Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study to Evaluate the Safety and Efficacy of ABT-450/Ritonavir/ABT-267; (ABT-267 Also Known as Ombitasvir) and ABT-333 (Also Known as Dasabuvir) Coadministered With Ribavirin (RBV) in Hepatitis C Virus (HCV) Genotype 1-infected Adults With Compensated Cirrhosis (TURQUOISE-II)

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: NCT01704755
Recruitment Status : Completed
First Posted : October 11, 2012
Results First Posted : January 6, 2015
Last Update Posted : October 19, 2015
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Chronic Hepatitis C Infection
Compensated Cirrhosis
Interventions Drug: ABT-450/r/ABT-267, ABT-333
Drug: Ribavirin (RBV)
Enrollment 381
Recruitment Details  
Pre-assignment Details In the 12-week treatment group, one participant withdrew from the study before receiving study drug.
Arm/Group Title ABT-450/r/ABT-267 and ABT-333, Plus RBV for 12 Weeks ABT-450/r/ABT-267 and ABT-333, Plus RBV for 24 Weeks
Hide Arm/Group Description ABT-450/r/ABT-267 (150/100/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; 1,000 mg/day if <75 kg or 1,200 mg/day if ≥75 kg, divided twice daily) for 12 weeks ABT-450/r/ABT-267 (150/100/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; 1,000 mg/day if <75 kg or 1,200 mg/day if ≥75 kg, divided twice daily) for 24 weeks
Period Title: Overall Study
Started 208 172
Completed Study Drug 204 163
Completed 196 165
Not Completed 12 7
Reason Not Completed
Adverse Event             4             1
Lost to Follow-up             3             4
Withdrew consent             1             1
Other (not specified)             3             1
Withdrew consent and personal issues             1             0
Arm/Group Title ABT-450/r/ABT-267 and ABT-333, Plus RBV for 12 Weeks ABT-450/r/ABT-267 and ABT-333, Plus RBV for 24 Weeks Total
Hide Arm/Group Description ABT-450/r/ABT-267 (150/100/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; 1,000 mg/day if <75 kg or 1,200 mg/day if ≥75 kg, divided twice daily) for 12 weeks ABT-450/r/ABT-267 (150/100/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; 1,000 mg/day if <75 kg or 1,200 mg/day if ≥75 kg, divided twice daily) for 24 weeks Total of all reporting groups
Overall Number of Baseline Participants 208 172 380
Hide Baseline Analysis Population Description
All participants who received at least 1 dose of study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 208 participants 172 participants 380 participants
57.1  (7.01) 56.5  (7.87) 56.8  (7.41)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 208 participants 172 participants 380 participants
Female
62
  29.8%
51
  29.7%
113
  29.7%
Male
146
  70.2%
121
  70.3%
267
  70.3%
1.Primary Outcome
Title Percentage of Participants With Sustained Virologic Response 12 Weeks Post-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 study drug
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug.
Arm/Group Title ABT-450/r/ABT-267 and ABT-333, Plus RBV for 12 Weeks ABT-450/r/ABT-267 and ABT-333, Plus RBV for 24 Weeks
Hide Arm/Group Description:
ABT-450/r/ABT-267 (150/100/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; 1,000 mg/day if <75 kg or 1,200 mg/day if ≥75 kg, divided twice daily) for 12 weeks
ABT-450/r/ABT-267 (150/100/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; 1,000 mg/day if <75 kg or 1,200 mg/day if ≥75 kg, divided twice daily) for 24 weeks
Overall Number of Participants Analyzed 208 172
Measure Type: Number
Unit of Measure: Percentage of participants
91.8 96.5
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ABT-450/r/ABT-267 and ABT-333, Plus RBV for 12 Weeks
Comments The study planned to enroll 380 subjects to a 12- or 24-week treatment arm. The primary efficacy endpoint (SVR12) was assessed for each arm. With a total sample size of 380 and assuming that 68% of the subjects in each arm would achieve SVR12, the study had greater than 90% power to demonstrate non-inferiority and superiority with a 2-sided 97.5% lower confidence bound greater than 43% and 54%, respectively, based on the normal approximation of a single binomial proportion.
