ClinicalTrials.gov
ClinicalTrials.gov Menu

Study of the Efficacy and Safety of Empegfilgrastim for Neutropenia Prophylaxis in Breast Cancer Patients

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: NCT02104830
Recruitment Status : Completed
First Posted : April 4, 2014
Results First Posted : October 24, 2016
Last Update Posted : October 24, 2016
Sponsor:
Information provided by (Responsible Party):
Biocad

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Supportive Care
Condition Chemotherapy-induced Neutropenia
Interventions Biological: Empegfilrastim 6 mg
Biological: Filgrastim
Biological: Placebo №1
Biological: Placebo №2
Biological: Empegfilrastim 7.5 mg
Enrollment 135
Recruitment Details  
Pre-assignment Details 7 patients were withdrawn for various reasons without receiving any dose of any of the studied products.
Arm/Group Title Empegfilgrastim 6 mg Empegfilgrastim 7.5 mg Filgrastim
Hide Arm/Group Description

Patients will receive a single administration of empegfilgrastim at a dose of 6 mg subcutaneously , 24 h after the chemotherapy

Placebo №2: Placebo №2 should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. Placebo №2 is supplied as solution for injection 0.0083 ml/kg.

Patients will receive a single administration of empegfilgrastim at a dose of 7.5 mg subcutaneously, 24 h after the chemotherapy

Placebo №2: Placebo №2 should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. Placebo №2 is supplied as solution for injection 0.0083 ml/kg.

Patients will receive filgrastim at a dose of 5 μg/kg subcutaneously daily (until ANC 10 000/μL or for 14 days, whichever occurred first), starting 24 h after the chemotherapy

Placebo №1: Placebo №1 is supplied as solution for injection 1.0 ml. Placebo №1 is to be administered 24 h after the chemotherapy at dose of 1.0.

Period Title: Overall Study
Started 42 43 43
Completed 38 36 36
Not Completed 4 7 7
Arm/Group Title Empegfilgrastim 6 mg Empegfilgrastim 7.5 mg Filgrastim Total
Hide Arm/Group Description

Patients will receive a single administration of empegfilgrastim at a dose of 6 mg subcutaneously, 24 h after the chemotherapy and placebo #2 in a dose of 0.0083 ml/kg in 24-27 hour after chemotherapy, then patient received placebo #2 in dose 0.0083 ml/kg until ANC ≥ 10x109/L or during 14 days

empegfilrastim 6 mg: Empegfilgrastim is supplied as solution for injection 3 mg/ml. Empegfilgrastim is to be administered 24 h after the chemotherapy at dose of 6 mg.

Placebo №2: Placebo №2 should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. Placebo №2 is supplied as solution for injection 0.0083 ml/kg.

Patients will receive a single administration of empegfilgrastim at a dose of 7.5 mg subcutaneously, 24 h after the chemotherapy and placebo #2 in a dose of 0.0083 ml/kg in 24-27 hour after chemotherapy, then patient received placebo #2 in dose 0.0083 ml/kg until ANC ≥ 10x109/L or during 14 days

Placebo №2: Placebo №2 should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. Placebo №2 is supplied as solution for injection 0.0083 ml/kg.

empegfilrastim 7.5 mg: Empegfilgrastim is supplied as solution for injection 3 mg/ml.

Empegfilgrastim is to be administered 24 h after the chemotherapy at dose of 6 mg.

Patients will receive filgrastim at a dose of 5 μg/kg subcutaneously daily (until ANC 10 000/μL or for 14 days, whichever occurred first), starting 24 h after the chemotherapy and placebo #1 in dose 1.0 ml ubcutaneously, 24 h after the chemotherapy.

filgrastim: Filgrastim should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. Filgrastim should be administered daily for up to 2 weeks until the ANC has reached 10 000/mm3 following the expected chemotherapy-induced neutrophil nadir.

Placebo №1: Placebo №1 is supplied as solution for injection 1.0 ml. Placebo №1 is to be administered 24 h after the chemotherapy at dose of 1.0.

