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Study to Evaluate the Efficacy and Safety of ABT-450/Ritonavir/ABT- 267 (ABT-450/r/ABT-267) in Japanese Adults With Genotype 2 Chronic Hepatitis C Virus (HCV) Infection (GIFT-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: NCT02023112
Recruitment Status : Completed
First Posted : December 30, 2013
Results First Posted : May 13, 2016
Last Update Posted : October 24, 2016
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: ABT-450/r/ABT-267
Drug: Ribavirin
Enrollment 171
Recruitment Details  
Pre-assignment Details  
Arm/Group Title ABT-450/r/ABT-267 Plus RBV for 12 Weeks ABT-450/r/ABT-267 Plus RBV for 16 Weeks
Hide Arm/Group Description ABT-450/r/ABT-267 (150/100/25 mg once daily) plus weight-based ribavirin (RBV; 400 to 1,000 mg/day, divided twice daily) for 12 weeks ABT-450/r/ABT-267 (150/100/25 mg once daily) plus weight-based RBV (400 to 1,000 mg/day, divided twice daily) for 16 weeks
Period Title: Overall Study
Started 85 86
Completed 83 85
Not Completed 2 1
Reason Not Completed
Withdrawal by Subject             2             1
Arm/Group Title ABT-450/r/ABT-267 Plus RBV for 12 Weeks ABT-450/r/ABT-267 Plus RBV for 16 Weeks Total
Hide Arm/Group Description ABT-450/r/ABT-267 (150/100/25 mg once daily) plus weight-based RBV (400 to 1,000 mg/day, divided twice daily) for 12 weeks ABT-450/r/ABT-267 (150/100/25 mg once daily) plus weight-based RBV (400 to 1,000 mg/day, divided twice daily) for 16 weeks Total of all reporting groups
Overall Number of Baseline Participants 85 86 171
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 85 participants 86 participants 171 participants
< 65 years 56 62 118
≥ 65 years 29 24 53
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 85 participants 86 participants 171 participants
Female
40
  47.1%
48
  55.8%
88
  51.5%
Male
45
  52.9%
38
  44.2%
83
  48.5%
1.Primary Outcome
Title Percentage of Non-cirrhotic, Treatment-naive Participants in Each Treatment Group With a Sustained Virologic Response 12 Weeks Post-treatment (SVR12)
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 last dose of study drug
Hide Outcome Measure Data
Hide Analysis Population Description
Primary efficacy population: all treatment-naïve, noncirrhotic participants in the intent-to-treat (ITT) population (all randomized participants who received at least 1 dose of study drug).
Arm/Group Title ABT-450/r/ABT-267 Plus RBV for 12 Weeks ABT-450/r/ABT-267 Plus RBV for 16 Weeks
Hide Arm/Group Description:
ABT-450/r/ABT-267 (150/100/25 mg once daily) plus weight-based RBV (400 to 1,000 mg/day, divided twice daily) for 12 weeks
ABT-450/r/ABT-267 (150/100/25 mg once daily) plus weight-based RBV (400 to 1,000 mg/day, divided twice daily) for 16 weeks
Overall Number of Participants Analyzed 48 47
Measure Type: Number
Unit of Measure: percentage of participants
75.0 91.5
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ABT-450/r/ABT-267 Plus RBV for 16 Weeks
Comments

Among non-cirrhotic treatment-naïve participants, superiority of the 16-week treatment arm to a clinically relevant threshold.

Lower bound of 95% confidence interval (LCB) must have exceeded 67% to achieve superiority. Threshold indicates value the LCB had to exceed to demonstrate superiority for the treatment arm and was based on the SVR rates with pegylated-interferon (IFN) alfa-2a or 2b/RBV in treatment-naïve, noncirrhotic HCV genotype 2-infected participants.

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter percentage of participants with SVR12
Estimated Value 91.5
Confidence Interval (2-Sided) 95%
80.1 to 96.6
Estimation Comments Tested using the following hierarchical order: among non-cirrhotic treatment-naïve participants 1) superiority of 16-week treatment arm to a clinically relevant threshold; 2) superiority of 12-week treatment arm to a clinically relevant threshold.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection ABT-450/r/ABT-267 Plus RBV for 12 Weeks
Comments

Among non-cirrhotic treatment-naïve participants, superiority of the 12-week treatment arm to a clinically relevant threshold.

LCB must have exceeded 67% to achieve superiority. Threshold indicates value the LCB had to exceed to demonstrate superiority for the treatment arm and was based on the SVR rates with pegylated-IFN alfa-2a or 2b/RBV in treatment-naïve, noncirrhotic HCV genotype 2-infected participants.

