Study of the Efficacy and Safety of Immune Globulin Intravenous (Human) Flebogamma® 5% Dual Inactivation and Filtration (DIF) in Participants With Post-polio Syndrome
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Instituto Grifols, S.A.
Age
18–75
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible 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 be 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.
Clareo Health | Study of the Efficacy and Safety of Immune Globulin Intravenous (Human) Flebogamma® 5% Dual Inactivation and Filtration (DIF) in Participants With Post-polio Syndrome
