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A Study to Evaluate Chronic Hepatitis C Infection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01716585
Recruitment Status : Completed
First Posted : October 30, 2012
Results First Posted : January 6, 2015
Last Update Posted : November 9, 2015
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Chronic Hepatitis C Infection
Interventions Drug: ABT-450/r/ABT-267, ABT-333
Drug: Ribavirin
Drug: Placebo for ABT-450/r/ABT-267
Drug: Placebo for ABT-333
Drug: Placebo for ribavirin
Enrollment 636
Recruitment Details  
Pre-assignment Details  
Arm/Group Title ABT-450/r/ABT-267 and ABT-333, Plus RBV Placebo Followed by ABT-450/r/ABT-267 and ABT-333, Plus RBV
Hide Arm/Group Description Double-blind ABT-450/r/ABT-267 (150 mg/100 mg/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks Double-blind placebo for 12 weeks followed by open-label ABT-450/r/ABT-267 (150 mg/100 mg/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
Period Title: Double-blind Treatment
Started 477 159
Randomized But Not Treated 4 1
Completed 464 [1] 157 [1]
Not Completed 13 2
Reason Not Completed
Did Not Receive Study Drug             4             1
Adverse Event             2             1
Withdrawal by Subject             3             0
Lost to Follow-up             2             0
Subject Noncompliant             1             0
Other             1             0
[1]
The number of participants who completed double-blind study drug.
Period Title: Open-label Treatment
Started 0 [1] 157
Completed 0 [1] 150 [2]
Not Completed 0 7
Reason Not Completed
Adverse Event             0             2
Virologic Failure             0             2
Withdrawal by Subject             0             3
[1]
not applicable to this arm
[2]
The number of participants who completed open-label study drug.
Arm/Group Title ABT-450/r/ABT-267 and ABT-333, Plus RBV Placebo Total
Hide Arm/Group Description Double-blind ABT-450/r/ABT-267 (150 mg/100 mg/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks Double-blind placebo for 12 weeks Total of all reporting groups
Overall Number of Baseline Participants 473 158 631
Hide Baseline Analysis Population Description
Safety population: all randomized participants who received at least 1 dose of blinded study drug
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 473 participants 158 participants 631 participants
49.4  (10.98) 51.2  (10.23) 49.9  (10.82)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 473 participants 158 participants 631 participants
Female
202
  42.7%
85
  53.8%
287
  45.5%
Male
271
  57.3%
73
  46.2%
344
  54.5%
1.Primary Outcome
Title Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment
Hide Description The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantitation [< LLOQ]) 12 weeks after the last dose of study drug.
Time Frame 12 weeks after the last actual dose of active study drug
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) Population: All randomized participants who received at least 1 dose of blinded study drug.
Arm/Group Title ABT-450/r/ABT-267 and ABT-333, Plus RBV
Hide Arm/Group Description:
Double-blind ABT-450/r/ABT-267 (150 mg/100 mg/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
Overall Number of Participants Analyzed 473
Measure Type: Number
Unit of Measure: percentage of participants
96.4
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ABT-450/r/ABT-267 and ABT-333, Plus RBV
Comments With a sample size of 450 subjects and assuming that 92% of the subjects in Arm A will achieve SVR12, this study has greater than 90% power to demonstrate non-inferiority with a 2-sided 95% lower confidence bound greater than 70% and greater than 90% power to demonstrate superiority with a 2-sided 95% lower confidence bound greater than 80% (based on the normal approximation of a single binomial proportion). 95% CI calculated using the normal approximation to the binomial distribution.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Based on historical SVR rates for noncirrhotic HCV treatment-naive subjects administered telaprevir plus peginterferon (pegIFN)/RBV, the lower confidence bound (LCB) of the 95% confidence interval (CI) must have exceeded 70% to achieve noninferiority of the ABT-450/r/ABT-267 and ABT-333, plus RBV treatment group as compared with the historical rate for telaprevir plus pegIFN and RBV, and the LCB of the 95% CI must have exceeded 80% to achieve superiority.
