|
0 participants
|
0 participants
|
|
Number of Participants Achieving Each Indicated HBsAg Category at Baseline, Week 24, Week 48 and Week 96
HBsAg 80-800 KIU/L, Baseline
|
1 participants
|
0 participants
|
|
Number of Participants Achieving Each Indicated HBsAg Category at Baseline, Week 24, Week 48 and Week 96
HBsAg 800-8000 KIU/L, Baseline
|
6 participants
|
12 participants
|
|
Number of Participants Achieving Each Indicated HBsAg Category at Baseline, Week 24, Week 48 and Week 96
HBsAg 8000-80,000 KIU/L, Baseline
|
6 participants
|
8 participants
|
|
Number of Participants Achieving Each Indicated HBsAg Category at Baseline, Week 24, Week 48 and Week 96
HBsAg >=80,000 KIU/L, Baseline
|
0 participants
|
1 participants
|
|
Number of Participants Achieving Each Indicated HBsAg Category at Baseline, Week 24, Week 48 and Week 96
HBsAg <80 KIU/L, Week 24
|
0 participants
|
0 participants
|
|
Number of Participants Achieving Each Indicated HBsAg Category at Baseline, Week 24, Week 48 and Week 96
HBsAg 80-800 KIU/L, Week 24
|
3 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Baseline, Week 24, Week 48 and Week 96Population: FAS Population
The number of participants achieving each indicated hepatitis B core-related antigen (HBcrAg) category (HBcrAg \<3.0 log10, 3.0 to 4.0 log10, 4.0 to 5.0 log10, 5.0 to 6.0 log10, \>=6.0 log10) (kilo units per liter \[KU/L\]) by study visit was summarized. The LOCF method was applied for missing values.
Outcome measures
| Measure |
LAM 100 mg/TDF 300 mg
n=13 Participants
Participants received a single, Open-Label (OL) Lamivudine (LAM) 100 milligram (mg) tablet once daily (OD) and a single, OL tenofovir disoproxil fumarate (TDF) 300 mg tablet OD for 96 weeks.
|
ETV 0.5 mg/TDF 300 mg
n=21 Participants
Participants received a single, OL entecavir (ETV) 0.5 mg tablet OD and a single, OL TDF 300 mg tablet OD for 96 weeks.
|
|---|---|---|
|
Number of Participants Achieving Each Indicated HBcrAg Category at Baseline,Week 24, Week 48 and Week 96
HBcrAg <3.0 Log KU/L, Baseline
|
0 Participants
|
0 Participants
|
|
Number of Participants Achieving Each Indicated HBcrAg Category at Baseline,Week 24, Week 48 and Week 96
HBcrAg 3.0-4.0 Log KU/L, Baseline
|
0 Participants
|
1 Participants
|
|
Number of Participants Achieving Each Indicated HBcrAg Category at Baseline,Week 24, Week 48 and Week 96
HBcrAg 4.0-5.0 Log KU/L, Baseline
|
0 Participants
|
1 Participants
|
|
Number of Participants Achieving Each Indicated HBcrAg Category at Baseline,Week 24, Week 48 and Week 96
HBcrAg 5.0-6.0 Log KU/L, Baseline
|
1 Participants
|
0 Participants
|
|
Number of Participants Achieving Each Indicated HBcrAg Category at Baseline,Week 24, Week 48 and Week 96
HBcrAg >=6.0 Log KU/L, Baseline
|
12 Participants
|
19 Participants
|
|
Number of Participants Achieving Each Indicated HBcrAg Category at Baseline,Week 24, Week 48 and Week 96
HBcrAg <3.0 Log KU/L, Week 24
|
0 Participants
|
0 Participants
|
|
Number of Participants Achieving Each Indicated HBcrAg Category at Baseline,Week 24, Week 48 and Week 96
HBcrAg 3.0-4.0 Log KU/L, Week 24
|
0 Participants
|
1 Participants
|
|
Number of Participants Achieving Each Indicated HBcrAg Category at Baseline,Week 24, Week 48 and Week 96
HBcrAg 4.0-5.0 Log KU/L, Week 24
|
1 Participants
|
1 Participants
|
|
Number of Participants Achieving Each Indicated HBcrAg Category at Baseline,Week 24, Week 48 and Week 96
HBcrAg 5.0-6.0 Log KU/L, Week 24
|
1 Participants
|
1 Participants
|
|
Number of Participants Achieving Each Indicated HBcrAg Category at Baseline,Week 24, Week 48 and Week 96
HBcrAg >=6.0 Log KU/L, Week 24
|
11 Participants
|
18 Participants
|
|
Number of Participants Achieving Each Indicated HBcrAg Category at Baseline,Week 24, Week 48 and Week 96
HBcrAg <3.0 Log KU/L, Week 48
|
0 Participants
|
0 Participants
|
|
Number of Participants Achieving Each Indicated HBcrAg Category at Baseline,Week 24, Week 48 and Week 96
HBcrAg 3.0-4.0 Log KU/L, Week 48
|
1 Participants
|
1 Participants
|
|
