Trial Outcomes & Findings for A Study of Combination or Sequential Treatment With PEGASYS (Peginterferon Alfa-2a) and Entecavir in Patients With HBeAg Positive Chronic Hepatitis B (NCT NCT00940485)
NCT ID: NCT00940485
Last Updated: 2016-03-25
Results Overview
Hepatitis B envelope Antigen (HBeAg) seroconversion was defined as the absence of HBeAg and the presence of antibody to Hepatitis B envelope antigen (anti-HBe).
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
200 participants
Primary outcome timeframe
At Week 48
Results posted on
2016-03-25
Participant Flow
A total of 332 participants were enrolled in this study conducted from 28 April 2009 to 23 December 2011 at seven centers in China.
Of 332 participants, 200 were randomized, out of which 97 participants were assigned to Peginterferon alfa-2a + entecavir and 100 were assigned to entecavir, and three participants did not take any study drug.
Participant milestones
| Measure |
Peginterferon Alfa-2a + Entecavir
Participants received PEGASYS® (peginterferon alfa-2a)180 micrograms (mcg) subcutaneously once weekly for 48 weeks, plus entecavir 0.5 milligram (mg) orally once daily for 8 weeks.
|
Entecavir
Participants received entecavir 0.5 mg orally once daily for 48 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
97
|
100
|
|
Overall Study
COMPLETED
|
82
|
93
|
|
Overall Study
NOT COMPLETED
|
15
|
7
|
Reasons for withdrawal
| Measure |
Peginterferon Alfa-2a + Entecavir
Participants received PEGASYS® (peginterferon alfa-2a)180 micrograms (mcg) subcutaneously once weekly for 48 weeks, plus entecavir 0.5 milligram (mg) orally once daily for 8 weeks.
|
Entecavir
Participants received entecavir 0.5 mg orally once daily for 48 weeks.
|
|---|---|---|
|
Overall Study
HBeAb positive at Baseline
|
3
|
2
|
|
Overall Study
Lost to Follow-up
|
2
|
3
|
|
Overall Study
Adverse Event
|
8
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
|
Overall Study
Others
|
1
|
1
|
Baseline Characteristics
A Study of Combination or Sequential Treatment With PEGASYS (Peginterferon Alfa-2a) and Entecavir in Patients With HBeAg Positive Chronic Hepatitis B
Baseline characteristics by cohort
| Measure |
Peginterferon Alfa-2a + Entecavir
n=94 Participants
Participants received peginterferon alfa-2a180 mcg subcutaneously once weekly for 48 weeks, plus entecavir 0.5 mg orally once daily for 8 weeks.
|
Entecavir
n=98 Participants
Participants received entecavir 0.5 mg orally once daily for 48 weeks.
|
Total
n=192 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
33.38 years
STANDARD_DEVIATION 8.25 • n=5 Participants
|
33.28 years
STANDARD_DEVIATION 8.95 • n=7 Participants
|
33.3 years
STANDARD_DEVIATION 8.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
75 Participants
n=5 Participants
|
85 Participants
n=7 Participants
|
160 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At Week 48Population: Full analysis set included all patients who were randomized and received at least one dose of the study drug.
Hepatitis B envelope Antigen (HBeAg) seroconversion was defined as the absence of HBeAg and the presence of antibody to Hepatitis B envelope antigen (anti-HBe).
Outcome measures
| Measure |
Peginterferon Alfa-2a + Entecavir
n=94 Participants
Participants received peginterferon alfa-2a180 mcg subcutaneously once weekly for 48 weeks, plus entecavir 0.5 mg orally once daily for 8 weeks.
|
Entecavir
n=98 Participants
Participants received entecavir 0.5 mg orally once daily for 48 weeks.
|
|---|---|---|
|
Percentage of Participants With Hepatitis B Envelope Antigen Seroconversion at Week 48
|
14.89 Percentage of participants
Interval 8.39 to 23.72
|
6.12 Percentage of participants
Interval 2.28 to 12.85
|
SECONDARY outcome
Timeframe: At Week 48Population: Full analysis set included all patients who were randomized and received at least one dose of the study drug.
Loss of Hepatitis B Envelope Antigen (HBeAg) is defined as the absence of HBeAg.
