ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02176863
Recruitment Status : Recruiting
First Posted : June 27, 2014
Last Update Posted : July 12, 2018
Sponsor:
Information provided by (Responsible Party):
Grifols Biologicals Inc. ( Instituto Grifols, S.A. )

Brief Summary:

This is a multicenter, prospective, randomized, placebo-controlled, double-blind, parallel group clinical trial with adaptive dose selection in subjects with post polio syndrome (PPS).

The main purpose of this study is 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 2 Minutes Walk Distance (2MWD) test.


Condition or disease Intervention/treatment Phase
Post-polio Syndrome Biological: Flebogamma 5% DIF Other: Placebo Phase 2 Phase 3

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 210 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter, Prospective, Randomized, Placebo-controlled, Double-blind, Parallel‑Group Clinical Trial to Assess the Efficacy and Safety of Immune Globulin Intravenous (Human) Flebogamma® 5% DIF in Patients With Post-Polio Syndrome
Actual Study Start Date : September 23, 2014
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : June 2021


Arm Intervention/treatment
Experimental: 2 g/kg Flebogamma 5% DIF
Flebogamma 5% DIF, 2 g/kg, intravenous infusion every 4 weeks over two days for 52 weeks
Biological: Flebogamma 5% DIF
Human plasma-derived immunoglobulin
Other Name: immune globulin intravenous (human)

Experimental: 1 g/kg Flebogamma 5% DIF
Flebogamma 5% DIF, 1 g/kg, intravenous infusion every 4 weeks over two days for 52 weeks
Biological: Flebogamma 5% DIF
Human plasma-derived immunoglobulin
Other Name: immune globulin intravenous (human)

Placebo Comparator: Placebo
Normal Saline Solution, matching volume, intravenous infusion every 4 weeks over two days for 52 weeks
Other: Placebo
Normal saline solution




Primary Outcome Measures :
  1. Change from baseline in 2MWD [ Time Frame: Baseline, Week 52 ]
    Physical performance (2MWD) from baseline (at Enrollment Visit) to the end of the treatment period


Secondary Outcome Measures :
  1. Change from baseline in Visual Analogue Scale (VAS) of pain [ Time Frame: Baseline, Week 52 ]
    Pain (Visual Analogue Scale [VAS] of pain) from baseline to the end of the treatment period.

  2. Change from baseline in Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) [ Time Frame: Baseline, Week 52 ]
    HRQoL (Medical Outcomes Study 36-Item Short Form Health Survey [SF-36] Physical Component Summary

  3. Change from baseline in Six Minutes Walk Distance (6MWD) [ Time Frame: Baseline, Week 52 ]
    Endurance (Six-Minute Walk Distance [6MWD]) from baseline to the end of the treatment period.


Other Outcome Measures:
  1. Muscle Strength of two newly weakened muscle groups (MMT using the MRC scale) [ Time Frame: Baseline, Week 52 ]
    Muscle strength of 2 newly weakened muscle groups (Manual Muscle Testing [MMT] using the Medical Research Council [MRC] scale) from baseline to the end of the treatment period.

  2. Muscle strength of two newly weakened muscle groups (QMT using a dynamometer) [ Time Frame: Baseline, Week 52 ]
    Muscle strength of 2 newly weakened muscle groups (Quantitative Muscle Testing [QMT] using a dynamometer) from baseline to the end of the treatment period.

  3. Walking activity in daily life (pedometer) [ Time Frame: Baseline, Week 52 ]
    Walking activity in daily life (pedometer)

  4. Subject's self-perceived exertion/fatigue level using the Borg scale [ Time Frame: Baseline, Week 52 ]
    Subject's self-perceived exertion/fatigue level using the Borg scale

  5. Fatigue (FSS) [ Time Frame: Baseline, Week 52 ]
    Fatigue (FSS)

  6. HRQoL (SF-36 MCS) [ Time Frame: Baseline, Week 52 ]
    HRQoL (SF-36 MCS)

  7. Blood and CSF (CSF is optional) inflammatory cytokines [ Time Frame: Baseline, Week 52 ]
    Blood and CSF (CSF is optional) inflammatory cytokines

