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Phase II Study to Investigate the Benefits of an Improved Deferasirox Formulation (Film-coated Tablet)

Primary Purpose

Chronic Iron Overload Due to Transfusion-dependant Anemias

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Deferasirox dispersible tablet
Defearisox film-coated tablet
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Iron Overload Due to Transfusion-dependant Anemias focused on measuring Iron overload, Chelation, Thalassemia, Myelodysplastic syndrome (MDS), Transfusional hemisiderosis, Deferasirox, ICL670, Dispersible tablet, Film-coated tablet

Eligibility Criteria

10 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria:

  • Male and female patients aged ≥ 10 years
  • Patients with transfusion-dependent thalassemia and iron overload, requiring deferasirox DT at doses of ≥ 30 mg/kg/day as per the investigator's decision OR Patients with very low, low or intermediate (int) risk myelodysplastic syndrome (MDS) and iron overload, requiring deferasirox DT at doses of ≥ 20 mg/kg/day as per the investigator's decision.
  • History of transfusion of at least 20 PRBC units and anticipated to be transfused with at least 8 units of PRBCs annually during the study
  • Serum ferritin > 1000 ng/mL, measured at screening Visit 1 and screening Visit 2 (the mean value will be used for eligibility criteria).

Key Exclusion Criteria:

  • Creatinine clearance below the contraindication limit in the locally approved prescribing information. Creatinine clearance will be estimated from serum creatinine at screening Visit 1 and screening Visit 2 and the mean value will be used for eligibility criteria.
  • Serum creatinine > 1.5 xULN at screening measured at screening Visit 1 and screening Visit 2 (the mean value will be used for eligibility criteria).
  • ALT (SGPT) > 5xULN, unless LIC confirmed as >10 mg Fe/dw within 6 months prior to screening visit 1.
  • Significant proteinuria as indicated by a urinary protein/creatinine ratio > 0.5 mg/mg in a non-first void urine sample at screening Visit 1 or screening Visit 2.
  • Patients with significant impaired gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral deferasirox (e.g. ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection).
  • Liver disease with severity of Child-Pugh Class B or C

Sites / Locations

  • Children's Hospital of Orange County Onc Dept
  • Lurie Children's Hospital of Chicago Onc Dept
  • Children's Hospital Boston Department of Hematology
  • Weill Cornell Medical College-Cornell University Onc Dept
  • Children's Hospital of Philadelphia Onc. Dept
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Deferasirox dispersible tablet (DFX-DT)

Deferasirox film-coated tablet (DFX-FCT)

Arm Description

Iron chelation naïve participants received DFX-DT 20 mg/kg/day once daily orally from weeks 1 - 4. After week 4, the dose could be adjusted by +/- 5 to 10 mg/kg/day, with a maximum dose of 40 mg/kg/day. Iron chelation pre-treated participants were supposed to start on a dose that was equivalent to their pre-washout dose.

Participants received DFX-FCT 14 mg/kg/day once daily orally from weeks 1 - 4. After week 4, the dose could be adjusted by +/- 3.5 to 7 mg/kg/day, with a maximum dose of 28 mg/kg/day. Iron chelation pre-treated participants were supposed to start on a dose that was equivalent to their pre-washout dose

Outcomes

Primary Outcome Measures

Overall Safety as Measured by Frequency of Adverse Events
The percentage of participants with adverse events, serious adverse events and deaths was assessed.
Overall Safety as Measured by Changes in Laboratory Values From Baseline
The percentage of participants with post-baseline laboratory values meeting specified criteria for notable/extended range was assessed. The following laboratory parameters were measured: platelet count, absolute neutrophils, serum creatinine , creatinine clearance, urinary protein/urinary creatinine ratio, alanine aminotransferase (ALT) and aspartate aminotransferase (AST). Note that within data categories, creat = creatinine, cons = consecutive, ULN = upper limit of normal and urin = urinary.