Outcome measures
| Measure |
Peginterferon Alfa-2a + Entecavir
n=94 Participants
Participants received peginterferon alfa-2a180 mcg subcutaneously once weekly for 48 weeks, plus entecavir 0.5 mg orally once daily for 8 weeks.
|
Entecavir
n=98 Participants
Participants received entecavir 0.5 mg orally once daily for 48 weeks.
|
|---|---|---|
|
Percentage of Participants With Loss of Hepatitis B Envelope Antigen at Week 48
|
62.77 Percentage of participants
Interval 52.18 to 72.52
|
60.20 Percentage of participants
Interval 49.82 to 69.96
|
SECONDARY outcome
Timeframe: At Week 48Population: Full analysis set included all patients who were randomized and received at least one dose of the study drug.
Blood was collected for Hepatitis B Virus - Deoxyribonucleic Acid (HBV -DNA) and was analysed at the central laboratories using the Roche approved polymerase chain reaction (PCR) methodology at Week 48. Percentage of participants with HBV-DNA \< 1000 copies/mL was reported.
Outcome measures
| Measure |
Peginterferon Alfa-2a + Entecavir
n=94 Participants
Participants received peginterferon alfa-2a180 mcg subcutaneously once weekly for 48 weeks, plus entecavir 0.5 mg orally once daily for 8 weeks.
|
Entecavir
n=98 Participants
Participants received entecavir 0.5 mg orally once daily for 48 weeks.
|
|---|---|---|
|
Percentage of Participants With Hepatitis B Virus - Deoxyribonucleic Acid <1000 Copies/ Millilitre at Week 48
|
62.77 Percentage of participants
Interval 52.18 to 72.52
|
91.84 Percentage of participants
Interval 84.55 to 96.41
|
SECONDARY outcome
Timeframe: At Week 48Population: Full analysis set included all patients who were randomized and received at least one dose of the study drug.
Loss of Hepatitis B Surface Antigen (HBsAg) was defined as change of detectable HBsAg from positive to negative.
Outcome measures
| Measure |
Peginterferon Alfa-2a + Entecavir
n=94 Participants
Participants received peginterferon alfa-2a180 mcg subcutaneously once weekly for 48 weeks, plus entecavir 0.5 mg orally once daily for 8 weeks.
|
Entecavir
n=98 Participants
Participants received entecavir 0.5 mg orally once daily for 48 weeks.
|
|---|---|---|
|
Percentage of Participants With Hepatitis B Surface Antigen Loss at Week 48
|
8.51 Percentage of participants
Interval 3.75 to 16.08
|
0 Percentage of participants
Interval 0.0 to 3.69
|
SECONDARY outcome
Timeframe: At Week 48Population: Full analysis set included all patients who were randomized and received at least one dose of the study drug.
Hepatitis B Surface Antigen (HBsAg) seroconversion was defined as loss of HBsAg and presence of anti-HBs .(antibody to Hepatitis B surface antigen)
Outcome measures
| Measure |
Peginterferon Alfa-2a + Entecavir
n=94 Participants
Participants received peginterferon alfa-2a180 mcg subcutaneously once weekly for 48 weeks, plus entecavir 0.5 mg orally once daily for 8 weeks.
|
Entecavir
n=98 Participants
Participants received entecavir 0.5 mg orally once daily for 48 weeks.
|
|---|---|---|
|
Percentage of Participants With Hepatitis B Surface Antigen Seroconversion at Week 48
|
4.26 Percentage of participants
Interval 1.17 to 10.54
|
0 Percentage of participants
Interval 0.0 to 3.69
|
SECONDARY outcome
Timeframe: At Week 48Population: Full analysis set included all patients who were randomized and received at least one dose of the study drug.
Normalized Alanine Aminotransferase (ALT) is defined as having a baseline ALT value \> upper limit of normal (ULN), and a decrease in ALT value to ≤ ULN at the given time point.
Outcome measures
| Measure |
Peginterferon Alfa-2a + Entecavir
n=94 Participants
Participants received peginterferon alfa-2a180 mcg subcutaneously once weekly for 48 weeks, plus entecavir 0.5 mg orally once daily for 8 weeks.
|
Entecavir
n=98 Participants
Participants received entecavir 0.5 mg orally once daily for 48 weeks.
|
|---|---|---|
|
Percentage of Participants With Normalized Alanine Aminotransferase at Week 48
|
51.06 Percentage of participants
Interval 40.54 to 61.52
|
85.71 Percentage of participants
Interval 77.19 to 91.96
|
SECONDARY outcome
Timeframe: Up to Week 48Population: Full analysis set included all patients who were randomized and received at least one dose of the study drug. Maximum participants available at particular time point were analysed.
