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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT00220740
• Date of registration: 13/09/2005
• Prospective Registration: No
• Primary sponsor: Grifols Therapeutics Inc.
• Public title: Immune Globulin Intravenous (IGIV) For Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) ICE
• Scientific 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
• Date of first enrolment: April 2004
• Target sample size: 117
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00220740
• Study type: Interventional
• Phase: Phase 3

Countries of recruitment

Argentina, Canada, Czech Republic, Former Serbia and Montenegro, Germany, Israel, Italy, Mexico, Poland, Serbia, United States

Contacts

• Name: Norman Latov, MD
• Affiliation: Columbia University

Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Polyradiculoneuropathy, Chronic Inflammatory Demyelinating

Intervention(s)

Drug: Albumin (Human) 25%, United States Pharmacopeia (USP)

Drug: Immune Globulin IV (Human), 10% Caprylate/Chromatography Purified

Primary Outcome(s)

Comparison of the Responder Rates Between Two Treatment Groups in the Efficacy Period [Time Frame: 6 months]

Secondary Outcome(s)

Time to Relapse for Subjects Who Were IGIV-C Responders or IGIV-C Rescue Successes, During the Randomized Withdrawal Period [Time Frame: 6 months]

Mean Change in Grip Strength During the Efficacy Period [Time Frame: 6 months]

Mean Change in the Amplitude (Millivolts) in the Most Severely Affected Motor Nerve During the Efficacy Period [Time Frame: 6 months]

Secondary ID(s)

100538

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 10/09/2015
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00220740