Extended Evaluation of Deferasirox Film-coated Tablet (FCT) Formulation

Sponsor
Novartis Pharmaceuticals (Industry)
Overall Status
Completed
CT.gov ID
NCT02720536
Collaborator
(none)
53
Enrollment
14
Locations
1
Arm
35.2
Actual Duration (Months)
3.8
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Extend evaluation of deferasirox film-coated tablet (FCT) formulation

Condition or DiseaseIntervention/TreatmentPhase
Phase 3

Detailed Description

Collection of additional safety and efficacy data with deferasirox film-coated tablet (FCT) in patients who had completed study CICL670F2201

  • Provide patients who completed 24 weeks of treatment in the core study, CICL670F2201, the possibility to have additional treatment with the deferasirox FCT.

  • Collect additional longer term data on the safety and the tolerability of the deferasirox FCT.

  • Collect efficacy data on the deferasirox FCT in reduction or maintenance of iron burden as measured by serum ferritin level.

Study Design

Study Type:
Interventional
Actual Enrollment :
53 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Open-label, Multicenter, Single Arm, Phase III Study to Collect Additional Safety and Efficacy Data With Deferasirox Film-coated Tablets in Patients Completing Study CICL670F2201
Actual Study Start Date :
Aug 16, 2016
Actual Primary Completion Date :
Jul 23, 2019
Actual Study Completion Date :
Jul 23, 2019

Arms and Interventions

ArmIntervention/Treatment
Experimental: Deferasirox

Treatment will be administered daily for up to 24 months. For each patient the daily dose is calculated based on the patient's actual body weight.

Drug: Deferasirox
Deferasirox FCT will be provided as 90 mg, 180 mg and 360 mg film-coated tablets for oral use.

Outcome Measures

Primary Outcome Measures

  1. Overview of Number of Participants With Adverse Events [Baseline up to approximately 25 months]

    Numbers represent counts of participants within the categories. An adverse event (AE) was defined as treatment emergent if its onset date is on or after (≥) the first administration of study treatment within this study or events present prior to start of study treatment but increased in severity on or after (≥) the first administration of study treatment within this study but not later than 30 days after the last study treatment in this study

  2. Change From Baseline Red Blood Cells (RBC) (10^12 Cells/L) at Month 6 and Month 12 [Baseline, 6 and 12 months]

    The change from baseline at each time point is calculated only for subjects with a value at baseline and the particular time point. Post = Post baseline, Change = Post - Baseline

  3. Change From Baseline White Blood Cells (WBC) (10^9 Cells/L) at Month 6 and Month 12 [Baseline, 6 and 12 months]

    The change from baseline at each time point is calculated only for subjects with a value at baseline and the particular time point. Post = Post baseline, Change = Post - Baseline

  4. Change From Baseline Platelets (10^9 Cells/L) at Month 6 and Month 12 [Baseline, 6 and 12 months]

    The change from baseline at each time point is calculated only for subjects with a value at baseline and the particular time point. Post = Post baseline, Change = Post - Baseline

  5. Change From Baseline Serum Creatinine (Umol/L) at Month 6 and Month 12 [Baseline, 6 and 12 months]

    The change from baseline at each time point is calculated only for subjects with a value at baseline and the particular time point. Post = Post baseline, Change = Post - Baseline

  6. Change From Baseline Creatinine Clearance (mL/Min) at Month 6 and Month 12 [Baseline, 6 and 12 months]

    The change from baseline at each time point is calculated only for subjects with a value at baseline and the particular time point. Post = Post baseline, Change = Post - Baseline

  7. Change From Baseline Alanine Aminotransferase/Serum Glutamic Pyruvic Transaminase (ALT/SGPT) (U/L) at Month 6 and Month 12 [Baseline, 6 and 12 months]

    The change from baseline at each time point is calculated only for subjects with a value at baseline and the particular time point. Post = Post baseline, Change = Post - Baseline

  8. Change From Baseline Aspartate Aminotransferase/Serum Glutamic Oxaloacetic Transaminase (AST/SGOT) (U/L) at Month 6 and Month 12 [Baseline, 6 and 12 months]