Total of all reporting groups
Overall Number of Baseline Participants 42 43 43 128
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 42 participants 43 participants 43 participants 128 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
42
 100.0%
43
 100.0%
43
 100.0%
128
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 42 participants 43 participants 43 participants 128 participants
48.38  (11.07) 50.42  (9.19) 51.86  (9.68) 50.23  (10.03)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 42 participants 43 participants 43 participants 128 participants
Female
42
 100.0%
43
 100.0%
43
 100.0%
128
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Russian Federation Number Analyzed 42 participants 43 participants 43 participants 128 participants
42 43 43 128
Histologic type  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 42 participants 43 participants 43 participants 128 participants
Infiltrative ductal 27 28 33 88
Infiltrative lobular 6 3 2 11
Medullar 0 1 0 1
Squamous cell cancer 0 1 0 1
Infiltrative not specified 4 5 4 13
Low-grade differentiated carcinoma 2 3 1 6
Undifferentiated cancer 3 2 3 8
Disease stage  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 42 participants 43 participants 43 participants 128 participants
IIA 13 12 10 35
IIB 5 7 9 21
IIIA 5 7 10 22
IIIB 12 10 8 30
IIIС 2 1 0 3
IV 5 6 6 17
History previous therapy of breast cancer   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 42 participants 43 participants 43 participants 128 participants
Adjuvant chemotherapy 7 8 10 25
Neoadjuvant chemotherapy 1 1 0 2
Radiotherapy 8 4 3 15
Hormone therapy 6 7 4 17
Surgery treatment 28 27 22 77
Any treatment 28 29 26 83
[1]
Measure Description: Patients with previous therapy could be treated with several different types of therapy (for example surgery treatment and adjuvant chemotherapy)
Duration of a disease  
Mean (Full Range)
Unit of measure:  Months
Number Analyzed 42 participants 43 participants 43 participants 128 participants
16.14
(1.0 to 144.0)
11.62
(1.0 to 144.0)
5.37
(1.0 to 51.0)
11.0
(1.0 to 144.0)
1.Primary Outcome
Title Duration of Neutropenia CTCAE Grade 4
Hide Description The primary endpoint, which will allow to compare the efficacy of the single dose of Extimia® versus nonpegylated daily filgrastim is the number of breast cancer patients developing CTCAE grade 3/4 neutropenia after the first AT chemotherapy cycle (doxorubicin+docetaxel).
Time Frame 3 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The efficacy analysis included only those patients who received at least one dose of study drug, and who were participated in the study for 2 weeks or more.
Arm/Group Title Empegfilgrastim 6 mg Empegfilgrastim 7.5 mg Filgrastim
Hide Arm/Group Description:

Patients will receive a single administration of empegfilgrastim at a dose of 6 mg subcutaneously , 24 h after the chemotherapy

Placebo №2: Placebo №2 should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. Placebo №2 is supplied as solution for injection 0.0083 ml/kg.

Patients will receive a single administration of empegfilgrastim at a dose of 7.5 mg subcutaneously, 24 h after the chemotherapy

Placebo №2: Placebo №2 should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. Placebo №2 is supplied as solution for injection 0.0083 ml/kg.

Patients will receive filgrastim at a dose of 5 μg/kg subcutaneously daily (until ANC 10 000/μL or for 14 days, whichever occurred first), starting 24 h after the chemotherapy

Placebo №1: Placebo №1 is supplied as solution for injection 1.0 ml. Placebo №1 is to be administered 24 h after the chemotherapy at dose of 1.0.

Overall Number of Participants Analyzed 42 43 40
Mean (Standard Deviation)
Unit of Measure: days
0.905  (1.206) 0.791  (1.013) 1.725  (1.519)
2.Secondary Outcome
Title The Duration of Grade 4 Neutropenia From the 2nd (Week 6) to 4th Cycle (Week 12);
Hide Description [Not Specified]
Time Frame 2nd cycle (week 6), 3rd cycle (week 9), 4th cycle (week 12)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The efficacy analysis included only those patients who received at least one dose of study drug, and who were participated in the study for 2 weeks or more.
Arm/Group Title Empegfilgrastim 6 mg Empegfilgrastim 7.5 mg Filgrastim
Hide Arm/Group Description:

Patients will receive a single administration of empegfilgrastim at a dose of 6 mg subcutaneously , 24 h after the chemotherapy

Placebo №2: Placebo №2 should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. Placebo №2 is supplied as solution for injection 0.0083 ml/kg.

Patients will receive a single administration of empegfilgrastim at a dose of 7.5 mg subcutaneously, 24 h after the chemotherapy

Placebo №2: Placebo №2 should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. Placebo №2 is supplied as solution for injection 0.0083 ml/kg.

