Who is sponsoring NCT02125877?

NCT02125877 is sponsored by Novartis Pharmaceuticals.

What drugs are being tested in NCT02125877?

Interventions in NCT02125877: Deferasirox dispersible tablet, Defearisox film-coated tablet.

What condition does NCT02125877 study?

NCT02125877 studies Chronic Iron Overload Due to Transfusion-dependant Anemias.

Is NCT02125877 still recruiting?

NCT02125877 is currently completed. Last updated 25 July 2017.

Are results published for NCT02125877?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2017-07-25 · How we verify

NCT02125877

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 2 Results posted Last updated 25 July 2017

What this trial tests

Phase 2 trial testing Deferasirox dispersible tablet in Chronic Iron Overload Due to Transfusion-dependant Anemias in 173 participants. Completed in 24 February 2016.

Timeline

8 July 2014

Primary endpoint
24 February 2016

24 February 2016

Quick facts

Lead sponsor	Novartis Pharmaceuticals
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	173
Start date	8 July 2014
Primary completion	24 February 2016
Estimated completion	24 February 2016
Sites	51 locations across France, Italy, Russia, Greece, Malaysia, Austria, Saudi Arabia, United Kingdom

Drugs / interventions tested

Deferasirox dispersible tablet — full drug profile →
Defearisox film-coated tablet — full drug profile →

Conditions studied

Chronic Iron Overload Due to Transfusion-dependant Anemias — all drugs for Chronic Iron Overload Due to Transfusion-dependant Anemias →

Sponsor

Novartis Pharmaceuticals — full company profile →

Who can join

10 and older, any sex, with Chronic Iron Overload Due to Transfusion-dependant Anemias. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Overall Safety as Measured by Frequency of Adverse Events Primary · 28 weeks

The percentage of participants with adverse events, serious adverse events and deaths was assessed.

Adverse events

Group	Value	95% CI
Deferasirox Dispersible Tablet (DFX-DT)	89.5
Deferasirox Film-coated Tablet (DFX-FCT)	89.7

SAEs

Group	Value	95% CI
Deferasirox Dispersible Tablet (DFX-DT)	15.1
Deferasirox Film-coated Tablet (DFX-FCT)	18.4

Deaths

Group	Value	95% CI
Deferasirox Dispersible Tablet (DFX-DT)	0
Deferasirox Film-coated Tablet (DFX-FCT)	1.1

Overall Safety as Measured by Changes in Laboratory Values From Baseline Primary · baseline (BL), 30 weeks

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.

platelet count, notable range: <100 x 10^9/L

Group	Value	95% CI
Deferasirox Dispersible Tablet (DFX-DT)	9.3
Deferasirox Film-coated Tablet (DFX-FCT)	8.0

platelet count, extended range: <50 x 10^9/L

Group	Value	95% CI
Deferasirox Dispersible Tablet (DFX-DT)	3.5
Deferasirox Film-coated Tablet (DFX-FCT)	5.7

absolute neutrophils, notable range: <1.5 x 10^9/L

Group	Value	95% CI
Deferasirox Dispersible Tablet (DFX-DT)	8.1
Deferasirox Film-coated Tablet (DFX-FCT)	13.8

absolute neut., extended range: <0.5 x 10^9/L

Group	Value	95% CI
Deferasirox Dispersible Tablet (DFX-DT)	4.7
Deferasirox Film-coated Tablet (DFX-FCT)	0

serum creat, 2 cons >33% incr. from BL and >ULN

Group	Value	95% CI
Deferasirox Dispersible Tablet (DFX-DT)	4.7
Deferasirox Film-coated Tablet (DFX-FCT)	3.4

creat clearance, notable range: 2 cons <60mL/min

Group	Value	95% CI
Deferasirox Dispersible Tablet (DFX-DT)	7.0
Deferasirox Film-coated Tablet (DFX-FCT)	2.3

creat clearance, extended range: 2 cons <40mL/min

Group	Value	95% CI
Deferasirox Dispersible Tablet (DFX-DT)	2.3
Deferasirox Film-coated Tablet (DFX-FCT)	2.3

urin protein/urin creat ratio, 2 cons >1.0 mg/mg

Group	Value	95% CI
Deferasirox Dispersible Tablet (DFX-DT)	2.3
Deferasirox Film-coated Tablet (DFX-FCT)	0

Frequency of Selected Gastro-intestinal (GI) Adverse Events Secondary · 28 weeks

The percentage of participants with any GI adverse event, diarrhea, constipation, nausea, vomiting, abdominal pain was assessed.

