Trial Outcomes & Findings for New Treatment Response in People With and Without Cirrhosis From Chronic Hepatitis C (NCT NCT01888900)
NCT ID: NCT01888900
Last Updated: 2017-02-07
Results Overview
Change in raw expression in interferon stimulated genes at week 2 or 4 compared to baseline is obtained by subtracting either 2 or 4 week measurement from baseline measurement. Negative values reflect a decrease in expression and positive values reflect an increase in expression. The raw gene expression data was normalized using quantile normalization based on all the genes in the microarray.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
35 participants
Primary outcome timeframe
baseline and either 2 or 4 weeks
Results posted on
2017-02-07
Participant Flow
Participant milestones
| Measure |
Hepatitis C Virus Genotype 1A
Subjects will be started on combination therapy with asunaprevir, daclatasvir, peginterferon alfa-2a and ribavirin for 24 weeks.
|
Hepatitis C Virus Genotype 1B
Subjects will receive combination therapy with asunaprevir and daclatasvir alone for 24 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
22
|
13
|
|
Overall Study
COMPLETED
|
22
|
11
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
Reasons for withdrawal
| Measure |
Hepatitis C Virus Genotype 1A
Subjects will be started on combination therapy with asunaprevir, daclatasvir, peginterferon alfa-2a and ribavirin for 24 weeks.
|
Hepatitis C Virus Genotype 1B
Subjects will receive combination therapy with asunaprevir and daclatasvir alone for 24 weeks.
|
|---|---|---|
|
Overall Study
failed treatment
|
0
|
2
|
Baseline Characteristics
New Treatment Response in People With and Without Cirrhosis From Chronic Hepatitis C
Baseline characteristics by cohort
| Measure |
Hepatitis C Virus Genotype 1A
n=22 Participants
subjects will be started on combination therapy with asunaprevir, daclatasvir, peginterferon alfa-2a and ribavirin for 24 weeks.
|
Hepatitis C Virus Genotype 1B
n=13 Participants
Patients will receive combination therapy with asunaprevir and daclatasvir alone for 24 weeks.
|
Total
n=35 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
56.50 years
STANDARD_DEVIATION 7.65 • n=5 Participants
|
59.31 years
STANDARD_DEVIATION 11.06 • n=7 Participants
|
57.54 years
STANDARD_DEVIATION 9.01 • n=5 Participants
|
|
Gender
Female
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Gender
Male
|
17 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
ALT
|
99.36 U/L
STANDARD_DEVIATION 52.84 • n=5 Participants
|
78.08 U/L
STANDARD_DEVIATION 42.18 • n=7 Participants
|
91.46 U/L
STANDARD_DEVIATION 49.68 • n=5 Participants
|
|
HCV RNA level
|
6.67 log10(IU/ml)
STANDARD_DEVIATION 0.49 • n=5 Participants
|
6.72 log10(IU/ml)
STANDARD_DEVIATION 0.37 • n=7 Participants
|
6.69 log10(IU/ml)
STANDARD_DEVIATION 0.44 • n=5 Participants
|
|
Race
Asian
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Race
Black
|
9 participants
n=5 Participants
|
4 participants
n=7 Participants
|
13 participants
n=5 Participants
|
|
Race
White
|
12 participants
n=5 Participants
|
7 participants
n=7 Participants
|
19 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline and either 2 or 4 weeksPopulation: one patient in genotype 1A arm was not included in primary outcome data collection due to late enrollment.
Change in raw expression in interferon stimulated genes at week 2 or 4 compared to baseline is obtained by subtracting either 2 or 4 week measurement from baseline measurement. Negative values reflect a decrease in expression and positive values reflect an increase in expression. The raw gene expression data was normalized using quantile normalization based on all the genes in the microarray.
Outcome measures
| Measure |
Hepatitis C Virus Genotype 1A
n=21 Participants
Patients will be started on combination therapy with asunaprevir, daclatasvir, peginterferon alfa-2a and ribavirin for 24 weeks.
|
Hepatitis C Virus Genotype 1B
n=11 Participants
Patients will receive combination therapy with asunaprevir and daclatasvir alone for 24 weeks.