Type of Statistical Test Non-Inferiority or Equivalence
Comments The noninferiority of the rate of sustained virologic response for the ABT-450/r/ABT-333 plus ribavirin 12-week treatment group as compared with the historical rate for telaprevir plus peginterferon-ribavirin. The lower confidence bound of the 2-sided 97.5% CI for the percentage of participants with sustained virologic response at 12 weeks after treatment must have exceeded 43% to achieve noninferiority.
Method of Estimation Estimation Parameter Percentage of Participants
Estimated Value 91.8
Confidence Interval (2-Sided) 97.5%
87.6 to 96.1
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection ABT-450/r/ABT-267 and ABT-333, Plus RBV for 12 Weeks
Comments The primary efficacy endpoints were the SVR12 rates in each arm. The overall 2-sided significance level of 0.05 was split between the arms using a Bonferroni correction of 0.025. A 2-sided 97.5% CI of the SVR12 rate per arm was computed using the normal approximation to the binomial distribution. A gatekeeping testing procedure was used to control the Type I error rate at 0.05, and the primary endpoints for Arm A were tested separately from Arm B in a pre-specified order.
Type of Statistical Test Non-Inferiority or Equivalence
Comments The superiority of the rate of sustained virologic response for the ABT-450/r/ABT-333 plus ribavirin 12-week treatment group as compared with the historical rate for telaprevir plus peginterferon-ribavirin. The lower confidence bound of the 2-sided 97.5% CI for the percentage of participants with sustained virologic response at 12 weeks after treatment must have exceeded 54% to achieve superiority.
Method of Estimation Estimation Parameter Percentage of Participants
Estimated Value 91.8
Confidence Interval (2-Sided) 97.5%
87.6 to 96.1
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection ABT-450/r/ABT-267 and ABT-333, Plus RBV for 24 Weeks
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments The noninferiority of the rate of sustained virologic response for the ABT-450/r/ABT-333 plus ribavirin 24-week treatment group as compared with the historical rate for telaprevir plus peginterferon-ribavirin. The lower confidence bound of the 2-sided 97.5% CI for the percentage of participants with sustained virologic response at 12 weeks after treatment must have exceeded 43% to achieve noninferiority.
Method of Estimation Estimation Parameter Percentage of Participants
Estimated Value 96.5
Confidence Interval (2-Sided) 97.5%
93.4 to 99.7
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection ABT-450/r/ABT-267 and ABT-333, Plus RBV for 24 Weeks
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments The superiority of the rate of sustained virologic response for the ABT-450/r/ABT-333 plus ribavirin 24-week treatment group as compared with the historical rate for telaprevir plus peginterferon-ribavirin. The lower confidence bound of the 2-sided 97.5% CI for the percentage of participants with sustained virologic response at 12 weeks after treatment must have exceeded 54% to achieve superiority.
Method of Estimation Estimation Parameter Percentage of Participants
Estimated Value 96.5
Confidence Interval (2-Sided) 97.5%
93.4 to 99.7
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment in the 24-week Arm Compared to the 12-week Arm
Hide Description A sustained virologic response is defined as plasma Hepatitis C virus ribonucleic acid (HCV RNA) 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 randomized participants who received at least 1 dose of study drug.