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter percentage of participants with SVR12
Estimated Value 75.0
Confidence Interval (2-Sided) 95%
61.2 to 85.1
Estimation Comments Tested using the following hierarchical order: among non-cirrhotic treatment-naïve participants 1) superiority of 16-week treatment arm to a clinically relevant threshold; 2) superiority of 12-week treatment arm to a clinically relevant threshold.
2.Secondary Outcome
Title Percentage of Participants in Each Treatment Arm With On-treatment Virologic Failure During the Treatment Period
Hide Description On-treatment virologic failure was defined as rebound (confirmed HCV RNA ≥ LLOQ after HCV RNA < LLOQ during treatment, or confirmed increase from nadir in HCV RNA [> 1 log10 IU/mL above nadir] at any time point during treatment) or failure to suppress HCV during treatment (all on-treatment values of HCV RNA ≥ LLOQ with at least 6 weeks of treatment).
Time Frame 12 or 16 weeks (end of treatment period)
Hide Outcome Measure Data
Hide Analysis Population Description
Primary efficacy population: all treatment-naïve, noncirrhotic participants in the ITT population (all randomized participants who received at least 1 dose of study drug).
Arm/Group Title ABT-450/r/ABT-267 Plus RBV for 12 Weeks ABT-450/r/ABT-267 Plus RBV for 16 Weeks
Hide Arm/Group Description:
ABT-450/r/ABT-267 (150/100/25 mg once daily) plus weight-based RBV (400 to 1,000 mg/day, divided twice daily) for 12 weeks
ABT-450/r/ABT-267 (150/100/25 mg once daily) plus weight-based RBV (400 to 1,000 mg/day, divided twice daily) for 16 weeks
Overall Number of Participants Analyzed 48 47
Measure Type: Number
Unit of Measure: percentage of participants
Overall 8.3 8.5
Rebound 8.3 8.5
Failure to suppress 0 0
3.Secondary Outcome
Title Percentage of Participants With Post-treatment Relapse
Hide Description Relapse by post-treatment Week 12 was defined as confirmed HCV RNA ≥ LLOQ between end of treatment and 12 weeks after last actual dose of study drug for a participant with HCV RNA < LLOQ at the final treatment visit and who completed study treatment. Completion of treatment was defined as a study drug duration ≥ 77 days for the 12-week treatment arm or ≥ 105 days for the 16-week treatment arm.
Time Frame within 12 weeks after the last dose of study drug
Hide Outcome Measure Data
Hide Analysis Population Description
Primary efficacy population: all treatment-naïve, noncirrhotic participants in the ITT population (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 Plus RBV for 12 Weeks ABT-450/r/ABT-267 Plus RBV for 16 Weeks
Hide Arm/Group Description:
ABT-450/r/ABT-267 (150/100/25 mg once daily) plus weight-based RBV (400 to 1,000 mg/day, divided twice daily) for 12 weeks
ABT-450/r/ABT-267 (150/100/25 mg once daily) plus weight-based RBV (400 to 1,000 mg/day, divided twice daily) for 16 weeks
Overall Number of Participants Analyzed 41 47
Measure Type: Number
Unit of Measure: percentage of participants
12.2 0
4.Secondary Outcome
Title Percentage of Participants With SVR12 Weeks Post-treatment for Each Treatment Arm Within Different Subpopulations
Hide Description The percentage of participants with SVR12 in each treatment arm within the following subpopulations: noncirrhotic participants; noncirrhotic treatment-experienced (T-exp) participants; noncirrhotic participants who relapsed after prior IFN-based therapy (relapsers); noncirrhotic T-exp participants who were non-responders to prior IFN-based therapy; noncirrhotic T-exp participants who were intolerant to IFN-based therapy; participants with compensated cirrhosis.
Time Frame 12 weeks after last dose of study drug
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population: all randomized participants who received at least 1 dose of study drug; n=participants in given subpopulation.
Arm/Group Title ABT-450/r/ABT-267 Plus RBV for 12 Weeks ABT-450/r/ABT-267 Plus RBV for 16 Weeks
Hide Arm/Group Description:
ABT-450/r/ABT-267 (150/100/25 mg once daily) plus weight-based RBV (400 to 1,000 mg/day, divided twice daily) for 12 weeks
ABT-450/r/ABT-267 (150/100/25 mg once daily) plus weight-based RBV (400 to 1,000 mg/day, divided twice daily) for 16 weeks
Overall Number of Participants Analyzed 85 86
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
All participants; n=85, 86
72.9
(62.7 to 81.2)
81.4
(71.9 to 88.2)
Noncirrhotic participants; n=80, 80
72.5
(61.9 to 81.1)
85.0
(75.6 to 91.2)
Noncirrhotic T-exp; n=32, 33
68.8
(51.4 to 82.0)
75.8
(59.0 to 87.2)
Noncirrhotic T-exp Relapser; n=15, 16
80.0
(54.8 to 93.0)
93.8
(71.7 to 98.9)
Noncirrhotic T-exp Nonresponder; n=5, 6
40.0
(11.8 to 76.9)
50.0
(18.8 to 81.2)
Noncirrhotic T-exp IFN-intolerant; n=12, 11
66.7
(39.1 to 86.2)
63.6
(35.4 to 84.8)
Cirrhotic Participants; n=5, 6
80.0
(37.6 to 96.4)
33.3
(9.7 to 70.0)
5.Secondary Outcome
Title Percentage of Participants in Each Treatment Arm With On-treatment Virologic Failure During the Treatment Period for Each Treatment Arm Within Different Subpopulations
Hide Description

