Trial Outcomes & Findings for Add-on Peginterferon Following Nucleos(t)Ide Analogue Treatment (NCT NCT02364336)
NCT ID: NCT02364336
Last Updated: 2019-09-04
Results Overview
Change in level of ISG expression before and after 1st peginterferon injection
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
14 participants
Primary outcome timeframe
6 hours after first injection of peginterferon
Results posted on
2019-09-04
Participant Flow
Screening occurred after participant enrollment. 14 patients were enrolled. One participant failed screening, and 13 started treatment.
Participant milestones
| Measure |
HBeAg Positive
Patients who have been treated with one or more nucleos(t)ides for at least 192 weeks who have known serum HBsAg and HBeAg positivity
|
HBeAg Negative
Patients who have been treated with one or more nucleos(t)ides for at least 192 weeks who have known serum HBsAg positivity and HBeAg negativity
|
|---|---|---|
|
Overall Study
STARTED
|
1
|
12
|
|
Overall Study
6 Hours Post First Peginterferon Inject
|
1
|
12
|
|
Overall Study
End of Peginterferon Treatment
|
1
|
11
|
|
Overall Study
24 Weeks After End of Peginterferon
|
1
|
11
|
|
Overall Study
48 Weeks After End of Peginterferon
|
1
|
10
|
|
Overall Study
COMPLETED
|
1
|
11
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
HBeAg Positive
Patients who have been treated with one or more nucleos(t)ides for at least 192 weeks who have known serum HBsAg and HBeAg positivity
|
HBeAg Negative
Patients who have been treated with one or more nucleos(t)ides for at least 192 weeks who have known serum HBsAg positivity and HBeAg negativity
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
Baseline Characteristics
Add-on Peginterferon Following Nucleos(t)Ide Analogue Treatment
Baseline characteristics by cohort
| Measure |
HBeAg Positive
n=1 Participants
Patients who have been treated with one or more nucleos(t)ides for at least 192 weeks who have known serum HBsAg and HBeAg positivity
|
HBeAg Negative
n=12 Participants
Patients who have been treated with one or more nucleos(t)ides for at least 192 weeks who have known serum HBsAg positivity and HBeAg negativity
|
Total
n=13 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
35 years
n=5 Participants
|
48 years
n=7 Participants
|
48 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 hours after first injection of peginterferonPopulation: One patient with HBeAg positive had insufficient liver tissue to perform the RNASeq.
Change in level of ISG expression before and after 1st peginterferon injection
Outcome measures
| Measure |
HBeAg Positive
n=1 Participants
Patients who have been treated with one or more nucleos(t)ides for at least 192 weeks who have known serum HBsAg and HBeAg positivity
|
HBeAg Negative
n=12 Participants
Patients who have been treated with one or more nucleos(t)ides for at least 192 weeks who have known serum HBsAg positivity and HBeAg negativity
|
|---|---|---|
|
Change in Interferon-stimulated-gene (ISG) Expression
PPP1R3G
|
—
|
-2.716 log 2 fold change
Standard Error 0.628
|
|
Change in Interferon-stimulated-gene (ISG) Expression
ALAS1
|
—
|
1.670 log 2 fold change
Standard Error 0.416
|
|
Change in Interferon-stimulated-gene (ISG) Expression
IGFBP3
|
—
|
-0.723 log 2 fold change
Standard Error 0.214
|
|
Change in Interferon-stimulated-gene (ISG) Expression
LTBP1
|
—
|
-0.548 log 2 fold change
Standard Error 0.163
|
|
Change in Interferon-stimulated-gene (ISG) Expression
STARD5
|
—
|
1.798 log 2 fold change
Standard Error 0.547
|
|
Change in Interferon-stimulated-gene (ISG) Expression
INHBB
|
—
|
-2.20 log 2 fold change
Standard Error 0.570
|
|
Change in Interferon-stimulated-gene (ISG) Expression
MMRN1
|
—
|
-1.597 log 2 fold change
Standard Error 0.432
|
|
Change in Interferon-stimulated-gene (ISG) Expression
LYVE1
|
—
|
-1.184 log 2 fold change
Standard Error 0.326
|
|
Change in Interferon-stimulated-gene (ISG) Expression
SLC8A1
|
—
|
-1.382 log 2 fold change
Standard Error 0.386
|
|
Change in Interferon-stimulated-gene (ISG) Expression
PPARGC1A
|
—
|
-1.573 log 2 fold change
Standard Error 0.443
|
|
Change in Interferon-stimulated-gene (ISG) Expression
NOTUM
|
—
|
0.870 log 2 fold change
Standard Error 0.250
|
|
Change in Interferon-stimulated-gene (ISG) Expression
RTN4RL1
|
—
|
1.808 log 2 fold change
Standard Error 0.556
|
|
Change in Interferon-stimulated-gene (ISG) Expression
ZPR1
|
—
|
-0.972 log 2 fold change
Standard Error 0.299
|
SECONDARY outcome
Timeframe: End of treatment, 24 weeks, and 48 weeksPopulation: Outcome only applies to HBeAg positive patients
Proportion of HBeAg positive patients showing eAg loss at end of treatment, and 24 and 48 weeks off peginterferon treatment.
