We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Safety, Tolerability and Efficacy for CGF166 in Patients With Unilateral or Bilateral Severe-to-profound Hearing Loss

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: NCT02132130
Recruitment Status : Completed
First Posted : May 7, 2014
Results First Posted : March 30, 2021
Last Update Posted : October 8, 2021
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Unilateral Severe to Profound Hearing Loss OR Bilateral Severe to Profound Hearing Loss
Intervention Drug: CGF166
Enrollment 22
Recruitment Details A total of 22 subjects were enrolled in the study, of which 19 completed the study and 2 subjects discontinued due to lost to follow-up and 1 subject withdrew consent
Pre-assignment Details Safety analysis set comprised all subjects who received study drug and with no protocol deviations having relevant impact on safety.
Arm/Group Title CGF166 Dose 20 μL CGF166 Dose 30 μL CGF166 Dose 40 μL CGF166 Dose 60 μL
Hide Arm/Group Description single dose volume #1 single dose volume #2 single dose volume #3 single dose volume #4
Period Title: Overall Study
Started 3 12 4 3
Completed 3 10 4 2
Not Completed 0 2 0 1
Reason Not Completed
Lost to Follow-up             0             2             0             0
Withdrawal by Subject             0             0             0             1
Arm/Group Title CGF166 Dose 20 μL CGF166 Dose 30 μL CGF166 Dose 40 μL CGF166 Dose 60 μL Total
Hide Arm/Group Description single dose volume #1 single dose volume #2 single dose volume #3 single dose volume #4 Total of all reporting groups
Overall Number of Baseline Participants 3 12 4 3 22
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 12 participants 4 participants 3 participants 22 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
3
 100.0%
9
  75.0%
3
  75.0%
2
  66.7%
17
  77.3%
>=65 years
0
   0.0%
3
  25.0%
1
  25.0%
1
  33.3%
5
  22.7%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 3 participants 12 participants 4 participants 3 participants 22 participants
39.0  (17.35) 50.8  (15.20) 52.8  (13.40) 51.3  (19.30) 49.6  (15.16)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 12 participants 4 participants 3 participants 22 participants
Female
2
  66.7%
3
  25.0%
1
  25.0%
1
  33.3%
7
  31.8%
Male
1
  33.3%
9
  75.0%
3
  75.0%
2
  66.7%
15
  68.2%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
 Number Analyzed 3 participants 12 participants 4 participants 3 participants 22 participants
Caucasian
3
 100.0%
10
  83.3%
4
 100.0%
3
 100.0%
20
  90.9%
Asian
0
   0.0%
1
   8.3%
0
   0.0%
0
   0.0%
1
   4.5%
Other
0
   0.0%
1
   8.3%
0
   0.0%
0
   0.0%
1
   4.5%
1.Primary Outcome
Title Number of Participants With Adverse Events
Hide Description AE tables are below in the Adverse Events section of this report.
Time Frame week 52
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Analysis Set was comprised of all subjects that received study drug and with no protocol deviations having relevant impact on safety.
Arm/Group Title CGF166 Dose 20 μL CGF166 Dose 30 μLEdit Single Dose Volume #2 CGF166 Dose 40 μL CGF166 Dose 60 μL Total
Hide Arm/Group Description:
single dose volume #1
single dose #2
single dose volume #3
single dose volume #4
Number of participants
Overall Number of Participants Analyzed 3 12 4 3 22
Measure Type: Count of Participants
Unit of Measure: Participants
3
 100.0%
6
  50.0%
4
 100.0%
3
 100.0%
16
  72.7%
2.Primary Outcome
Title Number of Adverse Events
Hide Description AE tables are below in the Adverse Events section of this report.
Time Frame week 52
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Analysis Set was comprised of all subjects that received study drug and with no protocol deviations having relevant impact on safety.
Arm/Group Title CGF166 Dose 20 μL CGF166 Dose 30 μL CGF166 Dose 40 μL CGF166 Dose 60 μL Total
Hide Arm/Group Description:
single dose volume #1
single dose volume #2
single dose volume #3
single dose volume #4
Number of AEs
Overall Number of Participants Analyzed 3 12 4 3 22
Measure Type: Number
Unit of Measure: Adverse events
9 16 13 8 46
3.Primary Outcome
Title Summary of Pure Tone Audiometry in Treated Ear Compared to Pretreatment Values
Hide Description Summary of pure tone audiometry air conduction thresholds at frequency 0.125 KHz
Time Frame Days 29, 57, 85, 113, 141, 169, 358, 537, 600
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacodynamics (PD) analysis set was comprised of all subjects with any available PD data, who received any study drug and experienced no protocol deviations with relevant impact on PD data.
