Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 24 of 128 for:    Venetoclax AND complete response

A Phase 2 Study of ABT-199 in Subjects With Acute Myelogenous Leukemia (AML)

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: NCT01994837
Recruitment Status : Completed
First Posted : November 26, 2013
Results First Posted : January 23, 2018
Last Update Posted : June 5, 2018
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
AbbVie

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Acute Myelogenous Leukemia
AML
Acute Myeloid Leukemia
Intervention Drug: ABT-199
Enrollment 32
Recruitment Details  
Pre-assignment Details All participants who received at least 1 dose of study drug
Arm/Group Title ABT-199
Hide Arm/Group Description Continuous dosing of venetoclax (ABT-199) QD (once daily) beginning with dose-escalation on Week 1 Day 1. Participants received a dose of 20 mg of ABT-199 on Week 1 Day 1, 50 mg on Day 2, 100 mg on Day 3, 200 mg on Day 4, 400 mg on Day 5, 800 mg on Day 6 and QD thereafter.
Period Title: Overall Study
Started 32
Treated 32
Completed 0
Not Completed 32
Reason Not Completed
Progressive disease per protocol             23
Adv event related to progressive disease             3
Fatal progressive disease             2
Adverse event not related to progression             1
Chose palliative care             1
Proceeded to transplant             1
Removed from study due to no response             1
Arm/Group Title ABT-199
Hide Arm/Group Description Continuous dosing of venetoclax (ABT-199) QD (once daily) beginning with dose-escalation on Week 1 Day 1. Participants received a dose of 20 mg of ABT-199 on Week 1 Day 1, 50 mg on Day 2, 100 mg on Day 3, 200 mg on Day 4, 400 mg on Day 5, 800 mg on Day 6 and QD thereafter.
Overall Number of Baseline Participants 32
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 32 participants
65.9  (14.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 32 participants
Female
16
  50.0%
Male
16
  50.0%
1.Primary Outcome
Title Objective Remission Rate
Hide Description The objective remission rate (ORR) was defined as the percentage of participants who achieved complete remission (CR), complete remission with incomplete bone marrow recovery (CRi), or partial remission (PR) per the International Working Group criteria for AML. Complete remission (CR) was defined as peripheral neutrophils at least 10˄3/μL, platelets ≥ 10˄5/μL and normocellular bone marrow with ≤ 5% blasts. Complete remission with incomplete bone marrow recovery (CRi) was defined as bone marrow with less than 5% blasts, with peripheral neutrophils of at least 10˄3/μL or platelets ≥ 10˄5/μL. Partial remission (PR) was defined as normalization in peripheral blood neutrophil and platelet counts with at least a 50% decrease in blasts persisting in bone marrow versus baseline.
Time Frame When 19 participants had completed at least 12 weeks of treatment or after all enrolled participants had discontinued venetoclax, whichever was earlier
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least 1 dose of study drug
Arm/Group Title ABT-199
Hide Arm/Group Description:
Continuous dosing of venetoclax (ABT-199) QD (once daily) beginning with dose-escalation on Week 1 Day 1. Participants received a dose of 20 mg of ABT-199 on Week 1 Day 1, 50 mg on Day 2, 100 mg on Day 3, 200 mg on Day 4, 400 mg on Day 5, 800 mg on Day 6 and QD thereafter.
Overall Number of Participants Analyzed 32
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
18.8
(7.2 to 36.4)
2.Secondary Outcome
Title Complete Remission Rate
Hide Description The complete remission (CR) rate was defined as the percentage of participants who achieved CR per the International Working Group criteria for AML. Complete remission was defined as peripheral neutrophils at least 10˄3/μL, platelets ≥ 10˄5/μL and normocellular bone marrow with ≤ 5% blasts.
Time Frame When 19 participants had completed at least 12 weeks of treatment or after all enrolled participants had discontinued venetoclax, whichever was earlier
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least 1 dose of study drug
Arm/Group Title ABT-199
Hide Arm/Group Description:
Continuous dosing of venetoclax (ABT-199) QD (once daily) beginning with dose-escalation on Week 1 Day 1. Participants received a dose of 20 mg of ABT-199 on Week 1 Day 1, 50 mg on Day 2, 100 mg on Day 3, 200 mg on Day 4, 400 mg on Day 5, 800 mg on Day 6 and QD thereafter.
Overall Number of Participants Analyzed 32
Measure Type: Number
Unit of Measure: percentage of participants
6.3
3.Secondary Outcome
Title Duration of Remission
Hide Description Duration of remission was defined as the number of days from the date of first remission (CR, CRi, or PR) per the International Working Group criteria for AML to the earliest recurrence or progressive disease (PD). In this study, the duration of remission analysis was not performed because of the low remission rate, per the Statistical Analysis Plan.