Quantitative hepatitis B envelope antigen (HBeAg) results were analyzed in central lab. Values that were less than lower limit of quantification (LLOQ) had been replaced by LLOQ when analyzed, e.g. \<1000 was replaced by 1000 and \<0.2 was replaced by 0.2. Quantitative HBeAg value unit was calculated using 'Paul Ehrlich Institute units per millilitre' (PEIU/ml). Change in HBeAg was analysed at Weeks 0, 8, 12, 24, 36, and 48.
Outcome measures
| Measure |
Peginterferon Alfa-2a + Entecavir
n=94 Participants
Participants received peginterferon alfa-2a180 mcg subcutaneously once weekly for 48 weeks, plus entecavir 0.5 mg orally once daily for 8 weeks.
|
Entecavir
n=97 Participants
Participants received entecavir 0.5 mg orally once daily for 48 weeks.
|
|---|---|---|
|
Quantitative Change in Mean Hepatitis B Envelope Antigen Over Time
At Week 0; n= 93, 95
|
8.33 PEIU/ml)
Standard Deviation 18.76
|
5.66 PEIU/ml)
Standard Deviation 10.33
|
|
Quantitative Change in Mean Hepatitis B Envelope Antigen Over Time
At Week 8; n= 93, 97
|
4.76 PEIU/ml)
Standard Deviation 11.63
|
5.85 PEIU/ml)
Standard Deviation 12.55
|
|
Quantitative Change in Mean Hepatitis B Envelope Antigen Over Time
At Week 12; n= 94, 97
|
3.83 PEIU/ml)
Standard Deviation 10.57
|
5.00 PEIU/ml)
Standard Deviation 10.56
|
|
Quantitative Change in Mean Hepatitis B Envelope Antigen Over Time
At Week 24; n= 91, 97
|
2.28 PEIU/ml)
Standard Deviation 5.81
|
4.76 PEIU/ml)
Standard Deviation 11.40
|
|
Quantitative Change in Mean Hepatitis B Envelope Antigen Over Time
At Week 36; n= 88, 94
|
3.58 PEIU/ml)
Standard Deviation 16.66
|
4.52 PEIU/ml)
Standard Deviation 10.10
|
|
Quantitative Change in Mean Hepatitis B Envelope Antigen Over Time
At Week 48; n= 85, 92
|
13.23 PEIU/ml)
Standard Deviation 93.02
|
4.07 PEIU/ml)
Standard Deviation 9.15
|
SECONDARY outcome
Timeframe: Up to Week 48Population: Full analysis set included all patients who were randomized and received at least one dose of the study drug. Maximum participants available at particular time point were analysed.
Quantitative Hepatitis B Surface Antigen (HBsAg) results were analyzed in central lab. Values that were less than LLOQ had been replaced by LLOQ when analyzed, e.g. \<1000 was replaced by 1000 and \<0.2 was replaced by 0.2. Quantitative HBsAg calculated using 'International Units Per Millilitre' (IU/mL). Change in HBsAg was analysed at Weeks 0, 8, 12, 24, 36, and 48.
Outcome measures
| Measure |
Peginterferon Alfa-2a + Entecavir
n=94 Participants
Participants received peginterferon alfa-2a180 mcg subcutaneously once weekly for 48 weeks, plus entecavir 0.5 mg orally once daily for 8 weeks.
|
Entecavir
n=97 Participants
Participants received entecavir 0.5 mg orally once daily for 48 weeks.
|
|---|---|---|
|
Quantitative Change in Mean Hepatitis B Surface Antigen Change Over Time
At Week 24; n= 91, 97
|
2280.60 IU/ml
Standard Deviation 3429.61
|
2895.25 IU/ml
Standard Deviation 3336.91
|
|
Quantitative Change in Mean Hepatitis B Surface Antigen Change Over Time
At Week 0; n= 93, 95
|
3737.84 IU/ml
Standard Deviation 4617.19
|
3241.06 IU/ml
Standard Deviation 3592.60
|
|
Quantitative Change in Mean Hepatitis B Surface Antigen Change Over Time
At Week 8; n= 93, 97
|
3603.56 IU/ml
Standard Deviation 4553.66
|
3050.79 IU/ml
Standard Deviation 3313.12
|
|
Quantitative Change in Mean Hepatitis B Surface Antigen Change Over Time
At Week 12; n= 94, 97
|
3041.86 IU/ml
Standard Deviation 3782.70
|
3037.82 IU/ml
Standard Deviation 3498.73
|
|
Quantitative Change in Mean Hepatitis B Surface Antigen Change Over Time
At Week 36; n= 88, 94
|
2097.89 IU/ml
Standard Deviation 3458.84
|
2699.18 IU/ml
Standard Deviation 2964.25
|
|
Quantitative Change in Mean Hepatitis B Surface Antigen Change Over Time
At Week 48; n= 85, 92
|
1886.02 IU/ml
Standard Deviation 2627.33
|
2672.71 IU/ml
Standard Deviation 3065.97
|
SECONDARY outcome
Timeframe: Up to Week 48Population: Safety set (SS) included all the participants who received at least 1 dose of study drug and who had at least undergone safety assessment once, regardless of whether the patients withdrew from the study or not.