|
|---|---|---|
|
Changes in Interferon Stimulated Genes in the Liver
ISG15
|
0.25402 relative expression
Interval -0.02712 to 0.37972
|
2.25228 relative expression
Interval 1.67411 to 2.57665
|
|
Changes in Interferon Stimulated Genes in the Liver
CCL20
|
0.41719 relative expression
Interval 0.1346 to 0.78103
|
0.91927 relative expression
Interval -0.01334 to 1.13015
|
|
Changes in Interferon Stimulated Genes in the Liver
CCL4
|
0.68293 relative expression
Interval 0.31016 to 1.13638
|
0.89852 relative expression
Interval 0.21807 to 1.07382
|
|
Changes in Interferon Stimulated Genes in the Liver
CXCL10
|
2.08246 relative expression
Interval 1.73241 to 2.57419
|
2.34623 relative expression
Interval 1.71264 to 2.91674
|
|
Changes in Interferon Stimulated Genes in the Liver
CXCL11
|
1.34781 relative expression
Interval 0.94627 to 1.89192
|
1.62034 relative expression
Interval 1.43302 to 1.92497
|
|
Changes in Interferon Stimulated Genes in the Liver
CXCL9
|
1.46361 relative expression
Interval 0.87882 to 2.60228
|
1.16119 relative expression
Interval 0.89738 to 1.92419
|
|
Changes in Interferon Stimulated Genes in the Liver
CYP1A1
|
0.31399 relative expression
Interval -0.48087 to 1.25841
|
-0.71461 relative expression
Interval -1.3426 to -0.42217
|
|
Changes in Interferon Stimulated Genes in the Liver
CYP4A11
|
-0.09207 relative expression
Interval -0.37379 to 0.00367
|
-0.21412 relative expression
Interval -0.34514 to 0.03285
|
|
Changes in Interferon Stimulated Genes in the Liver
DDX58
|
-0.11579 relative expression
Interval -0.4644 to -0.00993
|
0.71105 relative expression
Interval 0.34121 to 1.41336
|
|
Changes in Interferon Stimulated Genes in the Liver
DDX60
|
0.15820 relative expression
Interval 0.06634 to 0.51348
|
1.75573 relative expression
Interval 1.38395 to 2.15565
|
|
Changes in Interferon Stimulated Genes in the Liver
EIF2AK2
|
-0.30273 relative expression
Interval -0.58088 to -0.13209
|
0.79761 relative expression
Interval 0.39253 to 1.08915
|
|
Changes in Interferon Stimulated Genes in the Liver
FDPS
|
0.13720 relative expression
Interval -0.31418 to 0.30542
|
-0.62267 relative expression
Interval -0.977 to -0.23584
|
|
Changes in Interferon Stimulated Genes in the Liver
HMGCS2
|
-0.12509 relative expression
Interval -0.1819 to 0.00777
|
-0.24445 relative expression
Interval -0.41498 to -0.01065
|
|
Changes in Interferon Stimulated Genes in the Liver
IFI27
|
-0.02793 relative expression
Interval -0.14563 to 0.14139
|
0.95729 relative expression
Interval 0.74599 to 1.45239
|
|
Changes in Interferon Stimulated Genes in the Liver
IFI44L
|
-0.74607 relative expression
Interval -1.12864 to -0.33525
|
2.33014 relative expression
Interval 0.88173 to 2.89601
|
|
Changes in Interferon Stimulated Genes in the Liver
IFI6
|
0.35068 relative expression
Interval -0.09436 to 0.57536
|
0.44506 relative expression
Interval -0.03475 to 1.32183
|
|
Changes in Interferon Stimulated Genes in the Liver
IFIH1
|
-0.04591 relative expression
Interval -0.25975 to 0.24874
|
1.11512 relative expression
Interval 0.8672 to 1.52474
|
|
Changes in Interferon Stimulated Genes in the Liver
IFIT1
|
-0.07569 relative expression
Interval -0.41657 to 0.30933
|
1.49718 relative expression
Interval 0.63654 to 2.04239
|
|
Changes in Interferon Stimulated Genes in the Liver
IFIT2
|
0.36377 relative expression
Interval -0.18331 to 0.96812
|
1.09749 relative expression
Interval 0.1445 to 1.56788
|
|
Changes in Interferon Stimulated Genes in the Liver
IFIT3
|
-0.00220 relative expression
Interval -0.31494 to 0.34534
|
1.45782 relative expression
Interval 0.12098 to 1.92258
|
|
Changes in Interferon Stimulated Genes in the Liver
IFITM1
|
0.00657 relative expression
Interval -0.13774 to 0.15923
|
0.87242 relative expression
Interval 0.52497 to 1.00591
|
|
Changes in Interferon Stimulated Genes in the Liver
IRF9
|
-0.07023 relative expression
Interval -0.23137 to 0.30435
|
0.07203 relative expression
Interval -0.43579 to 0.44433
|
|
Changes in Interferon Stimulated Genes in the Liver
ISG20
|
0.55260 relative expression
Interval 0.11923 to 0.7792
|
0.79333 relative expression
Interval 0.17554 to 1.01774
|
|
Changes in Interferon Stimulated Genes in the Liver
LCAT
|
-0.23342 relative expression
Interval -0.42605 to -0.13411
|
-0.28993 relative expression
Interval -0.61976 to -0.10027
|
|
Changes in Interferon Stimulated Genes in the Liver
LIPC
|
