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A Phase IIa Trial to Test Safety and Efficacy Interferon Gamma Treatment in Elevating Frataxin Levels in FRDA Patients | Clinical Trials | Clareo Health

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A Phase IIa Trial to Test Safety and Efficacy Interferon Gamma Treatment in Elevating Frataxin Levels in FRDA Patients

A Phase IIa Clinical Trial to Test the Safety and Efficacy of Interferon Gamma Treatment in Elevating Frataxin Levels in Friedreich's Ataxia (FRDA) Patients

NCT02035020•Azienda Policlinico Umberto I

View on ClinicalTrials.gov

Summary

The primary objective of this study is to investigate whether the treatment with IFN gamma can induce significant accumulation of frataxin in FRDA patients, a possibility suggested by pre-clinical evidence in an animal model of the disease.

Detailed Description

This is a Phase 2 clinical trial. A total of 10 FRDA patients will be recruited All subjects will be treated with a dose of 100-150-200-micrograms of IFN gamma 1b (Imukin®) subcutaneously, with an interval of 14 days, for a total of 3 injections.

Eligibility

Age

18 - 45 years

Sex

ALL

Healthy Volunteers

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.
+11 more criteria

Locations (1)

Policlinico Umberto I°

Rome, Italy/Rome, Italy

Key Dates

Start Date

May 1, 2013

Primary Completion Date

July 30, 2014

Completion Date

July 30, 2014

Last Updated

April 21, 2017

Enrollment

ACTUAL participants

Conditions

Friedreich Ataxia

Interventions

gamma interferon

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 21, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

A Phase IIa Trial to Test Safety and Efficacy Interferon Gamma Treatment in Elevating Frataxin Levels in FRDA Patients

Inclusion Criteria

Exclusion Criteria

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