Outcome measures
| Measure |
HBeAg Positive
n=1 Participants
Patients who have been treated with one or more nucleos(t)ides for at least 192 weeks who have known serum HBsAg and HBeAg positivity
|
HBeAg Negative
Patients who have been treated with one or more nucleos(t)ides for at least 192 weeks who have known serum HBsAg positivity and HBeAg negativity
|
|---|---|---|
|
Hepatitis B e Antigen (HBeAg) Loss
End of treatment
|
0 Participants
|
—
|
|
Hepatitis B e Antigen (HBeAg) Loss
Week 24 post treatment
|
0 Participants
|
—
|
|
Hepatitis B e Antigen (HBeAg) Loss
Week 48 post treatment
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: End of treatment, 24 weeks, and 48 weeksProportion of HBsAg positive patients showing sAG loss at end of treatment and 24 and 48 weeks off peginterferon treatment
Outcome measures
| Measure |
HBeAg Positive
n=1 Participants
Patients who have been treated with one or more nucleos(t)ides for at least 192 weeks who have known serum HBsAg and HBeAg positivity
|
HBeAg Negative
n=12 Participants
Patients who have been treated with one or more nucleos(t)ides for at least 192 weeks who have known serum HBsAg positivity and HBeAg negativity
|
|---|---|---|
|
Hepatitis B s Antigen (HBsAg) Loss
End of treatment
|
0 Participants
|
1 Participants
|
|
Hepatitis B s Antigen (HBsAg) Loss
Week 24 post treatment
|
0 Participants
|
0 Participants
|
|
Hepatitis B s Antigen (HBsAg) Loss
Week 48 post treatment
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 6 hours after first injection of peginterferon and baselinePopulation: One patient with HBeAg positive had insufficient liver tissue to obtain frequency and degranulation measurement in liver.
NK cell frequency is calculated as 100\*(NK cells)/(mononuclear cells). Changes are calculated by subtracting baseline from 6 hours after first peginterferon injection.
Outcome measures
| Measure |
HBeAg Positive
n=1 Participants
Patients who have been treated with one or more nucleos(t)ides for at least 192 weeks who have known serum HBsAg and HBeAg positivity
|
HBeAg Negative
n=12 Participants
Patients who have been treated with one or more nucleos(t)ides for at least 192 weeks who have known serum HBsAg positivity and HBeAg negativity
|
|---|---|---|
|
Change in Natural Killer (NK) Cell Frequency
Blood baseline
|
15.60 percentage of mononuclear cells
Standard Deviation NA
There is only one patient and standard deviation cannot be obtained.
|
11.82 percentage of mononuclear cells
Standard Deviation 10.19
|
|
Change in Natural Killer (NK) Cell Frequency
Blood 6 hours
|
10.30 percentage of mononuclear cells
Standard Deviation NA
There is only one patient and standard deviation cannot be obtained.
|
13.74 percentage of mononuclear cells
Standard Deviation 10.68
|
|
Change in Natural Killer (NK) Cell Frequency
Blood change
|
-5.3 percentage of mononuclear cells
Standard Deviation NA
There is only one patient and standard deviation cannot be obtained.
|
1.92 percentage of mononuclear cells
Standard Deviation 7.48
|
|
Change in Natural Killer (NK) Cell Frequency
Liver baseline
|
—
|
24.69 percentage of mononuclear cells
Standard Deviation 6.26
|
|
Change in Natural Killer (NK) Cell Frequency
Liver 6 hours
|
—
|
24.78 percentage of mononuclear cells
Standard Deviation 7.28
|
|
Change in Natural Killer (NK) Cell Frequency
Liver change
|
—
|
0.09 percentage of mononuclear cells
Standard Deviation 4.08
|
SECONDARY outcome
Timeframe: 6 hours after first injection of peginterferon and baselinePopulation: One patient with HBeAg positive had insufficient liver tissue to obtain frequency and degranulation measurement in liver.
