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A Randomized, Open-Label Study to Evaluate the Safety and Efficacy of Ombitasvir/ABT-450/Ritonavir Co-administered With Ribavirin (RBV) in Adults With Genotype 4 Chronic Hepatitis C Virus (HCV) Infection and Cirrhosis (AGATE-1) (AGATE-1)

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ClinicalTrials.gov Identifier: NCT02265237
Recruitment Status : Completed
First Posted : October 15, 2014
Results First Posted : August 31, 2017
Last Update Posted : August 31, 2017
Sponsor:
Information provided by (Responsible Party):
AbbVie

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Hepatitis C Virus
Interventions Drug: ombitasvir/paritaprevir/ritonavir
Drug: ribavirin
Enrollment 184
Recruitment Details The study was divided into 2 parts with 184 total participants. Part I (Arms A and B) included participants who received either 12 or 16 weeks of treatment and Part II (Arms C and D) included participants who received 24 weeks of treatment. Enrollment into Part II opened once randomization in Part I was completed.
Pre-assignment Details Safety analysis population: all participants who received at least 1 dose of study drug. One participant randomized to the arm B (16 weeks arm) was erroneously administered study drug for 12 weeks (as in arm A). Therefore this participant is included in arm A for the safety population.
Arm/Group Title Arm A Arm B Arm C Arm D
Hide Arm/Group Description Ombitasvir/paritaprevir/ritonavir (25/150/100 mg) and Ribavirin dosed for 12 weeks for genotype 4 treatment-naïve or treatment-experienced with IFN/RBV. Ombitasvir/paritaprevir/ritonavir (25/150/100 mg) and Ribavirin dosed for 16 weeks for genotype 4 treatment-naive or treatment-experienced with IFN/RBV. Ombitasvir/paritaprevir/ritonavir (25/150/100 mg) and Ribavirin dosed for 24 weeks for genotype 4 treatment-naive and treatment-experienced with IFN/RBV. Ombitasvir/paritaprevir/ritonavir (25/150/100 mg) and Ribavirin dosed for 24 weeks for genotype 4 SOF/pegIFN/RBV or SOF/RBV treatment-experienced.
Period Title: As Enrolled (Overall Study)
Started 59 61 61 3
Completed 54 58 51 2
Not Completed 5 3 10 1
Period Title: As Treated (Overall Study)
Started 60 [1] 60 [1] 61 3
Completed 55 57 51 2
Not Completed 5 3 10 1
Reason Not Completed
Adverse Event             1             1             0             0
Withdrawal by Subject             1             0             1             0
Lost to Follow-up             1             2             6             0
Other             2             0             3             1
[1]
One arm B subject received the drug for the duration for arm A and was included in arm A for safety.
Arm/Group Title Arm A Arm B Arm C Arm D Total
Hide Arm/Group Description Ombitasvir/paritaprevir/ritonavir (25/150/100 mg) and Ribavirin dosed for 12 weeks for genotype 4 treatment-naïve or treatment-experienced with IFN/RBV. Ombitasvir/paritaprevir/ritonavir (25/150/100 mg) and Ribavirin dosed for 16 weeks for genotype 4 treatment-naive or treatment-experienced with IFN/RBV. Ombitasvir/paritaprevir/ritonavir (25/150/100 mg) and Ribavirin dosed for 24 weeks for genotype 4 treatment-naive and treatment-experienced with IFN/RBV. Ombitasvir/paritaprevir/ritonavir (25/150/100 mg) and Ribavirin dosed for 24 weeks for genotype 4 SOF/pegIFN/RBV or SOF/RBV treatment-experienced. Total of all reporting groups
Overall Number of Baseline Participants 60 60 61 3 184
Hide Baseline Analysis Population Description
Safety analysis population: all participants who received at least 1 dose of study drug. One participant randomized to arm B (16 weeks arm) was erroneously administered study drug for 12 weeks (as in arm A). Therefore this participant is included in arm A for the safety population.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 60 participants 60 participants 61 participants 3 participants 184 participants
57.7  (8.08) 57.1  (9.08) 54.6  (9.02) 62.3  (8.08) 56.6  (8.80)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants 60 participants 61 participants 3 participants 184 participants
Female 14 22 18 0 54
Male 46 38 43 3 130
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants 60 participants 61 participants 3 participants 184 participants
Hispanic or Latino 2 1 6 0 9
Not Hispanic or Latino 58 59 55 3 175
Unknown or Not Reported 0 0 0 0 0
1.Primary Outcome
Title Percentage of Participants in Arms A, B and C With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)
Hide Description SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification (<LLOQ) 12 weeks after the last dose of study drug.
