Healthy VolunteersPhase 1NCT01989455

A Blinded, Placebo-Controlled Study of the Safety and Pharmacokinetics of Single Doses of Intravenous Deferiprone in Healthy Volunteers

A Phase 1 study testing Deferiprone in people with Healthy Volunteers, run by ApoPharma at 1 site in Canada.

Completed

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

Trial summary

Single center, randomized, double-blind, placebo-controlled, adaptive sequential ascending-dose study for the evaluation of the safety, tolerability, and pharmacokinetics of single doses of deferiprone administered by intravenous infusion to healthy males and females. A bioavailability comparison will be included. Read more about this study

Who is it for?: Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Volunteers
What is being tested?: Deferiprone
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 64 participants
Where: 1 siteCanada
Study dates: Nov 2013to Mar 2014
Phase: Phase 1
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 18 to 50 years
All sexes
Healthy volunteers accepted
Adult

Main Inclusion Criteria:

Healthy adult males or females, at least 18 years old but not older than 50 years.
Body weight at least 60kg.
Body Mass Index (BMI) ≥ 18.50 and ≤ 30.00 kg/m2
Medically healthy with clinically insignificant screening results (e.g., laboratory profiles, medical history, ECG, vital signs, physical examination.
Non or ex-smoker (someone who has completely stopped smoking 6 months before study start)
For females, negative result on a serum pregnancy test.

Main Exclusion Criteria:

Absolute neutrophil count (ANC) <1.5x10^9/L.
History or presence of hypersensitivity to deferiprone or any related products.
History or presence of gastrointestinal, liver or kidney disease, or any other conditions known to interfere with the absorption, distribution, metabolism or excretion of drugs.
Presence of significant cardiovascular, pulmonary, hematologic, neurologic, psychiatric, endocrine, immunologic or dermatologic disease.
Any history of tuberculosis (TB) or prophylaxis for TB.
Suicidal tendency, history of seizures, head trauma with coma or craniotomy/trepanation, state of confusion or relevant psychiatric disease.
Inadequate venous access in either arm.
Presence of out-of-range cardiac interval or clinically significant ECG abnormalities (PR <110 msec or > 220 msec, QRS <60 msec or >119 msec, QTcB > 450 msec for males and >460 msec for females).
Use of acetaminophen, acetylsalicylic acid (ASA), or non-steroidal anti-inflammatory drugs (NSAIDs) in the previous 7 days before study start.
Use of any enzyme-modifying drugs, including strong inhibitors of P450 (CYP) enzymes such as cimetidine, fluoxetine, quinidine, erythromycin, ciprofloxacin, fluconazole, ketoconazole, diltiazem, and HIV antivirals OR strong inducers of CYP enzymes such as: barbiturates, carbamazepine, glucocorticoids, phenytoin, rifampin, and St. John's wart within 28 days prior to study start.
Maintenance therapy with any drug, or significant history of drug dependency or alcohol abuse.
Had a clinically significant illness during the 28 days prior to study start.
Receipt of an investigational product in another clinical trial within 28 days prior prior to study start.
Enrolment in a previous cohort of this study.

Trial locations and contacts

1 site in 1 country.

Canada1 site

Algorithme Pharma Inc.
Mount Royal, Quebec, H3P3P1

Other trials in Canada

About this study

Official title: A Single Center, Phase I, Double-blind, Placebo-controlled Evaluation of the Safety, Tolerability, and Pharmacokinetics of Single Ascending Doses of Deferiprone Administered by Intravenous Infusion to Healthy Male and Female Volunteers

Conditions: Healthy Volunteers
Being tested: Deferiprone, Placebo
Keywords: Healthy, Deferiprone, DFP, L1

What participants receive

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

DeferiproneDrug
Also called Ferriprox, DFP, L1
Deferiprone for infusion, 10mg/mL for intravenous infusion.
Oral dose of deferiprone: 80mg/mL oral solution. (Cohort 2)
PlaceboDrug
Also called Saline solution.
Placebo: normal saline solution.

