Trial Outcomes & Findings for Efficacy and Safety of Glecaprevir (ABT-493)/Pibrentasvir (ABT 530) (GLE/PIB) in Combination With Sofosbuvir and Ribavirin in Participants With Hepatitis C Virus Who Did Not Respond to Treatment in a Previous AbbVie Clinical Study (NCT NCT02939989)
NCT ID: NCT02939989
Last Updated: 2022-05-04
Results Overview
SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification (LLOQ; 15 IU/mL) 12 weeks after the last dose of study drug.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
33 participants
Primary outcome timeframe
12 weeks after the last actual dose of study drug, Week 24 or Week 28 depending on the treatment regimen.
Results posted on
2022-05-04
Participant Flow
Participants with hepatitis C virus (HCV) genotypes (GT) 1-6 infection who had virologic failure while participating in an AbbVie HCV Parent Study were enrolled at 26 sites in 12 countries.
Participants were allocated to 1 of 2 treatment arms based on HCV GT, cirrhosis status, and treatment experience with protease inhibitor (PI) and/or nonstructural viral protein 5A protease inhibitor (NS5Ai)-containing regimens prior to enrolling in the AbbVie HCV Parent Study.
Participant milestones
| Measure |
Glecaprevir/Pibrentasvir + SOF + RBV for 12 Weeks
Participants without cirrhosis who had non-genotype 3 infection and were naïve to protease inhibitor (PI) and/or nonstructural viral protein 5A inhibitor (NS5Ai) prior to participation in AbbVie HCV parent study received daily treatment with glecaprevir/pibrentasvir (GLE/PIB) 300 mg/120 mg plus sofosbuvir (SOF) 400 mg plus twice-daily weight-based ribavirin (RBV) 600 mg - 1200 mg daily total for 12 weeks.
|
Glecaprevir/Pibrentasvir + SOF + RBV for 16 Weeks
Participants with genotype 3, and/or compensated cirrhosis, and/or experience with PI and/or NS5Ai prior to participation in Abbvie HCV parent study received daily treatment with GLE/PIB 300 mg/120 mg plus SOF 400 mg plus twice-daily weight-based RBV 600 mg - 1200 mg daily total for 16 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
5
|
28
|
|
Overall Study
COMPLETED
|
5
|
28
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy and Safety of Glecaprevir (ABT-493)/Pibrentasvir (ABT 530) (GLE/PIB) in Combination With Sofosbuvir and Ribavirin in Participants With Hepatitis C Virus Who Did Not Respond to Treatment in a Previous AbbVie Clinical Study
Baseline characteristics by cohort
| Measure |
Glecaprevir/Pibrentasvir + SOF + RBV for 12 Weeks
n=5 Participants
Participants without cirrhosis who had non-genotype 3 infection and were naïve to PI and/or NS5Ai prior to participation in AbbVie HCV parent study received daily treatment with GLE/PIB 300 mg/120 mg plus SOF 400 mg plus twice-daily weight-based RBV 600 mg - 1200 mg daily total for 12 weeks.
|
Glecaprevir/Pibrentasvir + SOF + RBV for 16 Weeks
n=28 Participants
Participants with genotype 3, and/or compensated cirrhosis, and/or experience with PI and/or NS5Ai prior to participation in Abbvie HCV parent study received daily treatment with GLE/PIB 300 mg/120 mg plus SOF 400 mg plus twice-daily weight-based RBV 600 mg - 1200 mg daily total for 16 weeks.