Any GI adverse event

Group	Value	95% CI
Deferasirox Dispersible Tablet (DFX-DT)	61.6
Deferasirox Film-coated Tablet (DFX-FCT)	58.6

Abdominal pain

Group	Value	95% CI
Deferasirox Dispersible Tablet (DFX-DT)	26.7
Deferasirox Film-coated Tablet (DFX-FCT)	26.4

Constipation

Group	Value	95% CI
Deferasirox Dispersible Tablet (DFX-DT)	15.1
Deferasirox Film-coated Tablet (DFX-FCT)	8.0

Diarrhea

Group	Value	95% CI
Deferasirox Dispersible Tablet (DFX-DT)	34.9
Deferasirox Film-coated Tablet (DFX-FCT)	33.3

Nausea

Group	Value	95% CI
Deferasirox Dispersible Tablet (DFX-DT)	26.7
Deferasirox Film-coated Tablet (DFX-FCT)	27.6

Vomiting

Group	Value	95% CI
Deferasirox Dispersible Tablet (DFX-DT)	22.1
Deferasirox Film-coated Tablet (DFX-FCT)	17.2

Mean Domain Scores of the Modified Satisfaction With Iron Chelation Therapy (Modified SICT) Secondary · weeks 2, 3, 13 and 24 (end of treatment or within 7 days of last dose)

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

week 2, adherence (n=70,70)

Group	Value	95% CI
Deferasirox Dispersible Tablet (DFX-DT)	10.3	± 3.80
Deferasirox Film-coated Tablet (DFX-FCT)	7.6	± 2.14

week 2, satisfaction/preference (n=70,70)

Group	Value	95% CI
Deferasirox Dispersible Tablet (DFX-DT)	5.2	± 2.24
Deferasirox Film-coated Tablet (DFX-FCT)	2.8	± 1.37

week 2, concerns (n=70,70)

Group	Value	95% CI
Deferasirox Dispersible Tablet (DFX-DT)	12.9	± 2.94
Deferasirox Film-coated Tablet (DFX-FCT)	13.8	± 2.02

week 3, adherence (n=58,51)

Group	Value	95% CI
Deferasirox Dispersible Tablet (DFX-DT)	10.9	± 4.09
Deferasirox Film-coated Tablet (DFX-FCT)	7.7	± 2.06

week 3, satisfaction/preference (n=58,51)

Group	Value	95% CI
Deferasirox Dispersible Tablet (DFX-DT)	5.4	± 2.22
Deferasirox Film-coated Tablet (DFX-FCT)	2.6	± 1.05

week 3, concerns (n=58,51)

Group	Value	95% CI
Deferasirox Dispersible Tablet (DFX-DT)	12.4	± 2.73
Deferasirox Film-coated Tablet (DFX-FCT)	14.0	± 1.49

week 13, adherence (n=59,64)

Group	Value	95% CI
Deferasirox Dispersible Tablet (DFX-DT)	11.2	± 3.56
Deferasirox Film-coated Tablet (DFX-FCT)	7.8	± 2.05

week 13, satisfaction/preference (n=59,64)

Group	Value	95% CI
Deferasirox Dispersible Tablet (DFX-DT)	5.4	± 2.14
Deferasirox Film-coated Tablet (DFX-FCT)	2.9	± 1.54

Palatability Questionnaire Score Secondary · weeks 2, 3, 13 and 24 (end of treatment or within 7 days of last dose)

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 diffe

week 2 (n=69,70)

Group	Value	95% CI
Deferasirox Dispersible Tablet (DFX-DT)	9.0	± 3.01
Deferasirox Film-coated Tablet (DFX-FCT)	10.8	± 0.50

week 3 (n=57,51)

Group	Value	95% CI
Deferasirox Dispersible Tablet (DFX-DT)	8.8	± 3.01
Deferasirox Film-coated Tablet (DFX-FCT)	10.8	± 0.45

week 13 (n=59,62)

Group	Value	95% CI
Deferasirox Dispersible Tablet (DFX-DT)	9.3	± 2.84
Deferasirox Film-coated Tablet (DFX-FCT)	10.8	± 1.16

week 24 (n=63,60)

Group	Value	95% CI
Deferasirox Dispersible Tablet (DFX-DT)	8.8	± 3.10
Deferasirox Film-coated Tablet (DFX-FCT)	10.9	± 0.34

Weekly Average of Daily Scores of the Gastrointestinal (GI) Symptom Diary Secondary · weeks -1, 4, 8, 12, 16, 20, 24

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

week -1 (n=69,65)