Method of Estimation Estimation Parameter Percentage of Participants with SVR12
Estimated Value 96.4
Confidence Interval (2-Sided) 95%
94.7 to 98.1
Estimation Comments In order to control the Type I error rate at 0.05, a fixed-sequence testing procedure was used to proceed through the primary and first 3 secondary efficacy endpoints in the order numbered below.
2.Secondary Outcome
Title Percentage of Participants With Normalization of Alanine Aminotransferase (ALT) at Final Treatment Visit During the Double-Blind Treatment Period
Hide Description Normalization is defined as alanine aminotransferase less than or equal to the upper limit of normal (ULN) at final treatment visit for participants with alanine aminotransferase greater than ULN at baseline.
Time Frame At 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) Population: All randomized participants who received at least 1 dose of blinded study drug and had ALT ≥ ULN of the reference range at baseline were included in the analysis.
Arm/Group Title ABT-450/r/ABT-267 and ABT-333, Plus RBV Placebo
Hide Arm/Group Description:
Double-blind ABT-450/r/ABT-267 (150 mg/100 mg/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
Double-blind placebo for 12 weeks
Overall Number of Participants Analyzed 363 114
Measure Type: Number
Unit of Measure: percentage of participants
97.0 15.8
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ABT-450/r/ABT-267 and ABT-333, Plus RBV, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments In order to control the Type I error rate at 0.05, a fixed-sequence testing procedure will be used to proceed through the primary and first 3 secondary efficacy endpoints in the order numbered below.
Method Fisher Exact
Comments [Not Specified]
3.Secondary Outcome
Title Percentage of HCV Genotype 1a-infected Participants With Sustained Virologic Response 12 Weeks After Treatment
Hide Description The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantitation [< LLOQ]) 12 weeks after the last dose of study drug.
Time Frame 12 weeks after the last actual dose of active study drug
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) Population: All randomized participants in the Double-blind ABT-450/r/ABT-267 and ABT-333, plus RBV treatment arm with HCV genotype 1a who received at least 1 dose of blinded study drug.
Arm/Group Title ABT-450/r/ABT-267 and ABT-333, Plus RBV
Hide Arm/Group Description:
Double-blind ABT-450/r/ABT-267 (150 mg/100 mg/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
Overall Number of Participants Analyzed 322
Measure Type: Number
Unit of Measure: percentage of participants
95.7
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ABT-450/r/ABT-267 and ABT-333, Plus RBV
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Based on historical SVR rates for noncirrhotic HCV treatment-naive subjects of the appropriate HCV genotype 1 subtype administered telaprevir plus pegIFN/RBV, the lower confidence bound (LCB) of the 95% confidence interval (CI) must have exceeded 75% to achieve superiority of the ABT-450/r/ABT-267 and ABT-333, plus RBV treatment group as compared with the historical rate for telaprevir plus pegIFN and RBV.
Method of Estimation Estimation Parameter Percentage of Participants with SVR12
Estimated Value 95.7
Confidence Interval (2-Sided) 95%
93.4 to 97.9
Estimation Comments 95% CI calculated using the normal approximation to the binomial distribution.
4.Secondary Outcome
Title Percentage of HCV Genotype 1b-infected Participants With Sustained Virologic Response 12 Weeks After Treatment
Hide Description The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantitation [< LLOQ]) 12 weeks after the last dose of study drug.
Time Frame 12 weeks after the last actual dose of active study drug
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) Population: All randomized participants in the Double-blind ABT-450/r/ABT-267 and ABT-333, plus RBV treatment arm with HCV genotype 1b who received at least 1 dose of blinded study drug.