|
Total
n=33 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59.6 years
STANDARD_DEVIATION 8.08 • n=93 Participants
|
54.3 years
STANDARD_DEVIATION 9.35 • n=4 Participants
|
55.1 years
STANDARD_DEVIATION 9.25 • n=27 Participants
|
|
Age, Customized
< 65 years
|
3 Participants
n=93 Participants
|
23 Participants
n=4 Participants
|
26 Participants
n=27 Participants
|
|
Age, Customized
≥ 65 years
|
2 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=93 Participants
|
24 Participants
n=4 Participants
|
28 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=93 Participants
|
26 Participants
n=4 Participants
|
31 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=93 Participants
|
22 Participants
n=4 Participants
|
25 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
HCV Genotype
Genotype 1
|
1 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
8 Participants
n=27 Participants
|
|
HCV Genotype
Genotype 2
|
4 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
|
HCV Genotype
Genotype 3
|
0 Participants
n=93 Participants
|
19 Participants
n=4 Participants
|
19 Participants
n=27 Participants
|
|
HCV Genotype
Genotype 4
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
HCV Genotype
Genotype 5
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
HCV Genotype
Genotype 6
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
AbbVie HCV Parent Study
M13-594 (NCT02640157)
|
0 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
9 Participants
n=27 Participants
|
|
AbbVie HCV Parent Study
M13-596 (NCT02692703)
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
AbbVie HCV Parent Study
M14-172 (NCT02642432)
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
AbbVie HCV Parent Study
M14-242 (NCT02493855)
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
AbbVie HCV Parent Study
M14-868 (NCT02243293)
|
2 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
8 Participants
n=27 Participants
|
|
AbbVie HCV Parent Study
M15-410 (NCT02446717)
|
0 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
|
AbbVie HCV Parent Study
M15-592 (NCT03222583)
|
2 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
|
AbbVie HCV Parent Study
M16-126 (NCT02966795)
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
AbbVie HCV Parent Study
M16-135 (NCT03089944)
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Treatment Regimen Received in AbbVie HCV Parent Study
GLE/PIB
|
4 Participants
n=93 Participants
|
28 Participants
n=4 Participants
|
32 Participants
n=27 Participants
|
|
Treatment Regimen Received in AbbVie HCV Parent Study
OBV/PTV/RTV + DSV + RBV
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Treatment Response for AbbVie HCV Parent Study
On-treatment non-responder
|
0 Participants
n=93 Participants
|
10 Participants
n=4 Participants
|
10 Participants
n=27 Participants
|
|
Treatment Response for AbbVie HCV Parent Study
Breakthrough
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Treatment Response for AbbVie HCV Parent Study
Post-treatment relapse
|
5 Participants
n=93 Participants
|
18 Participants
n=4 Participants
|
23 Participants
n=27 Participants
|
|
HCV Ribonucleic Acid (RNA) Level
|
6.79 log10 IU/mL
STANDARD_DEVIATION 0.217 • n=93 Participants
|
6.23 log10 IU/mL
STANDARD_DEVIATION 0.958 • n=4 Participants
|
6.32 log10 IU/mL
STANDARD_DEVIATION 0.907 • n=27 Participants
|
PRIMARY outcome
Timeframe: 12 weeks after the last actual dose of study drug, Week 24 or Week 28 depending on the treatment regimen.Population: Intention-to-treat (ITT) population, which included all participants who received at least 1 dose of study drug. A backward imputation method was used to impute missing responses. Participants with missing data after backward imputation were counted as non-responders.
SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification (LLOQ; 15 IU/mL) 12 weeks after the last dose of study drug.
Outcome measures
| Measure |
Glecaprevir/Pibrentasvir + SOF + RBV for 12 Weeks
n=5 Participants
Participants without cirrhosis who had non-genotype 3 infection and were naïve to PI and/or NS5Ai prior to participation in AbbVie HCV parent study received daily treatment with GLE/PIB 300 mg/120 mg plus SOF 400 mg plus twice-daily weight-based RBV 600 mg - 1200 mg daily total for 12 weeks.
|
Glecaprevir/Pibrentasvir + SOF + RBV for 16 Weeks
n=28 Participants
Participants with genotype 3, and/or compensated cirrhosis, and/or experience with PI and/or NS5Ai prior to participation in Abbvie HCV parent study received daily treatment with GLE/PIB 300 mg/120 mg plus SOF 400 mg plus twice-daily weight-based RBV 600 mg - 1200 mg daily total for 16 weeks.
|
Total
n=33 Participants
Participants received daily treatment with GLE/PIB 300 mg/120 mg plus SOF 400 mg plus twice-daily weight-based RBV 600 mg - 1200 mg daily total for 12 or 16 weeks.
|
|---|---|---|---|
|
Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)
|
100 percentage of participants
Interval 56.6 to 100.0
|
96.4 percentage of participants
Interval 82.3 to 99.4
|
97.0 percentage of participants
Interval 84.7 to 99.5
|
SECONDARY outcome
Timeframe: 12 or 16 weeks depending on the treatment regimenPopulation: Intention-to-treat population
On-treatment virologic failure was defined as meeting one of the following: * confirmed increase from nadir in HCV RNA (two consecutive HCV RNA measurements \> 1 log10 IU/mL above nadir) at any time point during the treatment period; or * confirmed HCV RNA greater than or equal to 100 IU/mL after HCV RNA \< 15 IU/mL during the treatment period, or * HCV RNA ≥ 15 IU/mL at end of treatment with at least 6 weeks of treatment.