-0.16928 relative expression
Interval -0.47942 to -0.00974
|
-0.77129 relative expression
Interval -1.09584 to -0.32804
|
|
Changes in Interferon Stimulated Genes in the Liver
LSS
|
0.04955 relative expression
Interval -0.33891 to 0.32346
|
-0.87048 relative expression
Interval -1.06593 to -0.28066
|
|
Changes in Interferon Stimulated Genes in the Liver
MX1
|
-0.20869 relative expression
Interval -0.50587 to 0.05456
|
2.03597 relative expression
Interval 0.85705 to 2.573
|
|
Changes in Interferon Stimulated Genes in the Liver
NPC1L1
|
0.22706 relative expression
Interval -0.03894 to 0.64205
|
-0.14370 relative expression
Interval -0.6962 to 0.04284
|
|
Changes in Interferon Stimulated Genes in the Liver
OAS1
|
-0.16315 relative expression
Interval -0.48203 to -0.02391
|
1.38768 relative expression
Interval 0.18495 to 1.5213
|
|
Changes in Interferon Stimulated Genes in the Liver
OAS2
|
-0.07088 relative expression
Interval -0.29292 to 0.08164
|
2.08119 relative expression
Interval 0.75112 to 2.30308
|
|
Changes in Interferon Stimulated Genes in the Liver
OAS3
|
0.05866 relative expression
Interval -0.31366 to 0.19116
|
1.76892 relative expression
Interval 0.30701 to 2.1794
|
|
Changes in Interferon Stimulated Genes in the Liver
OASL
|
1.03897 relative expression
Interval 0.61243 to 1.56387
|
2.27481 relative expression
Interval 2.04035 to 2.44387
|
|
Changes in Interferon Stimulated Genes in the Liver
PLSCR1
|
-0.29797 relative expression
Interval -0.38649 to -0.09644
|
0.63596 relative expression
Interval 0.46577 to 0.9218
|
|
Changes in Interferon Stimulated Genes in the Liver
PPARA
|
-0.51770 relative expression
Interval -0.71264 to -0.12349
|
-0.50756 relative expression
Interval -0.84883 to -0.34797
|
|
Changes in Interferon Stimulated Genes in the Liver
PRKAB2
|
0.01071 relative expression
Interval -0.20709 to 0.13838
|
-0.30954 relative expression
Interval -0.4994 to -0.17102
|
|
Changes in Interferon Stimulated Genes in the Liver
RSAD2
|
-0.14051 relative expression
Interval -0.43403 to 0.16345
|
1.60724 relative expression
Interval 0.24005 to 1.96854
|
|
Changes in Interferon Stimulated Genes in the Liver
STAT1
|
0.15195 relative expression
Interval -0.0754 to 0.27268
|
1.44922 relative expression
Interval 0.72279 to 1.65143
|
|
Changes in Interferon Stimulated Genes in the Liver
TAP1
|
0.14096 relative expression
Interval -0.06953 to 0.48128
|
0.68816 relative expression
Interval -0.02488 to 1.01691
|
|
Changes in Interferon Stimulated Genes in the Liver
ACADSB
|
-0.04915 relative expression
Interval -0.20904 to 0.12412
|
-0.35948 relative expression
Interval -0.65364 to -0.32862
|
|
Changes in Interferon Stimulated Genes in the Liver
ACSM3
|
-0.49980 relative expression
Interval -0.64301 to -0.07697
|
-0.79328 relative expression
Interval -0.91284 to -0.47427
|
|
Changes in Interferon Stimulated Genes in the Liver
ADH6
|
-0.11373 relative expression
Interval -0.38039 to 0.03311
|
-0.36659 relative expression
Interval -0.73021 to -0.13545
|
|
Changes in Interferon Stimulated Genes in the Liver
ANXA9
|
-0.07636 relative expression
Interval -0.29628 to 0.03123
|
-0.50104 relative expression
Interval -0.66928 to -0.38972
|
|
Changes in Interferon Stimulated Genes in the Liver
APOA5
|
-0.12453 relative expression
Interval -0.45306 to 0.28019
|
-0.48167 relative expression
Interval -0.7287 to -0.29107
|
|
Changes in Interferon Stimulated Genes in the Liver
APOF
|
-0.26305 relative expression
Interval -0.63316 to -0.06705
|
-0.39732 relative expression
Interval -0.95115 to -0.21099
|
|
Changes in Interferon Stimulated Genes in the Liver
BDH1
|
-0.08100 relative expression
Interval -0.29314 to 0.06585
|
-0.27664 relative expression
Interval -0.49475 to -0.12647
|
|
Changes in Interferon Stimulated Genes in the Liver
CCL19
|
0.61221 relative expression
Interval -0.08379 to 1.13362
|
1.08586 relative expression
Interval -0.62653 to 1.49427
|
|
Changes in Interferon Stimulated Genes in the Liver
CCL2
|
0.15200 relative expression
Interval -0.15355 to 0.50558
|
0.66422 relative expression
Interval 0.4341 to 1.70929
|
SECONDARY outcome
Timeframe: Week 4 post treatmentrapid virological response (HCV RNA \<LLOQ Target not Detected) at week 4
Outcome measures
| Measure |
Hepatitis C Virus Genotype 1A
n=22 Participants
Patients will be started on combination therapy with asunaprevir, daclatasvir, peginterferon alfa-2a and ribavirin for 24 weeks.