Group	Value	95% CI
Deferasirox Dispersible Tablet (DFX-DT)	1.4	± 2.10
Deferasirox Film-coated Tablet (DFX-FCT)	1.9	± 3.69

week 4 (n=60,64)

Group	Value	95% CI
Deferasirox Dispersible Tablet (DFX-DT)	1.8	± 3.49
Deferasirox Film-coated Tablet (DFX-FCT)	1.1	± 2.15

week 8 (n=59,51)

Group	Value	95% CI
Deferasirox Dispersible Tablet (DFX-DT)	1.4	± 2.45
Deferasirox Film-coated Tablet (DFX-FCT)	1.1	± 2.16

week 12 (n=51,45)

Group	Value	95% CI
Deferasirox Dispersible Tablet (DFX-DT)	1.7	± 3.16
Deferasirox Film-coated Tablet (DFX-FCT)	1.0	± 1.78

week 16 (n=48,41)

Group	Value	95% CI
Deferasirox Dispersible Tablet (DFX-DT)	1.9	± 3.75
Deferasirox Film-coated Tablet (DFX-FCT)	0.9	± 1.92

week 20 (n40,39)

Group	Value	95% CI
Deferasirox Dispersible Tablet (DFX-DT)	1.5	± 3.27
Deferasirox Film-coated Tablet (DFX-FCT)	0.9	± 1.44

week 24 (n32,26)

Group	Value	95% CI
Deferasirox Dispersible Tablet (DFX-DT)	1.5	± 3.29
Deferasirox Film-coated Tablet (DFX-FCT)	1.2	± 1.89

Number of Participants With Weekly Average Compliance of Medication Consumption Secondary · 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

A compliance questionnaire assessed whether the medication was taken. Weekly average compliance was calculated when there were at least four non-missing daily responses.

week 1

Group	Value	95% CI
Deferasirox Dispersible Tablet (DFX-DT)	56
Deferasirox Film-coated Tablet (DFX-FCT)	53

week 2

Group	Value	95% CI
Deferasirox Dispersible Tablet (DFX-DT)	64
Deferasirox Film-coated Tablet (DFX-FCT)	64

week 3

Group	Value	95% CI
Deferasirox Dispersible Tablet (DFX-DT)	62
Deferasirox Film-coated Tablet (DFX-FCT)	56

week 4

Group	Value	95% CI
Deferasirox Dispersible Tablet (DFX-DT)	58
Deferasirox Film-coated Tablet (DFX-FCT)	58

week 5

Group	Value	95% CI
Deferasirox Dispersible Tablet (DFX-DT)	56
Deferasirox Film-coated Tablet (DFX-FCT)	58

week 6

Group	Value	95% CI
Deferasirox Dispersible Tablet (DFX-DT)	62
Deferasirox Film-coated Tablet (DFX-FCT)	51

week 7

Group	Value	95% CI
Deferasirox Dispersible Tablet (DFX-DT)	55
Deferasirox Film-coated Tablet (DFX-FCT)	48

week 8

Group	Value	95% CI
Deferasirox Dispersible Tablet (DFX-DT)	56
Deferasirox Film-coated Tablet (DFX-FCT)	46

Weekly Dose Violation Rate Secondary · weeks 1, 4, 8, 12, 16, 20, 24

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.

week 1 (n=56,53)

Group	Value	95% CI
Deferasirox Dispersible Tablet (DFX-DT)	17.7	± 31.04
Deferasirox Film-coated Tablet (DFX-FCT)	15.8	± 29.42

week 4 (n=58,58)

Group	Value	95% CI
Deferasirox Dispersible Tablet (DFX-DT)	15.8	± 32.51
Deferasirox Film-coated Tablet (DFX-FCT)	6.7	± 15.45

week 8 (n=56,46)

Group	Value	95% CI
Deferasirox Dispersible Tablet (DFX-DT)	18.0	± 35.38
Deferasirox Film-coated Tablet (DFX-FCT)	8.4	± 22.17

week 12 (n=50,41)

Group	Value	95% CI
Deferasirox Dispersible Tablet (DFX-DT)	15.7	± 34.22
Deferasirox Film-coated Tablet (DFX-FCT)	10.7	± 22.63

week 16 (n=48,40)

Group	Value	95% CI
Deferasirox Dispersible Tablet (DFX-DT)	13.5	± 31.08
Deferasirox Film-coated Tablet (DFX-FCT)	10.0	± 24.5

week 20 (n=40,36)

Group	Value	95% CI
Deferasirox Dispersible Tablet (DFX-DT)	22.6	± 38.38
Deferasirox Film-coated Tablet (DFX-FCT)	11.3	± 26.67

week 24 (n=30,24)

