Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:08 AM
Ignite Modification Date:
2025-12-25 @ 4:08 AM
NCT ID:
NCT02035020
Eligibility Criteria:
Inclusion Criteria:
1. FRDA patients should have their diagnosis genetically confirmed.
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 between the ages of \> 18 and \< 45 years
\-
Exclusion Criteria:
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.
5. Abnormality in any of the below hematology or chemistry profile values at screening:
* Positive hepatitis B surface antigen (HBsAg), Total hepatitis B core antibody (HBcAb; also called anti HBc), and/or hepatitis C antibody (HCVAb) with confirmation by hepatitis C virus ribonucleic acid (HCV RNA).
* ALT/AST levels \> or = 1.5X ULN.
* Total bilirubin level \> or = 1.5 times the ULN.
* Hemoglobin level \< or = 80 gL (8.0 g/dL).
* Platelet count \< or = 100 x 109/L (100,000 cells/mm³) or \> or = 1000 x 109/L (1,000,000 cells/mm³).
* White blood cell count \< or = 3.5 x 109/L (3500 cells/mm³).
* Absolute neutrophil count (ANC) \<2000 cells/mm³.
* Serum creatinine level \> or = 177 μmol/ L (2 mg/dL).
* Glycosylated hemoglobin (HbA1c \>10%).
6. Current or history of serious psychiatric disorder or alcohol or drug abuse.
7. Participation in other studies within 30 days before screening and/or during study participation.
8. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or ability to comply with study procedures, investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
\-
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT02035020
Study Brief:
Protocol Section:
NCT02035020