Outcome measures
| Measure |
Glecaprevir/Pibrentasvir + SOF + RBV for 12 Weeks
n=5 Participants
Participants without cirrhosis who had non-genotype 3 infection and were naïve to PI and/or NS5Ai prior to participation in AbbVie HCV parent study received daily treatment with GLE/PIB 300 mg/120 mg plus SOF 400 mg plus twice-daily weight-based RBV 600 mg - 1200 mg daily total for 12 weeks.
|
Glecaprevir/Pibrentasvir + SOF + RBV for 16 Weeks
n=28 Participants
Participants with genotype 3, and/or compensated cirrhosis, and/or experience with PI and/or NS5Ai prior to participation in Abbvie HCV parent study received daily treatment with GLE/PIB 300 mg/120 mg plus SOF 400 mg plus twice-daily weight-based RBV 600 mg - 1200 mg daily total for 16 weeks.
|
Total
n=33 Participants
Participants received daily treatment with GLE/PIB 300 mg/120 mg plus SOF 400 mg plus twice-daily weight-based RBV 600 mg - 1200 mg daily total for 12 or 16 weeks.
|
|---|---|---|---|
|
Percentage of Participants With On-treatment Virologic Failure
|
0 percentage of participants
Interval 0.0 to 43.4
|
0 percentage of participants
Interval 0.0 to 12.1
|
0 percentage of participants
Interval 0.0 to 10.4
|
SECONDARY outcome
Timeframe: From the end of treatment (Week 12 or 16) through 12 weeks after the last dose of study drug (Weeks 24 or 28 depending on the treatment regimen).Population: Intention-to-treat population
Post-treatment relapse was defined as confirmed HCV RNA greater than or equal to 15 IU/mL between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA levels \< 15 IU/mL at the end of treatment, and had post-treatment HCV RNA data; participants who had been shown to be re-infected were not considered to have relapsed.
Outcome measures
| Measure |
Glecaprevir/Pibrentasvir + SOF + RBV for 12 Weeks
n=5 Participants
Participants without cirrhosis who had non-genotype 3 infection and were naïve to PI and/or NS5Ai prior to participation in AbbVie HCV parent study received daily treatment with GLE/PIB 300 mg/120 mg plus SOF 400 mg plus twice-daily weight-based RBV 600 mg - 1200 mg daily total for 12 weeks.
|
Glecaprevir/Pibrentasvir + SOF + RBV for 16 Weeks
n=28 Participants
Participants with genotype 3, and/or compensated cirrhosis, and/or experience with PI and/or NS5Ai prior to participation in Abbvie HCV parent study received daily treatment with GLE/PIB 300 mg/120 mg plus SOF 400 mg plus twice-daily weight-based RBV 600 mg - 1200 mg daily total for 16 weeks.
|
Total
n=33 Participants
Participants received daily treatment with GLE/PIB 300 mg/120 mg plus SOF 400 mg plus twice-daily weight-based RBV 600 mg - 1200 mg daily total for 12 or 16 weeks.
|
|---|---|---|---|
|
Percentage of Participants With Post-treatment Relapse
|
0 percentage of participants
Interval 0.0 to 43.4
|
3.6 percentage of participants
Interval 0.6 to 17.7
|
3.0 percentage of participants
Interval 0.5 to 15.3
|
Adverse Events
GLE/PIB + SOF + RBV for 12 Weeks
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
GLE/PIB + SOF + RBV for 16 Weeks
Serious events: 2 serious events
Other events: 21 other events
Deaths: 0 deaths
Total
Serious events: 3 serious events
Other events: 26 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
GLE/PIB + SOF + RBV for 12 Weeks
n=5 participants at risk
Participants without cirrhosis who had non-genotype 3 infection and were naïve to PI and NS5Ai prior to participation in AbbVie HCV parent study received daily treatment with GLE/PIB 300 mg/120 mg plus SOF 400 mg plus twice-daily weight-based RBV 600 mg - 1200 mg daily total for 12 weeks.
