NCT02176863

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 Multicenter, Prospective, Randomized, Placebo-controlled, Double-blind, Parallel-group Clinical Trial to Assess the Efficacy and Safety of Immune Globulin Intravenous (Human) Flebogamma® 5% DIF in Participants With Post-Polio Syndrome

• Status: Terminated
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 191 (actual)
• Sponsor: Instituto Grifols, S.A. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Post-polio Syndrome

Interventions

Type	Name	Description
BIOLOGICAL	Flebogamma® 5% DIF	Human plasma-derived immunoglobulin
DRUG	Placebo	Matching placebo

Timeline

• Start date: 2014-09-23
• Primary completion: 2022-11-24
• Completion: 2022-11-24
• First posted: 2014-06-27
• Last updated: 2025-12-05
• Results posted: 2025-12-05

Locations

21 sites across 9 countries: United States, Canada, Czechia, Denmark, Germany, Italy, Netherlands, Poland, Spain

Regulatory

• FDA-regulated drug study