Study to evaluate the safety and efficacy of Flebogamma 5% DIF in patients with Post-Polio Syndorme
- Conditions
- Patients with Post-polio syndromeMedDRA version: 21.0Level: PTClassification code 10036239Term: Post polio syndromeSystem Organ Class: 10029205 - Nervous system disordersMedDRA version: 20.0Level: SOCClassification code 10029205Term: Nervous system disordersSystem Organ Class: 10029205 - Nervous system disordersTherapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2013-004503-39-DK
- Lead Sponsor
- Instituto Grifols, S.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 210
Clinical trial subject inclusion criteria:
1. Male or female aged 18 to 75 years.
2. Subjects who understand and voluntarily signed and dated
the Clinical Trial Written Informed Consent Form for
his/her clinical trial participation.
3. Subjects with a BMI less than 30 kg/m2.
4. Subjects who meet the clinical criteria for diagnosis of PPS
as set by the March-of-Dimes.
5. 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).
6. Subjects who have at least two newly weakened muscle groups due to PPS (as defined by medical history), with at least one of them in a lower extremity, and having a mMRC scale score of 3 or greater at the MMT performed by the independent assessor at the SV.
7. Female subjects of child-bearing potential must have a
negative test for pregnancy (human chorionic gonadotropin [HCG]-based assay).
8. Female subjects 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.
9. Subjects 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 whole duration of
the study.
10. Subjects who are able to walk a 2MWD of at least 50 meters
at the Screening Visit (SV) and EV/IV1.
11. Subjects who are able to walk a consistent baseline 2MWD,
that is, the difference in 2MWD between the SV and EV/IV1
is not more than 10%.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 70
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 140
Clinical trial subject exclusion criteria:
1. Subjects who have received human normal immune globulin treatment
given by intravenous, subcutaneous or intramuscular route
within the last 3 years.
2. Subjects who are not ambulatory (wheelchair-bound
individuals).
3. Subjects with poor venous access.
4. Subjects with intractable pain requiring narcotics or other
psychotropic drugs.
5. Subjects with a history of anaphylactic reactions or severe
reactions to any blood-derived product.
6. Subjects with a history of intolerance to any component of
the investigational products, such as sorbitol.
7. Subjects who are receiving corticosteroids, except for those
who are taking them for asthma.
8. Subjects with a documented diagnosis of hyperviscosity or
hypercoagulable state or thrombotic complications to
polyclonal IVIG therapy in the past.
9. Subjects with a history of recent (within the last year)
myocardial infarction, stroke, or uncontrolled hypertension.
10. Subjects who suffer from congestive heart failure, embolism,
or ECG changes indicative of unstable angina or atrial
fibrillation.
11. Subjects with a history of chronic alcoholism or illicit drug
abuse (addiction) in the preceding 12 months prior to the SV.
12. Subjects with active psychiatric illness that interferes with
compliance or communication with health care personnel.
13. Subjects with depression with scores >30 as assessed by the
CESD validated scale.
14. Females who are pregnant or are nursing an infant child.
15. 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.
16. Subjects currently receiving, or have received within 3
months prior to the Screening Visit, any investigational
medicinal product or device.
17. Subjects who are unlikely to adhere 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.
18. Subjects with a known selective IgA deficiency and serum
antibodies anti-IgA.
19. Subjects with renal impairment (i.e., serum creatinine
exceeds more than 1.5 time the upper limit of normal [ULN]
for the expected normal range for the testing laboratory).
20. Subjects with AST or ALT levels exceeding more than 2.5
times the ULN for the expected normal range for the testing
laboratory.
21. Subjects with hemoglobin levels <10 mg/dL, platelets levels
<100,000/mm3, white blood cells count <3.0 k/µL and ESR
>50 mm/h or twice above normal.
22. Subjects with known seropositive to HCV, HIV-1 and/or
HIV-2.
23. Subjects with a history of intolerance to fructose.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method