|
GLE/PIB + SOF + RBV for 16 Weeks
n=28 participants at risk
Participants with genotype 3, and/or compensated cirrhosis, and/or experience with PI and/or NS5Ai prior to participation in Abbvie HCV parent study received daily treatment with GLE/PIB 300 mg/120 mg plus SOF 400 mg plus twice-daily weight-based RBV 600 mg - 1200 mg daily total for 16 weeks.
|
Total
n=33 participants at risk
Participants received daily treatment with GLE/PIB 300 mg/120 mg plus SOF 400 mg plus twice-daily weight-based RBV 600 mg - 1200 mg daily total for 12 or 16 weeks.
|
|---|---|---|---|
|
Gastrointestinal disorders
CHRONIC GASTRITIS
|
20.0%
1/5 • Number of events 1 • From first dose of study drug up to 30 days after last dose; up to 20 weeks.
|
0.00%
0/28 • From first dose of study drug up to 30 days after last dose; up to 20 weeks.
|
3.0%
1/33 • Number of events 1 • From first dose of study drug up to 30 days after last dose; up to 20 weeks.
|
|
Hepatobiliary disorders
CHOLELITHIASIS
|
0.00%
0/5 • From first dose of study drug up to 30 days after last dose; up to 20 weeks.
|
3.6%
1/28 • Number of events 1 • From first dose of study drug up to 30 days after last dose; up to 20 weeks.
|
3.0%
1/33 • Number of events 1 • From first dose of study drug up to 30 days after last dose; up to 20 weeks.
|
|
Hepatobiliary disorders
HEPATIC FUNCTION ABNORMAL
|
0.00%
0/5 • From first dose of study drug up to 30 days after last dose; up to 20 weeks.
|
3.6%
1/28 • Number of events 1 • From first dose of study drug up to 30 days after last dose; up to 20 weeks.
|
3.0%
1/33 • Number of events 1 • From first dose of study drug up to 30 days after last dose; up to 20 weeks.
|
|
Infections and infestations
PNEUMONIA BACTERIAL
|
20.0%
1/5 • Number of events 1 • From first dose of study drug up to 30 days after last dose; up to 20 weeks.
|
0.00%
0/28 • From first dose of study drug up to 30 days after last dose; up to 20 weeks.
|
3.0%
1/33 • Number of events 1 • From first dose of study drug up to 30 days after last dose; up to 20 weeks.
|
|
Nervous system disorders
ALTERED STATE OF CONSCIOUSNESS
|
0.00%
0/5 • From first dose of study drug up to 30 days after last dose; up to 20 weeks.
|
3.6%
1/28 • Number of events 1 • From first dose of study drug up to 30 days after last dose; up to 20 weeks.
|
3.0%
1/33 • Number of events 1 • From first dose of study drug up to 30 days after last dose; up to 20 weeks.
|
|
Nervous system disorders
LOSS OF CONSCIOUSNESS
|
0.00%
0/5 • From first dose of study drug up to 30 days after last dose; up to 20 weeks.
|
3.6%
1/28 • Number of events 1 • From first dose of study drug up to 30 days after last dose; up to 20 weeks.
|
3.0%
1/33 • Number of events 1 • From first dose of study drug up to 30 days after last dose; up to 20 weeks.
|
|
Renal and urinary disorders
RENAL IMPAIRMENT
|
0.00%
0/5 • From first dose of study drug up to 30 days after last dose; up to 20 weeks.
|
3.6%
1/28 • Number of events 1 • From first dose of study drug up to 30 days after last dose; up to 20 weeks.
|
3.0%
1/33 • Number of events 1 • From first dose of study drug up to 30 days after last dose; up to 20 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
BRONCHIECTASIS
|
20.0%
1/5 • Number of events 1 • From first dose of study drug up to 30 days after last dose; up to 20 weeks.
|
0.00%
0/28 • From first dose of study drug up to 30 days after last dose; up to 20 weeks.
|
3.0%
1/33 • Number of events 1 • From first dose of study drug up to 30 days after last dose; up to 20 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
|
20.0%
1/5 • Number of events 1 • From first dose of study drug up to 30 days after last dose; up to 20 weeks.
