Immune Globulin Intravenous (IGIV) For Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) (ICE)

This study has been completed.
Information provided by (Responsible Party):
Grifols Therapeutics Inc. Identifier:
First received: September 13, 2005
Last updated: August 10, 2015
Last verified: August 2015
The intent of this study is to demonstrate the efficacy and safety of Immune Globulin Intravenous (Human), 10% Caprylate/Chromatography Purified (IGIV-C) in newly or previously diagnosed CIDP subjects. Eight courses of treatment with either placebo or IGIV-C will occur every 3 weeks. Neurological function will be measured by Inflammatory Neuropathy Cause and Treatment (INCAT) scores. Patients who deteriorate or show no improvement between day 16 and month 6 will receive the alternate study drug for an additional 6 months.

Condition Intervention Phase
Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
Drug: Immune Globulin IV (Human), 10% Caprylate/Chromatography Purified
Drug: Albumin (Human) 25%, United States Pharmacopeia (USP)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Multicenter, Randomized, Double-blind, Placebo-controlled, Study to Evaluate the Efficacy and Safety of IGIV-Chromatography (IGIV-C), 10% Treatment in Subjects With Chronic Inflammatory Demyelinating Polyneuropathy

Resource links provided by NLM:

Further study details as provided by Grifols Therapeutics Inc.:

Primary Outcome Measures:
  • Comparison of the Responder Rates Between Two Treatment Groups in the Efficacy Period [ Time Frame: 6 month ] [ Designated as safety issue: No ]

    The primary efficacy objective was the comparison of IGIV-C and Placebo group Responder rates. An Efficacy Period Responder was defined as a subject with ≥ 1 point improvement in the adjusted Inflammatory Neuropathy Case And Treatment (INCAT) score, with the improvement maintained through the end of Week 24 in the Efficacy Period.

    Measurements are reported in INCAT scale of 0-5 in both lower and upper extremities, for a total score of 0 to 10.

    INCAT scores for arm disability: 0 = no upper limb problems; 5 = inability to use either arm for any purposeful movement.

    INCAT scores for leg disability: 0= walking not affected; 5 = restricted to wheelchair, unable to stand and walk a few steps with help

Secondary Outcome Measures:
  • Mean Change in the Amplitude (Millivolts) in the Most Severely Affected Motor Nerve During the Efficacy Period [ Time Frame: 6 or 12 month ] [ Designated as safety issue: No ]
  • Mean Change in Grip Strength During the Efficacy Period [ Time Frame: 6 or 12 month ] [ Designated as safety issue: No ]
  • Time to Relapse for Subjects Who Were IGIV-C Responders or IGIV-C Rescue Successes, During the Randomized Withdrawal Period [ Time Frame: 6 month ] [ Designated as safety issue: Yes ]

Enrollment: 117
Study Start Date: April 2004
Study Completion Date: June 2006
Primary Completion Date: June 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1
Drug: Immune Globulin IV (Human), 10% Caprylate/Chromatography Purified
2 g/kg body weight ideally over 2-4 days . Thereafter, study drug infusion (IGIV-C) will be administered every 3 weeks at a dose of 1 g/kg bw, given over 1-2 days for a total of 7 additional infusions
Other Names:
  • IGIV-C
  • IGIV-Chromatography (IGIV-C), 10%
  • Gamunex®
  • Gaminex®
  • IGIVnex
  • Intravenous Immunoglobulin (Human) (IGIV)
  • Intravenous Immunoglobulin (Human)
  • IVIG
  • IGIV
  • Intravenous Immune Globulin (Human)
  • TAL-05-00004
  • Bay 41-1000
  • NDC13533-645-12
  • NDC13533-645-15
  • NDC13533-645-20
  • NDC13533-645-71
  • NDC13533-645-24
Placebo Comparator: Group 2 Drug: Albumin (Human) 25%, United States Pharmacopeia (USP)
Albumin 25%, USP diluted with dextrose 5% to a final concentration of 0.1% as an intravenous infusion. Alternatively, it may be a bottled placebo of 0.1% Albumin (Human) in 0.2 M Glycine, 1.1 mm sodium caprylate, 0.25% sodium chloride. 2 g/kg body weight ideally over 2-4 days . Thereafter, infusion (placebo) will be administered every 3 weeks at a dose of 1 g/kg bw, given over 1-2 days for a total of 7 additional infusions
Other Names:
  • Albumin (Human) 25%, USP
  • Plasbumin®-25
  • Plasbumin®-25 (Low Aluminum)
  • TAL-05-00009
  • TAL-05-00025
  • Bay 34-9255
  • NDC 13533-684-16
  • NDC 13533-684-20
  • NDC 13533-684-71
  • NDC 13533-692-16
  • NDC 13533-692-20
  • NDC 13533-692-71

Detailed Description:
110 subjects, 55 per treatment group, with newly or previously diagnosed CIDP defined by INCAT neurophysiological diagnostic criteria will be enrolled into the trial. Patients will not be replaced if they discontinue prematurely.

