Last updated on November 2018

Study of the Efficacy and Safety of Immune Globulin Intravenous (Human) Flebogamma 5% DIF in Patients With Post-polio Syndrome

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Postpolio syndrome
  • Age: Between 18 - 75 Years
  • Gender: Male or Female

Inclusion Criteria:

  • Subjects with Body Mass Index less than 35 kg/m^2.
  • Subjects meet March-of-Dimes clinical criteria for diagnosis of PPS.
  • Subjects who are ambulatory or are able to walk with a cane or other aids or use a wheelchair (but they are not wheelchair-bound).
  • Subjects 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 an Medical Research Council (MRC) scale score greater than 3 at the MMT performed by the independent assessor at the Screening Visit (SV).
  • Female of child-bearing potential must have a negative test for pregnancy.
  • Female of child-bearing potential and their sexual partners have agreed to practice contraception using a method of proven reliability.
  • Subjects who are able to walk a 2MWD of at least 50 meters at the SV and Enrollment Visit/Infusion Visit 1 (EV/IV1)
  • Subjects 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%.

Exclusion Criteria:

  • Subjects have received human normal immune globulin treatment given by intravenous, subcutaneous, or intramuscular route within the last 3 years.
  • Subjects who are not ambulatory (wheelchair-bound individuals).
  • Subjects with poor venous access.
  • Subjects with intractable pain requiring narcotics or other psychotropic drugs.
  • Subjects with a history of anaphylactic reactions or severe reactions to any blood-derived product.
  • Subjects with a history of intolerance to any component of the investigational products, such as sorbitol.
  • Subjects receiving corticosteroids, except for those who are taking inhaled corticosteroids for asthma.
  • Subjects with a documented diagnosis of hyperviscosity or hypercoagulable state or thrombotic complications to polyclonal intravenous immunoglobulin (IVIG) therapy in the past.
  • Subjects with a history of recent (within the last year) myocardial infarction, stroke, or uncontrolled hypertension.
  • Subjects who suffer from congestive heart failure, embolism, or electrocardiogram changes indicative of unstable angina or atrial fibrillation.
  • Subjects with a history of chronic alcoholism or illicit drug abuse (addiction) in the preceding 12 months prior to the SV.
  • Subjects with active psychiatric illness that interferes with compliance or communication with health care personnel.
  • Subjects with depression with scores >30 as assessed by the Center for Epidemiologic Studies Depression validated scale.
  • Females who are pregnant or are nursing an infant child.
  • Subjects 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.
  • Subjects currently receiving, or have received within 3 months prior to the SV, any investigational medicinal product or device.
  • Subjects 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.
  • Subjects with known selective IgA deficiency and serum antibodies anti-IgA.
  • Subjects with renal impairment (i.e., serum creatinine exceeds more than 1.5 time the upper limit of normal [ULN]).
  • Subjects with aspartate aminotransferase or alanine aminotransferase levels exceeding more than 2.5 times the ULN.
  • Subjects with hemoglobin levels <10 g/dL, platelets levels <100,000/mm^3, white blood cells count <3.0 k/L, and erythrocyte sedimentation rate >50 mm/h or twice above normal.
  • Subjects with known seropositive to Hepatitis C virus, Human immunodeficiency virus-1 and/or Human immunodeficiency virus-2.
  • Subjects with a history of intolerance to fructose.

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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