|
0.00%
0/28 • From first dose of study drug up to 30 days after last dose; up to 20 weeks.
|
3.0%
1/33 • Number of events 1 • From first dose of study drug up to 30 days after last dose; up to 20 weeks.
|
Other adverse events
| Measure |
GLE/PIB + SOF + RBV for 12 Weeks
n=5 participants at risk
Participants without cirrhosis who had non-genotype 3 infection and were naïve to PI and NS5Ai prior to participation in AbbVie HCV parent study received daily treatment with GLE/PIB 300 mg/120 mg plus SOF 400 mg plus twice-daily weight-based RBV 600 mg - 1200 mg daily total for 12 weeks.
|
GLE/PIB + SOF + RBV for 16 Weeks
n=28 participants at risk
Participants with genotype 3, and/or compensated cirrhosis, and/or experience with PI and/or NS5Ai prior to participation in Abbvie HCV parent study received daily treatment with GLE/PIB 300 mg/120 mg plus SOF 400 mg plus twice-daily weight-based RBV 600 mg - 1200 mg daily total for 16 weeks.
|
Total
n=33 participants at risk
Participants received daily treatment with GLE/PIB 300 mg/120 mg plus SOF 400 mg plus twice-daily weight-based RBV 600 mg - 1200 mg daily total for 12 or 16 weeks.
|
|---|---|---|---|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
0.00%
0/5 • From first dose of study drug up to 30 days after last dose; up to 20 weeks.
|
7.1%
2/28 • Number of events 2 • From first dose of study drug up to 30 days after last dose; up to 20 weeks.
|
6.1%
2/33 • Number of events 2 • From first dose of study drug up to 30 days after last dose; up to 20 weeks.
|
|
Gastrointestinal disorders
DRY MOUTH
|
0.00%
0/5 • From first dose of study drug up to 30 days after last dose; up to 20 weeks.
|
7.1%
2/28 • Number of events 2 • From first dose of study drug up to 30 days after last dose; up to 20 weeks.
|
6.1%
2/33 • Number of events 2 • From first dose of study drug up to 30 days after last dose; up to 20 weeks.
|
|
Gastrointestinal disorders
GASTRITIS
|
20.0%
1/5 • Number of events 1 • From first dose of study drug up to 30 days after last dose; up to 20 weeks.
|
0.00%
0/28 • From first dose of study drug up to 30 days after last dose; up to 20 weeks.
|
3.0%
1/33 • Number of events 1 • From first dose of study drug up to 30 days after last dose; up to 20 weeks.
|
|
Gastrointestinal disorders
GASTROOESOPHAGEAL REFLUX DISEASE
|
20.0%
1/5 • Number of events 1 • From first dose of study drug up to 30 days after last dose; up to 20 weeks.
|
3.6%
1/28 • Number of events 1 • From first dose of study drug up to 30 days after last dose; up to 20 weeks.
|
6.1%
2/33 • Number of events 2 • From first dose of study drug up to 30 days after last dose; up to 20 weeks.
|
|
Gastrointestinal disorders
NAUSEA
|
20.0%
1/5 • Number of events 1 • From first dose of study drug up to 30 days after last dose; up to 20 weeks.
|
0.00%
0/28 • From first dose of study drug up to 30 days after last dose; up to 20 weeks.
|
3.0%
1/33 • Number of events 1 • From first dose of study drug up to 30 days after last dose; up to 20 weeks.
|
|
Gastrointestinal disorders
VOMITING
|
0.00%
0/5 • From first dose of study drug up to 30 days after last dose; up to 20 weeks.
|
7.1%
2/28 • Number of events 2 • From first dose of study drug up to 30 days after last dose; up to 20 weeks.
|
6.1%
2/33 • Number of events 2 • From first dose of study drug up to 30 days after last dose; up to 20 weeks.
|
|
General disorders
ASTHENIA
|
0.00%
0/5 • From first dose of study drug up to 30 days after last dose; up to 20 weeks.
|
10.7%
3/28 • Number of events 3 • From first dose of study drug up to 30 days after last dose; up to 20 weeks.
|
9.1%
3/33 • Number of events 3 • From first dose of study drug up to 30 days after last dose; up to 20 weeks.