Number of Participants Achieving Each Indicated HBcrAg Category at Baseline,Week 24, Week 48 and Week 96
HBcrAg 4.0-5.0 Log KU/L, Week 48
|
0 Participants
|
1 Participants
|
|
Number of Participants Achieving Each Indicated HBcrAg Category at Baseline,Week 24, Week 48 and Week 96
HBcrAg 5.0-6.0 Log KU/L, Week 48
|
2 Participants
|
1 Participants
|
|
Number of Participants Achieving Each Indicated HBcrAg Category at Baseline,Week 24, Week 48 and Week 96
HBcrAg >=6.0 Log KU/L, Week 48
|
10 Participants
|
18 Participants
|
|
Number of Participants Achieving Each Indicated HBcrAg Category at Baseline,Week 24, Week 48 and Week 96
HBcrAg <3.0 Log KU/L, Week 96
|
0 Participants
|
0 Participants
|
|
Number of Participants Achieving Each Indicated HBcrAg Category at Baseline,Week 24, Week 48 and Week 96
HBcrAg 3.0-4.0 Log KU/L, Week 96
|
1 Participants
|
1 Participants
|
|
Number of Participants Achieving Each Indicated HBcrAg Category at Baseline,Week 24, Week 48 and Week 96
HBcrAg 4.0-5.0 Log KU/L, Week 96
|
0 Participants
|
1 Participants
|
|
Number of Participants Achieving Each Indicated HBcrAg Category at Baseline,Week 24, Week 48 and Week 96
HBcrAg 5.0-6.0 Log KU/L, Week 96
|
3 Participants
|
2 Participants
|
|
Number of Participants Achieving Each Indicated HBcrAg Category at Baseline,Week 24, Week 48 and Week 96
HBcrAg >=6.0 Log KU/L, Week 96
|
9 Participants
|
17 Participants
|
Adverse Events
LAM 100 mg/TDF 300 mg
Serious events: 1 serious events
Other events: 12 other events
Deaths: 0 deaths
ETV 0.5 mg/TDF 300 mg
Serious events: 2 serious events
Other events: 17 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
LAM 100 mg/TDF 300 mg
n=13 participants at risk
Participants received a single, Open-Label (OL) Lamivudine (LAM) 100 milligram (mg) tablet once daily (OD) and a single, OL tenofovir disoproxil fumarate (TDF) 300 mg tablet OD for 96 weeks.
|
ETV 0.5 mg/TDF 300 mg
n=21 participants at risk
Participants received a single, OL entecavir (ETV) 0.5 mg tablet OD and a single, OL TDF 300 mg tablet OD for 96 weeks.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
7.7%
1/13 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to average of 96 weeks).
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who received at least one dose of investigational product.
|
0.00%
0/21 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to average of 96 weeks).
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who received at least one dose of investigational product.
|
|
Renal and urinary disorders
Calculus ureteric
|
0.00%
0/13 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to average of 96 weeks).
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who received at least one dose of investigational product.
|
4.8%
1/21 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to average of 96 weeks).
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who received at least one dose of investigational product.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/13 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to average of 96 weeks).
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who received at least one dose of investigational product.
|
4.8%
1/21 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to average of 96 weeks).
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who received at least one dose of investigational product.
|
Other adverse events
| Measure |
LAM 100 mg/TDF 300 mg
n=13 participants at risk
Participants received a single, Open-Label (OL) Lamivudine (LAM) 100 milligram (mg) tablet once daily (OD) and a single, OL tenofovir disoproxil fumarate (TDF) 300 mg tablet OD for 96 weeks.
|
ETV 0.5 mg/TDF 300 mg
n=21 participants at risk
Participants received a single, OL entecavir (ETV) 0.5 mg tablet OD and a single, OL TDF 300 mg tablet OD for 96 weeks.
|
|---|---|---|
|
Infections and infestations
Respiratory tract infection
|
7.7%
1/13 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to average of 96 weeks).