Time Frame 12 weeks after the last actual dose of study drug
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) population: all participants who received at least 1 dose of study drug; participants with missing data after backwards imputation were imputed as nonresponders.
Arm/Group Title Arm A Arm B Arm C
Hide Arm/Group Description:
Ombitasvir/paritaprevir/ritonavir (25/150/100 mg) and Ribavirin dosed for 12 weeks for genotype 4 treatment-naïve or treatment-experienced with IFN/RBV.
Ombitasvir/paritaprevir/ritonavir (25/150/100 mg) and Ribavirin dosed for 16 weeks for genotype 4 treatment-naive or treatment-experienced with IFN/RBV.
Ombitasvir/paritaprevir/ritonavir (25/150/100 mg) and Ribavirin dosed for 24 weeks for genotype 4 treatment-naive and treatment-experienced with IFN/RBV.
Overall Number of Participants Analyzed 59 61 61
Measure Type: Number
Number (97.5% Confidence Interval)
Unit of Measure: percentage of participants
96.6
(86.7 to 99.2)
100.0
(92.4 to 100.0)
93.4
(82.6 to 97.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm B
Comments The overall 2-sided significance level of 0.05 was split between Part I (arms A and B) and Part II (arm C) using a Bonferroni corrected alpha level of 0.025 for each part. Additionally, a fixed sequence procedure for Part I was used to proceed through the primary efficacy comparisons in the following order: 1) test of superiority of arm B and 2) test of superiority of arm A. The primary outcome within Arm C was tested with a Bonferroni-corrected Type 1 error rate of 0.025 for superiority.
Type of Statistical Test Superiority
Comments 97.5% CI was calculated using the Wilson score method; the lower confidence bound for the percentage of participants with sustained virologic response at 12 weeks after treatment must exceed 67% to achieve superiority. The predefined threshold of 67% was based on historical SVR rates for HCV genotype 4 (GT4)-infected subjects treated with pegIFN/RBV.
Method of Estimation Estimation Parameter Percentage of Participants
Estimated Value 100
Confidence Interval (2-Sided) 97.5%
92.4 to 100.0
Estimation Comments The confidence interval was calculated using the Wilson score method.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Arm A
Comments The overall 2-sided significance level of 0.05 was split between Part I (arms A and B) and Part II (arm C) using a Bonferroni corrected alpha level of 0.025 for each part. Additionally, a fixed sequence procedure for Part I was used to proceed through the primary efficacy comparisons in the following order: 1) test of superiority of arm B and 2) test of superiority of arm A. The primary outcome within Arm C was tested with a Bonferroni-corrected Type 1 error rate of 0.025 for superiority.
Type of Statistical Test Superiority
Comments 97.5% confidence interval (CI) was calculated using the Wilson score method; the lower confidence bound for the percentage of participants with sustained virologic response at 12 weeks after treatment must exceed 67% to achieve superiority. The predefined threshold of 67% was based on historical SVR rates for HCV GT4-infected subjects treated with pegIFN/RBV.
Method of Estimation Estimation Parameter Percentage of Participants
Estimated Value 96.6
Confidence Interval (2-Sided) 97.5%
86.7 to 99.2
Estimation Comments The confidence interval was calculated using the Wilson score method.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Arm C
Comments The overall 2-sided significance level of 0.05 was split between Part I (arms A and B) and Part II (arm C) using a Bonferroni corrected alpha level of 0.025 for each part. Additionally, a fixed sequence procedure for Part I was used to proceed through the primary efficacy comparisons in the following order: 1) test of superiority of arm B and 2) test of superiority of arm A. The primary outcome within Arm C was tested with a Bonferroni-corrected Type 1 error rate of 0.025 for superiority.
Type of Statistical Test Superiority
Comments 97.5% CI was calculated using the Wilson score method; the lower confidence bound for the percentage of participants with sustained virologic response at 12 weeks after treatment must exceed 67% to achieve superiority. The predefined threshold of 67% was based on historical SVR rates for HCV genotype 4 (GT4)-infected subjects treated with pegIFN/RBV.