Study groups in NCT01989455
Study group	Role	What they receive
Cohort 1	Experimental	Single dose of 500mg deferiprone or placebo administered via intravenous infusion. First 2 subjects to enroll: 1 will be randomized to receive deferiprone and the other to receive placebo. Next 14 subjects enrolled: 13 will be randomized to receive deferiprone and 1 to receive placebo. Receives: Drug: Deferiprone; Drug: Placebo
Cohort 2	Experimental	Single dose of 1000mg deferiprone or placebo administered via intravenous infusion and oral solution. Randomization will be done for all 16 subjects at the same time: 14 will be randomized to receive deferiprone and 2 to receive placebo. Subjects enrolled to cohort 2 will receive an oral dose of deferiprone. Receives: Drug: Deferiprone; Drug: Placebo
Cohort 3	Experimental	Single dose of 1500mg deferiprone or placebo administered via intravenous infusion. Randomization will be done for all 16 subjects at the same time, 14 will be randomized to receive deferiprone and 2 to receive placebo. Receives: Drug: Deferiprone; Drug: Placebo
Cohort 4	Experimental	Single dose of 2000mg deferiprone or placebo administered via intravenous infusion. First 2 subjects to enroll: 1 will be randomized to receive deferiprone and the other to receive placebo. Next 14 subjects enrolled: 13 will be randomized to receive deferiprone and 1 to receive placebo. Receives: Drug: Deferiprone; Drug: Placebo

What is being measured

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

Maximum Measured Serum Concentration (Cmax) for Serum Deferiprone and Deferiprone 3-O-glucuronide
Cmax was assessed over a 14-hour interval for analyses of deferiprone and its 3-O-glucuronide metabolite in healthy volunteers who received single intravenous doses of 500 mg, 1000 mg, 1500 mg, and 2000 mg of intravenous deferiprone. Blood samples were obtained pre-dose and at 0.17, 0.33, 0.50, 0.75, 1, 1.33, 1.67, 2, 2.5, 3, 4, 6, 9, 12, and 14 hours post-dose.
Measured: 14-hour interval
Time to Maximum Observed Serum Concentration (Tmax) for Serum Deferiprone and Deferiprone 3-O-glucuronide
Tmax was assessed over a 14-hour interval for analyses of deferiprone and its 3-O-glucuronide metabolite in healthy volunteers who received single intravenous doses of 500 mg, 1000 mg, 1500 mg, and 2000 mg of intravenous deferiprone. Blood samples were obtained pre-dose and at 0.17, 0.33, 0.50, 0.75, 1, 1.33, 1.67, 2, 2.5, 3, 4, 6, 9, 12, and 14 hours post-dose.
The results of the Tmax parameter are reported as the median and range (other parameters are reported as mean and standard deviation).
Measured: 14-hour interval
Area Under the Curve From Zero to Infinity (AUC0-∞) for Serum Deferiprone and Deferiprone 3-O-glucuronide
AUC0-∞ was assessed over a 14-hour interval for analyses of deferiprone and its 3-O-glucuronide metabolite in healthy volunteers who received single intravenous doses of 500 mg, 1000 mg, 1500 mg, and 2000 mg of intravenous deferiprone. Blood samples were obtained pre-dose and at 0.17, 0.33, 0.50, 0.75, 1, 1.33, 1.67, 2, 2.5, 3, 4, 6, 9, 12, and 14 hours post-dose.
Measured: 14-hour interval
The Terminal Elimination Half-life (T1/2el) for Serum Deferiprone and Deferiprone 3-O-glucuronide
T1/2el was assessed over a 14-hour interval for analyses of deferiprone and its 3-O-glucuronide metabolite in healthy volunteers who received single intravenous doses of 500 mg, 1000 mg, 1500 mg, and 2000 mg of intravenous deferiprone. Blood samples were obtained pre-dose and at 0.17, 0.33, 0.50, 0.75, 1, 1.33, 1.67, 2, 2.5, 3, 4, 6, 9, 12, and 14 hours post-dose.
Measured: 14-hour interval
Safety and Tolerability of Single Ascending Doses of Deferiprone When Administered by Intravenous Infusion in Healthy Volunteers.
The number of participants who experienced adverse events (including any changes of clinical significance in physical examinations, vital signs, 12-lead ECG, and clinical laboratory tests) following a single dose of intravenous deferiprone.
Measured: From start of intravenous dosing until Day 5 post-dose for all subjects; and from time of oral dose until 24 hours post-dose for subjects who additionally received oral deferiprone

Secondary outcomes (3)