    The change from baseline at each time point is calculated only for subjects with a value at baseline and the particular time point. Post = Post baseline, Change = Post - Baseline

Secondary Outcome Measures

  1. Change From Baseline of Serum Ferritin Level (ug/L) at Month 6 and 12 [Baseline, 6 and 12 months]

    The change from baseline at each time point is calculated only for subjects with a value at baseline and the particular time point. Post = Post baseline, Change = Post - Baseline. A negative change from baseline is regarded as an improvement in this study

  2. Percentage Relative Change From Baseline of Serum Ferritin (%) at Month 6 and 12 [Baseline, 6 and 12 months]

    The percentage relative change from baseline at each time point is calculated only for subjects with a value at baseline and the particular time point. Post = Post baseline, Percentage relative change = 100 × ([Post - Baseline] / Baseline). Percentage relative change is calculated for each patient individually and then overall descriptive summary statistics is obtained for subjects with a value at baseline and the particular time point. A negative percentage relative change from baseline is regarded as an improvement in this study

Eligibility Criteria

Criteria

Ages Eligible for Study:
10 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Key Inclusion Criteria for subjects:
  • Completed 24-weeks of study treatment as described in the core protocol (CICL670F2201).

  • Were deemed to have tolerated deferasirox treatment by the investigator.

  • Provided written informed consent/assent before any study-specific procedures were performed. For pediatric patients, consent was obtained from parent(s) or legal patient's representative. Investigators were to have also obtained assent of patients according to local, regional or national guidelines.

Key Exclusion for subjects:

The exclusion criteria followed those described for the core protocol CICl670F2201, which were as follows:

  • Creatinine clearance below the contraindication limit in the locally approved prescribing information.

  • Serum creatinine > 1.5 × upper limit of normal range (ULN) at Screening

  • Alanine aminotransferase (ALT)/serum glutamic pyruvic transaminase (SGPT) > 5 × ULN,

  • Significant proteinuria

  • Patients with significant impaired gastrointestinal function or gastrointestinal disease

  • Clinical or laboratory evidence of active Hepatitis B or Hepatitis C

  • Patients with psychiatric or addictive disorders

  • Patients with a known history of HIV seropositivity (Elisa or Western blot).

  • History of malignancy of any organ system, treated or untreated, within the past 5 years whether or not there was an evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin.

  • Patients with a history of hypersensitivity to any of the study drug or excipients.

  • Patients with significant medical condition that could interfere with the ability to participate in this study

  • Patients who were participating in another clinical trial or receiving an investigational drug.

  • Patients using prohibited medication,

  • Patients with liver disease with severity of Child-Pugh Class B or C.

  • Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they were using effective methods of contraception during dosing of study treatment

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Novartis Investigative SiteViennaAustria1140
2Novartis Investigative SiteGoudi-AthensGRGreece115 27
3Novartis Investigative SitePatrasGreece265 00
4Novartis Investigative SiteThessalonikiGreece54642
5Novartis Investigative SiteCataniaCTItaly95125
6Novartis Investigative SiteConaFEItaly44100
7Novartis Investigative SiteGenovaGEItaly16128
8Novartis Investigative SiteCagliariITAItaly09121
9Novartis Investigative SiteLecceLEItaly73100
10Novartis Investigative SiteMilanoMIItaly20122
11Novartis Investigative SitePalermoPAItaly90127
12Novartis Investigative SitePalermoPAItaly90146
13Novartis Investigative SiteVeronaVRItaly37126
14Novartis Investigative SiteNapoliItaly80138

Sponsors and Collaborators

  • Novartis Pharmaceuticals

Investigators

None specified.

