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. 2017 Aug 15;2017(8):CD007476. doi: 10.1002/14651858.CD007476.pub3

NCT02198508.

Methods Randomised, open‐label, single‐centre, cross‐over study.
Participants Target sample size: 13
Inclusion criteria
  • 18 years of age or older

  • Serum ferritin greater than 2000 ng/mL

  • Serum creatinine within normal range for a measuring laboratory

  • Platelet count exceeding 140000/mm³

  • Body weight at least 40 kg

  • None had a history of clinical significant of gastrointestinal, hepatic, renal, endocrine, oncologic, infectious, pulmonary or cardiovascular disease


Exclusion criteria
  • HIV positive, history of immunologic hypersensitivity to any medication

  • Women pregnant or breastfeeding

  • Drug or alcohol abuse

  • Patients showed abnormal or irregular bowel function (defined as more than three bowel movements a day or less than one bowel movement every other day)

  • Receiving warfarin, digoxin, or anti‐arrhythmic or anti‐seizure medication

Interventions Experimental: combination treatment: DFX and DFP
Active comparator: DFX
Active comparator: DFP
Outcomes Primary outcome:
  • Iron excretion from urine and faeces by flame atomic absorption spectroscopy [time frame: 25 days]


Secondary outcome:
  • Drug concentration in plasma by pharmacokinetics analysis [time frame: 25 days]

Notes Primary completion date: July 2008
Recruitment status: completed
Author was contacted

AE: adverse event
 AUC: area under the curve
 Cmax: maximum or peak concentration (of a drug observed after its administration)
 Cmin: minimum concentration (of a drug observed after its administration)
 DFO: deferoxamine
 DFP: deferiprone
 DFX: deferasirox
 EU: European Union
 GFR: glomerular filtration rate
 GIQLI: Gastrointestinal Quality of Life Index
 GI: gastrointestinal
 GSRS: Gastrointestinal Symptom Rating Scale
 LIC: liver iron concentration
 LVEF: left ventricular ejection fraction
 MRI: magnetic resonance imaging
 SD: standard deviation
 SGPT: serum glutamic‐pyruvic transaminase
 TIBC: total iron building capacity