|
|
General disorders
FATIGUE
|
20.0%
1/5 • Number of events 1 • From first dose of study drug up to 30 days after last dose; up to 20 weeks.
|
10.7%
3/28 • Number of events 3 • From first dose of study drug up to 30 days after last dose; up to 20 weeks.
|
12.1%
4/33 • Number of events 4 • From first dose of study drug up to 30 days after last dose; up to 20 weeks.
|
|
General disorders
INFLUENZA LIKE ILLNESS
|
20.0%
1/5 • Number of events 1 • From first dose of study drug up to 30 days after last dose; up to 20 weeks.
|
0.00%
0/28 • From first dose of study drug up to 30 days after last dose; up to 20 weeks.
|
3.0%
1/33 • Number of events 1 • From first dose of study drug up to 30 days after last dose; up to 20 weeks.
|
|
General disorders
MALAISE
|
20.0%
1/5 • Number of events 1 • From first dose of study drug up to 30 days after last dose; up to 20 weeks.
|
0.00%
0/28 • From first dose of study drug up to 30 days after last dose; up to 20 weeks.
|
3.0%
1/33 • Number of events 1 • From first dose of study drug up to 30 days after last dose; up to 20 weeks.
|
|
General disorders
OEDEMA PERIPHERAL
|
20.0%
1/5 • Number of events 1 • From first dose of study drug up to 30 days after last dose; up to 20 weeks.
|
0.00%
0/28 • From first dose of study drug up to 30 days after last dose; up to 20 weeks.
|
3.0%
1/33 • Number of events 1 • From first dose of study drug up to 30 days after last dose; up to 20 weeks.
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
0.00%
0/5 • From first dose of study drug up to 30 days after last dose; up to 20 weeks.
|
14.3%
4/28 • Number of events 4 • From first dose of study drug up to 30 days after last dose; up to 20 weeks.
|
12.1%
4/33 • Number of events 4 • From first dose of study drug up to 30 days after last dose; up to 20 weeks.
|
|
Investigations
BLOOD BILIRUBIN INCREASED
|
20.0%
1/5 • Number of events 1 • From first dose of study drug up to 30 days after last dose; up to 20 weeks.
|
3.6%
1/28 • Number of events 1 • From first dose of study drug up to 30 days after last dose; up to 20 weeks.
|
6.1%
2/33 • Number of events 2 • From first dose of study drug up to 30 days after last dose; up to 20 weeks.
|
|
Investigations
HAEMATOCRIT DECREASED
|
20.0%
1/5 • Number of events 1 • From first dose of study drug up to 30 days after last dose; up to 20 weeks.
|
0.00%
0/28 • From first dose of study drug up to 30 days after last dose; up to 20 weeks.
|
3.0%
1/33 • Number of events 1 • From first dose of study drug up to 30 days after last dose; up to 20 weeks.
|
|
Investigations
HAEMOGLOBIN DECREASED
|
20.0%
1/5 • Number of events 1 • From first dose of study drug up to 30 days after last dose; up to 20 weeks.
|
3.6%
1/28 • Number of events 1 • From first dose of study drug up to 30 days after last dose; up to 20 weeks.
|
6.1%
2/33 • Number of events 2 • From first dose of study drug up to 30 days after last dose; up to 20 weeks.
|
|
Investigations
LYMPHOCYTE COUNT DECREASED
|
20.0%
1/5 • Number of events 1 • From first dose of study drug up to 30 days after last dose; up to 20 weeks.
|
0.00%
0/28 • From first dose of study drug up to 30 days after last dose; up to 20 weeks.
|
3.0%
1/33 • Number of events 1 • From first dose of study drug up to 30 days after last dose; up to 20 weeks.
|
|
Investigations
MEAN CELL VOLUME INCREASED
|
20.0%
1/5 • Number of events 1 • From first dose of study drug up to 30 days after last dose; up to 20 weeks.
|
0.00%
0/28 • From first dose of study drug up to 30 days after last dose; up to 20 weeks.
|
3.0%
1/33 • Number of events 1 • From first dose of study drug up to 30 days after last dose; up to 20 weeks.
|
|
Investigations
RED BLOOD CELL COUNT DECREASED
|
20.0%
1/5 • Number of events 1 • From first dose of study drug up to 30 days after last dose; up to 20 weeks.