Comparison of Cmax for Serum Deferiprone and Deferiprone 3-O-glucuronide Between Deferiprone for Infusion and Oral Deferiprone
Cmax was assessed over a 14-hour interval for deferiprone in healthy volunteers who received a single intravenous dose of 1000 mg and then one week later received a single oral dose of 1000 mg deferiprone oral solution. In both cases, blood samples were obtained pre-dose and at 0.17, 0.33, 0.50, 0.75, 1, 1.33, 1.67, 2, 2.5, 3, 4, 6, 9, 12, and 14 hours post-dose.
Measured: 14-hour interval
Absolute Bioavailability of Deferiprone
The pharmacokinetic profile was assessed over a 14-hour interval for deferiprone in healthy volunteers who received a single intravenous dose of 1000 mg and then one week later received a single oral dose of 1000 mg deferiprone oral solution. In both cases, blood samples were obtained pre-dose and at 0.17, 0.33, 0.50, 0.75, 1, 1.33, 1.67, 2, 2.5, 3, 4, 6, 9, 12, and 14 hours post-dose.
Measured: 14-hour interval
Safety and Tolerability of a Single 1000 mg Oral Dose of Deferiprone
The number of participants who experienced adverse events (including any changes of clinical significance in physical examinations, vital signs, 12-lead ECG, and clinical laboratory tests) following a single dose of oral deferiprone. Note: All subjects in the 1000 mg cohort received active product, including the 2 who had received placebo for the intravenous infusion.
Measured: From dosing until 24 hours post-dose

Timeline

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

Nov 2013Mar 2014

First posted21 Nov 2013 (estimated)
Study startNov 2013
Primary completionMar 2014
Study completionMar 2014

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.
Other trials for Healthy VolunteersStudies of the same condition, open and under way.
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 1
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 64 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01989455
Sponsor's protocol ID: LA42-0113
Status last verified: Dec 2014
First submitted: 15 Nov 2013
Last updated: 23 Dec 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

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?

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All Healthy Volunteers trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Single Center, Phase I, Double-blind, Placebo-controlled Evaluation of the Safety, Tolerability, and Pharmacokinetics of Single Ascending Doses of Deferiprone Administered by Intravenous Infusion to Healthy Male and Female Volunteers
ClinicalTrials.gov ID: NCT01989455
Acronym / sponsor ID: LA42-0113
Conditions: Healthy Volunteers
Keywords: Healthy, Deferiprone, DFP, L1
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 64 participants (actual)
Lead sponsor: ApoPharmaIndustry (pharma, biotech, devices)
Study start: Nov 2013
Primary completion: Mar 2014 (actual)
Study completion: Mar 2014 (actual)
First posted: 21 Nov 2013 (estimated)
Results: Posted 4 Dec 2014

Clinical summary

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

Study design

Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Cohort 1	Experimental	Drug: Deferiprone, Drug: PlaceboSingle dose of 500mg deferiprone or placebo administered via intravenous infusion. First 2 subjects to enroll: 1 will be randomized to receive deferiprone and the other to receive placebo. Next 14 subjects enrolled: 13 will be randomized to receive deferiprone and 1 to receive placebo.
Cohort 2	Experimental	Drug: Deferiprone, Drug: PlaceboSingle dose of 1000mg deferiprone or placebo administered via intravenous infusion and oral solution. Randomization will be done for all 16 subjects at the same time: 14 will be randomized to receive deferiprone and 2 to receive placebo. Subjects enrolled to cohort 2 will receive an oral dose of deferiprone.
Cohort 3	Experimental	Drug: Deferiprone, Drug: PlaceboSingle dose of 1500mg deferiprone or placebo administered via intravenous infusion. Randomization will be done for all 16 subjects at the same time, 14 will be randomized to receive deferiprone and 2 to receive placebo.
Cohort 4	Experimental	Drug: Deferiprone, Drug: PlaceboSingle dose of 2000mg deferiprone or placebo administered via intravenous infusion. First 2 subjects to enroll: 1 will be randomized to receive deferiprone and the other to receive placebo. Next 14 subjects enrolled: 13 will be randomized to receive deferiprone and 1 to receive placebo.

