CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 86 enrolled
Drug / intervention
Interferon γ-1bdrug
Likely dose
Interferon γ-1b 10 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/NCT02593773
NCT02593773Phase 3Completed
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Multicenter, Safety and Efficacy, Open-Label Extension Study of ACTIMMUNE® (Interferon γ-1b) in Children and Young Adults With Friedreich's Ataxia

Amgen·interventional·Posted Nov 2, 2015·Updated Dec 19, 2024

In Brief

A Phase 3 clinical trial evaluating Interferon γ-1b for Friedreich's Ataxia. Completed, enrolled 86 participants across 4 sites.

Detailed Summary

The purpose of this phase 3 multi-center, open-label extension study is to evaluate the long-term safety of ACTIMMUNE® (interferon-γ 1b) in participants with Friedreich's Ataxia.

Study Details

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

Timeline

Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedNov 2, 2015
Enrollment StartDec 25, 2015
Primary CompletionMar 21, 2017
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 10.7 years ago

Interventions

Interferon γ-1bdrug

The study drug dose is planned to be escalated on a weekly basis over the first 4 weeks of treatment (from 10 µg/m² to 25, 50, and 100 µg/m²). The dose may be reduced, interrupted, or held based on tolerability. By Week 13, all participants are to be on a stable tolerated dose of study drug in order to continue study participation; the dose may not be further increased after Week 13, however, it may be reduced on a case-by-case basis to manage drug-related adverse events (AEs).