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who received at least one dose of investigational product.
|
0.00%
0/21 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to average of 96 weeks).
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who received at least one dose of investigational product.
|
|
Infections and infestations
Tinea pedis
|
7.7%
1/13 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to average of 96 weeks).
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who received at least one dose of investigational product.
|
0.00%
0/21 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to average of 96 weeks).
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who received at least one dose of investigational product.
|
|
Investigations
Alanine aminotransferase increased
|
7.7%
1/13 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to average of 96 weeks).
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who received at least one dose of investigational product.
|
14.3%
3/21 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to average of 96 weeks).
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who received at least one dose of investigational product.
|
|
Investigations
Asparatate aminotransferase increased
|
7.7%
1/13 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to average of 96 weeks).
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who received at least one dose of investigational product.
|
9.5%
2/21 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to average of 96 weeks).
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who received at least one dose of investigational product.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/13 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to average of 96 weeks).
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who received at least one dose of investigational product.
|
14.3%
3/21 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to average of 96 weeks).
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who received at least one dose of investigational product.
|
|
Gastrointestinal disorders
Dyspepsia
|
7.7%
1/13 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to average of 96 weeks).
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who received at least one dose of investigational product.
|
9.5%
2/21 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to average of 96 weeks).
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who received at least one dose of investigational product.
|
|
Gastrointestinal disorders
Constipation
|
7.7%
1/13 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to average of 96 weeks).
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who received at least one dose of investigational product.
|
0.00%
0/21 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to average of 96 weeks).
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who received at least one dose of investigational product.
|
|
Gastrointestinal disorders
Gastritis
|
7.7%
1/13 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to average of 96 weeks).
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who received at least one dose of investigational product.
|
0.00%
0/21 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to average of 96 weeks).
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who received at least one dose of investigational product.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/13 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to average of 96 weeks).
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who received at least one dose of investigational product.
|
9.5%
2/21 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to average of 96 weeks).
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who received at least one dose of investigational product.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/13 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to average of 96 weeks).
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who received at least one dose of investigational product.
|
9.5%
2/21 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to average of 96 weeks).
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who received at least one dose of investigational product.
|
|
Gastrointestinal disorders
Haemorrhoids
|
7.7%
1/13 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to average of 96 weeks).
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who received at least one dose of investigational product.
|
0.00%
0/21 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to average of 96 weeks).
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who received at least one dose of investigational product.
|
|
Skin and subcutaneous tissue disorders
Rash
|
7.7%
1/13 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to average of 96 weeks).
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who received at least one dose of investigational product.
|
14.3%
3/21 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to average of 96 weeks).
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who received at least one dose of investigational product.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
7.7%
1/13 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to average of 96 weeks).
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who received at least one dose of investigational product.
|
4.8%
1/21 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to average of 96 weeks).
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who received at least one dose of investigational product.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
7.7%
1/13 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to average of 96 weeks).
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who received at least one dose of investigational product.
|
0.00%
0/21 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to average of 96 weeks).
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who received at least one dose of investigational product.
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
7.7%
1/13 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to average of 96 weeks).
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who received at least one dose of investigational product.
|
0.00%
0/21 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to average of 96 weeks).
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who received at least one dose of investigational product.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
7.7%
1/13 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to average of 96 weeks).
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who received at least one dose of investigational product.
|
0.00%
0/21 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to average of 96 weeks).
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who received at least one dose of investigational product.
|
|
Nervous system disorders
Headache
|
15.4%
2/13 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to average of 96 weeks).
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who received at least one dose of investigational product.
|
9.5%
2/21 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to average of 96 weeks).
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who received at least one dose of investigational product.
|
|
Nervous system disorders
Dysaesthesia
|
7.7%
1/13 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to average of 96 weeks).
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who received at least one dose of investigational product.
|
9.5%
2/21 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to average of 96 weeks).
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who received at least one dose of investigational product.
|
|
Nervous system disorders
Parosmia
|
7.7%
1/13 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to average of 96 weeks).
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who received at least one dose of investigational product.
|
0.00%
0/21 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to average of 96 weeks).
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who received at least one dose of investigational product.
|
|
Infections and infestations
Nasopharyngitis
|
53.8%
7/13 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to average of 96 weeks).
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who received at least one dose of investigational product.
|
52.4%
11/21 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to average of 96 weeks).