|
Hepatitis C Virus Genotype 1B
n=13 Participants
Patients will receive combination therapy with asunaprevir and daclatasvir alone for 24 weeks.
|
|---|---|---|
|
Rates of Rapid Virological Responder
|
22 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: Both weeks 4 and 12 post treatmentextended rapid virological response (HCV RNA \<LLOQ Target not Detected at both weeks 4 and 12)
Outcome measures
| Measure |
Hepatitis C Virus Genotype 1A
n=22 Participants
Patients will be started on combination therapy with asunaprevir, daclatasvir, peginterferon alfa-2a and ribavirin for 24 weeks.
|
Hepatitis C Virus Genotype 1B
n=13 Participants
Patients will receive combination therapy with asunaprevir and daclatasvir alone for 24 weeks.
|
|---|---|---|
|
Extended Rapid Virological Responder
|
21 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: Week 24 post treatmentend of treatment response (HCV RNA \<LLOQ Target not Detected at week24)
Outcome measures
| Measure |
Hepatitis C Virus Genotype 1A
n=22 Participants
Patients will be started on combination therapy with asunaprevir, daclatasvir, peginterferon alfa-2a and ribavirin for 24 weeks.
|
Hepatitis C Virus Genotype 1B
n=13 Participants
Patients will receive combination therapy with asunaprevir and daclatasvir alone for 24 weeks.
|
|---|---|---|
|
End of Treatment Responder
|
20 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: Week 12 post treatmentsustained virological response at follow-up week 12
Outcome measures
| Measure |
Hepatitis C Virus Genotype 1A
n=22 Participants
Patients will be started on combination therapy with asunaprevir, daclatasvir, peginterferon alfa-2a and ribavirin for 24 weeks.
|
Hepatitis C Virus Genotype 1B
n=13 Participants
Patients will receive combination therapy with asunaprevir and daclatasvir alone for 24 weeks.
|
|---|---|---|
|
Sustained Virological Responder
|
19 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: Week 12 post treatmentwhether raw ALT value is in normal range which is less than 41 U/L.
Outcome measures
| Measure |
Hepatitis C Virus Genotype 1A
n=22 Participants
Patients will be started on combination therapy with asunaprevir, daclatasvir, peginterferon alfa-2a and ribavirin for 24 weeks.
|
Hepatitis C Virus Genotype 1B
n=13 Participants
Patients will receive combination therapy with asunaprevir and daclatasvir alone for 24 weeks.
|
|---|---|---|
|
Serum Aminotransferase Levels
|
15 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: beyond Week 24 post treatmentHCV RNA \>= LLOQ level after therapy is stopped in a patient who previously achieved an end-of-treatment virological response
Outcome measures
| Measure |
Hepatitis C Virus Genotype 1A
n=22 Participants
Patients will be started on combination therapy with asunaprevir, daclatasvir, peginterferon alfa-2a and ribavirin for 24 weeks.
|
Hepatitis C Virus Genotype 1B
n=13 Participants
Patients will receive combination therapy with asunaprevir and daclatasvir alone for 24 weeks.
|
|---|---|---|
|
Virological Relapse
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: post treatmentOutcome measures
| Measure |
Hepatitis C Virus Genotype 1A
n=22 Participants
Patients will be started on combination therapy with asunaprevir, daclatasvir, peginterferon alfa-2a and ribavirin for 24 weeks.
|
Hepatitis C Virus Genotype 1B
n=13 Participants
Patients will receive combination therapy with asunaprevir and daclatasvir alone for 24 weeks.
|
|---|---|---|
|
Rates of Asunaprevir and Daclatasvir Resistance
|
1 Participants
|
4 Participants
|
Adverse Events
Hepatitis C Virus Genotype 1A
Serious events: 0 serious events
Other events: 24 other events
Deaths: 0 deaths
Hepatitis C Virus Genotype 1B
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Hepatitis C Virus Genotype 1A
n=24 participants at risk
Subjects will be started on combination therapy with asunaprevir, daclatasvir, peginterferon alfa-2a and ribavirin for 24 weeks.
Asunaprevir, daclatsvir, peginterferon, ribavirin
|
Hepatitis C Virus Genotype 1B
n=13 participants at risk
subjects will receive combination therapy with asunaprevir and daclatasvir alone for 24 weeks and undergo paired liver biopsies, pre-treatment and either at 2 or 4 weeks after starting therapy.