Arm/Group Title CGF166 Dose 20 μL CGF166 Dose 30 μL CGF166 Dose 40 μL CGF166 Dose 60 μL Total
Hide Arm/Group Description:
single dose volume #1
single dose volume #2
single dose volume #3
single dose volume #4
Number of participants
Overall Number of Participants Analyzed 3 12 4 3 22
Mean (Standard Deviation)
Unit of Measure: DECIBELS
Baseline Number Analyzed 3 participants 12 participants 4 participants 3 participants 22 participants
63.3  (18.93) 70.0  (14.62) 70.0  (20.41) 71.7  (16.07) 69.3  (15.38)
Day 29 Number Analyzed 3 participants 12 participants 4 participants 3 participants 22 participants
61.7  (20.82) 70.4  (22.10) 85.0  (10.80) 75.0  (15.00) 72.5  (19.62)
Day 57 Number Analyzed 3 participants 11 participants 4 participants 3 participants 21 participants
61.7  (20.82) 71.4  (15.34) 86.3  (8.54) 73.3  (15.28) 73.1  (15.85)
Day 85 Number Analyzed 3 participants 4 participants 4 participants 3 participants 14 participants
61.7  (25.66) 66.3  (14.36) 88.8  (24.96) 75.0  (15.00) 73.6  (21.16)
Day 113 Number Analyzed 3 participants 11 participants 4 participants 3 participants 21 participants
60.0  (27.84) 73.6  (14.33) 92.5  (23.63) 75.0  (15.00) 75.5  (19.55)
Day 141 Number Analyzed 3 participants 4 participants 4 participants 3 participants 14 participants
60.0  (27.84) 68.8  (14.93) 91.3  (22.87) 73.3  (14.43) 74.3  (21.65)
Day 169 Number Analyzed 0 participants 7 participants 0 participants 2 participants 9 participants
72.1  (11.85) 70.0  (7.07) 71.7  (10.61)
Day 358 Number Analyzed 0 participants 4 participants 0 participants 2 participants 6 participants
80.0  (14.14) 72.5  (10.61) 77.5  (12.55)
Day 537 Number Analyzed 0 participants 2 participants 0 participants 1 participants 3 participants
82.5  (10.61) 75.0 80.0  (8.66)
Day 600 Number Analyzed 3 participants 10 participants 4 participants 2 participants 19 participants
60.0  (27.84) 77.5  (15.68) 93.8  (9.46) 82.5  (17.68) 78.7  (18.77)
4.Primary Outcome
Title Summary Pure Tone Audiometry Bone Conduction Thresholds in Treated Ear by Time and Frequency
Hide Description Summary of pure tone audiometry bone conduction thresholds by time and frequency 0.250 KHz
Time Frame Days 29, 57, 85, 113, 141, 169, 358,537, EoS
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacodynamics (PD) analysis set was comprised of all subjects with any available PD data, who received any study drug and experienced no protocol deviations with relevant impact on PD data.
Arm/Group Title CGF166 Dose 20 μL CGF166 Dose 30 μL CGF166 Dose 40 μL CGF166 Dose 60 μL Total
Hide Arm/Group Description:
single dose volume #1
single dose volume #2
single dose volume #3
single dose volume #4
Number of participants
Overall Number of Participants Analyzed 3 12 4 3 22
Mean (Standard Deviation)
Unit of Measure: decibels
Baseline Number Analyzed 3 participants 12 participants 4 participants 3 participants 22 participants
55.0  (0.00) 64.2  (28.83) 87.5  (43.5) 55.0  (0.00) 65.9  (28.81)
Day 29 Number Analyzed 3 participants 12 participants 4 participants 3 participants 22 participants
55.0  (0.00) 73.8  (31.49) 63.8  (42.11) 55.0  (0.00) 66.8  (29.01)
Day 57 Number Analyzed 3 participants 11 participants 4 participants 3 participants 21 participants
50.0  (8.66) 56.8  (7.83) 90.0  (40.41) 55.0  (0.00) 61.9  (21.99)
Day 85 Number Analyzed 3 participants 4 participants 4 participants 3 participants 14 participants
48.3  (11.55) 90.0  (40.41) 90.0  (40.41) 51.7  (5.77) 72.9  (34.68)
Day 113 Number Analyzed 3 participants 11 participants 4 participants 3 participants 21 participants
50.0  (8.66) 57.7  (23.17) 86.3  (45.16) 53.3  (2.89) 61.4  (27.26)
Day 141 Number Analyzed 3 participants 4 participants 4 participants 3 participants 14 participants
46.7  (14.43) 51.3  (7.50) 90.0  (40.41) 51.7  (5.77) 61.4  (27.97)
Day 169 Number Analyzed 3 participants 7 participants 0 participants 2 participants 9 participants
0  (0) 48.6  (8.52) 50.0  (7.07) 48.9  (7.82)
Day 358 Number Analyzed 0 participants 4 participants 0 participants 2 participants 6 participants
45.0  (8.16) 55.00  (0.00) 48.3  (8.16)
Day 537 Number Analyzed 0 participants 2 participants 0 participants 1 participants 3 participants
50  (7.07) 40 46.7  (7.64)
End of Study Number Analyzed 3 participants 10 participants 4 participants 2 participants 19 participants
48.3  (11.55) 61.5  (22.37) 90.0  (40.41) 50.0  (7.07) 64.2  (27.50)
5.Primary Outcome
Title Summary of Change From Baseline in Treated Ear's Pure Tone Audiometry Air Conduction Threshold by Frequency for Last Study Visit
Hide Description Summary of change from baseline in pure tone audiometry air conduction threshold by frequency for last study visit is presented in table below.