NK cell degranulation is calculated as 100\*(degranulated NK cells)/(NK cells). Changes are calculated by subtracting baseline from 6 hours after first peginterferon injection.
Outcome measures
| Measure |
HBeAg Positive
n=1 Participants
Patients who have been treated with one or more nucleos(t)ides for at least 192 weeks who have known serum HBsAg and HBeAg positivity
|
HBeAg Negative
n=12 Participants
Patients who have been treated with one or more nucleos(t)ides for at least 192 weeks who have known serum HBsAg positivity and HBeAg negativity
|
|---|---|---|
|
Change in Natural Killer (NK) Cell Degranulation
Liver 6 hours
|
—
|
4.87 % of NK cells
Standard Deviation 4.47
|
|
Change in Natural Killer (NK) Cell Degranulation
Liver change
|
—
|
1.51 % of NK cells
Standard Deviation 5.08
|
|
Change in Natural Killer (NK) Cell Degranulation
Blood baseline
|
0.08 % of NK cells
Standard Deviation NA
There is only one patient and standard deviation cannot be obtained.
|
0.64 % of NK cells
Standard Deviation 0.65
|
|
Change in Natural Killer (NK) Cell Degranulation
Blood 6 hours
|
0.06 % of NK cells
Standard Deviation NA
There is only one patient and standard deviation cannot be obtained.
|
0.52 % of NK cells
Standard Deviation 0.66
|
|
Change in Natural Killer (NK) Cell Degranulation
Blood change
|
-0.02 % of NK cells
Standard Deviation NA
There is only one patient and standard deviation cannot be obtained.
|
-0.12 % of NK cells
Standard Deviation 0.93
|
|
Change in Natural Killer (NK) Cell Degranulation
Liver baseline
|
—
|
3.37 % of NK cells
Standard Deviation 1.46
|
Adverse Events
HBeAg Positive
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
HBeAg Negative
Serious events: 1 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
HBeAg Positive
n=1 participants at risk
Patients who have been treated with one or more nucleos(t)ides for at least 192 weeks who have known serum HBsAg and HBeAg positivity
|
HBeAg Negative
n=12 participants at risk
Patients who have been treated with one or more nucleos(t)ides for at least 192 weeks who have known serum HBsAg positivity and HBeAg negativity
|
|---|---|---|
|
Infections and infestations
Sepsis
|
0.00%
0/1 • Adverse event data were collected over three periods encompassing a total of 50 to 60 weeks. The first period was up to twelve weeks, from pre-treatment biopsy to start of peginterferon treatment. The second period was 24 weeks during treatment with peginterferon, and the third period was after completion of treatment with peginterferon.
|
8.3%
1/12 • Number of events 1 • Adverse event data were collected over three periods encompassing a total of 50 to 60 weeks. The first period was up to twelve weeks, from pre-treatment biopsy to start of peginterferon treatment. The second period was 24 weeks during treatment with peginterferon, and the third period was after completion of treatment with peginterferon.
|
Other adverse events
| Measure |
HBeAg Positive
n=1 participants at risk
Patients who have been treated with one or more nucleos(t)ides for at least 192 weeks who have known serum HBsAg and HBeAg positivity
|
HBeAg Negative
n=12 participants at risk
Patients who have been treated with one or more nucleos(t)ides for at least 192 weeks who have known serum HBsAg positivity and HBeAg negativity
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/1 • Adverse event data were collected over three periods encompassing a total of 50 to 60 weeks. The first period was up to twelve weeks, from pre-treatment biopsy to start of peginterferon treatment. The second period was 24 weeks during treatment with peginterferon, and the third period was after completion of treatment with peginterferon.