  8. Sustained effect of Flebogamma 5% DIF compared to placebo [ Time Frame: Baseline, Week 76 ]

    Sustained effect of Flebogamma® 5% DIF compared to placebo as measured by:

    • Physical performance (2MWD) from baseline to FU3 (Week 64) and to the FV (Week 76).
    • Pain (VAS of pain) from baseline to FU3 and to the FV.
    • HRQoL (SF-36 PCS) from baseline to FU3 and to the FV.
    • Endurance (6MWD) from baseline to FU3 and to the FV
    • Muscle strength (MMT using the MRC scale) from baseline to the FV.
    • Muscle strength (QMT using a dynamometer) from baseline to the FV.
    • Walking activity in daily life (pedometer) from baseline to the FV.
    • Subject's self-perceived exertion/fatigue level using the Borg scale before and after the 2MWD and 6MWD from baseline to FU 3 and to the FV.
    • Fatigue (FSS) from baseline to the FV.
    • HRQoL (SF-36 MCS) from baseline to FU3 and to the FV.
    • Blood and CSF (CSF is optional) inflammatory cytokines from baseline to the FV.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • BMI less than 35 kg/m2.
  • March-of-Dimes clinical criteria for diagnosis of PPS.
  • 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 MRC scale score greater than 3 at the MMT performed by the independent assessor at the 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.
  • Able to walk a 2MWD of at least 50 meters.
  • 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:

  • Have received human normal immune globulin treatment given by intravenous, subcutaneous or intramuscular route within the last 3 years.
  • Are not ambulatory (wheelchair-bound individuals).
  • Poor venous access.
  • Intractable pain requiring narcotics or other psychotropic drugs.
  • History of anaphylactic reactions or severe reactions to any blood-derived product.
  • History of intolerance to any component of the investigational products, such as sorbitol.
  • Receiving corticosteroids, except for those for asthma.
  • Documented diagnosis of hyperviscosity or hypercoagulable state or thrombotic complications to polyclonal IVIG therapy in the past.
  • History of recent (within the last year) myocardial infarction, stroke, or uncontrolled hypertension.
  • Suffer from congestive heart failure, embolism, or electrocardiogram changes indicative of unstable angina or atrial fibrillation.
  • History of chronic alcoholism or illicit drug abuse (addiction) in the preceding 12 months.
  • Active psychiatric illness that interferes with compliance or communication with health care personnel.
  • 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.
  • Currently receiving, or have received within 3 months prior to the Screening Visit, any investigational medicinal product or device.
  • Known selective IgA deficiency and serum antibodies anti-IgA.
  • 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.
  • 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.
  • Known seropositive to Hepatitis C virus, Human immunodeficiency virus-1 and/or -2.
  • Subjects with a history of intolerance to fructose.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02176863


Contacts
Contact: Sandra Camprubi sandra.camprubi@grifols.com
Contact: Karen Rucker karen.rucker@grifols.com

  Show 31 Study Locations
Sponsors and Collaborators
Instituto Grifols, S.A.
Investigators
Principal Investigator: Marinos Dalakas Coordinating Investigator

Responsible Party: Instituto Grifols, S.A.
ClinicalTrials.gov Identifier: NCT02176863     History of Changes
Other Study ID Numbers: IG1104
First Posted: June 27, 2014    Key Record Dates
Last Update Posted: July 12, 2018
Last Verified: July 2018

Keywords provided by Grifols Biologicals Inc. ( Instituto Grifols, S.A. ):
FORCE
post-polio syndrome
Flebogamma
Immune Globulin Intravenous
IGIV

Additional relevant MeSH terms:
Syndrome
Poliomyelitis
Postpoliomyelitis Syndrome
Disease
Pathologic Processes
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Myelitis
Central Nervous System Infections
Central Nervous System Diseases
Nervous System Diseases
Spinal Cord Diseases
Neuromuscular Diseases
Muscular Disorders, Atrophic
Muscular Diseases
Musculoskeletal Diseases
Neurodegenerative Diseases
Immunoglobulins
Antibodies
gamma-Globulins
Immunoglobulins, Intravenous
Rho(D) Immune Globulin
Immunologic Factors
Physiological Effects of Drugs