Secondary Outcome Measures

Frequency of Selected Gastro-intestinal (GI) Adverse Events
The percentage of participants with any GI adverse event, diarrhea, constipation, nausea, vomiting, abdominal pain was assessed.
Mean Domain Scores of the Modified Satisfaction With Iron Chelation Therapy (Modified SICT)
The modified SICT consisted of 13 items that represent 3 domains: adherence, satisfaction and concerns. The adherence domain consisted of 7 items, 6 which were measured using a 5-point response scale and was calculated by summing the 6 items. The score range from 6 to 30 and higher scores indicated worse adherence. The satisfaction domain consisted of 3 items, 2 which were measured using a 5-point response scale and was calculated by summing the 2 items. The score range from 2 to 10 and higher scores indicated worse satisfaction. The concerns domain consisted of 3 items to address any concerns or worries with his/her medication. All 3 items were measured on a 5-point response scale and were calculated by summing the 3 items. The score range from 3 to 15 and higher scores indicated fewer concerns. For all three domains, the meaningful difference between two treatment arms was determined to be 1 point.
Palatability Questionnaire Score
The palatability questionnaire consisted of 4 items. The first item measured the taste and aftertaste of the medication and were scored a on a 5-point response scale. The second item offered an additional response option of "no aftertaste". The last 2 items referred to whether the medication was taken, i.e. swallowed or vomited, and how the participant perceived the amount of medication to be taken. The palatability summary score was calculated using a scoring matrix from items 1, 3 and 4 scores and the score ranges from 0 - 11. Higher scores indicated the best palatability. A meaningful difference between two treatment arms was determined to be 1 point.
Weekly Average of Daily Scores of the Gastrointestinal (GI) Symptom Diary
The GI symptom diary consisted of 6 items, five which were scored using a 0 - 10 rating scale with item appropriate anchors to rate the symptom, for example, Pain in your belly: 0 = no pain and 10 = worst pain. The GI diary summary score was created using the 10 point response scale for the 5 items. The GI symptom daily diary had a minimum score of 0 and a maximum score of 50. The weekly average score for the 7 days was calculated for each individual item and the GI summary score was created from these weekly averages. Higher scores indicated worse symptoms. A meaningful difference between two treatment arms was determined to be 0.3 point.
Number of Participants With Weekly Average Compliance of Medication Consumption
A compliance questionnaire assessed whether the medication was taken. Weekly average compliance was calculated when there were at least four non-missing daily responses.
Weekly Dose Violation Rate
The dose violation is defined as a dose either missed completely or not taken in accordance with the timing instruction (no later than 12:00 pm. The rate was calculated as [number of dose violations/drug exposure (days)] x 100.
Area Under the Plasma Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUClast)
Blood samples were collected to assess AUClast.
Observed Maximum Plasma Concentration Following Drug Administration (Cmax)
Blood samples were collected to assess Cmax.
Time to Reach the Maximum Plasma Concentration After Drug Administration (Tmax)
Blood samples were collected to assess Tmax.
Dererasirox Plasma Concentration
Blood samples were collected to assess deferasirox concentration. Dose-adjusted calculations are presented: (concentration/actual dose)*20 for participants on DFX-DT and (concentration/actual dose)*14 for participants on DFX-FCT.

Full Information

First Posted
April 26, 2014
Last Updated
July 22, 2017
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT02125877
Brief Title
Phase II Study to Investigate the Benefits of an Improved Deferasirox Formulation (Film-coated Tablet)
Official Title
A Randomized, Open-label, Multicenter, Two Arm, Phase II Study to Investigate the Benefits of an Improved Deferasirox Formulation (Film-coated Tablet)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
July 8, 2014 (Actual)
Primary Completion Date
February 24, 2016 (Actual)
Study Completion Date
February 24, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Assessed the new film-coated tablet formulation to the currently approved dispersible tablet formulation with regards to overall safety, Gastrointestinal (GI) tolerability, palatability, satisfaction and compliance

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Iron Overload Due to Transfusion-dependant Anemias
Keywords
Iron overload, Chelation, Thalassemia, Myelodysplastic syndrome (MDS), Transfusional hemisiderosis, Deferasirox, ICL670, Dispersible tablet, Film-coated tablet