Asunaprevir and Daclatsvir
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
58.3%
14/24 • Number of events 40
Two participants from genotype 1b arm were switched to genotype 1a.
|
7.7%
1/13 • Number of events 1
Two participants from genotype 1b arm were switched to genotype 1a.
|
|
Psychiatric disorders
Anxiety
|
8.3%
2/24 • Number of events 2
Two participants from genotype 1b arm were switched to genotype 1a.
|
0.00%
0/13
Two participants from genotype 1b arm were switched to genotype 1a.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
62.5%
15/24 • Number of events 90
Two participants from genotype 1b arm were switched to genotype 1a.
|
92.3%
12/13 • Number of events 50
Two participants from genotype 1b arm were switched to genotype 1a.
|
|
Eye disorders
Blurry vision
|
41.7%
10/24 • Number of events 42
Two participants from genotype 1b arm were switched to genotype 1a.
|
7.7%
1/13 • Number of events 1
Two participants from genotype 1b arm were switched to genotype 1a.
|
|
Musculoskeletal and connective tissue disorders
Buttock and leg pain
|
8.3%
2/24 • Number of events 2
Two participants from genotype 1b arm were switched to genotype 1a.
|
0.00%
0/13
Two participants from genotype 1b arm were switched to genotype 1a.
|
|
Cardiac disorders
Chest pain
|
16.7%
4/24 • Number of events 4
Two participants from genotype 1b arm were switched to genotype 1a.
|
7.7%
1/13 • Number of events 1
Two participants from genotype 1b arm were switched to genotype 1a.
|
|
Cardiac disorders
Chest tightness
|
8.3%
2/24 • Number of events 2
Two participants from genotype 1b arm were switched to genotype 1a.
|
7.7%
1/13 • Number of events 1
Two participants from genotype 1b arm were switched to genotype 1a.
|
|
Infections and infestations
Chills
|
58.3%
14/24 • Number of events 58
Two participants from genotype 1b arm were switched to genotype 1a.
|
30.8%
4/13 • Number of events 5
Two participants from genotype 1b arm were switched to genotype 1a.
|
|
General disorders
Confusion
|
8.3%
2/24 • Number of events 2
Two participants from genotype 1b arm were switched to genotype 1a.
|
0.00%
0/13
Two participants from genotype 1b arm were switched to genotype 1a.
|
|
Gastrointestinal disorders
Constipation
|
29.2%
7/24 • Number of events 25
Two participants from genotype 1b arm were switched to genotype 1a.
|
38.5%
5/13 • Number of events 18
Two participants from genotype 1b arm were switched to genotype 1a.
|
|
Infections and infestations
Coughing
|
12.5%
3/24 • Number of events 6
Two participants from genotype 1b arm were switched to genotype 1a.
|
7.7%
1/13 • Number of events 1
Two participants from genotype 1b arm were switched to genotype 1a.
|
|
Gastrointestinal disorders
Diarrhea
|
58.3%
14/24 • Number of events 43
Two participants from genotype 1b arm were switched to genotype 1a.
|
30.8%
4/13 • Number of events 12
Two participants from genotype 1b arm were switched to genotype 1a.
|
|
Nervous system disorders
Dizziness
|
37.5%
9/24 • Number of events 36
Two participants from genotype 1b arm were switched to genotype 1a.
|
46.2%
6/13 • Number of events 21
Two participants from genotype 1b arm were switched to genotype 1a.
|
|
General disorders
Drowsiness
|
8.3%
2/24 • Number of events 3
Two participants from genotype 1b arm were switched to genotype 1a.
|
0.00%
0/13
Two participants from genotype 1b arm were switched to genotype 1a.
|
|
General disorders
Dry mouth
|
8.3%
2/24 • Number of events 3
Two participants from genotype 1b arm were switched to genotype 1a.
|
0.00%
0/13
Two participants from genotype 1b arm were switched to genotype 1a.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
83.3%
20/24 • Number of events 132
Two participants from genotype 1b arm were switched to genotype 1a.
|
53.8%
7/13 • Number of events 46
Two participants from genotype 1b arm were switched to genotype 1a.
|
|
Cardiac disorders
Edema
|
8.3%
2/24 • Number of events 2
Two participants from genotype 1b arm were switched to genotype 1a.
|
7.7%
1/13 • Number of events 1
Two participants from genotype 1b arm were switched to genotype 1a.
|
|
General disorders
Fatigue
|
100.0%
24/24 • Number of events 174
Two participants from genotype 1b arm were switched to genotype 1a.
|
84.6%
11/13 • Number of events 88
Two participants from genotype 1b arm were switched to genotype 1a.
|
|
Infections and infestations
Fever
|
54.2%
13/24 • Number of events 30
Two participants from genotype 1b arm were switched to genotype 1a.
|
23.1%
3/13 • Number of events 3
Two participants from genotype 1b arm were switched to genotype 1a.
|
|
Infections and infestations
Flu like sx
|
70.8%
17/24 • Number of events 82
Two participants from genotype 1b arm were switched to genotype 1a.
|
46.2%
6/13 • Number of events 12
Two participants from genotype 1b arm were switched to genotype 1a.
|
|
Renal and urinary disorders
Frequent urination
|
70.8%
17/24 • Number of events 49
Two participants from genotype 1b arm were switched to genotype 1a.
|
30.8%
4/13 • Number of events 13
Two participants from genotype 1b arm were switched to genotype 1a.
|
|
General disorders
Hair loss
|
54.2%
13/24 • Number of events 45
Two participants from genotype 1b arm were switched to genotype 1a.