Patients will receive filgrastim at a dose of 5 μg/kg subcutaneously daily (until ANC 10 000/μL or for 14 days, whichever occurred first), starting 24 h after the chemotherapy

Placebo №1: Placebo №1 is supplied as solution for injection 1.0 ml. Placebo №1 is to be administered 24 h after the chemotherapy at dose of 1.0.

Overall Number of Participants Analyzed 42 43 40
Mean (Standard Deviation)
Unit of Measure: days
2nd cycle (week 6) 0.452  (1.194) 0.326  (0.919) 0.925  (1.385)
3rd cycle (week 9) 0.244  (0.734) 0.310  (0.680) 0.641  (0.932)
4th cycle (week 12) 0.195  (0.601) 0.475  (1.320) 0.892  (1.197)
3.Secondary Outcome
Title The Incidence of Severe Neutropenia (Grade 3-4)
Hide Description [Not Specified]
Time Frame 16 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The efficacy analysis included only those patients who received at least one dose of study drug, and who were participated in the study for 2 weeks or more.
Arm/Group Title Empegfilgrastim 6 mg Empegfilgrastim 7.5 mg Filgrastim
Hide Arm/Group Description:

Patients will receive a single administration of empegfilgrastim at a dose of 6 mg subcutaneously , 24 h after the chemotherapy

Placebo №2: Placebo №2 should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. Placebo №2 is supplied as solution for injection 0.0083 ml/kg.

Patients will receive a single administration of empegfilgrastim at a dose of 7.5 mg subcutaneously, 24 h after the chemotherapy

Placebo №2: Placebo №2 should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. Placebo №2 is supplied as solution for injection 0.0083 ml/kg.

Patients will receive filgrastim at a dose of 5 μg/kg subcutaneously daily (until ANC 10 000/μL or for 14 days, whichever occurred first), starting 24 h after the chemotherapy

Placebo №1: Placebo №1 is supplied as solution for injection 1.0 ml. Placebo №1 is to be administered 24 h after the chemotherapy at dose of 1.0.

Overall Number of Participants Analyzed 42 43 40
Measure Type: Number
Unit of Measure: participants
40 34 40
4.Secondary Outcome
Title Low Level (Nadir) ANC x 10^9/L
Hide Description [Not Specified]
Time Frame 1st cycle (week 3), 2nd cycle (week 6), 3rd cycle (week 9), 4th cycle (week 12)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The efficacy analysis included only those patients who received at least one dose of study drug, and who were participated in the study for 2 weeks or more.
Arm/Group Title Empegfilgrastim 6 mg Empegfilgrastim 7.5 mg Filgrastim
Hide Arm/Group Description:

Patients will receive a single administration of empegfilgrastim at a dose of 6 mg subcutaneously , 24 h after the chemotherapy

Placebo №2: Placebo №2 should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. Placebo №2 is supplied as solution for injection 0.0083 ml/kg.

Patients will receive a single administration of empegfilgrastim at a dose of 7.5 mg subcutaneously, 24 h after the chemotherapy

Placebo №2: Placebo №2 should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. Placebo №2 is supplied as solution for injection 0.0083 ml/kg.

Patients will receive filgrastim at a dose of 5 μg/kg subcutaneously daily (until ANC 10 000/μL or for 14 days, whichever occurred first), starting 24 h after the chemotherapy

Placebo №1: Placebo №1 is supplied as solution for injection 1.0 ml. Placebo №1 is to be administered 24 h after the chemotherapy at dose of 1.0.

Overall Number of Participants Analyzed 42 43 40
Mean (Standard Deviation)
Unit of Measure: cells x 10^9/L
1st cycle (week 3) 0.68  (0.68) 0.91  (1.11) 0.47  (0.74)
2nd cycle (week 6) 1.44  (1.30) 2.10  (1.78) 0.87  (1.12)
3rd cycle (week 9) 1.77  (1.39) 1.88  (1.71) 0.94  (1.04)
4th cycle (week 12) 1.67  (1.12) 2.07  (1.75) 0.75  (0.87)
5.Secondary Outcome
Title Neutropenia Duration, Any Grade
Hide Description [Not Specified]
Time Frame 1st cycle (week 3), 2nd cycle (week 6), 3rd cycle (week 9), 4th cycle (week 12)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The efficacy analysis included only those patients who received at least one dose of study drug, and who were participated in the study for 2 weeks or more.
Arm/Group Title Empegfilgrastim 6 mg Empegfilgrastim 7.5 mg Filgrastim
Hide Arm/Group Description:

Patients will receive a single administration of empegfilgrastim at a dose of 6 mg subcutaneously , 24 h after the chemotherapy

Placebo №2: Placebo №2 should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. Placebo №2 is supplied as solution for injection 0.0083 ml/kg.