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
Novartis Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT02720536
Other Study ID Numbers:
  • CICL670AIC04
First Posted:
Mar 28, 2016
Last Update Posted:
Mar 3, 2020
Last Verified:
Feb 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Novartis Pharmaceuticals
Additional relevant MeSH terms:

Study Results

Participant Flow

Recruitment Details
Pre-assignment DetailAll patients completed study CICL670F2201 (NCT02125877) prior to entry into this study
Arm/Group TitleDeferasirox
Arm/Group DescriptionTreatment will be administered daily for up to 24 months. For each patient the daily dose is calculated based on the patient's actual body weight.
Period Title: Overall Study
STARTED53
COMPLETED34
NOT COMPLETED19

Baseline Characteristics

Arm/Group TitleDeferasirox
Arm/Group DescriptionTreatment will be administered daily for up to 24 months. For each patient the daily dose is calculated based on the patient's actual body weight.
Overall Participants53
Age, Customized (Number) [Number]
<18
3
5.7%
≥18 - <50
46
86.8%
≥ 50 - <65
1
1.9%
≥ 65
3
5.7%
Sex: Female, Male (Count of Participants)
Female
35
66%
Male
18
34%
Race/Ethnicity, Customized (Number) [Number]
Caucasian
50
94.3%
Asian
1
1.9%
Other
2
3.8%
Main underlying disease (participants) [Number]
MDS with very low risk as per the IPSS - R
2
3.8%
MDS with low risk as per the IPSS - R
1
1.9%
MDS with INT risk as per the IPSS - R
1
1.9%
Transfusion-dependent thalassemia
49
92.5%

Outcome Measures

1. Primary Outcome
TitleOverview of Number of Participants With Adverse Events
DescriptionNumbers represent counts of participants within the categories. An adverse event (AE) was defined as treatment emergent if its onset date is on or after (≥) the first administration of study treatment within this study or events present prior to start of study treatment but increased in severity on or after (≥) the first administration of study treatment within this study but not later than 30 days after the last study treatment in this study
Time FrameBaseline up to approximately 25 months

Outcome Measure Data

Analysis Population Description
Safety analysis set
Arm/Group TitleDeferasirox
Arm/Group DescriptionTreatment will be administered daily for up to 24 months. For each patient the daily dose is calculated based on the patient's actual body weight
Measure Participants53
Adverse events (AEs)
52
98.1%
Treatment related AEs
20
37.7%
Severe adverse events
14
26.4%
Treatment related severe adverse events
2
3.8%
Serious adverse events (SAEs)
13
24.5%
Treatment related SAEs
0
0%
Fatal SAEs
1
1.9%
Treatment related fatal SAEs
0
0%
AEs leading to discontinuation
4
7.5%
Treatment related AEs leading to discontinuation
2
3.8%
AEs leading to dose adjust/interruption
33
62.3%
AEs requiring additional therapy
4
7.5%
2. Primary Outcome
TitleChange From Baseline Red Blood Cells (RBC) (10^12 Cells/L) at Month 6 and Month 12
DescriptionThe change from baseline at each time point is calculated only for subjects with a value at baseline and the particular time point. Post = Post baseline, Change = Post - Baseline
Time FrameBaseline, 6 and 12 months

Outcome Measure Data

Analysis Population Description
Safety analysis set - at each timepoint the subjects from the safety analysis set who have a value of the lab parameter of interest at both baseline and the timepoint of interest
Arm/Group TitleBaselineMonth 6Month 12
Arm/Group DescriptionBaseline of laboratory valueChange from baseline at month 6Change from baseline at month 12
Measure Participants534240
Baseline
3.753
(0.4909)
3.733
(0.5016)
3.746
(0.5071)
Post
NA
(NA)
3.610
(0.5153)
3.607
(0.5423)
Change
NA
(NA)
-0.124
(0.3892)
-0.139
(0.4330)
3. Primary Outcome
TitleChange From Baseline White Blood Cells (WBC) (10^9 Cells/L) at Month 6 and Month 12
DescriptionThe change from baseline at each time point is calculated only for subjects with a value at baseline and the particular time point. Post = Post baseline, Change = Post - Baseline
Time FrameBaseline, 6 and 12 months

