Chronic Iron OverloadPhase 3NCT02720536

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

A Phase 3 study testing Deferasirox in people with Chronic Iron Overload, run by Novartis Pharmaceuticals at 14 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Extend evaluation of deferasirox film-coated tablet (FCT) formulation Read more about this study

Who is it for?: Ages 10 years and older
Conditions the study is for: Chronic Iron Overload
What is being tested?: Deferasirox
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 53 participants
Where: 14 sitesin 3 countries
Study dates: 16 Aug 2016to 23 Jul 2019
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 10 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

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.

Who cannot join

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

Show all 16Show fewer

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

Trial locations and contacts

14 sites in 3 countries.

Country

City, postcode or hospital

14 sites in 3 countries

Italy10 sites

Novartis Investigative Site
Cagliari, ITA, 09121
Novartis Investigative Site
Catania, CT, 95125
Novartis Investigative Site
Cona, FE, 44100
Novartis Investigative Site
Genova, GE, 16128
Novartis Investigative Site
Lecce, LE, 73100
Novartis Investigative Site
Milan, MI, 20122
Novartis Investigative Site
Naples, 80138
Novartis Investigative Site
Palermo, PA, 90127
Novartis Investigative Site
Palermo, PA, 90146
Novartis Investigative Site
Verona, VR, 37126

Other trials in Italy

Greece3 sites

Novartis Investigative Site
Goudi-Athens, GR, 115 27
Novartis Investigative Site
Pátrai, 265 00
Novartis Investigative Site
Thessaloniki, 54642

Other trials in Greece

Austria1 site

Novartis Investigative Site
Vienna, 1140

Other trials in Austria

About this study

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

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

Read the 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.

Conditions: Chronic Iron Overload
Being tested: Deferasirox
Keywords: adult, pediatric,, anemia., Myelodysplastic Syndrome, Thalassemia, Film coated tablet, ICL670, MDS, Chelation, Deferasirox, Iron overload
Medical subject headings: Anemia, Myelodysplastic Syndromes, Thalassemia, Iron Overload

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT02720536
Study group	Role	What they receive
Deferasirox	Experimental	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. Receives: Drug: Deferasirox

What is being measured

The primary outcome is the main question the study is designed to answer.

Overview of Number of Participants With Adverse Events
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
Measured: Baseline up to approximately 25 months
Change From Baseline Red Blood Cells (RBC) (10^12 Cells/L) at Month 6 and Month 12
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
Measured: Baseline, 6 and 12 months
Change From Baseline White Blood Cells (WBC) (10^9 Cells/L) at Month 6 and Month 12
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
Measured: Baseline, 6 and 12 months
Change From Baseline Platelets (10^9 Cells/L) at Month 6 and Month 12
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
Measured: Baseline, 6 and 12 months
Change From Baseline Serum Creatinine (Umol/L) at Month 6 and Month 12
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
Measured: Baseline, 6 and 12 months
Change From Baseline Creatinine Clearance (mL/Min) at Month 6 and Month 12
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
Measured: Baseline, 6 and 12 months
Change From Baseline Alanine Aminotransferase/Serum Glutamic Pyruvic Transaminase (ALT/SGPT) (U/L) at Month 6 and Month 12
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
Measured: Baseline, 6 and 12 months
Change From Baseline Aspartate Aminotransferase/Serum Glutamic Oxaloacetic Transaminase (AST/SGOT) (U/L) at Month 6 and Month 12
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
Measured: Baseline, 6 and 12 months

Secondary outcomes (2)

Change From Baseline of Serum Ferritin Level (ug/L) at Month 6 and 12
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
Measured: Baseline, 6 and 12 months
Percentage Relative Change From Baseline of Serum Ferritin (%) at Month 6 and 12
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
Measured: Baseline, 6 and 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