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
173 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Deferasirox dispersible tablet (DFX-DT)
Arm Type
Active Comparator
Arm Description
Iron chelation naïve participants received DFX-DT 20 mg/kg/day once daily orally from weeks 1 - 4. After week 4, the dose could be adjusted by +/- 5 to 10 mg/kg/day, with a maximum dose of 40 mg/kg/day. Iron chelation pre-treated participants were supposed to start on a dose that was equivalent to their pre-washout dose.
Arm Title
Deferasirox film-coated tablet (DFX-FCT)
Arm Type
Experimental
Arm Description
Participants received DFX-FCT 14 mg/kg/day once daily orally from weeks 1 - 4. After week 4, the dose could be adjusted by +/- 3.5 to 7 mg/kg/day, with a maximum dose of 28 mg/kg/day. Iron chelation pre-treated participants were supposed to start on a dose that was equivalent to their pre-washout dose
Intervention Type
Drug
Intervention Name(s)
Deferasirox dispersible tablet
Other Intervention Name(s)
ICL670, DT (dispersible tablet)
Intervention Description
Deferasirox DT was provided as 125 mg, 250 mg and 500 mg dispersible tablets for oral use.
Intervention Type
Drug
Intervention Name(s)
Defearisox film-coated tablet
Other Intervention Name(s)
ICL670, FCT (film-coated tablet)
Intervention Description
Deferasirox FCT was provided as 90 mg, 180 mg and 360 mg film-coated tablets for oral use.
Primary Outcome Measure Information:
Title
Overall Safety as Measured by Frequency of Adverse Events
Description
The percentage of participants with adverse events, serious adverse events and deaths was assessed.
Time Frame
28 weeks
Title
Overall Safety as Measured by Changes in Laboratory Values From Baseline
Description
The percentage of participants with post-baseline laboratory values meeting specified criteria for notable/extended range was assessed. The following laboratory parameters were measured: platelet count, absolute neutrophils, serum creatinine , creatinine clearance, urinary protein/urinary creatinine ratio, alanine aminotransferase (ALT) and aspartate aminotransferase (AST). Note that within data categories, creat = creatinine, cons = consecutive, ULN = upper limit of normal and urin = urinary.
Time Frame
baseline (BL), 30 weeks
Secondary Outcome Measure Information:
Title
Frequency of Selected Gastro-intestinal (GI) Adverse Events
Description
The percentage of participants with any GI adverse event, diarrhea, constipation, nausea, vomiting, abdominal pain was assessed.
Time Frame
28 weeks
Title
Mean Domain Scores of the Modified Satisfaction With Iron Chelation Therapy (Modified SICT)
Description
The modified SICT consisted of 13 items that represent 3 domains: adherence, satisfaction and concerns. The adherence domain consisted of 7 items, 6 which were measured using a 5-point response scale and was calculated by summing the 6 items. The score range from 6 to 30 and higher scores indicated worse adherence. The satisfaction domain consisted of 3 items, 2 which were measured using a 5-point response scale and was calculated by summing the 2 items. The score range from 2 to 10 and higher scores indicated worse satisfaction. The concerns domain consisted of 3 items to address any concerns or worries with his/her medication. All 3 items were measured on a 5-point response scale and were calculated by summing the 3 items. The score range from 3 to 15 and higher scores indicated fewer concerns. For all three domains, the meaningful difference between two treatment arms was determined to be 1 point.
Time Frame
weeks 2, 3, 13 and 24 (end of treatment or within 7 days of last dose)
Title
Palatability Questionnaire Score
Description
The palatability questionnaire consisted of 4 items. The first item measured the taste and aftertaste of the medication and were scored a on a 5-point response scale. The second item offered an additional response option of "no aftertaste". The last 2 items referred to whether the medication was taken, i.e. swallowed or vomited, and how the participant perceived the amount of medication to be taken. The palatability summary score was calculated using a scoring matrix from items 1, 3 and 4 scores and the score ranges from 0 - 11. Higher scores indicated the best palatability. A meaningful difference between two treatment arms was determined to be 1 point.
Time Frame
weeks 2, 3, 13 and 24 (end of treatment or within 7 days of last dose)
Title
Weekly Average of Daily Scores of the Gastrointestinal (GI) Symptom Diary
Description
The GI symptom diary consisted of 6 items, five which were scored using a 0 - 10 rating scale with item appropriate anchors to rate the symptom, for example, Pain in your belly: 0 = no pain and 10 = worst pain. The GI diary summary score was created using the 10 point response scale for the 5 items. The GI symptom daily diary had a minimum score of 0 and a maximum score of 50. The weekly average score for the 7 days was calculated for each individual item and the GI summary score was created from these weekly averages. Higher scores indicated worse symptoms. A meaningful difference between two treatment arms was determined to be 0.3 point.
Time Frame
weeks -1, 4, 8, 12, 16, 20, 24
Title
Number of Participants With Weekly Average Compliance of Medication Consumption
Description
A compliance questionnaire assessed whether the medication was taken. Weekly average compliance was calculated when there were at least four non-missing daily responses.
Time Frame
Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24
Title
Weekly Dose Violation Rate
Description
The dose violation is defined as a dose either missed completely or not taken in accordance with the timing instruction (no later than 12:00 pm. The rate was calculated as [number of dose violations/drug exposure (days)] x 100.
Time Frame
weeks 1, 4, 8, 12, 16, 20, 24
Title
Area Under the Plasma Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUClast)
Description
Blood samples were collected to assess AUClast.
Time Frame
week 1, day 1: pre-dose (0 hour) and 1, 2, 3, 4, 8 and 24 hours post dose; week 3, day 1: pre-dose (0 hour) and 1, 2, 3, 4, 8 and 24 hours post dose
Title
Observed Maximum Plasma Concentration Following Drug Administration (Cmax)
Description
Blood samples were collected to assess Cmax.
Time Frame
week 1, day 1: pre-dose (0 hour) and 1, 2, 3, 4, 8 and 24 hours post dose; week 3, day 1: pre-dose (0 hour) and 1, 2, 3, 4, 8 and 24 hours post dose
Title
Time to Reach the Maximum Plasma Concentration After Drug Administration (Tmax)
Description
Blood samples were collected to assess Tmax.
Time Frame
week 1, day 1: pre-dose (0 hour) and 1, 2, 3, 4, 8 and 24 hours post dose; week 3, day 1: pre-dose (0 hour) and 1, 2, 3, 4, 8 and 24 hours post dose
Title
Dererasirox Plasma Concentration
Description
Blood samples were collected to assess deferasirox concentration. Dose-adjusted calculations are presented: (concentration/actual dose)*20 for participants on DFX-DT and (concentration/actual dose)*14 for participants on DFX-FCT.
Time Frame
Week 3, day 1, pre-dose (0 hour (h)) and 2 h post-dose; week 13, day 1, pre-dose (0 hour (h)) and 2 h post-dose; and week 21, day 1, pre-dose (0 hour (h)) and 2 h post-dose