Outcome Measure Data

Analysis Population Description
Safety analysis set - at each timepoint the subjects from the safety analysis set who have a value of the lab parameter of interest at both baseline and the timepoint of interest
Arm/Group TitleBaselineMonth 6Month 12
Arm/Group DescriptionBaseline of laboratory valueChange from baseline at month 6Change from baseline at month 12
Measure Participants534240
Baseline
9.336
(5.1383)
9.559
(5.6650)
9.100
(5.4667)
Post
NA
(NA)
9.090
(4.3712)
9.007
(4.4385)
Change
NA
(NA)
-0.469
(4.0727)
-0.093
(4.5792)
4. Primary Outcome
TitleChange From Baseline Platelets (10^9 Cells/L) at Month 6 and Month 12
DescriptionThe change from baseline at each time point is calculated only for subjects with a value at baseline and the particular time point. Post = Post baseline, Change = Post - Baseline
Time FrameBaseline, 6 and 12 months

Outcome Measure Data

Analysis Population Description
Safety analysis set - at each timepoint the subjects from the safety analysis set who have a value of the lab parameter of interest at both baseline and the timepoint of interest
Arm/Group TitleBaselineMonth 6Month 12
Arm/Group DescriptionBaseline of laboratory valueChange from baseline at month 6Change from baseline at month 12
Measure Participants534240
Baseline
330.1
(188.81)
336.5
(195.97)
339.4
(196.41)
Post
NA
(NA)
344.2
(190.43)
361.9
(165.91)
Change
NA
(NA)
7.7
(112.98)
22.4
(100.72)
5. Primary Outcome
TitleChange From Baseline Serum Creatinine (Umol/L) at Month 6 and Month 12
DescriptionThe change from baseline at each time point is calculated only for subjects with a value at baseline and the particular time point. Post = Post baseline, Change = Post - Baseline
Time FrameBaseline, 6 and 12 months

Outcome Measure Data

Analysis Population Description
Safety analysis set - at each timepoint the subjects from the safety analysis set who have a value of the lab parameter of interest at both baseline and the timepoint of interest
Arm/Group TitleBaselineMonth 6Month 12
Arm/Group DescriptionBaseline of laboratory valueChange from baseline at month 6Change from baseline at month 12
Measure Participants534340
Baseline
55.1
(16.16)
54.4
(16.34)
57.4
(16.91)
Post
NA
(NA)
62.0
(16.17)
63.5
(16.78)
Change
NA
(NA)
7.6
(9.51)
6.1
(11.09)
6. Primary Outcome
TitleChange From Baseline Creatinine Clearance (mL/Min) at Month 6 and Month 12
DescriptionThe change from baseline at each time point is calculated only for subjects with a value at baseline and the particular time point. Post = Post baseline, Change = Post - Baseline
Time FrameBaseline, 6 and 12 months

Outcome Measure Data

Analysis Population Description
Safety analysis set - at each timepoint the subjects from the safety analysis set who have a value of the lab parameter of interest at both baseline and the timepoint of interest
Arm/Group TitleBaselineMonth 6Month 12
Arm/Group DescriptionBaseline of laboratory valueChange from baseline at month 6Change from baseline at month 12
Measure Participants524140
Baseline
131.9
(51.32)
131.8
(56.98)
129.6
(50.30)
Post
NA
(NA)
116.0
(48.71)
119.8
(49.34)
Change
NA
(NA)
-15.8
(35.12)
-9.8
(32.74)
7. Primary Outcome
TitleChange From Baseline Alanine Aminotransferase/Serum Glutamic Pyruvic Transaminase (ALT/SGPT) (U/L) at Month 6 and Month 12
DescriptionThe change from baseline at each time point is calculated only for subjects with a value at baseline and the particular time point. Post = Post baseline, Change = Post - Baseline
Time FrameBaseline, 6 and 12 months