Method of Estimation Estimation Parameter Percentage of Participants
Estimated Value 93.4
Confidence Interval (2-Sided) 97.5%
82.6 to 97.7
Estimation Comments The confidence interval was calculated using the Wilson score method.
2.Secondary Outcome
Title Percentage of Participants With SVR12 in Participants Receiving 12 Weeks (Arm A) of Treatment Compared to Participants Receiving 16 Weeks of Treatment (Arm B)
Hide Description SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [<LLOQ]) 12 weeks after the last dose of study drug.
Time Frame 12 weeks after the last actual dose of study drug
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least 1 dose of study drug (ITT population); participants with missing data after backwards imputation were imputed as nonresponders.
Arm/Group Title Arm A Arm B
Hide Arm/Group Description:
Ombitasvir/paritaprevir/ritonavir (25/150/100 mg) and Ribavirin dosed for 12 weeks for genotype 4 treatment-naïve or treatment-experienced with IFN/RBV.
Ombitasvir/paritaprevir/ritonavir (25/150/100 mg) and Ribavirin dosed for 16 weeks for genotype 4 treatment-naive or treatment-experienced with IFN/RBV.
Overall Number of Participants Analyzed 59 61
Measure Type: Number
Unit of Measure: percentage of participants
96.6 100
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm A, Arm B
Comments Within Part I (arm A and B), since superiority was demonstrated for both arms in the primary outcome measures, testing continued to the first secondary outcome measure.
Type of Statistical Test Superiority
Comments Treatment differences (with 95% confidence intervals) and corresponding P-value for the specified comparisons were estimated using stratum adjusted Mantel-Haenszel (MH) proportion and continuity-corrected variance, adjusting for IFN/RBV treatment history (treatment-naïve or treatment-experienced).
Statistical Test of Hypothesis P-Value 0.304
Comments [Not Specified]
Method Mantel Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Stratum-Adjusted MH Difference
Estimated Value -3.39
Confidence Interval (2-Sided) 95%
-9.85 to 3.07
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Percentage of Participants With SVR12 in Participants Receiving 16 Weeks (Arm B) of Treatment Compared to Participants Receiving 24 Weeks of Treatment (Arm C)
Hide Description SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [<LLOQ]) 12 weeks after the last dose of study drug.
Time Frame 12 weeks after the last actual dose of study drug
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least 1 dose of study drug (ITT population); participants with missing data after backwards imputation were imputed as nonresponders.
Arm/Group Title Arm B Arm C
Hide Arm/Group Description:
Ombitasvir/paritaprevir/ritonavir (25/150/100 mg) and Ribavirin dosed for 16 weeks for genotype 4 treatment-naive or treatment-experienced with IFN/RBV.
Ombitasvir/paritaprevir/ritonavir (25/150/100 mg) and Ribavirin dosed for 24 weeks for genotype 4 treatment-naive and treatment-experienced with IFN/RBV.
Overall Number of Participants Analyzed 61 57
Measure Type: Number
Unit of Measure: percentage of participants
100 93.4
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm B, Arm C
Comments Within Part II (arm C), since superiority was demonstrated for the primary outcome measure, testing continued to the second secondary outcome measure.
Type of Statistical Test Superiority
Comments Treatment differences (with 95% confidence intervals) and corresponding P-value for the specified comparisons were estimated using stratum adjusted Mantel-Haenszel proportion and continuity-corrected variance, adjusting for IFN/RBV treatment history (treatment-naïve or treatment-experienced).
Statistical Test of Hypothesis P-Value 0.086
Comments [Not Specified]
Method Mantel Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Stratum-Adjusted MH Difference
Estimated Value 6.45
Confidence Interval (2-Sided) 95%
-0.91 to 13.81
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Percentage of Participants in Arms A, B and C With On-treatment Virologic Failure
Hide Description On-treatment virologic failure was defined as confirmed HCV RNA ≥ LLOQ after HCV RNA < LLOQ during treatment; confirmed increase of > 1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline in HCV RNA during treatment; or all on-treatment values of HCV RNA >= LLOQ with at least 6 weeks of treatment.
Time Frame Up to Treatment Week 24 (end of treatment) or premature discontinuation from treatment
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least 1 dose of study drug (ITT population).