|
0.00%
0/28 • From first dose of study drug up to 30 days after last dose; up to 20 weeks.
|
3.0%
1/33 • Number of events 1 • From first dose of study drug up to 30 days after last dose; up to 20 weeks.
|
|
Investigations
WEIGHT DECREASED
|
20.0%
1/5 • Number of events 1 • From first dose of study drug up to 30 days after last dose; up to 20 weeks.
|
3.6%
1/28 • Number of events 1 • From first dose of study drug up to 30 days after last dose; up to 20 weeks.
|
6.1%
2/33 • Number of events 2 • From first dose of study drug up to 30 days after last dose; up to 20 weeks.
|
|
Investigations
WHITE BLOOD CELL COUNT DECREASED
|
20.0%
1/5 • Number of events 1 • From first dose of study drug up to 30 days after last dose; up to 20 weeks.
|
0.00%
0/28 • From first dose of study drug up to 30 days after last dose; up to 20 weeks.
|
3.0%
1/33 • Number of events 1 • From first dose of study drug up to 30 days after last dose; up to 20 weeks.
|
|
Nervous system disorders
DIZZINESS
|
20.0%
1/5 • Number of events 1 • From first dose of study drug up to 30 days after last dose; up to 20 weeks.
|
14.3%
4/28 • Number of events 4 • From first dose of study drug up to 30 days after last dose; up to 20 weeks.
|
15.2%
5/33 • Number of events 5 • From first dose of study drug up to 30 days after last dose; up to 20 weeks.
|
|
Nervous system disorders
HEADACHE
|
20.0%
1/5 • Number of events 1 • From first dose of study drug up to 30 days after last dose; up to 20 weeks.
|
17.9%
5/28 • Number of events 6 • From first dose of study drug up to 30 days after last dose; up to 20 weeks.
|
18.2%
6/33 • Number of events 7 • From first dose of study drug up to 30 days after last dose; up to 20 weeks.
|
|
Psychiatric disorders
INSOMNIA
|
20.0%
1/5 • Number of events 1 • From first dose of study drug up to 30 days after last dose; up to 20 weeks.
|
10.7%
3/28 • Number of events 3 • From first dose of study drug up to 30 days after last dose; up to 20 weeks.
|
12.1%
4/33 • Number of events 4 • From first dose of study drug up to 30 days after last dose; up to 20 weeks.
|
|
Psychiatric disorders
IRRITABILITY
|
0.00%
0/5 • From first dose of study drug up to 30 days after last dose; up to 20 weeks.
|
14.3%
4/28 • Number of events 4 • From first dose of study drug up to 30 days after last dose; up to 20 weeks.
|
12.1%
4/33 • Number of events 4 • From first dose of study drug up to 30 days after last dose; up to 20 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
0.00%
0/5 • From first dose of study drug up to 30 days after last dose; up to 20 weeks.
|
10.7%
3/28 • Number of events 3 • From first dose of study drug up to 30 days after last dose; up to 20 weeks.
|
9.1%
3/33 • Number of events 3 • From first dose of study drug up to 30 days after last dose; up to 20 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
LARYNGEAL PAIN
|
20.0%
1/5 • Number of events 1 • From first dose of study drug up to 30 days after last dose; up to 20 weeks.
|
0.00%
0/28 • From first dose of study drug up to 30 days after last dose; up to 20 weeks.
|
3.0%
1/33 • Number of events 1 • From first dose of study drug up to 30 days after last dose; up to 20 weeks.
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
20.0%
1/5 • Number of events 2 • From first dose of study drug up to 30 days after last dose; up to 20 weeks.
|
21.4%
6/28 • Number of events 6 • From first dose of study drug up to 30 days after last dose; up to 20 weeks.
|
21.2%
7/33 • Number of events 8 • From first dose of study drug up to 30 days after last dose; up to 20 weeks.
|
|
Skin and subcutaneous tissue disorders
RASH
|
20.0%
1/5 • Number of events 1 • From first dose of study drug up to 30 days after last dose; up to 20 weeks.
|
3.6%
1/28 • Number of events 2 • From first dose of study drug up to 30 days after last dose; up to 20 weeks.
|
6.1%
2/33 • Number of events 3 • From first dose of study drug up to 30 days after last dose; up to 20 weeks.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
- Publication restrictions are in place
Restriction type: OTHER