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NCT02415127 · ClinicalTrials.gov registry record · Phase 3

Safety, Tolerability and Efficacy of ACTIMMUNE® Dose Escalation in Friedreich's Ataxia

A Phase 3 study, sponsored by Amgen.

Completed
Registry status
Phase 3
Development phase
92
Enrollment target

NCT02415127 is a Phase 3 study that has completed, run by Amgen. The registered enrollment target is 92 participants.

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The verdict

NCT02415127, a Phase 3 study, has completed, sponsored by Amgen.

COMPLETED
Registry status
Phase 3
Development phase
92 participants
Enrollment target

Study Summary

The purpose of this phase 3 randomized, multi-center, double-blind, placebo-controlled study is to evaluate the efficacy and safety of ACTIMMUNE® (interferon-γ 1b) in the treatment of Friedreich's Ataxia (FA) and to evaluate the pharmacokinetic (PK) characteristics of ACTIMMUNE® in FA patients.

Interventions

  • DRUG Placebo
  • DRUG Interferon γ-1b

Trial Details

FieldValue
Enrollment Target 92 participants
Start Date 2015-06
Est. Completion 2016-11
Phase Phase 3

Sponsor

Amgen

558 total trials

What the Registry Record Tells You About NCT02415127

The ClinicalTrials.gov registry entry for NCT02415127 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 92 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Amgen, which has 558 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT02415127 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT02415127 about?

NCT02415127 is a clinical study titled "Safety, Tolerability and Efficacy of ACTIMMUNE® Dose Escalation in Friedreich's Ataxia". The purpose of this phase 3 randomized, multi-center, double-blind, placebo-controlled study is to evaluate the efficacy and safety of ACTIMMUNE® (interferon-γ 1b) in the treatment of Friedreich's Ataxia (FA) and to evaluate the pharmacokinetic (PK) characteristics of ACTIMMUNE® in FA patients.

What is the current status of trial NCT02415127?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 92 participants. The study started on 2015-06. Estimated completion is 2016-11.

What interventions are being tested in trial NCT02415127?

The interventions under investigation include: Placebo (DRUG), Interferon γ-1b (DRUG).

Who is sponsoring clinical trial NCT02415127?

This trial is sponsored by Amgen, which has 558 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.