A PHASE 3, OPEN-LABEL, MILTICENTRE, EXTENSION SAFETY AND TOLERABILITY STUDY FOR TRANSFUSIONALLY IRON OVERLOADED CHILDRE, ADOLISCENTS AND ADULTS USING FBS0701 (SSP-004184) - SPD602-301 (FBS0701 - CTP - 15)

FERROKIN BIOSCIENCES INC.0 个研究点目标入组 1,500 人开始时间: 2012年9月3日最近更新: 2015年3月23日

适应症

试验速览

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•1.SUBJECTS AND/OR PARENTS WILLING AND ABLE TO SIGN THE APPROVED INFORMED CONSENT AND/OR ASSENT (BASED ON ISTITUTIONAL GUIDELINES) 2,AN UNDERSTANDING, ABILITY, AND WILLINGNESS TO FULLY COMPLY WITH STUDY PROCEDURES AND RESTRICTION 3.HAS COMPLETED ONE OF THE FBS/SSP004184 FEEDER PROTOCOLS 4.MALE,OR NON PREGNANT, NON LACTATING FEMALE WHO FEMALE WHO AGREES TO COMPLY WITH ANY APPLICABLE CONTRACEPTIVE REQUIREMENTS OF THE PROTOCOL OR FEMALES OF NON -CHILDBEARING POTENTIAL. SUBJECT, WHO IS FEMALE OF CHILD-BEARING POTENTIAL (FOCP), MUST HAVE A NEGATIVE URINE PREGNANCY TEST AT THE QUALIFICATION AND ENROLLMENT VISIT PRIOR TO DOSING ON DAY1 AND AGREE TO COMPLY WITH ANY APPLICABLE CONTRACEPTIVE REQUIREMENTS OF THE PROTOCOL.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 8
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 30
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•1.Unwilling to remain off all existing chelation therapies during FBS0701 (SSP-004184) dosing and for 1 week after last dose. 2.A history of non-compliance in a prior FerroKin-sponsored FBS0701 (SSP-004184) study (excluding dose suspensions that were medically warranted). 3.Cardiac MRI T2* <8 milliseconds at the time of last MRI prior to study entry. 4.Has restarted prior chelation therapy. (NOTE: Should there be an administrative need to interrupt study treatment, the subject may be allowed to remain off all chelator therapy for a maximum of 3 weeks prior to starting the extension study, should the Medical Monitor and the subject’s Principal Investigator deem it safe and clinically reasonable to do so.) 5.Evidence of clinically relevant oral, cardiovascular, gastrointestinal, endocrine, pulmonary, neurologic, psychiatric, immunologic, bone marrow, dermatologic, hepatic or renal dysfunction where, in the opinion of the PI or the Medical Monitor, treatment with FBS0701 (SSP-004184) is relatively contraindicated. 6.Platelet count below 100,000/µL or absolute neutrophil count less than 1500/mm3 in the last assessment prior to study entry. 7.Known sensitivity to any ingredient in the FBS0701 (SSP-004184) formulation. 8.Pregnant or lactating females.

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