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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 is a Phase 2 study that was terminated before completion, run by Instituto Grifols, S.A.. The registered enrollment target is 191 participants.
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).
Interventions
- DRUG Placebo
- BIOLOGICAL Flebogamma® 5% DIF
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 191 participants |
| Start Date | 2014-09-23 |
| Est. Completion | 2022-11-24 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02176863
The ClinicalTrials.gov registry entry for NCT02176863 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 191 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Instituto Grifols, S.A., which has 10 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02176863 reports 0 study locations.
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.
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