|
41.7%
5/12 • Adverse event data were collected over three periods encompassing a total of 50 to 60 weeks. The first period was up to twelve weeks, from pre-treatment biopsy to start of peginterferon treatment. The second period was 24 weeks during treatment with peginterferon, and the third period was after completion of treatment with peginterferon.
|
|
Gastrointestinal disorders
Anorexia
|
100.0%
1/1 • Adverse event data were collected over three periods encompassing a total of 50 to 60 weeks. The first period was up to twelve weeks, from pre-treatment biopsy to start of peginterferon treatment. The second period was 24 weeks during treatment with peginterferon, and the third period was after completion of treatment with peginterferon.
|
75.0%
9/12 • Adverse event data were collected over three periods encompassing a total of 50 to 60 weeks. The first period was up to twelve weeks, from pre-treatment biopsy to start of peginterferon treatment. The second period was 24 weeks during treatment with peginterferon, and the third period was after completion of treatment with peginterferon.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/1 • Adverse event data were collected over three periods encompassing a total of 50 to 60 weeks. The first period was up to twelve weeks, from pre-treatment biopsy to start of peginterferon treatment. The second period was 24 weeks during treatment with peginterferon, and the third period was after completion of treatment with peginterferon.
|
58.3%
7/12 • Adverse event data were collected over three periods encompassing a total of 50 to 60 weeks. The first period was up to twelve weeks, from pre-treatment biopsy to start of peginterferon treatment. The second period was 24 weeks during treatment with peginterferon, and the third period was after completion of treatment with peginterferon.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/1 • Adverse event data were collected over three periods encompassing a total of 50 to 60 weeks. The first period was up to twelve weeks, from pre-treatment biopsy to start of peginterferon treatment. The second period was 24 weeks during treatment with peginterferon, and the third period was after completion of treatment with peginterferon.
|
50.0%
6/12 • Adverse event data were collected over three periods encompassing a total of 50 to 60 weeks. The first period was up to twelve weeks, from pre-treatment biopsy to start of peginterferon treatment. The second period was 24 weeks during treatment with peginterferon, and the third period was after completion of treatment with peginterferon.
|
|
Injury, poisoning and procedural complications
Biopsy Site Pain
|
0.00%
0/1 • Adverse event data were collected over three periods encompassing a total of 50 to 60 weeks. The first period was up to twelve weeks, from pre-treatment biopsy to start of peginterferon treatment. The second period was 24 weeks during treatment with peginterferon, and the third period was after completion of treatment with peginterferon.
|
33.3%
4/12 • Adverse event data were collected over three periods encompassing a total of 50 to 60 weeks. The first period was up to twelve weeks, from pre-treatment biopsy to start of peginterferon treatment. The second period was 24 weeks during treatment with peginterferon, and the third period was after completion of treatment with peginterferon.
|
|
Eye disorders
Blurred Vision
|
0.00%
0/1 • Adverse event data were collected over three periods encompassing a total of 50 to 60 weeks. The first period was up to twelve weeks, from pre-treatment biopsy to start of peginterferon treatment. The second period was 24 weeks during treatment with peginterferon, and the third period was after completion of treatment with peginterferon.
|
41.7%
5/12 • Adverse event data were collected over three periods encompassing a total of 50 to 60 weeks. The first period was up to twelve weeks, from pre-treatment biopsy to start of peginterferon treatment. The second period was 24 weeks during treatment with peginterferon, and the third period was after completion of treatment with peginterferon.
|
|
General disorders
Chills
|
100.0%
1/1 • Adverse event data were collected over three periods encompassing a total of 50 to 60 weeks. The first period was up to twelve weeks, from pre-treatment biopsy to start of peginterferon treatment. The second period was 24 weeks during treatment with peginterferon, and the third period was after completion of treatment with peginterferon.
|
58.3%
7/12 • Adverse event data were collected over three periods encompassing a total of 50 to 60 weeks. The first period was up to twelve weeks, from pre-treatment biopsy to start of peginterferon treatment. The second period was 24 weeks during treatment with peginterferon, and the third period was after completion of treatment with peginterferon.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/1 • Adverse event data were collected over three periods encompassing a total of 50 to 60 weeks. The first period was up to twelve weeks, from pre-treatment biopsy to start of peginterferon treatment. The second period was 24 weeks during treatment with peginterferon, and the third period was after completion of treatment with peginterferon.