The percentage of participants with on-treatment virologic failure in each treatment arm within the following subpopulations: noncirrhotic participants; noncirrhotic treatment-experienced (T-exp) participants; participants with compensated cirrhosis.

On-treatment virologic failure was defined as rebound (confirmed HCV RNA ≥ LLOQ after HCV RNA < LLOQ during treatment, or confirmed increase from nadir in HCV RNA [> 1 log10 IU/mL above nadir] at any time point during treatment) or failure to suppress HCV during treatment (all on-treatment values of HCV RNA ≥ LLOQ with at least 6 weeks of treatment).

Time Frame 12 or 16 weeks (end of treatment period)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population: all randomized participants who received at least 1 dose of study drug; n=participants in given subpopulation.
Arm/Group Title ABT-450/r/ABT-267 Plus RBV for 12 Weeks ABT-450/r/ABT-267 Plus RBV for 16 Weeks
Hide Arm/Group Description:
ABT-450/r/ABT-267 (150/100/25 mg once daily) plus weight-based RBV (400 to 1,000 mg/day, divided twice daily) for 12 weeks
ABT-450/r/ABT-267 (150/100/25 mg once daily) plus weight-based RBV (400 to 1,000 mg/day, divided twice daily) for 16 weeks
Overall Number of Participants Analyzed 85 86
Measure Type: Number
Unit of Measure: percentage of participants
All Participants: Overall; n=85, 86 15.3 16.3
All Participants: Rebound; n=85, 86 15.3 15.1
All Participants: Failure to Suppress; n=85, 86 4.7 4.7
Noncirrhotic: Overall; n=80, 80 15.0 13.8
Noncirrhotic: Rebound; n=80, 80 15.0 12.5
Noncirrhotic: Failure to Suppress; n=80, 80 3.8 3.8
Noncirrhotic T-exp: Overall; n=32, 33 25.0 21.2
Noncirrhotic T-exp: Rebound; n=32, 33 25.0 18.2
Noncirrhotic T-exp: Failure to Suppress; n=32, 33 9.4 9.1
Cirrhotic: Overall; n=5, 6 20.0 50.0
Cirrhotic: Rebound; n=5, 6 20.0 50.0
Cirrhotic: Failure to Suppress; n=5, 6 20.0 16.7
6.Secondary Outcome
Title Percentage of Participants With Post-treatment Relapse Within Different Subpopulations
Hide Description

The percentage of participants with relapse by post-treatment Week 12 in each treatment arm within the following subpopulations: noncirrhotic participants; noncirrhotic treatment-experienced (T-exp) participants; participants with compensated cirrhosis.

Relapse by post-treatment Week 12 was defined as confirmed HCV RNA ≥ LLOQ between end of treatment and 12 weeks after last actual dose of study drug for a participant with HCV RNA < LLOQ at the final treatment visit and who completed study treatment. Completion of treatment was defined as a study drug duration ≥ 77 days for the 12-week treatment arm or ≥ 105 days for the 16-week treatment arm.