Time Frame Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacodynamics (PD) analysis set was comprised of all subjects with any available PD data, who received any study drug and experienced no protocol deviations with relevant impact on PD data.
Arm/Group Title CGF166 Dose 20 μL CGF166 Dose 30 μL CGF166 Dose 40 μL CGF166 Dose 60 μL Total
Hide Arm/Group Description:
single dose volume #1
single dose volume #2
single dose volume #3
single dose volume #4
Number of participants
Overall Number of Participants Analyzed 3 12 4 3 22
Mean (Standard Deviation)
Unit of Measure: decibels
125 hz -4.2  (9.46) 6.7  (10.19) 26.3  (17.02) 5.0  (4.33) 8.5  (13.88)
250 Hz -3.3  (6.29) 6.0  (9.20) 26.3  (26.65) 0.8  (1.44) 7.7  (15.52)
500 Hz 0  (5.00) 7.7  (11.00) 26.3  (23.32) 0.8  (1.44) 9.1  (14.91)
1,000 Hz -0.8  (3.82) 8.1  (10.51) 16.9  (8.98) 5.8  (1.44) 8.2  (9.89)
2,000 Hz 0.8  (6.29) 6.0  (11.40) 6.9  (8.51) 0.8  (3.82) 4.8  (9.48)
3,000 Hz 2.5  (2.50) 5.8  (11.60) 11.9  (11.06) -4.2  (3.82) 5.1  (10.59)
4,000 Hz 0.8  (1.44) 4.4  (12.97) 5.0  (4.08) -0.8  (3.82) 3.3  (9.83)
6,000 Hz 1.7  (2.89) 3.3  (13.16) 7.5  (15.00) 1.7  (6.29) 3.2  (11.60)
8,000 Hz 1.7  (2.89) 2.9  (15.33) -8.8  (17.50) 4.2  (7.22) 0.8  (13.94)
6.Primary Outcome
Title Summary of Change From Baseline in Non-treated Ear's Pure Tone Audiometry Air Conduction Threshold by Frequency for Last Study Visit
Hide Description Summary of change from baseline in Non-treated ear's pure tone audiometry air conduction threshold by frequency for last study visit is presented in table below.
Time Frame Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacodynamics (PD) analysis set was comprised of all subjects with any available PD data, who received any study drug and experienced no protocol deviations with relevant impact on PD data.
Arm/Group Title CGF166 Dose 20 μL CGF166 Dose 30 μL CGF166 Dose 40 μL CGF166 Dose 60 μL Total
Hide Arm/Group Description:
single dose volume #1
single dose volume #2
single dose volume #3
single dose volume #4
Number of participants
Overall Number of Participants Analyzed 3 12 4 3 22
Mean (Standard Deviation)
Unit of Measure: decibels
125 hz -2.5  (6.61) 1.7  (4.92) -3.1  (2.39) -1.7  (3.82) 8.5  (4.87)
250 Hz 0  (8.66) 2.3  (5.48) -2.5  (3.54) 0.8  (2.89) 7.7  (5.45)
500 Hz 0.8  (1.44) 6.0  (18.87) -2.5  (3.54) -1.7  (2.50) 9.1  (14.32)
1,000 Hz 1.7  (2.89) 1.7  (4.81) 0  (2.04) -1.7  (1.44) 8.2  (3.83)
2,000 Hz 0.8  (2.89) 0.2  (7.27) -0.6  (2.39) -2.5  (4.33) 4.8  (5.66)
3,000 Hz 0  (5.00) 0.2  (4.94) 0.6  (1.25) -7.5  (2.50) 5.1  (4.84)
4,000 Hz -2.5  (6.61) 1.0  (3.76) 1.3  (2.50) -0.8  (6.29) 3.3  (4.25)
6,000 Hz -0.8  (1.44) -0.6  (3.56) -8.1  (11.79) -1.7  (5.77) 3.2  (6.19)
8,000 Hz -3.3  (5.77) -4.2  (10.78) -8.8  (17.50) -0.8  (6.29) 0.8  (10.83)
7.Secondary Outcome
Title Number of Participants With Change in Brainstem Auditory Evoked Responses (BAER) Compared to Pretreatment Values
Hide Description BAERs was assessed with standard techniques for clinically significant threshold improvements compared to baseline levels.