16 Aug 201623 Jul 2019

First posted28 Mar 2016 (estimated)
Study start16 Aug 2016
Primary completion23 Jul 2019
Study completion23 Jul 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Chronic Iron OverloadStudies of the same condition, open and under way.
More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 53 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02720536
Sponsor's protocol ID: CICL670AIC04
Status last verified: Feb 2020
First submitted: 21 Mar 2016
Last updated: 3 Mar 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Publications

Tartaglione I, Origa R, Kattamis A, Pfeilstocker M, Gunes S, Crowe S, Fagan N, Vincenzi B, Ruffo GB. Two-year long safety and efficacy of deferasirox film-coated tablets in patients with thalassemia or lower/intermediate risk MDS: phase 3 results from a subset of patients previously treated with deferasirox in the ECLIPSE study. Exp Hematol Oncol. 2020 Aug 10;9:20. doi: 10.1186/s40164-020-00174-2. eCollection 2020.
PubMed 32793403

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Evaluation of the Quality of Life in Patients With Chronic Iron Overload Due to Hemoglobinopathies in Greece.
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RecruitingObservational study
An Observational Study Evaluating Patients With Chronic Liver Diseases Associated With Hepatic Steatosis
Chronic Liver Disease

All Chronic Iron Overload trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT02720536
Acronym / sponsor ID: CICL670AIC04
Conditions: Chronic Iron Overload
Keywords: adult, pediatric,, anemia., Myelodysplastic Syndrome, Thalassemia, Film coated tablet, ICL670, MDS
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 53 participants (actual)
Lead sponsor: Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: 16 Aug 2016 (actual)
Primary completion: 23 Jul 2019 (actual)
Study completion: 23 Jul 2019 (actual)
First posted: 28 Mar 2016 (estimated)
Results: Posted 3 Mar 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

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

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Deferasirox	Experimental	Drug: DeferasiroxTreatment 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.

Who may qualify

Ages: 10 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (3 listed)

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 criteria (16 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

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

Primary outcome

Overview of Number of Participants With Adverse Events
Time frame: 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
Change From Baseline Red Blood Cells (RBC) (10^12 Cells/L) at Month 6 and Month 12
Time frame: 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
Change From Baseline White Blood Cells (WBC) (10^9 Cells/L) at Month 6 and Month 12
Time frame: 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
Change From Baseline Platelets (10^9 Cells/L) at Month 6 and Month 12
Time frame: 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
Change From Baseline Serum Creatinine (Umol/L) at Month 6 and Month 12
Time frame: 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
Change From Baseline Creatinine Clearance (mL/Min) at Month 6 and Month 12
Time frame: 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
Change From Baseline Alanine Aminotransferase/Serum Glutamic Pyruvic Transaminase (ALT/SGPT) (U/L) at Month 6 and Month 12
Time frame: 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
Change From Baseline Aspartate Aminotransferase/Serum Glutamic Oxaloacetic Transaminase (AST/SGOT) (U/L) at Month 6 and Month 12
Time frame: 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

2 secondary outcomes

Change From Baseline of Serum Ferritin Level (ug/L) at Month 6 and 12
Time frame: Baseline, 6 and 12 months
Percentage Relative Change From Baseline of Serum Ferritin (%) at Month 6 and 12
Time frame: Baseline, 6 and 12 months

Results and safety

Results posted to the registry on 3 Mar 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Deferasirox	53	34

Primary outcome: Overview of Number of Participants With Adverse Events

Time frame: Baseline up to approximately 25 months. Number. Unit: number of participants

Measure	Deferasirox n = 53
Adverse events (AEs)	52
Treatment related AEs	20
Severe adverse events	14
Treatment related severe adverse events	2
Serious adverse events (SAEs)	13
Treatment related SAEs	0
Fatal SAEs	1
Treatment related fatal SAEs	0

Population analysed: Safety analysis set

Primary outcome: Change From Baseline Red Blood Cells (RBC) (10^12 Cells/L) at Month 6 and Month 12