Patients will receive a single administration of empegfilgrastim at a dose of 7.5 mg subcutaneously, 24 h after the chemotherapy

Placebo №2: Placebo №2 should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. Placebo №2 is supplied as solution for injection 0.0083 ml/kg.

Patients will receive filgrastim at a dose of 5 μg/kg subcutaneously daily (until ANC 10 000/μL or for 14 days, whichever occurred first), starting 24 h after the chemotherapy

Placebo №1: Placebo №1 is supplied as solution for injection 1.0 ml. Placebo №1 is to be administered 24 h after the chemotherapy at dose of 1.0.

Overall Number of Participants Analyzed 42 43 40
Mean (Standard Deviation)
Unit of Measure: days
1st cycle (week 3) 2.214  (1.152) 1.953  (1.194) 4.0  (3.121)
2nd cycle (week 6) 1.881  (2.276) 1.233  (1.702) 2.775  (2.434)
3rd cycle (week 9) 1.585  (1.897) 1.024  (1.199) 2.487  (2.480)
4th cycle (week 12) 1.146  (1.195) 1.525  (2.364) 2.919  (2.488)
6.Secondary Outcome
Title Duration From ANC Nadir to ANC < 2.0 x 10^9/L
Hide Description [Not Specified]
Time Frame 1st cycle (week 3), 2nd cycle (week 6), 3rd cycle (week 9), 4th cycle (week 12)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The efficacy analysis included only those patients who received at least one dose of study drug, and who were participated in the study for 2 weeks or more.
Arm/Group Title Empegfilgrastim 6 mg Empegfilgrastim 7.5 mg Filgrastim
Hide Arm/Group Description:

Patients will receive a single administration of empegfilgrastim at a dose of 6 mg subcutaneously , 24 h after the chemotherapy

Placebo №2: Placebo №2 should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. Placebo №2 is supplied as solution for injection 0.0083 ml/kg.

Patients will receive a single administration of empegfilgrastim at a dose of 7.5 mg subcutaneously, 24 h after the chemotherapy

Placebo №2: Placebo №2 should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. Placebo №2 is supplied as solution for injection 0.0083 ml/kg.

Patients will receive filgrastim at a dose of 5 μg/kg subcutaneously daily (until ANC 10 000/μL or for 14 days, whichever occurred first), starting 24 h after the chemotherapy

Placebo №1: Placebo №1 is supplied as solution for injection 1.0 ml. Placebo №1 is to be administered 24 h after the chemotherapy at dose of 1.0.

Overall Number of Participants Analyzed 42 43 40
Mean (Standard Deviation)
Unit of Measure: days
1st cycle (week 3) 1.74  (0.98) 1.51  (0.86) 2.98  (2.40)
2nd cycle (week 6) 1.43  (1.29) 1.05  (1.31) 2.05  (1.08)
3rd cycle (week 9) 1.20  (1.21) 0.98  (0.90) 1.90  (1.87)
4th cycle (week 12) 1.12  (1.05) 1.03  (1.20) 2.14  (1.70)
Time Frame 3 month
Adverse Event Reporting Description In general, any AEs were reported in all patients in both groups over a period of study. The vast majority of AEs were due to myelosuppressive chemotherapy. When comparing the frequency of registration of individual AEs there was no significant difference. AEs specific for all G-CSF drugs were observed rarely.
 
Arm/Group Title Empegfilgrastim 6 mg Empegfilgrastim 7.5 mg Filgrastim
Hide Arm/Group Description

Patients will receive a single administration of empegfilgrastim at a dose of 6 mg subcutaneously , 24 h after the chemotherapy

Placebo №2: Placebo №2 should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. Placebo №2 is supplied as solution for injection 0.0083 ml/kg.

Patients will receive a single administration of empegfilgrastim at a dose of 7.5 mg subcutaneously, 24 h after the chemotherapy

Placebo №2: Placebo №2 should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. Placebo №2 is supplied as solution for injection 0.0083 ml/kg.