Arm/Group Title ABT-450/r/ABT-267 and ABT-333, Plus RBV
Hide Arm/Group Description:
Double-blind ABT-450/r/ABT-267 (150 mg/100 mg/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
Overall Number of Participants Analyzed 151
Measure Type: Number
Unit of Measure: percentage of participants
98.0
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ABT-450/r/ABT-267 and ABT-333, Plus RBV
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Based on historical SVR rates for noncirrhotic HCV treatment-naive subjects of the appropriate HCV genotype 1 subtype administered telaprevir plus pegIFN/RBV, the lower confidence bound (LCB) of the 95% confidence interval (CI) must have exceeded 84% to achieve superiority of the ABT-450/r/ABT-267 and ABT-333, plus RBV treatment group as compared with the historical rate for telaprevir plus pegIFN and RBV.
Method of Estimation Estimation Parameter Percentage of Participants with SVR12
Estimated Value 98.0
Confidence Interval (2-Sided) 95%
95.8 to 100.0
Estimation Comments 95% CI calculated using the normal approximation to the binomial distribution.
5.Secondary Outcome
Title Percentage of Participants With On-treatment Virologic Failure During the Double-blind Treatment Period: ABT-450/r/ABT-267 and ABT-333, Plus RBV Arm
Hide Description Virologic failure was defined as rebound (hepatitis C virus ribonucleic acid [HCV RNA] ≥ lower limit of quantification [LLOQ] after HCV RNA < LLOQ or increase in HCV RNA of at least 1 log10 IU/mL) or failure to suppress (all on-treatment values of plasma HCV RNA ≥ LLOQ with at least 36 days of treatment) during treatment.
Time Frame 12 weeks after the last actual dose of active study drug
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) Population: All randomized participants who received at least 1 dose of blinded study drug in the Double-blind ABT-450/r/ABT-267 and ABT-333, plus RBV treatment arm.
Arm/Group Title ABT-450/r/ABT-267 and ABT-333, Plus RBV
Hide Arm/Group Description:
Double-blind ABT-450/r/ABT-267 (150 mg/100 mg/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
Overall Number of Participants Analyzed 473
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
0.2
(0.0 to 0.6)
6.Secondary Outcome
Title Percentage of Participants With Virologic Relapse After Treatment: ABT-450/r/ABT-267 and ABT-333, Plus RBV Arm
Hide Description Participants were considered to have virologic relapse after treatment if they had confirmed quantifiable plasma hepatitis C virus ribonucleic acid (HCV RNA) greater than or equal to the lower limit of quantification (≥ LLOQ) between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA < LLOQ at the end of treatment.
Time Frame Within 12 weeks post-treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) Population: All randomized participants who received at least 1 dose of blinded study drug with HCV RNA < LLOQ at the final treatment visit who completed treatment in the Double-blind ABT-450/r/ABT-267 and ABT-333, plus RBV treatment arm.
Arm/Group Title ABT-450/r/ABT-267 and ABT-333, Plus RBV
Hide Arm/Group Description:
Double-blind ABT-450/r/ABT-267 (150 mg/100 mg/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
Overall Number of Participants Analyzed 463
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
1.5
(0.4 to 2.6)
Time Frame Adverse events (AEs) were collected from the start of active study drug administration (double-blind [DB]/open-label, OL active) to 30 days after the last dose of active study drug 16 weeks.
Adverse Event Reporting Description DB Placebo Arm: AEs collected from start of placebo until 30 days following discontinuation of placebo and prior to the OL period (if applicable; total 16 weeks). Serious AES collected from informed consent until the end of participation in the study (12 weeks, DB period; 12 weeks, OL period + 48-week post-treatment period; total up to 72 weeks).