|
15.4%
2/13 • Number of events 10
Two participants from genotype 1b arm were switched to genotype 1a.
|
|
General disorders
Headache
|
83.3%
20/24 • Number of events 153
Two participants from genotype 1b arm were switched to genotype 1a.
|
84.6%
11/13 • Number of events 39
Two participants from genotype 1b arm were switched to genotype 1a.
|
|
General disorders
Insomnia
|
41.7%
10/24 • Number of events 62
Two participants from genotype 1b arm were switched to genotype 1a.
|
53.8%
7/13 • Number of events 26
Two participants from genotype 1b arm were switched to genotype 1a.
|
|
General disorders
Irritability
|
66.7%
16/24 • Number of events 80
Two participants from genotype 1b arm were switched to genotype 1a.
|
0.00%
0/13
Two participants from genotype 1b arm were switched to genotype 1a.
|
|
Skin and subcutaneous tissue disorders
Itching
|
70.8%
17/24 • Number of events 116
Two participants from genotype 1b arm were switched to genotype 1a.
|
15.4%
2/13 • Number of events 2
Two participants from genotype 1b arm were switched to genotype 1a.
|
|
Musculoskeletal and connective tissue disorders
Joint pain
|
66.7%
16/24 • Number of events 89
Two participants from genotype 1b arm were switched to genotype 1a.
|
7.7%
1/13 • Number of events 1
Two participants from genotype 1b arm were switched to genotype 1a.
|
|
Gastrointestinal disorders
Loose stool
|
8.3%
2/24 • Number of events 2
Two participants from genotype 1b arm were switched to genotype 1a.
|
7.7%
1/13 • Number of events 1
Two participants from genotype 1b arm were switched to genotype 1a.
|
|
Gastrointestinal disorders
Loss of appetite
|
20.8%
5/24 • Number of events 5
Two participants from genotype 1b arm were switched to genotype 1a.
|
0.00%
0/13
Two participants from genotype 1b arm were switched to genotype 1a.
|
|
Product Issues
Lump injection site
|
8.3%
2/24 • Number of events 2
Two participants from genotype 1b arm were switched to genotype 1a.
|
0.00%
0/13
Two participants from genotype 1b arm were switched to genotype 1a.
|
|
General disorders
Memory loss
|
16.7%
4/24 • Number of events 4
Two participants from genotype 1b arm were switched to genotype 1a.
|
0.00%
0/13
Two participants from genotype 1b arm were switched to genotype 1a.
|
|
Musculoskeletal and connective tissue disorders
Muscle aches
|
87.5%
21/24 • Number of events 138
Two participants from genotype 1b arm were switched to genotype 1a.
|
15.4%
2/13 • Number of events 2
Two participants from genotype 1b arm were switched to genotype 1a.
|
|
Infections and infestations
Nasal stuffines
|
33.3%
8/24 • Number of events 8
Two participants from genotype 1b arm were switched to genotype 1a.
|
0.00%
0/13
Two participants from genotype 1b arm were switched to genotype 1a.
|
|
Gastrointestinal disorders
Nausea
|
58.3%
14/24 • Number of events 72
Two participants from genotype 1b arm were switched to genotype 1a.
|
53.8%
7/13 • Number of events 14
Two participants from genotype 1b arm were switched to genotype 1a.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
8.3%
2/24 • Number of events 2
Two participants from genotype 1b arm were switched to genotype 1a.
|
0.00%
0/13
Two participants from genotype 1b arm were switched to genotype 1a.
|
|
General disorders
Nose bleeds
|
8.3%
2/24 • Number of events 9
Two participants from genotype 1b arm were switched to genotype 1a.
|
0.00%
0/13
Two participants from genotype 1b arm were switched to genotype 1a.
|
|
Skin and subcutaneous tissue disorders
Rash
|
66.7%
16/24 • Number of events 62
Two participants from genotype 1b arm were switched to genotype 1a.
|
0.00%
0/13
Two participants from genotype 1b arm were switched to genotype 1a.
|
|
Infections and infestations
Runny nose
|
12.5%
3/24 • Number of events 3
Two participants from genotype 1b arm were switched to genotype 1a.
|
0.00%
0/13
Two participants from genotype 1b arm were switched to genotype 1a.
|
|
Cardiac disorders
Shortness of breath
|
70.8%
17/24 • Number of events 73
Two participants from genotype 1b arm were switched to genotype 1a.
|
46.2%
6/13 • Number of events 18
Two participants from genotype 1b arm were switched to genotype 1a.
|
|
Psychiatric disorders
Sadness
|
33.3%
8/24 • Number of events 31
Two participants from genotype 1b arm were switched to genotype 1a.
|
0.00%
0/13
Two participants from genotype 1b arm were switched to genotype 1a.
|
|
Infections and infestations
Shivers
|
8.3%
2/24 • Number of events 6
Two participants from genotype 1b arm were switched to genotype 1a.
|
0.00%
0/13
Two participants from genotype 1b arm were switched to genotype 1a.