Arm/Group Title ABT-450/r/ABT-267 and ABT-333, Plus RBV for 12 Weeks ABT-450/r/ABT-267 and ABT-333, Plus RBV for 24 Weeks
Hide Arm/Group Description:
ABT-450/r/ABT-267 (150/100/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; 1,000 mg/day if <75 kg or 1,200 mg/day if ≥75 kg, divided twice daily) for 12 weeks
ABT-450/r/ABT-267 (150/100/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; 1,000 mg/day if <75 kg or 1,200 mg/day if ≥75 kg, divided twice daily) for 24 weeks
Overall Number of Participants Analyzed 208 172
Measure Type: Number
Unit of Measure: Percentage of participants
91.8 96.5
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ABT-450/r/ABT-267 and ABT-333, Plus RBV for 12 Weeks, ABT-450/r/ABT-267 and ABT-333, Plus RBV for 24 Weeks
Comments To test the hypothesis that the percentages of participants who achieved sustained virologic response 12 weeks after treatment was different between the two treatment groups, the percentages were compared using a logistic regression model with treatment group, baseline log(subscript)10(subscript) HCV RNA level, HCV subgenotype (1a, non-1a), IL28B genotype (CC, non CC), and peginterferon-ribavirin treatment history (treatment-naïve or treatment-experienced) as predictors.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.051
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
3.Secondary Outcome
Title Percentage of Participants in Each Arm With On-treatment Virologic Failure During the Treatment Period
Hide Description Virologic failure during treatment was defined as rebound (confirmed HCV RNA greater than or equal to the lower limit of quantitation [≥ LLOQ] after HCV RNA < LLOQ during treatment, or confirmed increase from the lowest value post baseline in HCV RNA [2 consecutive HCV RNA measurements > 1 log(subscript)10(subscript) IU/mL above the lowest value post baseline] at any time point during treatment), or fail to suppress (HCV RNA ≥ LLOQ persistently during treatment with at least 6 weeks [≥ 36 days] of treatment).
Time Frame Baseline (Day 1), and Treatment Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug.
Arm/Group Title ABT-450/r/ABT-267 and ABT-333, Plus RBV for 12 Weeks ABT-450/r/ABT-267 and ABT-333, Plus RBV for 24 Weeks
Hide Arm/Group Description:
ABT-450/r/ABT-267 (150/100/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; 1,000 mg/day if <75 kg or 1,200 mg/day if ≥75 kg, divided twice daily) for 12 weeks
ABT-450/r/ABT-267 (150/100/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; 1,000 mg/day if <75 kg or 1,200 mg/day if ≥75 kg, divided twice daily) for 24 weeks
Overall Number of Participants Analyzed 208 172
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
0.5
(0.0 to 1.4)
1.7
(0.0 to 3.7)
4.Secondary Outcome
Title Percentage of Participants With Virologic Relapse After Treatment
Hide Description Participants were considered to have virologic relapse after treatment if they had confirmed quantifiable plasma Hepatitis C virus ribonucleic acid (HCV RNA) ≥ 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 after the last dose of study drug
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug with HCV RNA < LLOQ at the final treatment visit who completed treatment.
Arm/Group Title ABT-450/r/ABT-267 and ABT-333, Plus RBV for 12 Weeks ABT-450/r/ABT-267 and ABT-333, Plus RBV for 24 Weeks
Hide Arm/Group Description:
ABT-450/r/ABT-267 (150/100/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; 1,000 mg/day if <75 kg or 1,200 mg/day if ≥75 kg, divided twice daily) for 12 weeks
ABT-450/r/ABT-267 (150/100/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; 1,000 mg/day if <75 kg or 1,200 mg/day if ≥75 kg, divided twice daily) for 24 weeks
Overall Number of Participants Analyzed 203 164
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
5.9
(2.7 to 9.2)
0.6
(0.0 to 1.8)
Time Frame Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for the 12-week treatment group and 28 weeks for the 24-week treatment group.
Adverse Event Reporting Description Serious adverse events were collected from the time of informed consent until the end of participation in the study (up to 72 weeks).