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who received at least one dose of investigational product.
|
|
Infections and infestations
Otitis externa
|
7.7%
1/13 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to average of 96 weeks).
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who received at least one dose of investigational product.
|
0.00%
0/21 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to average of 96 weeks).
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who received at least one dose of investigational product.
|
|
Infections and infestations
Rhinitis
|
7.7%
1/13 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to average of 96 weeks).
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who received at least one dose of investigational product.
|
0.00%
0/21 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to average of 96 weeks).
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who received at least one dose of investigational product.
|
|
Investigations
Blood creatinine increased
|
7.7%
1/13 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to average of 96 weeks).
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who received at least one dose of investigational product.
|
0.00%
0/21 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to average of 96 weeks).
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who received at least one dose of investigational product.
|
|
Investigations
Hepatic enzyme increased
|
7.7%
1/13 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to average of 96 weeks).
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who received at least one dose of investigational product.
|
4.8%
1/21 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to average of 96 weeks).
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who received at least one dose of investigational product.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/13 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to average of 96 weeks).
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who received at least one dose of investigational product.
|
9.5%
2/21 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to average of 96 weeks).
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who received at least one dose of investigational product.
|
|
General disorders
Fatigue
|
0.00%
0/13 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to average of 96 weeks).
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who received at least one dose of investigational product.
|
9.5%
2/21 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to average of 96 weeks).
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who received at least one dose of investigational product.
|
|
General disorders
Malaise
|
7.7%
1/13 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to average of 96 weeks).
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who received at least one dose of investigational product.
|
0.00%
0/21 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to average of 96 weeks).
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who received at least one dose of investigational product.
|
|
Hepatobiliary disorders
Hepatic steatosis
|
7.7%
1/13 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to average of 96 weeks).
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who received at least one dose of investigational product.
|
14.3%
3/21 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to average of 96 weeks).
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who received at least one dose of investigational product.
|
|
Hepatobiliary disorders
Gallbladder polyp
|
15.4%
2/13 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to average of 96 weeks).
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who received at least one dose of investigational product.
|
0.00%
0/21 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to average of 96 weeks).
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who received at least one dose of investigational product.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.7%
1/13 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to average of 96 weeks).
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who received at least one dose of investigational product.
|
9.5%
2/21 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to average of 96 weeks).
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who received at least one dose of investigational product.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
7.7%
1/13 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to average of 96 weeks).
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who received at least one dose of investigational product.
|
0.00%
0/21 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to average of 96 weeks).
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who received at least one dose of investigational product.
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
7.7%
1/13 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to average of 96 weeks).
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who received at least one dose of investigational product.
|
0.00%
0/21 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to average of 96 weeks).
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who received at least one dose of investigational product.
|
|
Injury, poisoning and procedural complications
Contusion
|
7.7%
1/13 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to average of 96 weeks).
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who received at least one dose of investigational product.
|
4.8%
1/21 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to average of 96 weeks).
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who received at least one dose of investigational product.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
7.7%
1/13 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to average of 96 weeks).
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who received at least one dose of investigational product.
|
0.00%
0/21 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to average of 96 weeks).
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who received at least one dose of investigational product.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
7.7%
1/13 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to average of 96 weeks).
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who received at least one dose of investigational product.
|
0.00%
0/21 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to average of 96 weeks).
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who received at least one dose of investigational product.
|
|
Eye disorders
Cataract
|
7.7%
1/13 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to average of 96 weeks).
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who received at least one dose of investigational product.
|
0.00%
0/21 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to average of 96 weeks).
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who received at least one dose of investigational product.
|
|
Immune system disorders
Seasonal allergy
|
7.7%
1/13 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to average of 96 weeks).
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who received at least one dose of investigational product.
|
0.00%
0/21 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to average of 96 weeks).
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who received at least one dose of investigational product.
|
|
Renal and urinary disorders
Nephrolithiasis
|
7.7%
1/13 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to average of 96 weeks).
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who received at least one dose of investigational product.
|
0.00%
0/21 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to average of 96 weeks).
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who received at least one dose of investigational product.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
7.7%
1/13 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to average of 96 weeks).
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who received at least one dose of investigational product.
|
0.00%
0/21 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to average of 96 weeks).
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who received at least one dose of investigational product.
|
|
Vascular disorders
Hypertension
|
7.7%
1/13 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to average of 96 weeks).
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who received at least one dose of investigational product.
|
0.00%
0/21 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to average of 96 weeks).
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who received at least one dose of investigational product.
|
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