Arm/Group Title Arm A Arm B Arm C
Hide Arm/Group Description:
Ombitasvir/paritaprevir/ritonavir (25/150/100 mg) and Ribavirin dosed for 12 weeks for genotype 4 treatment-naïve or treatment-experienced with IFN/RBV.
Ombitasvir/paritaprevir/ritonavir (25/150/100 mg) and Ribavirin dosed for 16 weeks for genotype 4 treatment-naive or treatment-experienced with IFN/RBV.
Ombitasvir/paritaprevir/ritonavir (25/150/100 mg) and Ribavirin dosed for 24 weeks for genotype 4 treatment-naive and treatment-experienced with IFN/RBV.
Overall Number of Participants Analyzed 59 61 61
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
1.7
(0.3 to 9.0)
0
(0.0 to 5.9)
0
(0.0 to 5.9)
5.Secondary Outcome
Title Percentage of Participants in Arms A, B and C With Post-treatment Relapse
Hide Description Post-treatment relapse was defined as confirmed HCV RNA ≥ LLOQ between the end of treatment and 12 weeks after the last dose of study drug among participants with HCV RNA levels < LLOQ at the end of treatment.
Time Frame From the end of treatment through 12 weeks after the last dose of study drug
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least 1 dose of study drug (ITT population) with at least one post-treatment HCV RNA value, completed treatment, and had HCV RNA <LLOQ at the final treatment visit.
Arm/Group Title Arm A Arm B Arm C
Hide Arm/Group Description:
Ombitasvir/paritaprevir/ritonavir (25/150/100 mg) and Ribavirin dosed for 12 weeks for genotype 4 treatment-naïve or treatment-experienced with IFN/RBV.
Ombitasvir/paritaprevir/ritonavir (25/150/100 mg) and Ribavirin dosed for 16 weeks for genotype 4 treatment-naive or treatment-experienced with IFN/RBV.
Ombitasvir/paritaprevir/ritonavir (25/150/100 mg) and Ribavirin dosed for 24 weeks for genotype 4 treatment-naive and treatment-experienced with IFN/RBV.
Overall Number of Participants Analyzed 57 59 56
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
0
(0.0 to 6.3)
0
(0.0 to 6.1)
0
(0.0 to 6.4)
Time Frame Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug (up to 28 weeks)
Adverse Event Reporting Description TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 30 days after the last dose of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
 
Arm/Group Title Arm A Arm B Arm C Arm D
Hide Arm/Group Description Ombitasvir/paritaprevir/ritonavir (25/150/100 mg) and Ribavirin dosed for 12 weeks for genotype 4 treatment-naïve or treatment-experienced with IFN/RBV. Ombitasvir/paritaprevir/ritonavir (25/150/100 mg) and Ribavirin dosed for 16 weeks for genotype 4 treatment-naive or treatment-experienced with IFN/RBV. Ombitasvir/paritaprevir/ritonavir (25/150/100 mg) and Ribavirin dosed for 24 weeks for genotype 4 treatment-naive and treatment-experienced with IFN/RBV. Ombitasvir/paritaprevir/ritonavir (25/150/100 mg) and Ribavirin dosed for 24 weeks for genotype 4 SOF/pegIFN/RBV or SOF/RBV treatment-experienced.