Group	Value	95% CI
Deferasirox Dispersible Tablet (DFX-DT)	17.1	± 34.26
Deferasirox Film-coated Tablet (DFX-FCT)	10.1	± 25.47

Area Under the Plasma Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUClast) Secondary · 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

Blood samples were collected to assess AUClast.

week1 (n=14,15)

Group	Value	95% CI
Deferasirox Dispersible Tablet (DFX-DT)	1110	± 495
Deferasirox Film-coated Tablet (DFX-FCT)	1040	± 405

week 3 (n=13,15)

Group	Value	95% CI
Deferasirox Dispersible Tablet (DFX-DT)	1590	± 540
Deferasirox Film-coated Tablet (DFX-FCT)	2110	± 987

Observed Maximum Plasma Concentration Following Drug Administration (Cmax) Secondary · 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

Blood samples were collected to assess Cmax.

week 1 (n=14,15)

Group	Value	95% CI
Deferasirox Dispersible Tablet (DFX-DT)	74.6	± 30.7
Deferasirox Film-coated Tablet (DFX-FCT)	79.3	± 23.5

week 3 (n=14,15)

Group	Value	95% CI
Deferasirox Dispersible Tablet (DFX-DT)	118	± 82.3
Deferasirox Film-coated Tablet (DFX-FCT)	139	± 57.2

Time to Reach the Maximum Plasma Concentration After Drug Administration (Tmax) Secondary · 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

Blood samples were collected to assess Tmax.

week 1 (n=14,15)

Group	Value	95% CI
Deferasirox Dispersible Tablet (DFX-DT)	3.57	1.15 – 7.89
Deferasirox Film-coated Tablet (DFX-FCT)	2.00	1.15 – 15.6

week 3 (n=14,15)

Group	Value	95% CI
Deferasirox Dispersible Tablet (DFX-DT)	2.85	1.40 – 8.39
Deferasirox Film-coated Tablet (DFX-FCT)	2.02	1.07 – 5.06

Dererasirox Plasma Concentration Secondary · 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

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.

week 3, pre-dose (n=63,70)

Group	Value	95% CI
Deferasirox Dispersible Tablet (DFX-DT)	39.6	± 48.4
Deferasirox Film-coated Tablet (DFX-FCT)	27.3	± 20.4

week 3, 2 hours post-dose (n=67,76)

Group	Value	95% CI
Deferasirox Dispersible Tablet (DFX-DT)	80.8	± 52.2
Deferasirox Film-coated Tablet (DFX-FCT)	95.5	± 53.0

week 13, pre-dose (n=69.56)

Group	Value	95% CI
Deferasirox Dispersible Tablet (DFX-DT)	37.1	± 37.8
Deferasirox Film-coated Tablet (DFX-FCT)	31.3	± 22.9

week 13, 2 hours post-dose (n=74,59)

Group	Value	95% CI
Deferasirox Dispersible Tablet (DFX-DT)	78.7	± 39.5
Deferasirox Film-coated Tablet (DFX-FCT)	92.5	± 39.1

week 21, pre-dose (n=54,59)

Group	Value	95% CI
Deferasirox Dispersible Tablet (DFX-DT)	46.6	± 46.4
Deferasirox Film-coated Tablet (DFX-FCT)	43.1	± 36.8

week 21, 2 hours post-dose (n=59,64)

Group	Value	95% CI
Deferasirox Dispersible Tablet (DFX-DT)	89.8	± 59.3
Deferasirox Film-coated Tablet (DFX-FCT)	105	± 51.2

Adverse events — posted to ClinicalTrials.gov

Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Deferasirox Dispersible Tablet (DFX-DT)

Serious: 13/86 (15%)

Deaths: —

Deferasirox Film-coated Tablet (DFX-FCT)

Serious: 16/87 (18%)

Deaths: —

Serious adverse events (49 terms)