|
33.3%
4/12 • Adverse event data were collected over three periods encompassing a total of 50 to 60 weeks. The first period was up to twelve weeks, from pre-treatment biopsy to start of peginterferon treatment. The second period was 24 weeks during treatment with peginterferon, and the third period was after completion of treatment with peginterferon.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
100.0%
1/1 • Adverse event data were collected over three periods encompassing a total of 50 to 60 weeks. The first period was up to twelve weeks, from pre-treatment biopsy to start of peginterferon treatment. The second period was 24 weeks during treatment with peginterferon, and the third period was after completion of treatment with peginterferon.
|
58.3%
7/12 • Adverse event data were collected over three periods encompassing a total of 50 to 60 weeks. The first period was up to twelve weeks, from pre-treatment biopsy to start of peginterferon treatment. The second period was 24 weeks during treatment with peginterferon, and the third period was after completion of treatment with peginterferon.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/1 • Adverse event data were collected over three periods encompassing a total of 50 to 60 weeks. The first period was up to twelve weeks, from pre-treatment biopsy to start of peginterferon treatment. The second period was 24 weeks during treatment with peginterferon, and the third period was after completion of treatment with peginterferon.
|
41.7%
5/12 • Adverse event data were collected over three periods encompassing a total of 50 to 60 weeks. The first period was up to twelve weeks, from pre-treatment biopsy to start of peginterferon treatment. The second period was 24 weeks during treatment with peginterferon, and the third period was after completion of treatment with peginterferon.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/1 • Adverse event data were collected over three periods encompassing a total of 50 to 60 weeks. The first period was up to twelve weeks, from pre-treatment biopsy to start of peginterferon treatment. The second period was 24 weeks during treatment with peginterferon, and the third period was after completion of treatment with peginterferon.
|
66.7%
8/12 • Adverse event data were collected over three periods encompassing a total of 50 to 60 weeks. The first period was up to twelve weeks, from pre-treatment biopsy to start of peginterferon treatment. The second period was 24 weeks during treatment with peginterferon, and the third period was after completion of treatment with peginterferon.
|
|
Gastrointestinal disorders
Dry Mouth
|
0.00%
0/1 • Adverse event data were collected over three periods encompassing a total of 50 to 60 weeks. The first period was up to twelve weeks, from pre-treatment biopsy to start of peginterferon treatment. The second period was 24 weeks during treatment with peginterferon, and the third period was after completion of treatment with peginterferon.
|
66.7%
8/12 • Adverse event data were collected over three periods encompassing a total of 50 to 60 weeks. The first period was up to twelve weeks, from pre-treatment biopsy to start of peginterferon treatment. The second period was 24 weeks during treatment with peginterferon, and the third period was after completion of treatment with peginterferon.
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
100.0%
1/1 • Adverse event data were collected over three periods encompassing a total of 50 to 60 weeks. The first period was up to twelve weeks, from pre-treatment biopsy to start of peginterferon treatment. The second period was 24 weeks during treatment with peginterferon, and the third period was after completion of treatment with peginterferon.
|
66.7%
8/12 • Adverse event data were collected over three periods encompassing a total of 50 to 60 weeks. The first period was up to twelve weeks, from pre-treatment biopsy to start of peginterferon treatment. The second period was 24 weeks during treatment with peginterferon, and the third period was after completion of treatment with peginterferon.
|
|
Cardiac disorders
Fast or pounding heartbeat
|
100.0%
1/1 • Adverse event data were collected over three periods encompassing a total of 50 to 60 weeks. The first period was up to twelve weeks, from pre-treatment biopsy to start of peginterferon treatment. The second period was 24 weeks during treatment with peginterferon, and the third period was after completion of treatment with peginterferon.
|
33.3%
4/12 • Adverse event data were collected over three periods encompassing a total of 50 to 60 weeks. The first period was up to twelve weeks, from pre-treatment biopsy to start of peginterferon treatment. The second period was 24 weeks during treatment with peginterferon, and the third period was after completion of treatment with peginterferon.
|
|
General disorders
Fatigue
|
100.0%
1/1 • Adverse event data were collected over three periods encompassing a total of 50 to 60 weeks. The first period was up to twelve weeks, from pre-treatment biopsy to start of peginterferon treatment. The second period was 24 weeks during treatment with peginterferon, and the third period was after completion of treatment with peginterferon.