 
Arm/Group Title ABT-450/r/ABT-267 and ABT-333, Plus RBV for 12 Weeks ABT-450/r/ABT-267 and ABT-333, Plus RBV for 24 Weeks
Hide Arm/Group Description ABT-450/r/ABT-267 (150/100/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; 1,000 mg/day if <75 kg or 1,200 mg/day if ≥75 kg, divided twice daily) for 12 weeks ABT-450/r/ABT-267 (150/100/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; 1,000 mg/day if <75 kg or 1,200 mg/day if ≥75 kg, divided twice daily) for 24 weeks
All-Cause Mortality
ABT-450/r/ABT-267 and ABT-333, Plus RBV for 12 Weeks ABT-450/r/ABT-267 and ABT-333, Plus RBV for 24 Weeks
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
ABT-450/r/ABT-267 and ABT-333, Plus RBV for 12 Weeks ABT-450/r/ABT-267 and ABT-333, Plus RBV for 24 Weeks
Affected / at Risk (%) Affected / at Risk (%)
Total   13/208 (6.25%)   7/172 (4.07%) 
Blood and lymphatic system disorders     
ANAEMIA  1  1/208 (0.48%)  1/172 (0.58%) 
Cardiac disorders     
ATRIAL FIBRILLATION  1  1/208 (0.48%)  0/172 (0.00%) 
Gastrointestinal disorders     
HAEMATEMESIS  1  0/208 (0.00%)  1/172 (0.58%) 
MELAENA  1  0/208 (0.00%)  1/172 (0.58%) 
NAUSEA  1  1/208 (0.48%)  0/172 (0.00%) 
OESOPHAGEAL VARICES HAEMORRHAGE  1  0/208 (0.00%)  1/172 (0.58%) 
VOMITING  1  1/208 (0.48%)  0/172 (0.00%) 
General disorders     
MULTI-ORGAN FAILURE  1  1/208 (0.48%)  0/172 (0.00%) 
OEDEMA PERIPHERAL  1  1/208 (0.48%)  0/172 (0.00%) 
Hepatobiliary disorders     
CHOLECYSTITIS ACUTE  1  1/208 (0.48%)  0/172 (0.00%) 
HEPATITIS ACUTE  1  1/208 (0.48%)  0/172 (0.00%) 
Infections and infestations     
CANDIDIASIS  1  1/208 (0.48%)  0/172 (0.00%) 
CELLULITIS  1  0/208 (0.00%)  1/172 (0.58%) 
ENTEROCOCCAL BACTERAEMIA  1  1/208 (0.48%)  0/172 (0.00%) 
ESCHERICHIA SEPSIS  1  1/208 (0.48%)  0/172 (0.00%) 
PHARYNGITIS  1  1/208 (0.48%)  0/172 (0.00%) 
PNEUMONIA  1  1/208 (0.48%)  0/172 (0.00%) 
UPPER RESPIRATORY TRACT INFECTION  1  1/208 (0.48%)  0/172 (0.00%) 
Injury, poisoning and procedural complications     
CLAVICLE FRACTURE  1  1/208 (0.48%)  0/172 (0.00%) 
EXTRADURAL HAEMATOMA  1  1/208 (0.48%)  0/172 (0.00%) 
FALL  1  0/208 (0.00%)  1/172 (0.58%) 
FEMORAL NECK FRACTURE  1  1/208 (0.48%)  0/172 (0.00%) 
HEAD INJURY  1  0/208 (0.00%)  1/172 (0.58%) 
TOXICITY TO VARIOUS AGENTS  1  1/208 (0.48%)  0/172 (0.00%) 
WOUND  1  1/208 (0.48%)  0/172 (0.00%) 
Investigations     
BLOOD GLUCOSE INCREASED  1  0/208 (0.00%)  1/172 (0.58%) 
Metabolism and nutrition disorders     
LACTIC ACIDOSIS  1  1/208 (0.48%)  0/172 (0.00%) 
Musculoskeletal and connective tissue disorders     
OSTEOARTHRITIS  1  0/208 (0.00%)  1/172 (0.58%) 
RHABDOMYOLYSIS  1  1/208 (0.48%)  0/172 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
HEPATOCELLULAR CARCINOMA  1  1/208 (0.48%)  1/172 (0.58%) 
Nervous system disorders     
INTRACRANIAL ANEURYSM  1  0/208 (0.00%)  1/172 (0.58%) 