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Documented diagnosis of CIDP must be made by a neurologist specializing/experienced in neuromuscular diseases based on: a) Progressive or relapsing motor and sensory dysfunction of more than one limb resulting from neuropathy over the 2 months prior to the date informed consent is obtained, and b) Cerebrospinal fluid (CSF) less than 50 white cells/µl since CIDP diagnosis (CSF testing studies are NOT mandatory)
  • Fulfillment of INCAT neurophysiological criteria for focal demyelinating polyradiculoneuropathy
  • Overall INCAT score between 2-9 and significant disability in upper or lower limb function in at least 2 limbs. (An INCAT score of 2 must be exclusively from leg disability to qualify.)

Exclusion Criteria:

  • Treatment with IGIV or plasma within 3 months prior to entry
  • Steroids (Prednisolone or equivalent) > 10 mg/day or equivalent (i.e., > 20 mg every 2 days) during the last 3 months prior to entry
  • Treatment with immunomodulatory/immunosuppressive agents (azathioprin, tacrolimus,cyclosporin, Muromonab-CD3 (OKT3), any interferon), previous lymphoid irradiation or prior treatment with cyclophosphamide, methotrexate, mitoxantrone or any other immunosuppressant drug within the past 6 months prior to entry
  • Concomitant use of supplements containing any amount of fish oil within 30 days prior to entry
  • Respiratory impairment requiring mechanical ventilation
  • Myelopathy or evidence of central demyelination or persisting neurological deficits from stroke, central nervous system (CNS) trauma or peripheral neuropathies of other cause which include diabetes mellitus (defined as a history of type 1 or type 2 diabetes with fasting plasma glucose ≥ 7.0 mmol/L), uremic, toxic and familial neuropathies
  • Pure motor syndrome fulfilling criteria for multifocal motor neuropathy with conduction block. Lower motor neuron disorder with motor weakness in an upper limb, without sensory deficit and with proximal conduction block (50% decrease in amplitude/area with proximal distal stimulation ) in motor nerves and normal sensory nerve conduction studies.
  • Clinical or known evidence of associated systemic diseases that might cause neuropathy, including but not limited to connective tissue disease, HIV infection, hepatitis, Lyme disease, cancer (with the exception of benign skin cancer), Castleman's disease and systemic lupus erythematosus, diabetes mellitus (defined as a history of type 1 or type 2 diabetes with fasting plasma glucose ≥ 7.0 mmol/L), a malignant plasma cell dysplasia, immunoglobulin M (IgM) paraproteinemia, and amiodarone therapy.
  • History of anaphylaxis or severe systemic response to immunoglobulin or with a blood product.
  • Cardiac insufficiency (NYHA III/IV), cardiomyopathy, significant cardiac dysrhythmia requiring treatment, unstable or advanced ischemic heart disease, or history of congestive heart failure, severe hypertension (diastolic pressure >120 mmHg or systolic >170 mmHg).
  • Females who are pregnant, breast feeding, or if of childbearing potential, unwilling to practice adequate contraception throughout the study.
  • Known hyperviscosity.
  • History of renal insufficiency or serum creatinine levels > 221 µmol/L (2.5 mg/dL).
  • Known selective immunoglobulin A (IgA) deficiency.
  • Other investigational drugs received within the 30 days prior to entry
  • Conditions whose symptoms and effects could alter protein catabolism and/or immunoglobulin G (IgG) utilization (e.g. protein-losing enteropathies, nephrotic syndrome).
  • Known hypercoagulable state.
  • Mentally challenged adult subjects who cannot give independent informed consent.
  • Subjects with uncompensated hypothyroidism (abnormally high thyroid-stimulating hormone (TSH) and abnormally low T4) or vitamin B12 deficiency (abnormally low) within the last 3 months prior to entry.
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Please refer to this study by its identifier: NCT00220740

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Sponsors and Collaborators
Grifols Therapeutics Inc.
Principal Investigator: Norman Latov, MD Columbia University
  More Information

Additional Information:
Additional publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Grifols Therapeutics Inc. Identifier: NCT00220740     History of Changes
Other Study ID Numbers: 100538
Study First Received: September 13, 2005
Results First Received: September 24, 2009
Last Updated: August 10, 2015
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Czech Republic: State Institute for Drug Control
Italy: Ministry of Health
Mexico: Federal Commission for Protection Against Health Risks
Poland: Ministry of Health
Israel: Israeli Health Ministry Pharmaceutical Administration
Germany: Federal Institute for Drugs and Medical Devices
Serbia and Montenegro: Agency for Drugs and Medicinal Devices

Keywords provided by Grifols Therapeutics Inc.:
Immunoglobulin G

Additional relevant MeSH terms:
Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
Autoimmune Diseases
Autoimmune Diseases of the Nervous System
Demyelinating Diseases
Immune System Diseases
Nervous System Diseases
Neuromuscular Diseases
Peripheral Nervous System Diseases
Immunoglobulins, Intravenous
Rho(D) Immune Globulin
Contrast Media
Diagnostic Uses of Chemicals
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs processed this record on November 25, 2015