Time Frame within 12 weeks after the last dose of study drug
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population: all randomized participants who received at least 1 dose of study drug with HCV RNA < LLOQ at the final treatment visit who completed treatment; n=participants in given subpopulation.
Arm/Group Title ABT-450/r/ABT-267 Plus RBV for 12 Weeks ABT-450/r/ABT-267 Plus RBV for 16 Weeks
Hide Arm/Group Description:
ABT-450/r/ABT-267 (150/100/25 mg once daily) plus weight-based RBV (400 to 1,000 mg/day, divided twice daily) for 12 weeks
ABT-450/r/ABT-267 (150/100/25 mg once daily) plus weight-based RBV (400 to 1,000 mg/day, divided twice daily) for 16 weeks
Overall Number of Participants Analyzed 69 70
Measure Type: Number
Unit of Measure: percentage of participants
All Participants; n=69, 70 10.1 0
Noncirrhotic Participants; n=65, 68 10.8 0
Noncirrhotic T-exp Participants; n=24, 25 8.3 0
Cirrhotic Participants; n=4, 2 0 0
Time Frame Non-serious adverse events collected from initiation of study drug through 30 days post-study drug dosing (12 weeks or 16 weeks, depending on arm assignment); serious adverse events collected from signing of Informed Consent up to Post-treatment Week 48.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title ABT-450/r/ABT-267 Plus RBV for 12 Weeks (Non-cirrhotic) ABT-450/r/ABT-267 Plus RBV for 16 Weeks (Non-cirrhotic) ABT-450/r/ABT-267 Plus RBV for 12 Weeks (Cirrhotic) ABT-450/r/ABT-267 Plus RBV for 16 Weeks (Cirrhotic)
Hide Arm/Group Description ABT-450/r/ABT-267 (150/100/25 mg once daily) plus weight-based RBV (400 to 1,000 mg/day, divided twice daily) for 12 weeks in non-cirrhotic participants ABT-450/r/ABT-267 (150/100/25 mg once daily) plus weight-based RBV (400 to 1,000 mg/day, divided twice daily) for 16 weeks in non-cirrhotic participants ABT-450/r/ABT-267 (150/100/25 mg once daily) plus weight-based RBV (400 to 1,000 mg/day, divided twice daily) for 12 weeks in cirrhotic participants ABT-450/r/ABT-267 (150/100/25 mg once daily) plus weight-based RBV (400 to 1,000 mg/day, divided twice daily) for 16 weeks in cirrhotic participants
All-Cause Mortality
ABT-450/r/ABT-267 Plus RBV for 12 Weeks (Non-cirrhotic) ABT-450/r/ABT-267 Plus RBV for 16 Weeks (Non-cirrhotic) ABT-450/r/ABT-267 Plus RBV for 12 Weeks (Cirrhotic) ABT-450/r/ABT-267 Plus RBV for 16 Weeks (Cirrhotic)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Hide Serious Adverse Events
ABT-450/r/ABT-267 Plus RBV for 12 Weeks (Non-cirrhotic) ABT-450/r/ABT-267 Plus RBV for 16 Weeks (Non-cirrhotic) ABT-450/r/ABT-267 Plus RBV for 12 Weeks (Cirrhotic) ABT-450/r/ABT-267 Plus RBV for 16 Weeks (Cirrhotic)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/80 (0.00%)   3/80 (3.75%)   0/5 (0.00%)   0/6 (0.00%) 
Gastrointestinal disorders         
GASTRITIS ALCOHOLIC  1  0/80 (0.00%)  1/80 (1.25%)  0/5 (0.00%)  0/6 (0.00%) 
Infections and infestations         
BRONCHOPNEUMONIA  1  0/80 (0.00%)  1/80 (1.25%)  0/5 (0.00%)  0/6 (0.00%) 
Injury, poisoning and procedural complications         
INCISIONAL HERNIA  1  0/80 (0.00%)  1/80 (1.25%)  0/5 (0.00%)  0/6 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 17.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
ABT-450/r/ABT-267 Plus RBV for 12 Weeks (Non-cirrhotic) ABT-450/r/ABT-267 Plus RBV for 16 Weeks (Non-cirrhotic) ABT-450/r/ABT-267 Plus RBV for 12 Weeks (Cirrhotic) ABT-450/r/ABT-267 Plus RBV for 16 Weeks (Cirrhotic)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   52/80 (65.00%)   53/80 (66.25%)   3/5 (60.00%)   4/6 (66.67%) 