|
100.0%
12/12 • Adverse event data were collected over three periods encompassing a total of 50 to 60 weeks. The first period was up to twelve weeks, from pre-treatment biopsy to start of peginterferon treatment. The second period was 24 weeks during treatment with peginterferon, and the third period was after completion of treatment with peginterferon.
|
|
General disorders
Fever
|
100.0%
1/1 • Adverse event data were collected over three periods encompassing a total of 50 to 60 weeks. The first period was up to twelve weeks, from pre-treatment biopsy to start of peginterferon treatment. The second period was 24 weeks during treatment with peginterferon, and the third period was after completion of treatment with peginterferon.
|
41.7%
5/12 • Adverse event data were collected over three periods encompassing a total of 50 to 60 weeks. The first period was up to twelve weeks, from pre-treatment biopsy to start of peginterferon treatment. The second period was 24 weeks during treatment with peginterferon, and the third period was after completion of treatment with peginterferon.
|
|
Renal and urinary disorders
Urinary frequency
|
100.0%
1/1 • Adverse event data were collected over three periods encompassing a total of 50 to 60 weeks. The first period was up to twelve weeks, from pre-treatment biopsy to start of peginterferon treatment. The second period was 24 weeks during treatment with peginterferon, and the third period was after completion of treatment with peginterferon.
|
58.3%
7/12 • Adverse event data were collected over three periods encompassing a total of 50 to 60 weeks. The first period was up to twelve weeks, from pre-treatment biopsy to start of peginterferon treatment. The second period was 24 weeks during treatment with peginterferon, and the third period was after completion of treatment with peginterferon.
|
|
Skin and subcutaneous tissue disorders
hair loss
|
0.00%
0/1 • Adverse event data were collected over three periods encompassing a total of 50 to 60 weeks. The first period was up to twelve weeks, from pre-treatment biopsy to start of peginterferon treatment. The second period was 24 weeks during treatment with peginterferon, and the third period was after completion of treatment with peginterferon.
|
41.7%
5/12 • Adverse event data were collected over three periods encompassing a total of 50 to 60 weeks. The first period was up to twelve weeks, from pre-treatment biopsy to start of peginterferon treatment. The second period was 24 weeks during treatment with peginterferon, and the third period was after completion of treatment with peginterferon.
|
|
Nervous system disorders
headache
|
100.0%
1/1 • Adverse event data were collected over three periods encompassing a total of 50 to 60 weeks. The first period was up to twelve weeks, from pre-treatment biopsy to start of peginterferon treatment. The second period was 24 weeks during treatment with peginterferon, and the third period was after completion of treatment with peginterferon.
|
91.7%
11/12 • Adverse event data were collected over three periods encompassing a total of 50 to 60 weeks. The first period was up to twelve weeks, from pre-treatment biopsy to start of peginterferon treatment. The second period was 24 weeks during treatment with peginterferon, and the third period was after completion of treatment with peginterferon.
|
|
Psychiatric disorders
insomnia
|
100.0%
1/1 • Adverse event data were collected over three periods encompassing a total of 50 to 60 weeks. The first period was up to twelve weeks, from pre-treatment biopsy to start of peginterferon treatment. The second period was 24 weeks during treatment with peginterferon, and the third period was after completion of treatment with peginterferon.
|
75.0%
9/12 • Adverse event data were collected over three periods encompassing a total of 50 to 60 weeks. The first period was up to twelve weeks, from pre-treatment biopsy to start of peginterferon treatment. The second period was 24 weeks during treatment with peginterferon, and the third period was after completion of treatment with peginterferon.
|
|
Psychiatric disorders
irritability
|
100.0%
1/1 • Adverse event data were collected over three periods encompassing a total of 50 to 60 weeks. The first period was up to twelve weeks, from pre-treatment biopsy to start of peginterferon treatment. The second period was 24 weeks during treatment with peginterferon, and the third period was after completion of treatment with peginterferon.
|
50.0%
6/12 • Adverse event data were collected over three periods encompassing a total of 50 to 60 weeks. The first period was up to twelve weeks, from pre-treatment biopsy to start of peginterferon treatment. The second period was 24 weeks during treatment with peginterferon, and the third period was after completion of treatment with peginterferon.