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria: Male and female patients aged ≥ 10 years Patients with transfusion-dependent thalassemia and iron overload, requiring deferasirox DT at doses of ≥ 30 mg/kg/day as per the investigator's decision OR Patients with very low, low or intermediate (int) risk myelodysplastic syndrome (MDS) and iron overload, requiring deferasirox DT at doses of ≥ 20 mg/kg/day as per the investigator's decision. History of transfusion of at least 20 PRBC units and anticipated to be transfused with at least 8 units of PRBCs annually during the study Serum ferritin > 1000 ng/mL, measured at screening Visit 1 and screening Visit 2 (the mean value will be used for eligibility criteria). Key Exclusion Criteria: Creatinine clearance below the contraindication limit in the locally approved prescribing information. Creatinine clearance will be estimated from serum creatinine at screening Visit 1 and screening Visit 2 and the mean value will be used for eligibility criteria. Serum creatinine > 1.5 xULN at screening measured at screening Visit 1 and screening Visit 2 (the mean value will be used for eligibility criteria). ALT (SGPT) > 5xULN, unless LIC confirmed as >10 mg Fe/dw within 6 months prior to screening visit 1. Significant proteinuria as indicated by a urinary protein/creatinine ratio > 0.5 mg/mg in a non-first void urine sample at screening Visit 1 or screening Visit 2. Patients with significant impaired gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral deferasirox (e.g. ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection). Liver disease with severity of Child-Pugh Class B or C
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Children's Hospital of Orange County Onc Dept
City
Orange
State/Province
California
ZIP/Postal Code
92868-3874
Country
United States
Facility Name
Lurie Children's Hospital of Chicago Onc Dept
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Children's Hospital Boston Department of Hematology
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Weill Cornell Medical College-Cornell University Onc Dept
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Children's Hospital of Philadelphia Onc. Dept
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104-4399
Country
United States
Facility Name
Novartis Investigative Site
City
Buenos aires
ZIP/Postal Code
C1221ADC
Country
Argentina
Facility Name
Novartis Investigative Site
City
Linz
ZIP/Postal Code
A-4010
Country
Austria
Facility Name
Novartis Investigative Site
City
Wien
ZIP/Postal Code
1140
Country
Austria
Facility Name
Novartis Investigative Site
City
Lille cedex
ZIP/Postal Code
59020
Country
France
Facility Name
Novartis Investigative Site
City
Paris
ZIP/Postal Code
75010
Country
France
Facility Name
Novartis Investigative Site
City
Mannheim
State/Province
Baden-Württemberg
ZIP/Postal Code
68305
Country
Germany
Facility Name
Novartis Investigative Site
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
Novartis Investigative Site
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Novartis Investigative Site
City
Goslar
ZIP/Postal Code
38642
Country
Germany
Facility Name
Novartis Investigative Site
City
Hannover
ZIP/Postal Code
30170
Country
Germany
Facility Name
Novartis Investigative Site
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Facility Name
Novartis Investigative Site
City
Potsdam
ZIP/Postal Code
14467
Country
Germany
Facility Name
Novartis Investigative Site
City
Athens
State/Province
GR
ZIP/Postal Code
GR-115 27
Country
Greece
Facility Name
Novartis Investigative Site
City
Patra - RIO
State/Province
GR
ZIP/Postal Code
265 04
Country
Greece
Facility Name
Novartis Investigative Site
City
Thessaloniki
State/Province
GR
ZIP/Postal Code
546 42
Country
Greece
Facility Name
