CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 38 enrolled
Drug / intervention
interferon γ-1bdrug
Likely dose
interferon γ-1b 100 μgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02797080
NCT02797080Phase 3Completed
CompareCT.gov

Long-Term Safety Extension Study of ACTIMMUNE® (Interferon γ-1b) in Children and Young Adults With Friedreich's Ataxia

Amgen·interventional·Posted Jun 13, 2016·Updated Dec 10, 2024

In Brief

A Phase 3 clinical trial evaluating interferon γ-1b for Friedreich's Ataxia. Completed, enrolled 38 participants across 4 sites.

Detailed Summary

The purpose of this long term extension study is to evaluate the long-term safety of ACTIMMUNE® (interferon-γ 1b) in participants with Friedreich's Ataxia (FA).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFriedreich's Ataxia
CountriesUnited States
CollaboratorsFriedreich's Ataxia Research Alliance

Timeline

Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedJun 13, 2016
Enrollment StartJun 28, 2016
Primary CompletionMar 31, 2017
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 10.1 years ago

Interventions

interferon γ-1bdrug

ACTIMMUNE® will be administered three times per week by subcutaneous injection. The initial dose will be individualized for each participant and will be determined by the investigator, provided that the initial dose does not exceed the maximum tolerated dose in HZNP-ACT-302 (NCT02593773). The investigator may subsequently adjust the dose for any participant if deemed clinically appropriate, provided that the dose does not exceed 100 μg/m².