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

Stopped early · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Post-polio Syndrome

In brief

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).

Key facts

Study ID

NCT02176863

Run by

Instituto Grifols, S.A.

People needed

191

Starts

2014-09-23

Expected to finish

2022-11-24

Last updated by the study team

2025-12-05

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participants with Body Mass Index less than 35 kg/m\^2.
• Participants who meet the clinical criteria for diagnosis of PPS as set by March-of-Dimes.
• Participants who are ambulatory or are able to walk with a cane or other aids or use a wheelchair (but they are not wheelchair-bound).
• Participants who have at least 2 newly weakened muscle groups due to PPS (as defined by medical history), with at least 1 of them in a lower extremity, and having a Medical Research Council (MRC) scale score greater than 3 at the Manual Muscle Testing (MMT) performed by the independent assessor at the Screening Visit (SV).
• Female of child-bearing potential must have a negative test for pregnancy (Human chorionic gonadotropin (HCG)-based assay).
• Female of child-bearing potential and their sexual partners have agreed to practice contraception using a method of proven reliability (i.e., hormonal methods; barrier methods; intrauterine devices methods) to prevent a pregnancy during the course of the clinical trial.
• Participants must be willing to comply with all aspects of the clinical trial protocol, including blood sampling and long-term storage of extra samples for the entire duration of the study.
• Participants who are able to walk a 2MWD of at least 50 meters at the SV and Enrollment Visit/Infusion Visit 1 (EV/IV1)
• Participants who are able to walk a consistent baseline 2 MWD, that is, the difference in 2MWD between the SV and EV/IV1 is not more than 10%.

You may not qualify if…

• Participants who have received human normal immune globulin treatment given by intravenous, subcutaneous, or intramuscular route within the last 3 years.
• Participants who are not ambulatory (wheelchair-bound individuals).
• Participants with poor venous access.
• Participants with intractable pain requiring narcotics or other psychotropic drugs.
• Participants with a history of anaphylactic reactions or severe reactions to any blood-derived product.
• Participants with a history of intolerance to any component of the investigational products, such as sorbitol.
• Participants receiving corticosteroids, except for those who are taking inhaled corticosteroids for asthma.
• Participants with a documented diagnosis of hyper viscosity or hypercoagulable state or thrombotic complications to polyclonal intravenous immunoglobulin (IVIG) therapy in the past.
• Participants with a history of recent (within the last year) myocardial infarction, stroke, or uncontrolled hypertension.
• Participants who suffer from congestive heart failure, embolism, or electrocardiogram changes indicative of unstable angina or atrial fibrillation.
• Participants with a history of chronic alcoholism or illicit drug abuse (addiction) in the preceding 12 months prior to the SV.
• Participants with active psychiatric illness that interferes with compliance or communication with health care personnel.
• Participants with depression with scores >30 as assessed by the Center for Epidemiologic Studies Depression (CESD) validated scale.
• Females who are pregnant or are nursing an infant child.
• Participants with any medical condition which makes clinical trial participation unadvisable or which is likely to interfere with the evaluation of the study treatment and/or the satisfactory conduct of the clinical trial according to the Investigator's judgment.
• Participants currently receiving, or have received within 3 months prior to the SV, any investigational medicinal product or device.
• Participants who are unlikely to adhere to the protocol requirements, or are likely to be uncooperative, or unable to provide a storage serum/plasma sample prior to the first investigational drug infusion.
• Participants with known selective Immune globulin A class (IgA) deficiency and serum antibodies anti-IgA.
• Participants with renal impairment (i.e., serum creatinine exceeds more than 1.5 times the upper limit of normal [ULN]) for the expected normal range for the testing laboratory).
• Participants with aspartate aminotransferase (AST) or alanine aminotransferase (ALT) levels exceeding more than 2.5 times the ULN.
• Participants with hemoglobin levels <10 g/dL, platelets levels <100,000 /mm\^3, white blood cells count <3.0 k/µL, and erythrocyte sedimentation rate >50 mm/h or twice above normal.
• Participants with known seropositive to Hepatitis C virus (HCV), Human immunodeficiency virus-1 (HIV-1) and/or Human immunodeficiency virus-2 (HIV-2).
• Participants with a history of intolerance to fructose.

Where it is running

• Washington University — St Louis, Missouri, United States
• SUNY Upstate Medical University — Syracuse, New York, United States
• Thomas Jefferson University Hospital — Philadelphia, Pennsylvania, United States
• Medical College of Wisconsin — Milwaukee, Wisconsin, United States
• Montreal Neurological Institute Clinical Research Unit, McGill University — Montreal, Quebec, Canada
• Thomayerova nemocnice, Klinicko-farmakologická jednotka — Prague, Czechia
• Aarhus Universitets Hospital-Neurologisk Forskning — Aarhus N, Denmark
• Rigshospitalet — København Ø, Denmark
• Charité Campus Mitte — Berlin, Germany
• Hannover Medical School — Hanover, Germany
• Universitätsklinikum Jena — Jena, Germany
• Klinik für konservative Orthopädie und des Poliozentrums — Koblenz, Germany
• Westfälische Wilhelms-Universität Münster — Münster, Germany
• Azienda Ospedaliera Universitaria Integrata Verona (Ospedale Borgo Roma) — Verona, Italy
• Academisch Medisch Centrum Amsterdam UMC, Locatie AMC — Amsterdam, Netherlands
• MedTrials — Krakow, Poland
• Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie — Lublin, Poland
• Clinical Research Center Sp. z o.o. — Poznan, Poland
• Samodzielny Publiczny Centralny Szpital Kliniczny — Warsaw, Poland
• Institut Guttman — Badalona, Spain
• Hospital Universitari Vall d'Hebron — Barcelona, Spain

Full record on ClinicalTrials.gov

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