Time frame: Baseline, 6 and 12 months. Mean (Standard Deviation). Unit: 10^12 cells/L

Measure	Baseline n = 53	Month 6 n = 42	Month 12 n = 40
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)

Population analysed: 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

Primary outcome: Change From Baseline White Blood Cells (WBC) (10^9 Cells/L) at Month 6 and Month 12

Time frame: Baseline, 6 and 12 months. Mean (Standard Deviation). Unit: 10^9 cells/L

Measure	Baseline n = 53	Month 6 n = 42	Month 12 n = 40
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)

Population analysed: 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

Primary outcome: Change From Baseline Platelets (10^9 Cells/L) at Month 6 and Month 12

Time frame: Baseline, 6 and 12 months. Mean (Standard Deviation). Unit: 10^9 cells/L

Measure	Baseline n = 53	Month 6 n = 42	Month 12 n = 40
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)

Population analysed: 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

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse 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. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Deferasirox	13 of 53 (24.5%)	48 of 53 (90.6%)	1 of 53

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 32793403Tartaglione I, Origa R, Kattamis A, Pfeilstocker M, Gunes S, Crowe S, Fagan N, Vincenzi B, Ruffo GB. Two-year long safety and efficacy of deferasirox film-coated tablets in patients with thalassemia or lower/intermediate risk MDS: phase 3 results from a subset of patients previously treated with deferasirox in the ECLIPSE study. Exp Hematol Oncol. 2020 Aug 10;9:20. doi: 10.1186/s40164-020-00174-2. eCollection 2020.
Individual participant dataSharing planned: Yes. Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Related trials for Chronic Iron Overload

Not yet recruitingObservational study
Native T1 Mapping and ECV in Chronic Hemolytic Anemia
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Not yet recruitingObservational study
Evaluation of the Quality of Life in Patients With Chronic Iron Overload Due to Hemoglobinopathies in Greece.
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RecruitingObservational study
An Observational Study Evaluating Patients With Chronic Liver Diseases Associated With Hepatic Steatosis
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

14 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Deferasirox in people with Chronic Iron Overload, run by Novartis Pharmaceuticals at 14 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in Italy, Greece, Austria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Mar 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overview of Number of Participants With Adverse Events (time frame: Baseline up to approximately 25 months). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02720536, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2020.

Trial summary

Key requirements

Who may be able to join

Who cannot join

Trial locations and contacts

About this study

What participants receive

What is being measured

Timeline

Resources

More details

Publications

Study at a glance

Clinical summary

Study design

Who may qualify

Key inclusion criteria (3 listed)

Key exclusion criteria (16 listed)

Interventions

Primary outcome

Results and safety

Participant flow

Primary outcome: Overview of Number of Participants With Adverse Events

Primary outcome: Change From Baseline Red Blood Cells (RBC) (10^12 Cells/L) at Month 6 and Month 12

Primary outcome: Change From Baseline White Blood Cells (WBC) (10^9 Cells/L) at Month 6 and Month 12

Primary outcome: Change From Baseline Platelets (10^9 Cells/L) at Month 6 and Month 12

Adverse events

Research links

Related trials for Chronic Iron Overload

Native T1 Mapping and ECV in Chronic Hemolytic Anemia

Evaluation of the Quality of Life in Patients With Chronic Iron Overload Due to Hemoglobinopathies in Greece.

An Observational Study Evaluating Patients With Chronic Liver Diseases Associated With Hepatic Steatosis

Referral and contact

Questions about this trial

Participant flow

Primary outcome: Overview of Number of Participants With Adverse Events

Primary outcome: Change From Baseline Red Blood Cells (RBC) (10^12 Cells/L) at Month 6 and Month 12

Primary outcome: Change From Baseline White Blood Cells (WBC) (10^9 Cells/L) at Month 6 and Month 12

Primary outcome: Change From Baseline Platelets (10^9 Cells/L) at Month 6 and Month 12

Adverse events