Patients will receive filgrastim at a dose of 5 μg/kg subcutaneously daily (until ANC 10 000/μL or for 14 days, whichever occurred first), starting 24 h after the chemotherapy

Placebo №1: Placebo №1 is supplied as solution for injection 1.0 ml. Placebo №1 is to be administered 24 h after the chemotherapy at dose of 1.0.

All-Cause Mortality
Empegfilgrastim 6 mg Empegfilgrastim 7.5 mg Filgrastim
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Empegfilgrastim 6 mg Empegfilgrastim 7.5 mg Filgrastim
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/42 (2.38%)      1/43 (2.33%)      5/43 (11.63%)    
Blood and lymphatic system disorders       
Febrile neutropenia  1  0/42 (0.00%)  0 1/43 (2.33%)  1 1/43 (2.33%)  1
Agranulocytosis  1  0/42 (0.00%)  0 0/43 (0.00%)  0 1/43 (2.33%)  1
Infections and infestations       
nose furunculus 3 grade  1  0/42 (0.00%)  0 0/43 (0.00%)  0 1/43 (2.33%)  1
Musculoskeletal and connective tissue disorders       
Left hand fracture  1  0/42 (0.00%)  0 0/43 (0.00%)  0 1/43 (2.33%)  1
Reproductive system and breast disorders       
Uterine bleeding  1  1/42 (2.38%)  1 0/43 (0.00%)  0 0/43 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Pneumonia  1  0/42 (0.00%)  0 0/43 (0.00%)  0 1/43 (2.33%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (4.03)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Empegfilgrastim 6 mg Empegfilgrastim 7.5 mg Filgrastim
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   42/42 (100.00%)      43/43 (100.00%)      43/43 (100.00%)    
Blood and lymphatic system disorders       
neutropenia any grade  1  41/42 (97.62%)  41 37/43 (86.05%)  37 41/43 (95.35%)  41
Anemia  1  17/42 (40.48%)  17 13/43 (30.23%)  13 19/43 (44.19%)  19
Leucopenia  1  41/42 (97.62%)  41 38/43 (88.37%)  38 41/43 (95.35%)  41
Febrile neutropenia  1  1/42 (2.38%)  1 3/43 (6.98%)  3 2/43 (4.65%)  2
Endocrine disorders       
Hyperglycemia  1  6/42 (14.29%)  6 8/43 (18.60%)  8 9/43 (20.93%)  9
Gastrointestinal disorders       
Abdominal pain  1  2/42 (4.76%)  2 2/43 (4.65%)  2 1/43 (2.33%)  1
General disorders       
Weakness / asthenia  1  26/42 (61.90%)  26 24/43 (55.81%)  24 24/43 (55.81%)  24
Fever  1  2/42 (4.76%)  2 3/43 (6.98%)  3 2/43 (4.65%)  2
Headache  1  1/42 (2.38%)  1 1/43 (2.33%)  1 2/43 (4.65%)  2
Hepatobiliary disorders       
Hyperbilirubinemia  1  7/42 (16.67%)  7 7/43 (16.28%)  7 2/43 (4.65%)  2
Liver enzymes (ALT) elevation  1  4/42 (9.52%)  4 2/43 (4.65%)  2 2/43 (4.65%)  2
Injury, poisoning and procedural complications       
Hyperemia after injection  1  3/42 (7.14%)  3 0/43 (0.00%)  0 0/43 (0.00%)  0
Musculoskeletal and connective tissue disorders       
Bone pain  1  4/42 (9.52%)  4 4/43 (9.30%)  4 2/43 (4.65%)  2
Myalgia  1  3/42 (7.14%)  3 2/43 (4.65%)  2 2/43 (4.65%)  2
Arthralgia  1  6/42 (14.29%)  6 3/43 (6.98%)  3 3/43 (6.98%)  3
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (4.03)
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Roman Ivanov, Director of Clinical Trials
Organization: Biocad
Phone: +7 (812) 380 49 33 ext 950
Responsible Party: Biocad
ClinicalTrials.gov Identifier: NCT02104830     History of Changes
Other Study ID Numbers: BCD-017-3
First Submitted: April 2, 2014
First Posted: April 4, 2014
Results First Submitted: February 5, 2015
Results First Posted: October 24, 2016
Last Update Posted: October 24, 2016