Psychiatric disorders     
MAJOR DEPRESSION  1  1/208 (0.48%)  0/172 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
CHRONIC OBSTRUCTIVE PULMONARY DISEASE  1  0/208 (0.00%)  1/172 (0.58%) 
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%
ABT-450/r/ABT-267 and ABT-333, Plus RBV for 12 Weeks ABT-450/r/ABT-267 and ABT-333, Plus RBV for 24 Weeks
Affected / at Risk (%) Affected / at Risk (%)
Total   175/208 (84.13%)   146/172 (84.88%) 
Blood and lymphatic system disorders     
ANAEMIA  1  15/208 (7.21%)  17/172 (9.88%) 
Gastrointestinal disorders     
ABDOMINAL DISTENSION  1  6/208 (2.88%)  9/172 (5.23%) 
ABDOMINAL PAIN UPPER  1  11/208 (5.29%)  16/172 (9.30%) 
DIARRHOEA  1  30/208 (14.42%)  29/172 (16.86%) 
GASTROOESOPHAGEAL REFLUX DISEASE  1  7/208 (3.37%)  10/172 (5.81%) 
NAUSEA  1  36/208 (17.31%)  35/172 (20.35%) 
VOMITING  1  6/208 (2.88%)  14/172 (8.14%) 
General disorders     
ASTHENIA  1  29/208 (13.94%)  22/172 (12.79%) 
FATIGUE  1  68/208 (32.69%)  80/172 (46.51%) 
IRRITABILITY  1  15/208 (7.21%)  21/172 (12.21%) 
OEDEMA PERIPHERAL  1  12/208 (5.77%)  10/172 (5.81%) 
Hepatobiliary disorders     
HYPERBILIRUBINAEMIA  1  15/208 (7.21%)  2/172 (1.16%) 
Infections and infestations     
NASOPHARYNGITIS  1  13/208 (6.25%)  13/172 (7.56%) 
UPPER RESPIRATORY TRACT INFECTION  1  4/208 (1.92%)  13/172 (7.56%) 
Investigations     
BLOOD BILIRUBIN INCREASED  1  12/208 (5.77%)  9/172 (5.23%) 
Metabolism and nutrition disorders     
DECREASED APPETITE  1  12/208 (5.77%)  14/172 (8.14%) 
Musculoskeletal and connective tissue disorders     
ARTHRALGIA  1  10/208 (4.81%)  14/172 (8.14%) 
BACK PAIN  1  4/208 (1.92%)  13/172 (7.56%) 
MUSCLE SPASMS  1  14/208 (6.73%)  14/172 (8.14%) 
Nervous system disorders     
DIZZINESS  1  18/208 (8.65%)  10/172 (5.81%) 
HEADACHE  1  58/208 (27.88%)  53/172 (30.81%) 
MEMORY IMPAIRMENT  1  5/208 (2.40%)  12/172 (6.98%) 
Psychiatric disorders     
ANXIETY  1  15/208 (7.21%)  14/172 (8.14%) 
DEPRESSION  1  8/208 (3.85%)  12/172 (6.98%) 
INSOMNIA  1  32/208 (15.38%)  31/172 (18.02%) 
Respiratory, thoracic and mediastinal disorders     
COUGH  1  24/208 (11.54%)  19/172 (11.05%) 
DYSPNOEA  1  12/208 (5.77%)  21/172 (12.21%) 
DYSPNOEA EXERTIONAL  1  13/208 (6.25%)  11/172 (6.40%) 
Skin and subcutaneous tissue disorders     
DRY SKIN  1  18/208 (8.65%)  11/172 (6.40%) 
PRURITUS  1  38/208 (18.27%)  33/172 (19.19%) 
PRURITUS GENERALISED  1  10/208 (4.81%)  12/172 (6.98%) 
RASH  1  23/208 (11.06%)  25/172 (14.53%) 
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: NCT01704755    
Other Study ID Numbers: M13-099
2012-003088-23 ( EudraCT Number )
First Submitted: September 28, 2012
First Posted: October 11, 2012
Results First Submitted: December 23, 2014
Results First Posted: January 6, 2015
Last Update Posted: October 19, 2015