All-Cause Mortality
Arm A Arm B Arm C Arm D
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Arm A Arm B Arm C Arm D
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   4/60 (6.67%)   4/60 (6.67%)   3/61 (4.92%)   0/3 (0.00%) 
Blood and lymphatic system disorders         
ANAEMIA  1  2/60 (3.33%)  0/60 (0.00%)  0/61 (0.00%)  0/3 (0.00%) 
HAEMORRHAGIC ANAEMIA  1  1/60 (1.67%)  0/60 (0.00%)  0/61 (0.00%)  0/3 (0.00%) 
Cardiac disorders         
ACUTE CORONARY SYNDROME  1  0/60 (0.00%)  2/60 (3.33%)  0/61 (0.00%)  0/3 (0.00%) 
MYOCARDIAL INFARCTION  1  0/60 (0.00%)  0/60 (0.00%)  1/61 (1.64%)  0/3 (0.00%) 
Gastrointestinal disorders         
OESOPHAGEAL VARICES HAEMORRHAGE  1  1/60 (1.67%)  0/60 (0.00%)  0/61 (0.00%)  0/3 (0.00%) 
Hepatobiliary disorders         
HEPATOTOXICITY  1  0/60 (0.00%)  0/60 (0.00%)  1/61 (1.64%)  0/3 (0.00%) 
PORTAL VEIN THROMBOSIS  1  0/60 (0.00%)  1/60 (1.67%)  0/61 (0.00%)  0/3 (0.00%) 
Infections and infestations         
CLOSTRIDIUM COLITIS  1  0/60 (0.00%)  1/60 (1.67%)  0/61 (0.00%)  0/3 (0.00%) 
MENINGITIS  1  0/60 (0.00%)  1/60 (1.67%)  0/61 (0.00%)  0/3 (0.00%) 
PNEUMONIA  1  0/60 (0.00%)  1/60 (1.67%)  0/61 (0.00%)  0/3 (0.00%) 
PNEUMONIA KLEBSIELLA  1  0/60 (0.00%)  1/60 (1.67%)  0/61 (0.00%)  0/3 (0.00%) 
Musculoskeletal and connective tissue disorders         
INTERVERTEBRAL DISC PROTRUSION  1  0/60 (0.00%)  2/60 (3.33%)  0/61 (0.00%)  0/3 (0.00%) 
Nervous system disorders         
SCIATICA  1  0/60 (0.00%)  1/60 (1.67%)  0/61 (0.00%)  0/3 (0.00%) 
Psychiatric disorders         
MANIA  1  1/60 (1.67%)  0/60 (0.00%)  0/61 (0.00%)  0/3 (0.00%) 
SUICIDAL IDEATION  1  0/60 (0.00%)  0/60 (0.00%)  1/61 (1.64%)  0/3 (0.00%) 
SUICIDE ATTEMPT  1  0/60 (0.00%)  1/60 (1.67%)  0/61 (0.00%)  0/3 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA version 19.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Arm A Arm B Arm C Arm D
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   46/60 (76.67%)   55/60 (91.67%)   50/61 (81.97%)   3/3 (100.00%) 
Blood and lymphatic system disorders         
ANAEMIA  1  7/60 (11.67%)  12/60 (20.00%)  7/61 (11.48%)  0/3 (0.00%) 
Ear and labyrinth disorders         
EAR PAIN  1  0/60 (0.00%)  0/60 (0.00%)  0/61 (0.00%)  1/3 (33.33%) 
Gastrointestinal disorders         
ABDOMINAL PAIN  1  2/60 (3.33%)  4/60 (6.67%)  6/61 (9.84%)  0/3 (0.00%) 
ABDOMINAL PAIN UPPER  1  4/60 (6.67%)  1/60 (1.67%)  2/61 (3.28%)  1/3 (33.33%) 
CONSTIPATION  1  4/60 (6.67%)  1/60 (1.67%)  2/61 (3.28%)  0/3 (0.00%) 
DIARRHOEA  1  1/60 (1.67%)  3/60 (5.00%)  2/61 (3.28%)  0/3 (0.00%) 
NAUSEA  1  6/60 (10.00%)  8/60 (13.33%)  5/61 (8.20%)  1/3 (33.33%) 
TOOTHACHE  1  2/60 (3.33%)  3/60 (5.00%)  2/61 (3.28%)  0/3 (0.00%) 
VOMITING  1  4/60 (6.67%)  3/60 (5.00%)  4/61 (6.56%)  0/3 (0.00%) 
General disorders         
ASTHENIA  1  11/60 (18.33%)  19/60 (31.67%)  15/61 (24.59%)  1/3 (33.33%) 
FATIGUE  1  10/60 (16.67%)  20/60 (33.33%)  16/61 (26.23%)  0/3 (0.00%) 
INFLUENZA LIKE ILLNESS  1  0/60 (0.00%)  3/60 (5.00%)  1/61 (1.64%)  0/3 (0.00%) 