Outcome Measure Data

Analysis Population Description
Safety analysis set - at each timepoint the subjects from the safety analysis set who have a value of the lab parameter of interest at both baseline and the timepoint of interest
Arm/Group TitleBaselineMonth 6Month 12
Arm/Group DescriptionBaseline of laboratory valueChange from baseline at month 6Change from baseline at month 12
Measure Participants534440
Baseline
37.4
(31.47)
39.4
(33.51)
39.5
(33.32)
Post
NA
(NA)
28.9
(21.12)
25.9
(19.08)
Change
NA
(NA)
-10.5
(29.16)
-13.6
(27.44)
8. Primary Outcome
TitleChange From Baseline Aspartate Aminotransferase/Serum Glutamic Oxaloacetic Transaminase (AST/SGOT) (U/L) at Month 6 and Month 12
DescriptionThe change from baseline at each time point is calculated only for subjects with a value at baseline and the particular time point. Post = Post baseline, Change = Post - Baseline
Time FrameBaseline, 6 and 12 months

Outcome Measure Data

Analysis Population Description
Safety analysis set - at each timepoint the subjects from the safety analysis set who have a value of the lab parameter of interest at both baseline and the timepoint of interest
Arm/Group TitleBaselineMonth 6Month 12
Arm/Group DescriptionBaseline of laboratory valueChange from baseline at month 6Change from baseline at month 12
Measure Participants534339
Baseline
30.7
(24.40)
32.9
(26.48)
33.7
(26.67)
Post
NA
(NA)
27.6
(18.81)
25.2
(12.78)
Change
NA
(NA)
-5.3
(21.03)
-8.5
(19.18)
9. Secondary Outcome
TitleChange From Baseline of Serum Ferritin Level (ug/L) at Month 6 and 12
DescriptionThe change from baseline at each time point is calculated only for subjects with a value at baseline and the particular time point. Post = Post baseline, Change = Post - Baseline. A negative change from baseline is regarded as an improvement in this study
Time FrameBaseline, 6 and 12 months

Outcome Measure Data

Analysis Population Description
Safety analysis set - at each timepoint the subjects from the safety analysis set who have a value of the lab parameter of interest at both baseline and the timepoint of interest
Arm/Group TitleBaselineMonth 6Month 12
Arm/Group DescriptionSerum ferritin value at baselineSerum ferritin value at baseline and at month 6Serum ferritin value at baseline and at month 12
Measure Participants534436
Baseline
2523.51
(1746.087)
2614.12
(1781.287)
2542.76
(1904.087)
Post
NA
(NA)
2228.94
(1910.182)
1924.49
(1839.818)
Change
NA
(NA)
-385.18
(1038.789)
-618.26
(1054.150)
10. Secondary Outcome
TitlePercentage Relative Change From Baseline of Serum Ferritin (%) at Month 6 and 12
DescriptionThe percentage relative change from baseline at each time point is calculated only for subjects with a value at baseline and the particular time point. Post = Post baseline, Percentage relative change = 100 × ([Post - Baseline] / Baseline). Percentage relative change is calculated for each patient individually and then overall descriptive summary statistics is obtained for subjects with a value at baseline and the particular time point. A negative percentage relative change from baseline is regarded as an improvement in this study
Time FrameBaseline, 6 and 12 months

Outcome Measure Data

Analysis Population Description
Safety analysis set - at each timepoint the subjects from the safety analysis set who have a value of the lab parameter of interest at both baseline and the timepoint of interest
Arm/Group TitleBaselineMonth 6Month 12
Arm/Group DescriptionSerum ferritin value at baselineSerum ferritin value at baseline and at month 6Serum ferritin value at baseline and at month 12
Measure Participants534436
Mean (Standard Deviation) [percentage of relative change]
NA
(NA)
-18.61
(32.969)
-29.08
(33.056)

