A phase II clinical trial to evaluate the safety and efficacy of interferon gamma in elevating frataxin levels in Friedreich ataxia patients - GIFT/1

AZIENDA UNIVERSITARIA POLICLINICO UMBERTO I DI ROMA0 sitesJanuary 11, 2013

Overview

No summary available.

Registry

who.int

Start Date

January 11, 2013

End Date

TBD

Last Updated

12 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

AZIENDA UNIVERSITARIA POLICLINICO UMBERTO I DI ROMA

•1\. Genetically confirmed diagnosis of Friederich’s Ataxia 2\. Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study. 3\. Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures. 4\. Male and/or female subjects \>/\=18 .
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0
•F.1\.2 Adults (18\-64 years) yes
•F.1\.2\.1 Number of subjects for this age range 15
•F.1\.3 Elderly (\>\=65 years) no
•F.1\.3\.1 Number of subjects for this age range

•Subjects presenting with any of the following will not be included in the study: Medical History 1\. Pregnant or breastfeeding women. 2\. Significant concurrent medical conditions at the time of screening or baseline visit, including, but not limited to, the following: • Any major illness/condition or evidence of an unstable clinical condition (eg, renal, hepatic, hematologic, GI, endocrine, pulmonary, immunologic, or local active infection/infectious illness) that, in the investigator’s judgment, will substantially increase the risk to the subject if he or she participates in the study. • Class III or IV congestive heart failure as defined by the New York Heart Association. • Acute coronary syndrome (eg, myocardial infarction, unstable angina pectoris) and any history of significant cerebrovascular disease within 24 weeks before screening. 3\. Presence of a transplanted organ. 4\. Previous assumption of IFN gamma 1b.