 
Arm/Group Title Double Blind ABT-450/r/ABT-267 and ABT-333, Plus RBV Double Blind Placebo Open Label ABT-450/r/ABT-267 and ABT-333, Plus RBV
Hide Arm/Group Description Double-blind ABT-450/r/ABT-267 (150 mg/100 mg/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks Double-blind placebo for 12 weeks Open-label ABT-450/r/ABT-267 (150 mg/100 mg/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
All-Cause Mortality
Double Blind ABT-450/r/ABT-267 and ABT-333, Plus RBV Double Blind Placebo Open Label ABT-450/r/ABT-267 and ABT-333, Plus RBV
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Hide Serious Adverse Events
Double Blind ABT-450/r/ABT-267 and ABT-333, Plus RBV Double Blind Placebo Open Label ABT-450/r/ABT-267 and ABT-333, Plus RBV
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   10/473 (2.11%)   0/158 (0.00%)   2/157 (1.27%) 
Blood and lymphatic system disorders       
ANAEMIA  1  1/473 (0.21%)  0/158 (0.00%)  0/157 (0.00%) 
Cardiac disorders       
SINUS TACHYCARDIA  1  1/473 (0.21%)  0/158 (0.00%)  0/157 (0.00%) 
VENTRICULAR EXTRASYSTOLES  1  1/473 (0.21%)  0/158 (0.00%)  0/157 (0.00%) 
Gastrointestinal disorders       
ABDOMINAL PAIN  1  1/473 (0.21%)  0/158 (0.00%)  0/157 (0.00%) 
DIARRHOEA  1  1/473 (0.21%)  0/158 (0.00%)  0/157 (0.00%) 
NAUSEA  1  1/473 (0.21%)  0/158 (0.00%)  0/157 (0.00%) 
VOMITING  1  1/473 (0.21%)  0/158 (0.00%)  0/157 (0.00%) 
General disorders       
CHILLS  1  1/473 (0.21%)  0/158 (0.00%)  0/157 (0.00%) 
NON-CARDIAC CHEST PAIN  1  1/473 (0.21%)  0/158 (0.00%)  0/157 (0.00%) 
Hepatobiliary disorders       
BILIARY COLIC  1  0/473 (0.00%)  0/158 (0.00%)  1/157 (0.64%) 
CHOLECYSTITIS  1  1/473 (0.21%)  0/158 (0.00%)  0/157 (0.00%) 
Infections and infestations       
APPENDICITIS  1  1/473 (0.21%)  0/158 (0.00%)  0/157 (0.00%) 
LOBAR PNEUMONIA  1  1/473 (0.21%)  0/158 (0.00%)  0/157 (0.00%) 
POSTOPERATIVE WOUND INFECTION  1  1/473 (0.21%)  0/158 (0.00%)  0/157 (0.00%) 
SUBCUTANEOUS ABSCESS  1  0/473 (0.00%)  0/158 (0.00%)  1/157 (0.64%) 
Injury, poisoning and procedural complications       
LUMBAR VERTEBRAL FRACTURE  1  1/473 (0.21%)  0/158 (0.00%)  0/157 (0.00%) 
OVERDOSE  1  1/473 (0.21%)  0/158 (0.00%)  0/157 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
NON-SMALL CELL LUNG CANCER  1  1/473 (0.21%)  0/158 (0.00%)  0/157 (0.00%) 
Nervous system disorders       
ENCEPHALOPATHY  1  1/473 (0.21%)  0/158 (0.00%)  0/157 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
ACUTE RESPIRATORY FAILURE  1  1/473 (0.21%)  0/158 (0.00%)  0/157 (0.00%) 
HYPOXIA  1  1/473 (0.21%)  0/158 (0.00%)  0/157 (0.00%) 
MEDIASTINAL MASS  1  1/473 (0.21%)  0/158 (0.00%)  0/157 (0.00%) 
Vascular disorders       
AORTIC STENOSIS  1  1/473 (0.21%)  0/158 (0.00%)  0/157 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 16.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Double Blind ABT-450/r/ABT-267 and ABT-333, Plus RBV Double Blind Placebo Open Label ABT-450/r/ABT-267 and ABT-333, Plus RBV