|
|
Musculoskeletal and connective tissue disorders
Shoulder pain
|
12.5%
3/24 • Number of events 3
Two participants from genotype 1b arm were switched to genotype 1a.
|
7.7%
1/13 • Number of events 1
Two participants from genotype 1b arm were switched to genotype 1a.
|
|
Infections and infestations
Sore Throat
|
12.5%
3/24 • Number of events 3
Two participants from genotype 1b arm were switched to genotype 1a.
|
7.7%
1/13 • Number of events 1
Two participants from genotype 1b arm were switched to genotype 1a.
|
|
Infections and infestations
Sore mouth
|
8.3%
2/24 • Number of events 3
Two participants from genotype 1b arm were switched to genotype 1a.
|
0.00%
0/13
Two participants from genotype 1b arm were switched to genotype 1a.
|
|
Gastrointestinal disorders
Stomach cramps
|
45.8%
11/24 • Number of events 48
Two participants from genotype 1b arm were switched to genotype 1a.
|
23.1%
3/13 • Number of events 8
Two participants from genotype 1b arm were switched to genotype 1a.
|
|
Infections and infestations
Sweating
|
8.3%
2/24 • Number of events 2
Two participants from genotype 1b arm were switched to genotype 1a.
|
7.7%
1/13 • Number of events 1
Two participants from genotype 1b arm were switched to genotype 1a.
|
|
Nervous system disorders
Tingling sensation
|
8.3%
2/24 • Number of events 2
Two participants from genotype 1b arm were switched to genotype 1a.
|
0.00%
0/13
Two participants from genotype 1b arm were switched to genotype 1a.
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
8/24 • Number of events 15
Two participants from genotype 1b arm were switched to genotype 1a.
|
15.4%
2/13 • Number of events 2
Two participants from genotype 1b arm were switched to genotype 1a.
|
|
Metabolism and nutrition disorders
Weight gain
|
8.3%
2/24 • Number of events 2
Two participants from genotype 1b arm were switched to genotype 1a.
|
15.4%
2/13 • Number of events 2
Two participants from genotype 1b arm were switched to genotype 1a.
|
|
Musculoskeletal and connective tissue disorders
limb cramp
|
12.5%
3/24 • Number of events 3
Two participants from genotype 1b arm were switched to genotype 1a.
|
0.00%
0/13
Two participants from genotype 1b arm were switched to genotype 1a.
|
|
Metabolism and nutrition disorders
weight loss
|
16.7%
4/24 • Number of events 4
Two participants from genotype 1b arm were switched to genotype 1a.
|
7.7%
1/13 • Number of events 1
Two participants from genotype 1b arm were switched to genotype 1a.
|
|
General disorders
Adrenaline
|
0.00%
0/24
Two participants from genotype 1b arm were switched to genotype 1a.
|
7.7%
1/13 • Number of events 1
Two participants from genotype 1b arm were switched to genotype 1a.
|
|
General disorders
Bleeding from ear
|
0.00%
0/24
Two participants from genotype 1b arm were switched to genotype 1a.
|
7.7%
1/13 • Number of events 1
Two participants from genotype 1b arm were switched to genotype 1a.
|
|
Reproductive system and breast disorders
Decreased sex drive
|
0.00%
0/24
Two participants from genotype 1b arm were switched to genotype 1a.
|
7.7%
1/13 • Number of events 1
Two participants from genotype 1b arm were switched to genotype 1a.
|
|
Infections and infestations
Ear drainage
|
0.00%
0/24
Two participants from genotype 1b arm were switched to genotype 1a.
|
7.7%
1/13 • Number of events 1
Two participants from genotype 1b arm were switched to genotype 1a.
|
|
Nervous system disorders
Equilibrium problems
|
0.00%
0/24
Two participants from genotype 1b arm were switched to genotype 1a.
|
7.7%
1/13 • Number of events 1
Two participants from genotype 1b arm were switched to genotype 1a.
|
|
Eye disorders
Eye spots
|
0.00%
0/24
Two participants from genotype 1b arm were switched to genotype 1a.
|
7.7%
1/13 • Number of events 1
Two participants from genotype 1b arm were switched to genotype 1a.
|
|
Nervous system disorders
Hand tremor
|
0.00%
0/24
Two participants from genotype 1b arm were switched to genotype 1a.
|
7.7%
1/13 • Number of events 1
Two participants from genotype 1b arm were switched to genotype 1a.
|
|
Ear and labyrinth disorders
Hearing loss
|
0.00%
0/24
Two participants from genotype 1b arm were switched to genotype 1a.
|
7.7%
1/13 • Number of events 1
Two participants from genotype 1b arm were switched to genotype 1a.
|
|
Gastrointestinal disorders
Heartburn
|
0.00%
0/24
Two participants from genotype 1b arm were switched to genotype 1a.
|
7.7%
1/13 • Number of events 1
Two participants from genotype 1b arm were switched to genotype 1a.
|
|
General disorders
Heavy legs
|
0.00%
0/24
Two participants from genotype 1b arm were switched to genotype 1a.