Time Frame When 19 participants had completed at least 12 weeks of treatment or after all enrolled participants had discontinued venetoclax, whichever was earlier
Hide Outcome Measure Data
Hide Analysis Population Description
The duration of remission analysis was not performed because of the low remission rate, per the Statistical Analysis Plan.
Arm/Group Title ABT-199
Hide Arm/Group Description:
Continuous dosing of venetoclax (ABT-199) QD (once daily) beginning with dose-escalation on Week 1 Day 1. Participants received a dose of 20 mg of ABT-199 on Week 1 Day 1, 50 mg on Day 2, 100 mg on Day 3, 200 mg on Day 4, 400 mg on Day 5, 800 mg on Day 6 and QD thereafter.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Time to Progression
Hide Description Time to progression was defined as the number of months from the date of enrollment to the date of earliest disease progression. If a participant did not experience disease progression, then the data for that participant was censored at the date of the last disease assessment.
Time Frame When 19 participants had completed at least 12 weeks of treatment or after all enrolled participants had discontinued venetoclax, whichever was earlier
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least 1 dose of study drug
Arm/Group Title ABT-199
Hide Arm/Group Description:
Continuous dosing of venetoclax (ABT-199) QD (once daily) beginning with dose-escalation on Week 1 Day 1. Participants received a dose of 20 mg of ABT-199 on Week 1 Day 1, 50 mg on Day 2, 100 mg on Day 3, 200 mg on Day 4, 400 mg on Day 5, 800 mg on Day 6 and QD thereafter.
Overall Number of Participants Analyzed 32
Median (95% Confidence Interval)
Unit of Measure: months
2.5
(1.0 to 3.0)
5.Secondary Outcome
Title Progression-free Survival
Hide Description Progression-free survival was defined as the number of months from the date of enrollment to the date of earliest progression or death. If a participant did not experience disease progression or death, then the data was censored at the date of the last disease assessment.
Time Frame When 19 participants had completed at least 12 weeks of treatment or after all enrolled participants had discontinued venetoclax, whichever was earlier
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least 1 dose of study drug
Arm/Group Title ABT-199
Hide Arm/Group Description:
Continuous dosing of venetoclax (ABT-199) QD (once daily) beginning with dose-escalation on Week 1 Day 1. Participants received a dose of 20 mg of ABT-199 on Week 1 Day 1, 50 mg on Day 2, 100 mg on Day 3, 200 mg on Day 4, 400 mg on Day 5, 800 mg on Day 6 and QD thereafter.
Overall Number of Participants Analyzed 32
Median (95% Confidence Interval)
Unit of Measure: months
2.3
(1.0 to 2.7)
6.Secondary Outcome
Title Overall Survival
Hide Description Overall survival was defined as the number of months from the date of enrollment to the date of death for all dosed participants. For participants who did not die, their data were censored at the date of last study visit or the last known date to be alive, whichever was later.
Time Frame Measured up to 2 years after the last subject had enrolled in the study.
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least 1 dose of study drug
Arm/Group Title ABT-199
Hide Arm/Group Description:
Continuous dosing of venetoclax (ABT-199) QD (once daily) beginning with dose-escalation on Week 1 Day 1. Participants received a dose of 20 mg of ABT-199 on Week 1 Day 1, 50 mg on Day 2, 100 mg on Day 3, 200 mg on Day 4, 400 mg on Day 5, 800 mg on Day 6 and QD thereafter.
Overall Number of Participants Analyzed 32
Median (95% Confidence Interval)
Unit of Measure: months
4.7
(2.3 to 6.0)
7.Secondary Outcome
Title Percentage of Participants Who Received Subsequent Stem Cell Transplant
Hide Description The percentage of participants who received a subsequent allogenic (from a healthy donor) stem cell transplant was summarized.
Time Frame When 19 participants had completed at least 12 weeks of treatment or after all enrolled participants had discontinued venetoclax, whichever was earlier
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least 1 dose of study drug
Arm/Group Title ABT-199
Hide Arm/Group Description:
Continuous dosing of venetoclax (ABT-199) QD (once daily) beginning with dose-escalation on Week 1 Day 1. Participants received a dose of 20 mg of ABT-199 on Week 1 Day 1, 50 mg on Day 2, 100 mg on Day 3, 200 mg on Day 4, 400 mg on Day 5, 800 mg on Day 6 and QD thereafter.
