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11 February 2012
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| A randomised, comparative, open label phase III trial on efficacy and safety of long-term treatment with ICL670 (5 to 40 mg/kg/day) in comparison with deferoxamine (DFO) (20 to 60 mg/kg/day) in β-thalassaemia patients with transfusional haemosiderosis |
| ISRCTN | ISRCTN93355192 |
| ClinicalTrials.gov identifier | |
| Public title | A randomised, comparative, open label phase III trial on efficacy and safety of long-term treatment with ICL670 (5 to 40 mg/kg/day) in comparison with deferoxamine (DFO) (20 to 60 mg/kg/day) in β-thalassaemia patients with transfusional haemosiderosis |
| Scientific title | |
| Acronym | ICL107 |
| Serial number at source | CICL670 0107 |
| Study hypothesis | This study was undertaken to investigate the hypothesis that deferasirox (ICL670) was noninferior to deferoxamine (DFO). |
| Lay summary | |
| Ethics approval | This trial was conducted in accordance with good clinical practices. Institutional review board or ethics committee approval was obtained at each participating institution and written informed consent was obtained from all patients or their legal guardians prior to participation in any study procedures. |
| Study design | Randomised controlled trial |
| Countries of recruitment | Argentina, Belgium, Brazil, Canada, France, Germany, Greece, Italy, Tunisia, Turkey, United Kingdom, United States of America |
| Disease/condition/study domain | β-thalassaemia |
| Participants - inclusion criteria |
1. β-thalassaemia outpatients 2 years old or greater
2. Transfusional haemosiderosis 3. Previously treated with DFO, or never treated with any iron chelator 4. Without any contra-indications to either trial medication |
| Participants - exclusion criteria |
1. Alanine aminotransferase (ALT) level greater than 250 U/L during the year prior to enrolment
2. Chronic hepatitis B infection 3. Active hepatitis C infection 4. A history of a positive human immunodeficiency virus (HIV) test 5. Serum creatinine above the upper limit of normal (ULN) 6. A urinary protein-creatinine ratio of greater than 0.5 mg/mg 7. Nephrotic syndrome 8. Uncontrolled systemic hypertension 9. A prolonged corrected QT interval 10. Systemic infection within the 10 days prior to entry 11. Gastrointestinal conditions preventing absorption of an oral medication 12. Concomitant conditions preventing therapy with deferasirox or deferoxamine 13. A history of ocular toxicity related to iron chelation therapy 14. A poor response to deferoxamine 15. Noncompliance with prescribed therapy |
| Anticipated start date | 01/03/2003 |
| Anticipated end date | 01/11/2003 |
| Status of trial | Completed |
| Patient information material | |
| Target number of participants | 586 |
| Interventions |
Patients meeting the eligibility requirements were randomised to receive deferasirox or deferoxamine. Randomisation was stratified by age groups:
1. 2 to younger than 12 years 2. 12 to younger than 18 years 3. 18 years or older After randomisation, patients were assigned by the investigator to a dose dependent on their baseline liver iron concentrations (LIC). Once-daily treatment with deferasirox at the assigned dose was administered as a suspension in water half an hour prior to breakfast 7 days a week. Deferoxamine was administered as a slow subcutaneous infusion using electronic Microject Chrono infusion pumps (Cane Medical Technology, Torino, Italy) over 8 to 12 hours, 5 days a week. Treatment with either therapy was continued for 1 year. |
| Primary outcome measure(s) | Maintenance or reduction of LIC. |
| Secondary outcome measure(s) |
1. Safety and tolerability
2. Change in serum ferritin level 3. Net body iron balance |
| Sources of funding | Novartis Pharmaceuticals Corporation (USA) |
| Trial website | |
| Publications |
Results:
1. http://www.ncbi.nlm.nih.gov/pubmed/16352812 2. http://www.ncbi.nlm.nih.gov/pubmed/18469351 (ancillary study) |
| Contact name | Dr Elliot Vichinsky |
| Address |
Children's Hospital & Research Center at Oakland
747 52nd Street OPC-PCRC, 1st Floor |
| City/town | Oakland |
| Zip/Postcode | 94609-1809 |
| Country | United States of America |
| Sponsor | Novartis Pharmaceuticals Corporation (USA) |
| Address | One Health Plaza |
| City/town | East Hanover |
| Zip/Postcode | 07936 |
| Country | United States of America |
| Tel | +1 862 778 7042 |
| Fax | +1 973 781 5511 |
| jerry.retkwa@pharma.novartis.com | |
| Date applied | 23/07/2003 |
| Last edited | 08/09/2008 |
| Date ISRCTN assigned | 05/09/2003 |
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| © 2012 ISRCTN unless otherwise stated. | |
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