An adverse event (AE) was defined as any untoward medical occurrence that occurred during the course of the trial after study treatment had started. An adverse event was therefore any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. A Serious Adverse Events (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect.
Outcome measures
| Measure |
Peginterferon Alfa-2a + Entecavir
n=97 Participants
Participants received peginterferon alfa-2a180 mcg subcutaneously once weekly for 48 weeks, plus entecavir 0.5 mg orally once daily for 8 weeks.
|
Entecavir
n=100 Participants
Participants received entecavir 0.5 mg orally once daily for 48 weeks.
|
|---|---|---|
|
Number of Participants With Incidence of Adverse Events and Serious Adverse Events
Non serious AE
|
65 Participants
|
5 Participants
|
|
Number of Participants With Incidence of Adverse Events and Serious Adverse Events
Serious AE
|
6 Participants
|
0 Participants
|
|
Number of Participants With Incidence of Adverse Events and Serious Adverse Events
AE
|
67 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Up to Week 48Population: Safety set (SS) included all the participants who received at least 1 dose of study drug and who had at least undergone safety assessment once, regardless of whether the patients withdrew from the study or not.
Participants with clinically significant laboratory abnormalities which were captured as an AE (at the \>=5% threshold) were presented.
Outcome measures
| Measure |
Peginterferon Alfa-2a + Entecavir
n=97 Participants
Participants received peginterferon alfa-2a180 mcg subcutaneously once weekly for 48 weeks, plus entecavir 0.5 mg orally once daily for 8 weeks.
|
Entecavir
n=100 Participants
Participants received entecavir 0.5 mg orally once daily for 48 weeks.
|
|---|---|---|
|
Number of Participants With Laboratory Abnormalities Which Were Captured as an Adverse Event
Haemoglobin decreased
|
6 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities Which Were Captured as an Adverse Event
Aspartate aminotransferase increased
|
8 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities Which Were Captured as an Adverse Event
Alanine aminotransferase increased
|
9 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities Which Were Captured as an Adverse Event
Platelet count decreased
|
42 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities Which Were Captured as an Adverse Event
Neutrophil count decreased
|
53 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities Which Were Captured as an Adverse Event
White blood cell count decreased
|
59 Participants
|
0 Participants
|
Adverse Events
Peginterferon Alfa-2a + Entecavir
Serious events: 6 serious events
Other events: 65 other events
Deaths: 0 deaths
Entecavir
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Peginterferon Alfa-2a + Entecavir
n=97 participants at risk
Participants received peginterferon alfa-2a180 mcg subcutaneously once weekly for 48 weeks, plus entecavir 0.5 mg orally once daily for 8 weeks.
|
Entecavir
n=100 participants at risk
Participants received entecavir 0.5 mg orally once daily for 48 weeks.
|
|---|---|---|
|
Endocrine disorders
Hypothyroidism
|
1.0%
1/97 • Up to Week 48
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/100 • Up to Week 48
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Endocrine disorders
Hyperthyroidism
|
2.1%
2/97 • Up to Week 48
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/100 • Up to Week 48
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Infections and infestations
Viral myocarditis
|
1.0%
1/97 • Up to Week 48
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/100 • Up to Week 48
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Infections and infestations
Lung infection
|
1.0%
1/97 • Up to Week 48
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/100 • Up to Week 48
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Cardiac disorders
Myocardial ischaemia
|
1.0%
1/97 • Up to Week 48
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/100 • Up to Week 48
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Gastrointestinal disorders
Haemorrhoids
|
1.0%
1/97 • Up to Week 48
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/100 • Up to Week 48
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
Other adverse events
| Measure |
Peginterferon Alfa-2a + Entecavir
n=97 participants at risk
Participants received peginterferon alfa-2a180 mcg subcutaneously once weekly for 48 weeks, plus entecavir 0.5 mg orally once daily for 8 weeks.
|
Entecavir
n=100 participants at risk
Participants received entecavir 0.5 mg orally once daily for 48 weeks.