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
PD analysis set
Arm/Group Title CGF166 Dose 20 μL CGF166 Dose 30 μL CGF166 Dose 40 μL CGF166 Dose 60 μL Total
Hide Arm/Group Description:
single dose volume #1
single dose volume #2
single dose volume #3
single dose volume #4
Number of participants
Overall Number of Participants Analyzed 3 12 4 3 22
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
8.Secondary Outcome
Title Number of Participants With Response in Vestibular Function in Treated Ear Compared to Pretreatment Values
Hide Description Response in vestibular assessments (Head impulse test (HIT), Vestibular evoked myogenic potential (VEMP), Subjective visual vertical (SVV)) to CGF166.
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
PD Analysis Set
Arm/Group Title CGF166 Dose 20 μL CGF166 Dose 30 μL CGF166 Dose 40 μL CGF166 Dose 60 μL Total
Hide Arm/Group Description:
single dose volume #1
single dose volume #2
single dose volume #3
single dose volume #4
Number of participants
Overall Number of Participants Analyzed 3 12 4 3 22
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
9.Secondary Outcome
Title Number of Participants With Changes in Auditory Functions (Speech Recognition) and Vestibular Functions Before and After IL Infusion of CGF166 Between the Study Ear and the Contralateral Ear
Hide Description Clinically signficant speech recognition improvement (word and/or sentence) following treatment. The individual auditory assessments were speech audiometry, AzBio sentence test, consonant nucleus consonant test, word recognition, Hearing-in-Noise Test (HINT), Brainstem auditory evoked response evaluations (BAER), Distortion product otoacoustic emission testing (DPOE) and shoebox audiometry.
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
PD analysis set
Arm/Group Title CGF166 Dose 20 μL CGF166 Dose 30 μL CGF166 Dose 40 μL CGF166 Dose 60 μL Total
Hide Arm/Group Description:
single dose volume #1
single dose volume #2
single dose volume #3
single dose volume #4
Total Number of participants
Overall Number of Participants Analyzed 3 12 4 3 22
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Time Frame Adverse events (AEs) were collected from first dose of study treatment until end of study treatment at 52 weeks
Adverse Event Reporting Description AEs are any untoward sign or symptom that occurs during the study treatment
 
Arm/Group Title CGF166 20 μL CGF166 30 μL CGF166 40 μL CGF166 60 μL
Hide Arm/Group Description CCGF166X2201 20 μL CCGF166X2201 30 μL CCGF166X2201 40 μL CCGF166X2201 60 μL
All-Cause Mortality
CGF166 20 μL CGF166 30 μL CGF166 40 μL CGF166 60 μL
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/3 (0.00%)   0/12 (0.00%)   0/4 (0.00%)   0/3 (0.00%) 
Hide Serious Adverse Events
CGF166 20 μL CGF166 30 μL CGF166 40 μL CGF166 60 μL
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/3 (0.00%)   0/12 (0.00%)   0/4 (0.00%)   0/3 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
CGF166 20 μL CGF166 30 μL CGF166 40 μL CGF166 60 μL
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   3/3 (100.00%)   6/12 (50.00%)   4/4 (100.00%)   3/3 (100.00%) 
Cardiac disorders         
Left ventricular hypertrophy † 1  0/3 (0.00%)  0/12 (0.00%)  0/4 (0.00%)  1/3 (33.33%) 