Adverse Events

Time FrameAdverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 25 months
Adverse Event Reporting Description Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Arm/Group TitleDeferasirox
Arm/Group DescriptionTreatment will be administered daily for up to 24 months. For each patient the daily dose is calculated based on the patient's actual body weight
All Cause Mortality
Deferasirox
Affected / at Risk (%)# Events
Total1/53 (1.9%)
Serious Adverse Events
Deferasirox
Affected / at Risk (%)# Events
Total13/53 (24.5%)
Cardiac disorders
Atrial fibrillation1/53 (1.9%)
Cardiac failure1/53 (1.9%)
Endocrine disorders
Goitre1/53 (1.9%)
Hepatobiliary disorders
Biliary colic1/53 (1.9%)
Cholecystitis1/53 (1.9%)
Cholestasis1/53 (1.9%)
Hepatic failure1/53 (1.9%)
Infections and infestations
Diverticulitis1/53 (1.9%)
Lower respiratory tract infection1/53 (1.9%)
Lymph gland infection1/53 (1.9%)
Urosepsis1/53 (1.9%)
Injury, poisoning and procedural complications
Femur fracture1/53 (1.9%)
Fracture1/53 (1.9%)
Lumbar vertebral fracture1/53 (1.9%)
Rib fracture1/53 (1.9%)
Ulna fracture1/53 (1.9%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma1/53 (1.9%)
Ovarian adenoma1/53 (1.9%)
Papillary thyroid cancer1/53 (1.9%)
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous1/53 (1.9%)
Product Issues
Device failure1/53 (1.9%)
Psychiatric disorders
Panic attack1/53 (1.9%)
Renal and urinary disorders
Calculus urinary1/53 (1.9%)
Hydronephrosis1/53 (1.9%)
Renal colic1/53 (1.9%)
Ureterolithiasis1/53 (1.9%)
Other (Not Including Serious) Adverse Events
Deferasirox
Affected / at Risk (%)# Events
Total48/53 (90.6%)
Cardiac disorders
Palpitations3/53 (5.7%)
Gastrointestinal disorders
Abdominal pain10/53 (18.9%)
Abdominal pain upper11/53 (20.8%)
Constipation3/53 (5.7%)
Diarrhoea14/53 (26.4%)
Dyspepsia4/53 (7.5%)
Gastritis5/53 (9.4%)
Nausea12/53 (22.6%)
Vomiting12/53 (22.6%)
General disorders
Asthenia10/53 (18.9%)
Influenza like illness5/53 (9.4%)
Pyrexia13/53 (24.5%)
Hepatobiliary disorders
Hypertransaminasaemia4/53 (7.5%)
Infections and infestations
Ear infection4/53 (7.5%)
Gastroenteritis7/53 (13.2%)
Influenza9/53 (17%)
Nasopharyngitis3/53 (5.7%)
Pharyngitis7/53 (13.2%)
Respiratory tract infection4/53 (7.5%)
Rhinitis8/53 (15.1%)
Sinusitis3/53 (5.7%)
Tonsillitis5/53 (9.4%)
Upper respiratory tract infection4/53 (7.5%)
Urinary tract infection6/53 (11.3%)
Investigations
Blood creatinine increased4/53 (7.5%)
Urine protein/creatinine ratio increased8/53 (15.1%)
Musculoskeletal and connective tissue disorders
Arthralgia3/53 (5.7%)
Back pain5/53 (9.4%)
Musculoskeletal pain6/53 (11.3%)
Myalgia3/53 (5.7%)
Neck pain3/53 (5.7%)
Pain in extremity5/53 (9.4%)
Nervous system disorders
Headache14/53 (26.4%)
Renal and urinary disorders
Dysuria3/53 (5.7%)
Glycosuria3/53 (5.7%)
Proteinuria4/53 (7.5%)
Renal colic3/53 (5.7%)
Respiratory, thoracic and mediastinal disorders
Cough12/53 (22.6%)
Oropharyngeal pain9/53 (17%)
Productive cough3/53 (5.7%)
Vascular disorders
Hypertension3/53 (5.7%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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

Name/TitleStudy Director
OrganizationNovartis Pharmaceuticals
Phone888-778-8300
EmailNovartis.email@novartis.com
Responsible Party:
Novartis Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT02720536
Other Study ID Numbers:
  • CICL670AIC04
First Posted:
Mar 28, 2016
Last Update Posted:
Mar 3, 2020
Last Verified:
Feb 1, 2020