Novartis Investigative Site
City
Brindisi
State/Province
BR
ZIP/Postal Code
72100
Country
Italy
Facility Name
Novartis Investigative Site
City
Catania
State/Province
CT
ZIP/Postal Code
95125
Country
Italy
Facility Name
Novartis Investigative Site
City
Cona
State/Province
FE
ZIP/Postal Code
44100
Country
Italy
Facility Name
Novartis Investigative Site
City
Genova
State/Province
GE
ZIP/Postal Code
16128
Country
Italy
Facility Name
Novartis Investigative Site
City
Genova
State/Province
GE
ZIP/Postal Code
16132
Country
Italy
Facility Name
Novartis Investigative Site
City
Cagliari
State/Province
ITA
ZIP/Postal Code
09121
Country
Italy
Facility Name
Novartis Investigative Site
City
Lecce
State/Province
LE
ZIP/Postal Code
73100
Country
Italy
Facility Name
Novartis Investigative Site
City
Milano
State/Province
MI
ZIP/Postal Code
20122
Country
Italy
Facility Name
Novartis Investigative Site
City
Milano
State/Province
MI
ZIP/Postal Code
20162
Country
Italy
Facility Name
Novartis Investigative Site
City
Palermo
State/Province
PA
ZIP/Postal Code
90127
Country
Italy
Facility Name
Novartis Investigative Site
City
Palermo
State/Province
PA
ZIP/Postal Code
90146
Country
Italy
Facility Name
Novartis Investigative Site
City
Reggio Calabria
State/Province
RC
ZIP/Postal Code
89100
Country
Italy
Facility Name
Novartis Investigative Site
City
Verona
State/Province
VR
ZIP/Postal Code
37126
Country
Italy
Facility Name
Novartis Investigative Site
City
Napoli
ZIP/Postal Code
80138
Country
Italy
Facility Name
Novartis Investigative Site
City
Hazmiyeh
State/Province
Beirut
ZIP/Postal Code
PO Box 213
Country
Lebanon
Facility Name
Novartis Investigative Site
City
Kuala Lumpur
ZIP/Postal Code
50589
Country
Malaysia
Facility Name
Novartis Investigative Site
City
Pulau Pinang
ZIP/Postal Code
10990
Country
Malaysia
Facility Name
Novartis Investigative Site
City
Mexico
State/Province
Distrito Federal
ZIP/Postal Code
06726
Country
Mexico
Facility Name
Novartis Investigative Site
City
Moskow
State/Province
Russia
ZIP/Postal Code
117198
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Dammam
ZIP/Postal Code
15215
Country
Saudi Arabia
Facility Name
Novartis Investigative Site
City
Dammam
ZIP/Postal Code
40145
Country
Saudi Arabia
Facility Name
Novartis Investigative Site
City
Jeddah
ZIP/Postal Code
21589
Country
Saudi Arabia
Facility Name
Novartis Investigative Site
City
Riyadh
ZIP/Postal Code
11472
Country
Saudi Arabia
Facility Name
Novartis Investigative Site
City
Barcelona
ZIP/Postal Code
08041
Country
Spain
Facility Name
Novartis Investigative Site
City
Madrid
ZIP/Postal Code
28033
Country
Spain
Facility Name
Novartis Investigative Site
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
Facility Name
Novartis Investigative Site
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand
Facility Name
Novartis Investigative Site
City
Al Ain - Abu Dhabi
Country
United Arab Emirates
Facility Name
Novartis Investigative Site
City
Dubai
ZIP/Postal Code
9115
Country
United Arab Emirates
Facility Name
Novartis Investigative Site
City
London
ZIP/Postal Code
N19 5NF
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
London
ZIP/Postal Code
NW1 2PJ
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
30453981
Citation
Taher AT, Origa R, Perrotta S, Kouraklis A, Ruffo GB, Kattamis A, Goh AS, Huang V, Zia A, Herranz RM, Porter JB. Patient-reported outcomes from a randomized phase II study of the deferasirox film-coated tablet in patients with transfusion-dependent anemias. Health Qual Life Outcomes. 2018 Nov 19;16(1):216. doi: 10.1186/s12955-018-1041-5.
Results Reference
derived

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Phase II Study to Investigate the Benefits of an Improved Deferasirox Formulation (Film-coated Tablet)

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