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   391/473 (82.66%)   108/158 (68.35%)   117/157 (74.52%) 
Blood and lymphatic system disorders       
ANAEMIA  1  24/473 (5.07%)  0/158 (0.00%)  14/157 (8.92%) 
Gastrointestinal disorders       
ABDOMINAL PAIN UPPER  1  29/473 (6.13%)  5/158 (3.16%)  8/157 (5.10%) 
DIARRHOEA  1  65/473 (13.74%)  11/158 (6.96%)  19/157 (12.10%) 
DRY MOUTH  1  19/473 (4.02%)  9/158 (5.70%)  0/157 (0.00%) 
DYSPEPSIA  1  26/473 (5.50%)  7/158 (4.43%)  6/157 (3.82%) 
NAUSEA  1  112/473 (23.68%)  22/158 (13.92%)  24/157 (15.29%) 
VOMITING  1  23/473 (4.86%)  6/158 (3.80%)  9/157 (5.73%) 
General disorders       
ASTHENIA  1  59/473 (12.47%)  6/158 (3.80%)  10/157 (6.37%) 
FATIGUE  1  164/473 (34.67%)  45/158 (28.48%)  35/157 (22.29%) 
IRRITABILITY  1  26/473 (5.50%)  4/158 (2.53%)  6/157 (3.82%) 
Infections and infestations       
NASOPHARYNGITIS  1  33/473 (6.98%)  10/158 (6.33%)  11/157 (7.01%) 
UPPER RESPIRATORY TRACT INFECTION  1  22/473 (4.65%)  8/158 (5.06%)  10/157 (6.37%) 
Metabolism and nutrition disorders       
DECREASED APPETITE  1  37/473 (7.82%)  5/158 (3.16%)  11/157 (7.01%) 
Musculoskeletal and connective tissue disorders       
ARTHRALGIA  1  23/473 (4.86%)  9/158 (5.70%)  9/157 (5.73%) 
BACK PAIN  1  22/473 (4.65%)  7/158 (4.43%)  9/157 (5.73%) 
MYALGIA  1  21/473 (4.44%)  8/158 (5.06%)  6/157 (3.82%) 
Nervous system disorders       
DIZZINESS  1  38/473 (8.03%)  6/158 (3.80%)  5/157 (3.18%) 
HEADACHE  1  156/473 (32.98%)  42/158 (26.58%)  26/157 (16.56%) 
Psychiatric disorders       
ANXIETY  1  22/473 (4.65%)  5/158 (3.16%)  8/157 (5.10%) 
INSOMNIA  1  67/473 (14.16%)  12/158 (7.59%)  21/157 (13.38%) 
SLEEP DISORDER  1  24/473 (5.07%)  4/158 (2.53%)  4/157 (2.55%) 
Respiratory, thoracic and mediastinal disorders       
COUGH  1  34/473 (7.19%)  8/158 (5.06%)  7/157 (4.46%) 
DYSPNOEA  1  38/473 (8.03%)  4/158 (2.53%)  12/157 (7.64%) 
DYSPNOEA EXERTIONAL  1  24/473 (5.07%)  3/158 (1.90%)  8/157 (5.10%) 
Skin and subcutaneous tissue disorders       
DRY SKIN  1  27/473 (5.71%)  2/158 (1.27%)  7/157 (4.46%) 
PRURITUS  1  80/473 (16.91%)  7/158 (4.43%)  16/157 (10.19%) 
RASH  1  51/473 (10.78%)  9/158 (5.70%)  8/157 (5.10%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 16.0
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
Layout table for Results Point of Contact information
Name/Title: Global Medical Information
Organization: AbbVie (prior sponsor, Abbott)
Phone: 800-633-9110
Layout table for additonal information
Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT01716585    
Other Study ID Numbers: M11-646
2012-002019-25 ( EudraCT Number )
First Submitted: October 18, 2012
First Posted: October 30, 2012
Results First Submitted: December 23, 2014
Results First Posted: January 6, 2015
Last Update Posted: November 9, 2015