Blood and lymphatic system disorders         
ANAEMIA  1  16/80 (20.00%)  20/80 (25.00%)  0/5 (0.00%)  1/6 (16.67%) 
Cardiac disorders         
PALPITATIONS  1  1/80 (1.25%)  0/80 (0.00%)  0/5 (0.00%)  1/6 (16.67%) 
Eye disorders         
VITREOUS HAEMORRHAGE  1  0/80 (0.00%)  0/80 (0.00%)  0/5 (0.00%)  1/6 (16.67%) 
Gastrointestinal disorders         
DIARRHOEA  1  4/80 (5.00%)  0/80 (0.00%)  0/5 (0.00%)  1/6 (16.67%) 
NAUSEA  1  5/80 (6.25%)  3/80 (3.75%)  0/5 (0.00%)  0/6 (0.00%) 
General disorders         
FATIGUE  1  6/80 (7.50%)  2/80 (2.50%)  0/5 (0.00%)  0/6 (0.00%) 
MALAISE  1  4/80 (5.00%)  7/80 (8.75%)  0/5 (0.00%)  0/6 (0.00%) 
PYREXIA  1  2/80 (2.50%)  4/80 (5.00%)  0/5 (0.00%)  0/6 (0.00%) 
Infections and infestations         
NASOPHARYNGITIS  1  10/80 (12.50%)  13/80 (16.25%)  0/5 (0.00%)  0/6 (0.00%) 
Injury, poisoning and procedural complications         
CONTUSION  1  0/80 (0.00%)  4/80 (5.00%)  0/5 (0.00%)  0/6 (0.00%) 
HEAT ILLNESS  1  0/80 (0.00%)  0/80 (0.00%)  1/5 (20.00%)  0/6 (0.00%) 
Investigations         
BLOOD BILIRUBIN INCREASED  1  16/80 (20.00%)  14/80 (17.50%)  0/5 (0.00%)  1/6 (16.67%) 
BLOOD CHOLESTEROL DECREASED  1  3/80 (3.75%)  4/80 (5.00%)  0/5 (0.00%)  0/6 (0.00%) 
HAEMOGLOBIN DECREASED  1  6/80 (7.50%)  4/80 (5.00%)  1/5 (20.00%)  0/6 (0.00%) 
NEUTROPHIL COUNT DECREASED  1  1/80 (1.25%)  4/80 (5.00%)  0/5 (0.00%)  0/6 (0.00%) 
RED BLOOD CELL COUNT DECREASED  1  4/80 (5.00%)  3/80 (3.75%)  0/5 (0.00%)  0/6 (0.00%) 
RETICULOCYTE COUNT INCREASED  1  6/80 (7.50%)  5/80 (6.25%)  0/5 (0.00%)  0/6 (0.00%) 
WHITE BLOOD CELL COUNT DECREASED  1  1/80 (1.25%)  4/80 (5.00%)  0/5 (0.00%)  0/6 (0.00%) 
BLOOD URIC ACID INCREASED  1  0/80 (0.00%)  0/80 (0.00%)  1/5 (20.00%)  0/6 (0.00%) 
Musculoskeletal and connective tissue disorders         
MUSCULOSKELETAL STIFFNESS  1  0/80 (0.00%)  0/80 (0.00%)  1/5 (20.00%)  0/6 (0.00%) 
Nervous system disorders         
HEADACHE  1  11/80 (13.75%)  6/80 (7.50%)  1/5 (20.00%)  0/6 (0.00%) 
DIZZINESS  1  2/80 (2.50%)  2/80 (2.50%)  0/5 (0.00%)  1/6 (16.67%) 
SOMNOLENCE  1  0/80 (0.00%)  0/80 (0.00%)  1/5 (20.00%)  0/6 (0.00%) 
Renal and urinary disorders         
POLLAKIURIA  1  0/80 (0.00%)  0/80 (0.00%)  1/5 (20.00%)  0/6 (0.00%) 
URINARY RETENTION  1  0/80 (0.00%)  0/80 (0.00%)  1/5 (20.00%)  0/6 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
COUGH  1  4/80 (5.00%)  5/80 (6.25%)  0/5 (0.00%)  0/6 (0.00%) 
Skin and subcutaneous tissue disorders         
PRURITUS  1  7/80 (8.75%)  9/80 (11.25%)  0/5 (0.00%)  1/6 (16.67%) 
RASH  1  4/80 (5.00%)  4/80 (5.00%)  0/5 (0.00%)  0/6 (0.00%) 
PRURITUS GENERALISED  1  0/80 (0.00%)  1/80 (1.25%)  1/5 (20.00%)  0/6 (0.00%) 
Vascular disorders         
HOT FLUSH  1  0/80 (0.00%)  1/80 (1.25%)  1/5 (20.00%)  0/6 (0.00%) 
HYPOTENSION  1  2/80 (2.50%)  0/80 (0.00%)  0/5 (0.00%)  1/6 (16.67%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 17.0
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
Phone: 800-633-9110
Layout table for additonal information
Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT02023112    
Other Study ID Numbers: M14-153
First Submitted: December 23, 2013
First Posted: December 30, 2013
Results First Submitted: April 7, 2016
Results First Posted: May 13, 2016
Last Update Posted: October 24, 2016