Study of the Efficacy and Safety of Immune Globulin Intravenous (Human) Flebogamma® 5% Dual Inactivation and Filtration (DIF) in Participants With Post-polio Syndrome (FORCE)
Status and phase
Terminated
Phase 3
Phase 2
Conditions
Post-polio Syndrome
Treatments
Biological: Flebogamma® 5% DIF
Drug: Placebo
Study type
Interventional
Funder types
Industry
Identifiers
Details and patient eligibility
About
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).
Enrollment
191 patients
Sex
All
Ages
18 to 75 years old
Volunteers
No Healthy Volunteers
Inclusion criteria
- 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%.
Exclusion criteria
- 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.
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
Quadruple Blind
191 participants in 5 patient groups, including a placebo group
Stage 1 Arm 1: 2 g/kg Flebogamma® 5% DIF
Experimental group
Description:
Participants received Flebogamma® 5% DIF 2 g/kg of body weight administered via intravenous (IV) infusion over 2 consecutive days (Flebogamma® 5% DIF 1 g/kg infused on Day 1, followed by Flebogamma® 5% DIF 1 g/kg infused on Day 2) every 4 weeks for 52 weeks.
Treatment:
Biological: Flebogamma® 5% DIF
Stage 1 Arm 2: 1 g/kg Flebogamma® 5% DIF
Experimental group
Description:
Participants received Flebogamma® 5% DIF 1 g/kg of body weight administered via IV infusion on Day 1, followed by 20 mL/kg of matching placebo administered on a separate day, for a total dosing period of 2 consecutive days, every 4 weeks for 52 weeks. The order of 1 g/kg Flebogamma® 5% DIF or matching placebo was randomly determined for each participant and was the same for the participant for all infusion visits during the treatment period.
Treatment:
Drug: Placebo
Biological: Flebogamma® 5% DIF
Stage 1 Arm 3: Placebo
Placebo Comparator group
Description:
Participants received matching placebo at a total dose of 40 mL/kg of body weight administered via IV infusion over 2 consecutive days. On Day 1, a dose of 20 mL/kg of matching placebo was given, followed by the second dose of 20 mL/kg of matching placebo on Day 2, administered every 4 weeks for 52 weeks.
Treatment:
Drug: Placebo
Stage 2 Arm 1: 1 g/kg Flebogamma® 5% DIF
Experimental group
Description:
Participants received Flebogamma® 5% DIF 1 g/kg of body weight administered via IV infusion on Day 1, followed by 20 mL/kg of matching placebo administered on a separate day, for a total dosing period of 2 consecutive days, every 4 weeks for 52 weeks. The order of 1 g/kg of Flebogamma® 5% DIF or matching placebo was randomly determined for each participant and was the same for the participant for all infusion visits during the treatment period.
Treatment:
Drug: Placebo
Biological: Flebogamma® 5% DIF
Stage 2 Arm 2: Placebo
Placebo Comparator group
Description:
Participants received matching placebo at a total dose of 40 mL/kg of body weight administered via IV infusion over 2 consecutive days. On Day 1, a dose of 20 mL/kg of matching placebo was given, followed by the second dose of 20 mL/kg of matching placebo on Day 2, administered every 4 weeks for 52 weeks.
Treatment:
Drug: Placebo
Trial contacts and locations
21
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Data sourced from clinicaltrials.gov
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