OEDEMA PERIPHERAL  1  5/60 (8.33%)  4/60 (6.67%)  2/61 (3.28%)  0/3 (0.00%) 
PYREXIA  1  0/60 (0.00%)  3/60 (5.00%)  1/61 (1.64%)  0/3 (0.00%) 
Hepatobiliary disorders         
JAUNDICE  1  3/60 (5.00%)  2/60 (3.33%)  4/61 (6.56%)  0/3 (0.00%) 
Infections and infestations         
SINUSITIS  1  0/60 (0.00%)  3/60 (5.00%)  0/61 (0.00%)  0/3 (0.00%) 
Investigations         
BLOOD BILIRUBIN INCREASED  1  1/60 (1.67%)  3/60 (5.00%)  0/61 (0.00%)  0/3 (0.00%) 
HAEMOGLOBIN DECREASED  1  3/60 (5.00%)  8/60 (13.33%)  4/61 (6.56%)  0/3 (0.00%) 
Metabolism and nutrition disorders         
DECREASED APPETITE  1  2/60 (3.33%)  5/60 (8.33%)  2/61 (3.28%)  0/3 (0.00%) 
HYPERGLYCAEMIA  1  0/60 (0.00%)  4/60 (6.67%)  1/61 (1.64%)  0/3 (0.00%) 
Musculoskeletal and connective tissue disorders         
ARTHRALGIA  1  3/60 (5.00%)  4/60 (6.67%)  1/61 (1.64%)  0/3 (0.00%) 
BACK PAIN  1  1/60 (1.67%)  2/60 (3.33%)  5/61 (8.20%)  0/3 (0.00%) 
MUSCULOSKELETAL CHEST PAIN  1  0/60 (0.00%)  1/60 (1.67%)  1/61 (1.64%)  1/3 (33.33%) 
MYALGIA  1  3/60 (5.00%)  6/60 (10.00%)  3/61 (4.92%)  0/3 (0.00%) 
NECK PAIN  1  1/60 (1.67%)  0/60 (0.00%)  0/61 (0.00%)  1/3 (33.33%) 
Nervous system disorders         
DIZZINESS  1  4/60 (6.67%)  9/60 (15.00%)  0/61 (0.00%)  0/3 (0.00%) 
HEADACHE  1  14/60 (23.33%)  14/60 (23.33%)  13/61 (21.31%)  0/3 (0.00%) 
MEMORY IMPAIRMENT  1  1/60 (1.67%)  4/60 (6.67%)  1/61 (1.64%)  0/3 (0.00%) 
Psychiatric disorders         
ANXIETY  1  3/60 (5.00%)  2/60 (3.33%)  3/61 (4.92%)  0/3 (0.00%) 
INSOMNIA  1  5/60 (8.33%)  6/60 (10.00%)  5/61 (8.20%)  1/3 (33.33%) 
SLEEP DISORDER  1  2/60 (3.33%)  5/60 (8.33%)  0/61 (0.00%)  0/3 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
COUGH  1  5/60 (8.33%)  5/60 (8.33%)  4/61 (6.56%)  1/3 (33.33%) 
DYSPNOEA  1  4/60 (6.67%)  4/60 (6.67%)  4/61 (6.56%)  0/3 (0.00%) 
DYSPNOEA EXERTIONAL  1  2/60 (3.33%)  3/60 (5.00%)  0/61 (0.00%)  0/3 (0.00%) 
NASAL CONGESTION  1  0/60 (0.00%)  0/60 (0.00%)  1/61 (1.64%)  1/3 (33.33%) 
PARANASAL SINUS DISCOMFORT  1  0/60 (0.00%)  0/60 (0.00%)  0/61 (0.00%)  1/3 (33.33%) 
Skin and subcutaneous tissue disorders         
DRY SKIN  1  1/60 (1.67%)  1/60 (1.67%)  4/61 (6.56%)  0/3 (0.00%) 
PRURITUS  1  5/60 (8.33%)  14/60 (23.33%)  12/61 (19.67%)  1/3 (33.33%) 
PRURITUS GENERALISED  1  0/60 (0.00%)  0/60 (0.00%)  2/61 (3.28%)  1/3 (33.33%) 
RASH  1  4/60 (6.67%)  3/60 (5.00%)  2/61 (3.28%)  1/3 (33.33%) 
Vascular disorders         
HYPERTENSION  1  4/60 (6.67%)  1/60 (1.67%)  1/61 (1.64%)  0/3 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA version 19.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Name/Title: Global Medical Information
Organization: AbbVie
Phone: 800-633-9110
Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT02265237     History of Changes
Other Study ID Numbers: M11-665
2014-001496-31 ( EudraCT Number )
First Submitted: October 10, 2014
First Posted: October 15, 2014
Results First Submitted: April 26, 2017
Results First Posted: August 31, 2017
Last Update Posted: August 31, 2017