Ear and labyrinth disorders         
Deafness unilateral † 1  0/3 (0.00%)  1/12 (8.33%)  0/4 (0.00%)  0/3 (0.00%) 
Ear haemorrhage † 1  1/3 (33.33%)  0/12 (0.00%)  0/4 (0.00%)  0/3 (0.00%) 
Ear pain † 1  1/3 (33.33%)  0/12 (0.00%)  0/4 (0.00%)  0/3 (0.00%) 
Hypoacusis † 1  0/3 (0.00%)  2/12 (16.67%)  4/4 (100.00%)  1/3 (33.33%) 
Tinnitus † 1  0/3 (0.00%)  0/12 (0.00%)  1/4 (25.00%)  0/3 (0.00%) 
Tympanic membrane disorder † 1  0/3 (0.00%)  0/12 (0.00%)  1/4 (25.00%)  0/3 (0.00%) 
Vertigo † 1  1/3 (33.33%)  1/12 (8.33%)  1/4 (25.00%)  0/3 (0.00%) 
Vestibular disorder † 1  0/3 (0.00%)  0/12 (0.00%)  1/4 (25.00%)  0/3 (0.00%) 
Gastrointestinal disorders         
Nausea † 1  0/3 (0.00%)  1/12 (8.33%)  0/4 (0.00%)  0/3 (0.00%) 
General disorders         
Fatigue † 1  1/3 (33.33%)  0/12 (0.00%)  0/4 (0.00%)  0/3 (0.00%) 
Immune system disorders         
Food allergy † 1  0/3 (0.00%)  1/12 (8.33%)  0/4 (0.00%)  0/3 (0.00%) 
Seasonal allergy † 1  1/3 (33.33%)  0/12 (0.00%)  0/4 (0.00%)  0/3 (0.00%) 
Infections and infestations         
Otitis media † 1  0/3 (0.00%)  0/12 (0.00%)  0/4 (0.00%)  1/3 (33.33%) 
Sinusitis † 1  1/3 (33.33%)  0/12 (0.00%)  0/4 (0.00%)  0/3 (0.00%) 
Vestibular neuronitis † 1  0/3 (0.00%)  1/12 (8.33%)  0/4 (0.00%)  0/3 (0.00%) 
Investigations         
Electrocardiogram T wave abnormal † 1  0/3 (0.00%)  0/12 (0.00%)  0/4 (0.00%)  1/3 (33.33%) 
Metabolism and nutrition disorders         
Gout † 1  0/3 (0.00%)  0/12 (0.00%)  1/4 (25.00%)  0/3 (0.00%) 
Musculoskeletal and connective tissue disorders         
Arthralgia † 1  0/3 (0.00%)  0/12 (0.00%)  1/4 (25.00%)  0/3 (0.00%) 
Intervertebral disc protrusion † 1  0/3 (0.00%)  1/12 (8.33%)  0/4 (0.00%)  0/3 (0.00%) 
Myalgia † 1  0/3 (0.00%)  0/12 (0.00%)  0/4 (0.00%)  2/3 (66.67%) 
Spinal stenosis † 1  0/3 (0.00%)  1/12 (8.33%)  0/4 (0.00%)  0/3 (0.00%) 
Nervous system disorders         
Dizziness † 1  0/3 (0.00%)  2/12 (16.67%)  1/4 (25.00%)  1/3 (33.33%) 
Dysgeusia † 1  0/3 (0.00%)  0/12 (0.00%)  1/4 (25.00%)  0/3 (0.00%) 
Nystagmus † 1  0/3 (0.00%)  1/12 (8.33%)  0/4 (0.00%)  0/3 (0.00%) 
Syncope † 1  1/3 (33.33%)  0/12 (0.00%)  0/4 (0.00%)  0/3 (0.00%) 
Vestibular migraine † 1  0/3 (0.00%)  0/12 (0.00%)  1/4 (25.00%)  0/3 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Nasal congestion † 1  0/3 (0.00%)  1/12 (8.33%)  0/4 (0.00%)  0/3 (0.00%) 
Skin and subcutaneous tissue disorders         
Dermal cyst † 1  1/3 (33.33%)  0/12 (0.00%)  0/4 (0.00%)  0/3 (0.00%) 
Dermatitis allergic † 1  0/3 (0.00%)  1/12 (8.33%)  0/4 (0.00%)  0/3 (0.00%) 
Urticaria † 1  0/3 (0.00%)  1/12 (8.33%)  0/4 (0.00%)  0/3 (0.00%) 
Vascular disorders         
Hypertension † 1  0/3 (0.00%)  0/12 (0.00%)  0/4 (0.00%)  1/3 (33.33%) 
1
Term from vocabulary, MedDRA (22.1)
†
Indicates events were collected by systematic assessment
[Not Specified]
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.
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
Phone: +1 (862) 778-8300
EMail: novartis.email@novartis.com
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT02132130    
Other Study ID Numbers: CCGF166X2201
First Submitted: May 5, 2014
First Posted: May 7, 2014
Results First Submitted: December 2, 2020
Results First Posted: March 30, 2021
Last Update Posted: October 8, 2021