Overall Number of Participants Analyzed 32
Measure Type: Number
Unit of Measure: percentage of participants
3.1
8.Secondary Outcome
Title Rate of Minimal Residual Disease (MRD) Negativity
Hide Description The rate of minimal residual disease (MRD) response was defined as the percentage of participants who had MRD negative status. Only participants with a reported MRD assessment (negative or positive) from the local laboratory at the investigator site were used in the calculation of MRD response rate.
Time Frame When 19 participants had completed at least 12 weeks of treatment or after all enrolled participants had discontinued venetoclax, whichever was earlier
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with available data
Arm/Group Title ABT-199
Hide Arm/Group Description:
Continuous dosing of venetoclax (ABT-199) QD (once daily) beginning with dose-escalation on Week 1 Day 1. Participants received a dose of 20 mg of ABT-199 on Week 1 Day 1, 50 mg on Day 2, 100 mg on Day 3, 200 mg on Day 4, 400 mg on Day 5, 800 mg on Day 6 and QD thereafter.
Overall Number of Participants Analyzed 23
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
43.5
(23.2 to 65.5)
9.Secondary Outcome
Title Complete Remission With Incomplete Marrow Recovery (CRi) Rate
Hide Description The complete remission with incomplete bone marrow recovery (CRi) rate was defined as the percentage of participants who achieved CRi per the International Working Group criteria for AML. Complete remission with incomplete bone marrow recovery was defined as bone marrow with less than 5% blasts, with peripheral neutrophils of at least 10˄3/μL or platelets ≥ 10˄5/μL.
Time Frame When 19 participants had completed at least 12 weeks of treatment or after all enrolled participants had discontinued venetoclax, whichever was earlier
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least 1 dose of study drug
Arm/Group Title ABT-199
Hide Arm/Group Description:
Continuous dosing of venetoclax (ABT-199) QD (once daily) beginning with dose-escalation on Week 1 Day 1. Participants received a dose of 20 mg of ABT-199 on Week 1 Day 1, 50 mg on Day 2, 100 mg on Day 3, 200 mg on Day 4, 400 mg on Day 5, 800 mg on Day 6 and QD thereafter.
Overall Number of Participants Analyzed 32
Measure Type: Number
Unit of Measure: percentage of participants
12.5
10.Secondary Outcome
Title Complete Remission Rate and Complete Remission With Incomplete Marrow Recovery (CRi) Rate
Hide Description The complete remission rate and the complete remission with incomplete marrow recovery rate (Cri) was defined as the percentage of participants who achieved complete remission (CR) or complete remission with incomplete bone marrow recovery (CRi), per the International Working Group criteria for AML. Complete remission (CR) was defined as peripheral neutrophils at least 10˄3/μL, platelets ≥ 10˄5/μL and normocellular bone marrow with ≤ 5% blasts. Complete remission with incomplete bone marrow recovery (CRi) was defined as bone marrow with less than 5% blasts, with peripheral neutrophils of at least 10˄3/μL or platelets ≥ 10˄5/μL.
Time Frame When 19 participants had completed at least 12 weeks of treatment or after all enrolled participants had discontinued venetoclax, whichever was earlier
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least 1 dose of study drug
Arm/Group Title ABT-199
Hide Arm/Group Description:
Continuous dosing of venetoclax (ABT-199) QD (once daily) beginning with dose-escalation on Week 1 Day 1. Participants received a dose of 20 mg of ABT-199 on Week 1 Day 1, 50 mg on Day 2, 100 mg on Day 3, 200 mg on Day 4, 400 mg on Day 5, 800 mg on Day 6 and QD thereafter.
Overall Number of Participants Analyzed 32
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
18.8
(7.2 to 36.4)
Time Frame All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 40 weeks.
Adverse Event Reporting Description Serious adverse events occurring after the study-specific informed consent was signed but prior to the first dose of the investigational product were to be collected only if they were considered by the investigator to be causally related to the study required procedures.
 
Arm/Group Title ABT-199
Hide Arm/Group Description Continuous dosing of venetoclax (ABT-199) QD (once daily) beginning with dose-escalation on Week 1 Day 1. Participants received a dose of 20 mg of ABT-199 on Week 1 Day 1, 50 mg on Day 2, 100 mg on Day 3, 200 mg on Day 4, 400 mg on Day 5, 800 mg on Day 6 and QD thereafter.