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
100.0%
1/1 • Adverse event data were collected over three periods encompassing a total of 50 to 60 weeks. The first period was up to twelve weeks, from pre-treatment biopsy to start of peginterferon treatment. The second period was 24 weeks during treatment with peginterferon, and the third period was after completion of treatment with peginterferon.
|
75.0%
9/12 • Adverse event data were collected over three periods encompassing a total of 50 to 60 weeks. The first period was up to twelve weeks, from pre-treatment biopsy to start of peginterferon treatment. The second period was 24 weeks during treatment with peginterferon, and the third period was after completion of treatment with peginterferon.
|
|
Musculoskeletal and connective tissue disorders
joint pain
|
100.0%
1/1 • Adverse event data were collected over three periods encompassing a total of 50 to 60 weeks. The first period was up to twelve weeks, from pre-treatment biopsy to start of peginterferon treatment. The second period was 24 weeks during treatment with peginterferon, and the third period was after completion of treatment with peginterferon.
|
50.0%
6/12 • Adverse event data were collected over three periods encompassing a total of 50 to 60 weeks. The first period was up to twelve weeks, from pre-treatment biopsy to start of peginterferon treatment. The second period was 24 weeks during treatment with peginterferon, and the third period was after completion of treatment with peginterferon.
|
|
Musculoskeletal and connective tissue disorders
myalgia
|
100.0%
1/1 • Adverse event data were collected over three periods encompassing a total of 50 to 60 weeks. The first period was up to twelve weeks, from pre-treatment biopsy to start of peginterferon treatment. The second period was 24 weeks during treatment with peginterferon, and the third period was after completion of treatment with peginterferon.
|
91.7%
11/12 • Adverse event data were collected over three periods encompassing a total of 50 to 60 weeks. The first period was up to twelve weeks, from pre-treatment biopsy to start of peginterferon treatment. The second period was 24 weeks during treatment with peginterferon, and the third period was after completion of treatment with peginterferon.
|
|
Gastrointestinal disorders
nausea
|
100.0%
1/1 • Adverse event data were collected over three periods encompassing a total of 50 to 60 weeks. The first period was up to twelve weeks, from pre-treatment biopsy to start of peginterferon treatment. The second period was 24 weeks during treatment with peginterferon, and the third period was after completion of treatment with peginterferon.
|
50.0%
6/12 • Adverse event data were collected over three periods encompassing a total of 50 to 60 weeks. The first period was up to twelve weeks, from pre-treatment biopsy to start of peginterferon treatment. The second period was 24 weeks during treatment with peginterferon, and the third period was after completion of treatment with peginterferon.
|
|
Skin and subcutaneous tissue disorders
rash
|
0.00%
0/1 • Adverse event data were collected over three periods encompassing a total of 50 to 60 weeks. The first period was up to twelve weeks, from pre-treatment biopsy to start of peginterferon treatment. The second period was 24 weeks during treatment with peginterferon, and the third period was after completion of treatment with peginterferon.
|
33.3%
4/12 • Adverse event data were collected over three periods encompassing a total of 50 to 60 weeks. The first period was up to twelve weeks, from pre-treatment biopsy to start of peginterferon treatment. The second period was 24 weeks during treatment with peginterferon, and the third period was after completion of treatment with peginterferon.
|
|
Psychiatric disorders
melancholy
|
0.00%
0/1 • Adverse event data were collected over three periods encompassing a total of 50 to 60 weeks. The first period was up to twelve weeks, from pre-treatment biopsy to start of peginterferon treatment. The second period was 24 weeks during treatment with peginterferon, and the third period was after completion of treatment with peginterferon.
|
58.3%
7/12 • Adverse event data were collected over three periods encompassing a total of 50 to 60 weeks. The first period was up to twelve weeks, from pre-treatment biopsy to start of peginterferon treatment. The second period was 24 weeks during treatment with peginterferon, and the third period was after completion of treatment with peginterferon.
|
|
Respiratory, thoracic and mediastinal disorders
shortness of breath
|
100.0%
1/1 • Adverse event data were collected over three periods encompassing a total of 50 to 60 weeks. The first period was up to twelve weeks, from pre-treatment biopsy to start of peginterferon treatment. The second period was 24 weeks during treatment with peginterferon, and the third period was after completion of treatment with peginterferon.