|
7.7%
1/13 • Number of events 1
Two participants from genotype 1b arm were switched to genotype 1a.
|
|
Infections and infestations
Hoarseness
|
0.00%
0/24
Two participants from genotype 1b arm were switched to genotype 1a.
|
7.7%
1/13 • Number of events 1
Two participants from genotype 1b arm were switched to genotype 1a.
|
|
Musculoskeletal and connective tissue disorders
Knee pain
|
0.00%
0/24
Two participants from genotype 1b arm were switched to genotype 1a.
|
7.7%
1/13 • Number of events 2
Two participants from genotype 1b arm were switched to genotype 1a.
|
|
General disorders
Lack of concentration
|
0.00%
0/24
Two participants from genotype 1b arm were switched to genotype 1a.
|
7.7%
1/13 • Number of events 1
Two participants from genotype 1b arm were switched to genotype 1a.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasm
|
0.00%
0/24
Two participants from genotype 1b arm were switched to genotype 1a.
|
7.7%
1/13 • Number of events 1
Two participants from genotype 1b arm were switched to genotype 1a.
|
|
General disorders
Night Sweats
|
0.00%
0/24
Two participants from genotype 1b arm were switched to genotype 1a.
|
7.7%
1/13 • Number of events 4
Two participants from genotype 1b arm were switched to genotype 1a.
|
|
Psychiatric disorders
Nightmares
|
0.00%
0/24
Two participants from genotype 1b arm were switched to genotype 1a.
|
7.7%
1/13 • Number of events 1
Two participants from genotype 1b arm were switched to genotype 1a.
|
|
General disorders
Poor smell
|
0.00%
0/24
Two participants from genotype 1b arm were switched to genotype 1a.
|
7.7%
1/13 • Number of events 1
Two participants from genotype 1b arm were switched to genotype 1a.
|
|
Surgical and medical procedures
Post BX shoulder pain
|
0.00%
0/24
Two participants from genotype 1b arm were switched to genotype 1a.
|
7.7%
1/13 • Number of events 1
Two participants from genotype 1b arm were switched to genotype 1a.
|
|
Surgical and medical procedures
Post BX site pain
|
0.00%
0/24
Two participants from genotype 1b arm were switched to genotype 1a.
|
7.7%
1/13 • Number of events 1
Two participants from genotype 1b arm were switched to genotype 1a.
|
|
Musculoskeletal and connective tissue disorders
R hip pain
|
0.00%
0/24
Two participants from genotype 1b arm were switched to genotype 1a.
|
7.7%
1/13 • Number of events 1
Two participants from genotype 1b arm were switched to genotype 1a.
|
|
Psychiatric disorders
Restlessness
|
0.00%
0/24
Two participants from genotype 1b arm were switched to genotype 1a.
|
15.4%
2/13 • Number of events 2
Two participants from genotype 1b arm were switched to genotype 1a.
|
|
Musculoskeletal and connective tissue disorders
Right rib cage pain
|
0.00%
0/24
Two participants from genotype 1b arm were switched to genotype 1a.
|
7.7%
1/13 • Number of events 1
Two participants from genotype 1b arm were switched to genotype 1a.
|
|
Gastrointestinal disorders
Stomach pain
|
0.00%
0/24
Two participants from genotype 1b arm were switched to genotype 1a.
|
23.1%
3/13 • Number of events 3
Two participants from genotype 1b arm were switched to genotype 1a.
|
|
Infections and infestations
Stuffy nose
|
0.00%
0/24
Two participants from genotype 1b arm were switched to genotype 1a.
|
15.4%
2/13 • Number of events 2
Two participants from genotype 1b arm were switched to genotype 1a.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/24
Two participants from genotype 1b arm were switched to genotype 1a.
|
7.7%
1/13 • Number of events 1
Two participants from genotype 1b arm were switched to genotype 1a.
|
|
Musculoskeletal and connective tissue disorders
Toe pain
|
0.00%
0/24
Two participants from genotype 1b arm were switched to genotype 1a.
|
15.4%
2/13 • Number of events 2
Two participants from genotype 1b arm were switched to genotype 1a.
|
|
Infections and infestations
Tooth abcess
|
0.00%
0/24
Two participants from genotype 1b arm were switched to genotype 1a.
|
15.4%
2/13 • Number of events 2
Two participants from genotype 1b arm were switched to genotype 1a.
|
|
Infections and infestations
Tooth pain
|
0.00%
0/24
Two participants from genotype 1b arm were switched to genotype 1a.
|
7.7%
1/13 • Number of events 1
Two participants from genotype 1b arm were switched to genotype 1a.
|
|
General disorders
Warm
|
0.00%
0/24
Two participants from genotype 1b arm were switched to genotype 1a.
|
7.7%
1/13 • Number of events 1
Two participants from genotype 1b arm were switched to genotype 1a.
|
Additional Information
Dr. Marc Ghany
National Institute of Diabetes and Digestive and Kidney Diseases
Phone: 301-402-5515
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place