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NCT02176863 · ClinicalTrials.gov registry record · Phase 2

Study of the Efficacy and Safety of Immune Globulin Intravenous (Human) Flebogamma® 5% Dual Inactivation and Filtration (DIF) in Participants With Post-polio Syndrome

A Phase 2 study, sponsored by Instituto Grifols, S.A..

Terminated
Registry status
Phase 2
Development phase
191
Enrollment target

NCT02176863: Clinical Trial Phase 2 study, sponsored by Instituto Grifols, S.A..

NCT02176863 is a Phase 2 study that was terminated before completion, run by Instituto Grifols, S.A.. The registered enrollment target is 191 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (44% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02176863, a Phase 2 study, was terminated before completion, sponsored by Instituto Grifols, S.A..

TERMINATED
Registry status
Phase 2
Development phase
191 participants
Enrollment target

Study Summary

This was a multicenter, prospective, randomized, placebo-controlled, double-blind, parallel group clinical trial with adaptive dose selection in participants with post-polio syndrome (PPS). The main purpose of this study was to select a dose of Flebogamma® 5% DIF and confirm the efficacy of the selected Flebogamma® 5% DIF dose by assessing physical performance, as measured by Two-Minute Walk Distance (2MWD) test. The study consisted of 2 stages, with each stage consisting of a screening period (up to 4 weeks), a treatment period (52 weeks), and a follow-up period (24 weeks).

Primary Outcome

The 2MWD was used to assess physical performance by measuring the distance that a participant can quickly walk at a self-preferred speed on an indoor flat, hard surface 30 m (100-ft) hallway in a period of 2 minutes. A positive change from baseline indicates improvement (i.e. a patient can walk farther). Increase in distance walked (in meters) indicates improvement.

Interventions

  • DRUG Placebo
  • BIOLOGICAL Flebogamma® 5% DIF

Trial Details

FieldValue
Enrollment Target 191 participants
Start Date 2014-09-23
Est. Completion 2022-11-24
Phase Phase 2
Instituto Grifols, S.A.

10 total trials

Why NCT02176863 stopped before completion

NCT02176863 is an interventional study that assigns participants to a tested intervention. The registered 191 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (44% higher).

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

NCT02176863 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02176863 about?

NCT02176863 is a clinical study titled "Study of the Efficacy and Safety of Immune Globulin Intravenous (Human) Flebogamma® 5% Dual Inactivation and Filtration (DIF) in Participants With Post-polio Syndrome". This was a multicenter, prospective, randomized, placebo-controlled, double-blind, parallel group clinical trial with adaptive dose selection in participants with post-polio syndrome (PPS). The main purpose of this study was to select a dose of Flebogamma® 5% DIF and confirm the efficacy of the sel...

What is the current status of trial NCT02176863?

This trial is currently terminated. It is a Phase 2 study. The enrollment target is 191 participants. The study started on 2014-09-23. Estimated completion is 2022-11-24.

What interventions are being tested in trial NCT02176863?

The interventions under investigation include: Placebo (DRUG), Flebogamma® 5% DIF (BIOLOGICAL).

Who is sponsoring clinical trial NCT02176863?

This trial is sponsored by Instituto Grifols, S.A., which has 10 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02176863's enrollment target sits among peer trials

191 353rd of 2000 higher than 1,648 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02176863, the US trial registry maintained by the National Library of Medicine. NCT02176863 (mid enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.