Who may qualify

Ages: 18 to 50 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

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
DeferiproneAlso: Ferriprox, DFP, L1Deferiprone for infusion, 10mg/mL for intravenous infusion. Oral dose of deferiprone: 80mg/mL oral solution. (Cohort 2)	Drug	Cohort 1, Cohort 2, Cohort 3, Cohort 4
PlaceboAlso: Saline solution.Placebo: normal saline solution.	Drug	Cohort 1, Cohort 2, Cohort 3, Cohort 4

Primary outcome

Maximum Measured Serum Concentration (Cmax) for Serum Deferiprone and Deferiprone 3-O-glucuronide
Time frame: 14-hour interval
Cmax was assessed over a 14-hour interval for analyses of deferiprone and its 3-O-glucuronide metabolite in healthy volunteers who received single intravenous doses of 500 mg, 1000 mg, 1500 mg, and 2000 mg of intravenous deferiprone. Blood samples were obtained pre-dose and at 0.17, 0.33, 0.50, 0.75, 1, 1.33, 1.67, 2, 2.5, 3, 4, 6, 9, 12, and 14 hours post-dose.
Time to Maximum Observed Serum Concentration (Tmax) for Serum Deferiprone and Deferiprone 3-O-glucuronide
Time frame: 14-hour interval
Tmax was assessed over a 14-hour interval for analyses of deferiprone and its 3-O-glucuronide metabolite in healthy volunteers who received single intravenous doses of 500 mg, 1000 mg, 1500 mg, and 2000 mg of intravenous deferiprone. Blood samples were obtained pre-dose and at 0.17, 0.33, 0.50, 0.75, 1, 1.33, 1.67, 2, 2.5, 3, 4, 6, 9, 12, and 14 hours post-dose. The results of the Tmax parameter are reported as the median and range (other parameters are reported as mean and standard deviation).
Area Under the Curve From Zero to Infinity (AUC0-∞) for Serum Deferiprone and Deferiprone 3-O-glucuronide
Time frame: 14-hour interval
AUC0-∞ was assessed over a 14-hour interval for analyses of deferiprone and its 3-O-glucuronide metabolite in healthy volunteers who received single intravenous doses of 500 mg, 1000 mg, 1500 mg, and 2000 mg of intravenous deferiprone. Blood samples were obtained pre-dose and at 0.17, 0.33, 0.50, 0.75, 1, 1.33, 1.67, 2, 2.5, 3, 4, 6, 9, 12, and 14 hours post-dose.
The Terminal Elimination Half-life (T1/2el) for Serum Deferiprone and Deferiprone 3-O-glucuronide
Time frame: 14-hour interval
T1/2el was assessed over a 14-hour interval for analyses of deferiprone and its 3-O-glucuronide metabolite in healthy volunteers who received single intravenous doses of 500 mg, 1000 mg, 1500 mg, and 2000 mg of intravenous deferiprone. Blood samples were obtained pre-dose and at 0.17, 0.33, 0.50, 0.75, 1, 1.33, 1.67, 2, 2.5, 3, 4, 6, 9, 12, and 14 hours post-dose.
Safety and Tolerability of Single Ascending Doses of Deferiprone When Administered by Intravenous Infusion in Healthy Volunteers.
Time frame: From start of intravenous dosing until Day 5 post-dose for all subjects; and from time of oral dose until 24 hours post-dose for subjects who additionally received oral deferiprone
The number of participants who experienced adverse events (including any changes of clinical significance in physical examinations, vital signs, 12-lead ECG, and clinical laboratory tests) following a single dose of intravenous deferiprone.

3 secondary outcomes

Comparison of Cmax for Serum Deferiprone and Deferiprone 3-O-glucuronide Between Deferiprone for Infusion and Oral Deferiprone
Time frame: 14-hour interval
Absolute Bioavailability of Deferiprone
Time frame: 14-hour interval
Safety and Tolerability of a Single 1000 mg Oral Dose of Deferiprone
Time frame: From dosing until 24 hours post-dose

Results and safety

Results posted to the registry on 4 Dec 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
500 mg Deferiprone	14	14
1000 mg Deferiprone	14	12
1500 mg Deferiprone	14	13
2000 mg Deferiprone	14	14
Placebo	8	7

Primary outcome: Maximum Measured Serum Concentration (Cmax) for Serum Deferiprone and Deferiprone 3-O-glucuronide