All-Cause Mortality
ABT-199
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
ABT-199
Affected / at Risk (%)
Total   27/32 (84.38%) 
Blood and lymphatic system disorders   
FEBRILE NEUTROPENIA  1  9/32 (28.13%) 
Cardiac disorders   
ATRIAL FIBRILLATION  1  1/32 (3.13%) 
CARDIAC FAILURE CONGESTIVE  1  1/32 (3.13%) 
Congenital, familial and genetic disorders   
HYDROCELE  1  1/32 (3.13%) 
Gastrointestinal disorders   
ABDOMINAL PAIN  1  2/32 (6.25%) 
CROHN'S DISEASE  1  1/32 (3.13%) 
DIARRHOEA  1  1/32 (3.13%) 
INTRA-ABDOMINAL HAEMORRHAGE  1  1/32 (3.13%) 
MESENTERITIS  1  1/32 (3.13%) 
General disorders   
ASTHENIA  1  1/32 (3.13%) 
DEATH  1  1/32 (3.13%) 
PYREXIA  1  1/32 (3.13%) 
Infections and infestations   
BACTERAEMIA  1  1/32 (3.13%) 
CELLULITIS  1  1/32 (3.13%) 
CELLULITIS OF MALE EXTERNAL GENITAL ORGAN  1  1/32 (3.13%) 
DEVICE RELATED INFECTION  1  1/32 (3.13%) 
ENTEROCOCCAL BACTERAEMIA  1  1/32 (3.13%) 
LEPTOTRICHIA INFECTION  1  1/32 (3.13%) 
PHARYNGITIS  1  1/32 (3.13%) 
PNEUMONIA  1  5/32 (15.63%) 
PNEUMONIA FUNGAL  1  1/32 (3.13%) 
PSEUDOMONAL BACTERAEMIA  1  1/32 (3.13%) 
PSEUDOMONAS INFECTION  1  1/32 (3.13%) 
SEPSIS  1  2/32 (6.25%) 
SEPTIC SHOCK  1  1/32 (3.13%) 
SINUSITIS  1  1/32 (3.13%) 
URINARY TRACT INFECTION  1  2/32 (6.25%) 
VIRAL PHARYNGITIS  1  1/32 (3.13%) 
VULVAL CELLULITIS  1  1/32 (3.13%) 
Metabolism and nutrition disorders   
DEHYDRATION  1  1/32 (3.13%) 
FAILURE TO THRIVE  1  2/32 (6.25%) 
HYPOKALAEMIA  1  1/32 (3.13%) 
Musculoskeletal and connective tissue disorders   
MUSCULAR WEAKNESS  1  1/32 (3.13%) 
PAIN IN JAW  1  1/32 (3.13%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
ACUTE MYELOID LEUKAEMIA  1  1/32 (3.13%) 
MALIGNANT NEOPLASM PROGRESSION  1  8/32 (25.00%) 
MALIGNANT PLEURAL EFFUSION  1  1/32 (3.13%) 
Nervous system disorders   
POST HERPETIC NEURALGIA  1  1/32 (3.13%) 
PRESYNCOPE  1  1/32 (3.13%) 
Renal and urinary disorders   
RENAL FAILURE ACUTE  1  2/32 (6.25%) 
Reproductive system and breast disorders   
SCROTAL PAIN  1  1/32 (3.13%) 
Respiratory, thoracic and mediastinal disorders   
RHINORRHOEA  1  1/32 (3.13%) 
Vascular disorders   
HYPOTENSION  1  2/32 (6.25%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 17.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
ABT-199
Affected / at Risk (%)
Total   31/32 (96.88%) 
Blood and lymphatic system disorders   
ANAEMIA  1  4/32 (12.50%) 
Cardiac disorders   
ATRIAL FIBRILLATION  1  3/32 (9.38%) 
SINUS BRADYCARDIA  1  2/32 (6.25%) 
SINUS TACHYCARDIA  1  4/32 (12.50%) 
Ear and labyrinth disorders   
EAR PAIN  1  2/32 (6.25%) 
Gastrointestinal disorders   
ABDOMINAL DISTENSION  1  2/32 (6.25%) 
ABDOMINAL PAIN  1  7/32 (21.88%) 
CONSTIPATION  1  4/32 (12.50%) 
DIARRHOEA  1  17/32 (53.13%) 
DYSPEPSIA  1  3/32 (9.38%) 
GINGIVAL BLEEDING  1  2/32 (6.25%) 
HAEMORRHOIDS  1  3/32 (9.38%) 
NAUSEA  1  19/32 (59.38%) 
STOMATITIS  1  2/32 (6.25%) 
VOMITING  1  13/32 (40.63%) 
General disorders   
ASTHENIA  1  2/32 (6.25%) 
CHILLS  1  2/32 (6.25%) 
FATIGUE  1  11/32 (34.38%) 