Reaction	System	Deferasirox Dispersible Ta…	Deferasirox Film-coated Ta…
Diarrhoea	Gastrointestinal disorders	—	—
Sepsis	Infections and infestations	—	—
Accidental overdose	Injury, poisoning and procedural complications	—	—
Anaemia	Blood and lymphatic system disorders	—	—
Autoimmune haemolytic anaemia	Blood and lymphatic system disorders	—	—
Febrile neutropenia	Blood and lymphatic system disorders	—	—
Haemolysis	Blood and lymphatic system disorders	—	—
Atrial fibrillation	Cardiac disorders	—	—
Cardiac failure acute	Cardiac disorders	—	—
Abdominal pain upper	Gastrointestinal disorders	—	—
Anal fissure	Gastrointestinal disorders	—	—
Ascites	Gastrointestinal disorders	—	—
Dysphagia	Gastrointestinal disorders	—	—
Neutropenic colitis	Gastrointestinal disorders	—	—
Rectal haemorrhage	Gastrointestinal disorders	—	—
Vomiting	Gastrointestinal disorders	—	—
Face oedema	General disorders	—	—
Oedema	General disorders	—	—
Pyrexia	General disorders	—	—
Biliary colic	Hepatobiliary disorders	—	—
Cholecystitis	Hepatobiliary disorders	—	—
Hepatitis	Hepatobiliary disorders	—	—
Appendicitis	Infections and infestations	—	—
Brucellosis	Infections and infestations	—	—
Gastroenteritis	Infections and infestations	—	—

Other adverse events (24 terms — click to expand)

Reaction	System	Deferasirox Dispersible Ta…	Deferasirox Film-coated Ta…
Diarrhoea	Gastrointestinal disorders	—	—
Nausea	Gastrointestinal disorders	—	—
Abdominal pain	Gastrointestinal disorders	—	—
Vomiting	Gastrointestinal disorders	—	—
Urine protein/creatinine ratio increased	Investigations	—	—
Constipation	Gastrointestinal disorders	—	—
Headache	Nervous system disorders	—	—
Abdominal pain upper	Gastrointestinal disorders	—	—
Asthenia	General disorders	—	—
Blood creatinine increased	Investigations	—	—
Haematuria	Renal and urinary disorders	—	—
Proteinuria	Renal and urinary disorders	—	—
Fatigue	General disorders	—	—
Pyrexia	General disorders	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—
Dyspepsia	Gastrointestinal disorders	—	—
Upper respiratory tract infection	Infections and infestations	—	—
Urinary tract infection	Infections and infestations	—	—
Pyuria	Renal and urinary disorders	—	—
Bacteriuria	Infections and infestations	—	—
Gastroenteritis	Infections and infestations	—	—
Influenza	Infections and infestations	—	—
Hyperphosphataemia	Metabolism and nutrition disorders	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—

Most-reported serious reactions: Diarrhoea, Sepsis, Accidental overdose, Anaemia, Autoimmune haemolytic anaemia, Febrile neutropenia, Haemolysis, Atrial fibrillation.

Data from ClinicalTrials.gov NCT02125877 adverse events section.

Sponsor's own description

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

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Iron homeostasis and ferroptosis in human diseases: mechanisms and therapeutic prospects.
Ru Q, Li Y, Chen L, Wu Y, et al · · 2024 · cited 365× · PMID 39396974 · DOI 10.1038/s41392-024-01969-z
Iron chelation therapy in transfusion-dependent thalassemia patients: current strategies and future directions.
Saliba AN, Saliba AN, Harb AR, Taher AT. · · 2015 · cited 60× · PMID 26124688 · DOI 10.2147/jbm.s72463
Deferasirox for managing iron overload in people with thalassaemia.
Bollig C, Schell LK, Rücker G, Allert R, et al · · 2017 · cited 26× · PMID 28809446 · DOI 10.1002/14651858.cd007476.pub3
Interventions for improving adherence to iron chelation therapy in people with sickle cell disease or thalassaemia.
Fortin PM, Fisher SA, Madgwick KV, Trivella M, et al · · 2018 · cited 21× · PMID 29737522 · DOI 10.1002/14651858.cd012349.pub2
Patient-reported outcomes from a randomized phase II study of the deferasirox film-coated tablet in patients with transfusion-dependent anemias.
Taher AT, Origa R, Perrotta S, Kouraklis A, et al · · 2018 · cited 17× · PMID 30453981 · DOI 10.1186/s12955-018-1041-5
Advances in iron chelation therapy: transitioning to a new oral formulation.
Shah NR. · · 2017 · cited 15× · PMID 28706555 · DOI 10.7573/dic.212502
Patient preference for deferasirox film-coated versus dispersible tablet formulation: a sequential-design phase 2 study in patients with thalassemia.
Viprakasit V, Hamdy MM, Hassab HMA, Sherief LM, et al · · 2023 · cited 4× · PMID 37227493 · DOI 10.1007/s00277-023-05240-3
Interventions for improving adherence to iron chelation therapy in people with sickle cell disease or thalassaemia.
Geneen LJ, Dorée C, Estcourt LJ. · · 2023 · cited 4× · PMID 36877640 · DOI 10.1002/14651858.cd012349.pub3

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02125877 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Novartis Pharmaceuticals
Last refreshed: 25 July 2017

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02125877.

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