Time frame: 14-hour interval. Mean (Standard Deviation). Unit: μg/mL

Measure	500 mg Deferiprone for Infusion n = 14	1000 mg Deferiprone for Infusion n = 13	1500 mg Deferiprone for Infusion n = 13	2000 mg Deferiprone for Infusion n = 14
Cmax for serum deferiprone	7.406 (1.889)	17.835 (2.162)	27.749 (2.768)	36.644 (6.643)
Cmax for serum deferiprone-3-O-glucuronide	8.037 (1.374)	16.490 (4.348)	20.032 (3.757)	30.517 (3.947)

Primary outcome: Time to Maximum Observed Serum Concentration (Tmax) for Serum Deferiprone and Deferiprone 3-O-glucuronide

Time frame: 14-hour interval. Median (Full Range). Unit: hour

Measure	500 mg Deferiprone for Infusion n = 14	1000 mg Deferiprone for Infusion n = 13	1500 mg Deferiprone for Infusion n = 13	2000 mg Deferiprone for Infusion n = 14
Tmax for Serum Deferiprone	1.00 (1.00 to 1.33)	1.00 (0.75 to 1.07)	1.00 (1.00 to 1.00)	1.00 (1.00 to 1.00)
Tmax for Serum Deferiprone 3-O-glucuronide	2.50 (1.67 to 3.00)	2.50 (1.67 to 3.00)	2.50 (2.00 to 3.00)	2.50 (1.67 to 3.00)

Population analysed: The pharmacokinetic population included all subjects who had sufficient data to derive the value of at least one pharmacokinetic parameter.

Primary outcome: Area Under the Curve From Zero to Infinity (AUC0-∞) for Serum Deferiprone and Deferiprone 3-O-glucuronide

Time frame: 14-hour interval. Mean (Standard Deviation). Unit: μg*h/mL

Measure	500 mg Deferiprone for Infusion n = 14	1000 mg Deferiprone for Infusion n = 13	1500 mg Deferiprone for Infusion n = 14	2000 mg Deferiprone for Infusion n = 14
AUC0-∞ for serum deferiprone	18.326 (4.115)	41.805 (6.797)	69.390 (8.937)	89.250 (17.223)
AUC0-∞ for serum deferiprone 3-O-glucuronide	38.504 (8.011)	79.210 (15.686)	105.829 (13.052)	161.507 (16.876)

Population analysed: The pharmacokinetic population included all subjects who had sufficient data to derive the value of at least one pharmacokinetic parameter.

Primary outcome: The Terminal Elimination Half-life (T1/2el) for Serum Deferiprone and Deferiprone 3-O-glucuronide

Time frame: 14-hour interval. Mean (Standard Deviation). Unit: hour

Measure	500 mg Deferiprone for Infusion n = 14	1000 mg Deferiprone for Infusion n = 13	1500 mg Deferiprone for Infusion n = 13	2000 mg Deferiprone for Infusion n = 14
T1/2el for serum deferiprone	1.68 (0.22)	1.77 (0.32)	1.83 (0.22)	1.85 (0.17)
T1/2el for serum deferiprone 3-O-glucuronide	2.00 (0.25)	1.94 (0.25)	2.01 (0.18)	1.94 (0.26)

Population analysed: The pharmacokinetic population included all subjects who had sufficient data to derive the value of at least one pharmacokinetic parameter.

3 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
500 mg Deferiprone for Infusion	0 of 14 (0%)	10 of 14 (71.4%)	Not reported
1000 mg Deferiprone for Infusion	0 of 14 (0%)	7 of 14 (50%)	Not reported
1500 mg Deferiprone for Infusion	0 of 14 (0%)	8 of 14 (57.1%)	Not reported
2000 mg Deferiprone for Infusion	0 of 14 (0%)	10 of 14 (71.4%)	Not reported
Placebo	0 of 8 (0%)	3 of 8 (37.5%)	Not reported
1000 mg Oral Deferiprone	0 of 14 (0%)	2 of 14 (14.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

Fernando Tricta, MD study chair

ApoPharma Inc.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Deferiprone in people with Healthy Volunteers, run by ApoPharma at 1 site in Canada.

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

Who may be eligible to take part?

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 23 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 4 Dec 2014). 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?

Maximum Measured Serum Concentration (Cmax) for Serum Deferiprone and Deferiprone 3-O-glucuronide (time frame: 14-hour interval). The study lists 5 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 NCT01989455.

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 23 Dec 2014.