|
|---|---|---|
|
Investigations
Haemoglobin decreased
|
6.2%
6/97 • Up to Week 48
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/100 • Up to Week 48
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Investigations
Aspartate aminotransferase increased
|
8.2%
8/97 • Up to Week 48
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/100 • Up to Week 48
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Investigations
Alanine aminotransferase increased
|
9.3%
9/97 • Up to Week 48
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/100 • Up to Week 48
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Investigations
Platelet count decreased
|
43.3%
42/97 • Up to Week 48
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/100 • Up to Week 48
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Investigations
Neutrophil count decreased
|
54.6%
53/97 • Up to Week 48
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/100 • Up to Week 48
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Investigations
White blood cell count decreased
|
60.8%
59/97 • Up to Week 48
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/100 • Up to Week 48
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
General disorders
Pyrexia
|
15.5%
15/97 • Up to Week 48
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/100 • Up to Week 48
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
5.2%
5/97 • Up to Week 48
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/100 • Up to Week 48
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Blood and lymphatic system disorders
Erythropenia
|
5.2%
5/97 • Up to Week 48
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/100 • Up to Week 48
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Investigations
Red blood cells urine positive
|
0.00%
0/97 • Up to Week 48
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
1.0%
1/100 • Up to Week 48
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Investigations
Ultrasound liver abnormal
|
0.00%
0/97 • Up to Week 48
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
1.0%
1/100 • Up to Week 48
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Investigations
Blood thyroid stimulating hormone decreased
|
1.0%
1/97 • Up to Week 48
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/100 • Up to Week 48
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Investigations
Liver function test abnormal
|
1.0%
1/97 • Up to Week 48
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/100 • Up to Week 48
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Investigations
Protein urine present
|
1.0%
1/97 • Up to Week 48
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/100 • Up to Week 48
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Investigations
Thyroxine increased
|
1.0%
1/97 • Up to Week 48
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/100 • Up to Week 48
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Investigations
Tri-iodothyronine increased
|
1.0%
1/97 • Up to Week 48
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/100 • Up to Week 48
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Investigations
White blood cells urine positive
|
1.0%
1/97 • Up to Week 48
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/100 • Up to Week 48
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Investigations
Blood bilirubin increased
|
2.1%
2/97 • Up to Week 48
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/100 • Up to Week 48
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Investigations
Weight decreased
|
2.1%
2/97 • Up to Week 48
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/100 • Up to Week 48
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/97 • Up to Week 48
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
2.0%
2/100 • Up to Week 48
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Infections and infestations
Pharyngitis
|
1.0%
1/97 • Up to Week 48
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/100 • Up to Week 48
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Psychiatric disorders
Anxiety
|
1.0%
1/97 • Up to Week 48
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/100 • Up to Week 48
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Psychiatric disorders
Depression
|
1.0%
1/97 • Up to Week 48
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/100 • Up to Week 48
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
General disorders
Asthenia
|
1.0%
1/97 • Up to Week 48
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/100 • Up to Week 48
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
General disorders
Chest pain
|
1.0%
1/97 • Up to Week 48
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/100 • Up to Week 48
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
General disorders
Influenza like illness
|
3.1%
3/97 • Up to Week 48
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/100 • Up to Week 48
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Eye disorders
Conjunctivitis
|
1.0%
1/97 • Up to Week 48
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/100 • Up to Week 48
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Hepatobiliary disorders
Hepatic steatosis
|
1.0%
1/97 • Up to Week 48
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/100 • Up to Week 48
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
3.1%
3/97 • Up to Week 48
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/100 • Up to Week 48
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Metabolism and nutrition disorders
Marasmus
|
1.0%
1/97 • Up to Week 48
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/100 • Up to Week 48
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
4.1%
4/97 • Up to Week 48
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
1.0%
1/100 • Up to Week 48
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
1.0%
1/97 • Up to Week 48
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/100 • Up to Week 48
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.0%
1/97 • Up to Week 48
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/100 • Up to Week 48
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Endocrine disorders
Hyperthyroidism
|
2.1%
2/97 • Up to Week 48
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/100 • Up to Week 48
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
3.1%
3/97 • Up to Week 48
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/100 • Up to Week 48
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Nervous system disorders
Headache
|
4.1%
4/97 • Up to Week 48
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/100 • Up to Week 48
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
4.1%
4/97 • Up to Week 48
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/100 • Up to Week 48
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
Additional Information
Roche Trial Information Hotline
F. Hoffmann-La Roche AG
Phone: +41 616878333
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER