Safety, Tolerability and Efficacy of ACTIMMUNE® Dose Escalation in Friedreich's Ataxia (STEADFAST)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02415127 |
Recruitment Status :
Completed
First Posted : April 14, 2015
Results First Posted : December 8, 2017
Last Update Posted : December 8, 2017
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Sponsor:
Horizon Pharma Ireland, Ltd., Dublin Ireland
Collaborator:
Friedreich's Ataxia Research Alliance
Information provided by (Responsible Party):
Horizon Pharma Ireland, Ltd., Dublin Ireland
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment |
Condition |
Friedreich's Ataxia |
Interventions |
Drug: Interferon γ-1b Drug: Placebo |
Enrollment | 92 |
Participant Flow
Recruitment Details | |
Pre-assignment Details |
Arm/Group Title | Interferon γ-1b | Placebo |
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Subcutaneous (SC) doses of ACTIMMUNE® 3 times a week (TIW) for a total of 26 weeks. | SC doses of placebo TIW for a total of 26 weeks. |
Period Title: Overall Study | ||
Started | 47 | 45 |
Completed | 46 | 45 |
Not Completed | 1 | 0 |
Reason Not Completed | ||
Adverse Event | 1 | 0 |
Baseline Characteristics
Arm/Group Title | Interferon γ-1b | Placebo | Total | |
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SC doses of ACTIMMUNE® TIW for a total of 26 weeks. | SC doses of placebo TIW for a total of 26 weeks. | Total of all reporting groups | |
Overall Number of Baseline Participants | 47 | 45 | 92 | |
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[Not Specified]
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 47 participants | 45 participants | 92 participants | |
16.5 (4.41) | 16.1 (3.75) | 16.3 (4.08) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 47 participants | 45 participants | 92 participants | |
Female |
26 55.3%
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26 57.8%
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52 56.5%
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Male |
21 44.7%
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19 42.2%
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40 43.5%
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.
Horizon requests that any Investigator/institution that plans on presenting or publishing results provide written notification of their request a minimum of 60 days prior to presentation or publication. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsors' Intellectual Property rights .
Results Point of Contact
Name/Title: | Julie Ball, Executive Director Clinical Development & Operations |
Organization: | Horizon Pharma Ireland, Ltd. Dublin, Ireland |
EMail: | clinicaltrials@horizonpharma.com |
Responsible Party: | Horizon Pharma Ireland, Ltd., Dublin Ireland |
ClinicalTrials.gov Identifier: | NCT02415127 |
Other Study ID Numbers: |
HZNP-ACT-301 |
First Submitted: | February 12, 2015 |
First Posted: | April 14, 2015 |
Results First Submitted: | November 6, 2017 |
Results First Posted: | December 8, 2017 |
Last Update Posted: | December 8, 2017 |