|
33.3%
4/12 • Adverse event data were collected over three periods encompassing a total of 50 to 60 weeks. The first period was up to twelve weeks, from pre-treatment biopsy to start of peginterferon treatment. The second period was 24 weeks during treatment with peginterferon, and the third period was after completion of treatment with peginterferon.
|
|
Gastrointestinal disorders
toothache
|
0.00%
0/1 • Adverse event data were collected over three periods encompassing a total of 50 to 60 weeks. The first period was up to twelve weeks, from pre-treatment biopsy to start of peginterferon treatment. The second period was 24 weeks during treatment with peginterferon, and the third period was after completion of treatment with peginterferon.
|
16.7%
2/12 • Adverse event data were collected over three periods encompassing a total of 50 to 60 weeks. The first period was up to twelve weeks, from pre-treatment biopsy to start of peginterferon treatment. The second period was 24 weeks during treatment with peginterferon, and the third period was after completion of treatment with peginterferon.
|
|
Gastrointestinal disorders
Vomiting
|
100.0%
1/1 • Adverse event data were collected over three periods encompassing a total of 50 to 60 weeks. The first period was up to twelve weeks, from pre-treatment biopsy to start of peginterferon treatment. The second period was 24 weeks during treatment with peginterferon, and the third period was after completion of treatment with peginterferon.
|
8.3%
1/12 • Adverse event data were collected over three periods encompassing a total of 50 to 60 weeks. The first period was up to twelve weeks, from pre-treatment biopsy to start of peginterferon treatment. The second period was 24 weeks during treatment with peginterferon, and the third period was after completion of treatment with peginterferon.
|
|
Investigations
Weight loss
|
100.0%
1/1 • Adverse event data were collected over three periods encompassing a total of 50 to 60 weeks. The first period was up to twelve weeks, from pre-treatment biopsy to start of peginterferon treatment. The second period was 24 weeks during treatment with peginterferon, and the third period was after completion of treatment with peginterferon.
|
66.7%
8/12 • Adverse event data were collected over three periods encompassing a total of 50 to 60 weeks. The first period was up to twelve weeks, from pre-treatment biopsy to start of peginterferon treatment. The second period was 24 weeks during treatment with peginterferon, and the third period was after completion of treatment with peginterferon.
|
|
Injury, poisoning and procedural complications
irritation at injection site
|
100.0%
1/1 • Adverse event data were collected over three periods encompassing a total of 50 to 60 weeks. The first period was up to twelve weeks, from pre-treatment biopsy to start of peginterferon treatment. The second period was 24 weeks during treatment with peginterferon, and the third period was after completion of treatment with peginterferon.
|
25.0%
3/12 • Adverse event data were collected over three periods encompassing a total of 50 to 60 weeks. The first period was up to twelve weeks, from pre-treatment biopsy to start of peginterferon treatment. The second period was 24 weeks during treatment with peginterferon, and the third period was after completion of treatment with peginterferon.
|
|
Gastrointestinal disorders
Indigestion
|
0.00%
0/1 • Adverse event data were collected over three periods encompassing a total of 50 to 60 weeks. The first period was up to twelve weeks, from pre-treatment biopsy to start of peginterferon treatment. The second period was 24 weeks during treatment with peginterferon, and the third period was after completion of treatment with peginterferon.
|
8.3%
1/12 • Adverse event data were collected over three periods encompassing a total of 50 to 60 weeks. The first period was up to twelve weeks, from pre-treatment biopsy to start of peginterferon treatment. The second period was 24 weeks during treatment with peginterferon, and the third period was after completion of treatment with peginterferon.
|
|
Infections and infestations
infection
|
0.00%
0/1 • Adverse event data were collected over three periods encompassing a total of 50 to 60 weeks. The first period was up to twelve weeks, from pre-treatment biopsy to start of peginterferon treatment. The second period was 24 weeks during treatment with peginterferon, and the third period was after completion of treatment with peginterferon.
|
33.3%
4/12 • Adverse event data were collected over three periods encompassing a total of 50 to 60 weeks. The first period was up to twelve weeks, from pre-treatment biopsy to start of peginterferon treatment. The second period was 24 weeks during treatment with peginterferon, and the third period was after completion of treatment with peginterferon.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place