MALAISE  1  3/32 (9.38%) 
NON-CARDIAC CHEST PAIN  1  4/32 (12.50%) 
OEDEMA PERIPHERAL  1  8/32 (25.00%) 
PYREXIA  1  6/32 (18.75%) 
Infections and infestations   
CANDIDA INFECTION  1  2/32 (6.25%) 
CONJUNCTIVITIS  1  3/32 (9.38%) 
PNEUMONIA  1  3/32 (9.38%) 
UPPER RESPIRATORY TRACT INFECTION  1  2/32 (6.25%) 
URINARY TRACT INFECTION  1  3/32 (9.38%) 
Injury, poisoning and procedural complications   
CONTUSION  1  2/32 (6.25%) 
FALL  1  3/32 (9.38%) 
LACERATION  1  2/32 (6.25%) 
Investigations   
ALANINE AMINOTRANSFERASE INCREASED  1  3/32 (9.38%) 
ASPARTATE AMINOTRANSFERASE INCREASED  1  4/32 (12.50%) 
BLOOD ALKALINE PHOSPHATASE INCREASED  1  3/32 (9.38%) 
BLOOD BILIRUBIN INCREASED  1  4/32 (12.50%) 
BLOOD CREATININE INCREASED  1  2/32 (6.25%) 
ELECTROCARDIOGRAM QT PROLONGED  1  2/32 (6.25%) 
WEIGHT DECREASED  1  2/32 (6.25%) 
WEIGHT INCREASED  1  2/32 (6.25%) 
WHITE BLOOD CELL COUNT DECREASED  1  2/32 (6.25%) 
Metabolism and nutrition disorders   
DECREASED APPETITE  1  4/32 (12.50%) 
FLUID OVERLOAD  1  2/32 (6.25%) 
HYPERGLYCAEMIA  1  4/32 (12.50%) 
HYPERKALAEMIA  1  3/32 (9.38%) 
HYPERMAGNESAEMIA  1  3/32 (9.38%) 
HYPERPHOSPHATAEMIA  1  8/32 (25.00%) 
HYPERURICAEMIA  1  2/32 (6.25%) 
HYPOALBUMINAEMIA  1  4/32 (12.50%) 
HYPOCALCAEMIA  1  8/32 (25.00%) 
HYPOKALAEMIA  1  12/32 (37.50%) 
HYPOMAGNESAEMIA  1  11/32 (34.38%) 
HYPONATRAEMIA  1  3/32 (9.38%) 
HYPOPHOSPHATAEMIA  1  10/32 (31.25%) 
Musculoskeletal and connective tissue disorders   
ARTHRALGIA  1  4/32 (12.50%) 
BACK PAIN  1  3/32 (9.38%) 
PAIN IN EXTREMITY  1  2/32 (6.25%) 
Nervous system disorders   
DIZZINESS  1  2/32 (6.25%) 
DYSGEUSIA  1  2/32 (6.25%) 
HEADACHE  1  11/32 (34.38%) 
SYNCOPE  1  2/32 (6.25%) 
TREMOR  1  2/32 (6.25%) 
Psychiatric disorders   
ANXIETY  1  3/32 (9.38%) 
DELIRIUM  1  3/32 (9.38%) 
DEPRESSION  1  2/32 (6.25%) 
INSOMNIA  1  5/32 (15.63%) 
Renal and urinary disorders   
HAEMOGLOBINURIA  1  3/32 (9.38%) 
Respiratory, thoracic and mediastinal disorders   
COUGH  1  9/32 (28.13%) 
DYSPNOEA  1  7/32 (21.88%) 
EPISTAXIS  1  8/32 (25.00%) 
HYPOXIA  1  2/32 (6.25%) 
NASAL CONGESTION  1  2/32 (6.25%) 
OROPHARYNGEAL PAIN  1  4/32 (12.50%) 
PLEURAL EFFUSION  1  2/32 (6.25%) 
PNEUMONIA ASPIRATION  1  2/32 (6.25%) 
Skin and subcutaneous tissue disorders   
PRURITUS  1  2/32 (6.25%) 
PURPURA  1  2/32 (6.25%) 
RASH MACULO-PAPULAR  1  4/32 (12.50%) 
Vascular disorders   
HYPERTENSION  1  4/32 (12.50%) 
HYPOTENSION  1  5/32 (15.63%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 17.1
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
Layout table for Results Point of Contact information
Name/Title: Global Medical Services
Organization: AbbVie
Phone: 800-633-9110
Layout table for additonal information
Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT01994837     History of Changes
Other Study ID Numbers: M14-212
First Submitted: November 20, 2013
First Posted: November 26, 2013
Results First Submitted: December 15, 2017
Results First Posted: January 23, 2018
Last Update Posted: June 5, 2018