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IVIG in Acute Ischemic Stroke: A Pilot Study

Information source: Inova Health Care Services
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Ischemic Stroke

Intervention: Privigen (Biological); Normal Saline (Other)

Phase: Phase 1

Status: Withdrawn

Sponsored by: Inova Health Care Services

Official(s) and/or principal investigator(s):
Beverly C Walters, MD, Study Director, Affiliation: Inova Health Systems
Milan Basta, MD, Study Chair, Affiliation: BioVisions, Inc.
Jack Cochran, MD, Principal Investigator, Affiliation: Inova Health Systems


The purpose of the study is to evaluate the ability of IVIG to affect the rate of progression of brain ischemia, as evidenced by neuroimaging. The results of an ongoing epidemiological study indicate that patients with primary immunodeficiency (PID) on IVIG replacement therapy have an overall prevalence of stroke that is 5 times less than in the general population. Even more striking is the absence of stroke in IVIG-treated PID patients over 65, while in the same general population age group the stroke prevalence goes up to 8. 1%. This suggests that the degree of stroke protection correlates with the length of IVIG treatment, since older PID patients have been treated with IVIG significantly longer than younger ones.

Clinical Details

Official title: IVIG in Acute Ischemic Stroke: A Pilot Study

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Post-IVIG DWI/PI mismatch measurement

Secondary outcome:

Favorable clinical outcome

Clinical outcome measure by NIHSS

Active complement fragment levels

Adverse Events

Detailed description: Two pre-clinical studies demonstrated the effectiveness of IVIG preparations in improving the clinical outcome of stroke and at the same time provided evidence of the role of complement fragments in the pathogenesis of ischemia-induced brain damage. Scavenging of these active fragments by IVIG is the likely mechanism of beneficial effect. In one of these studies CSL's own Privigen preparation was used. Considering that it exhibited in-vitro scavenging abilities more pronounced than several other IVIG preparations, and that its in-vivo scavenging capacity was also proven in a relevant animal model, a need to test this preparation in stroke patients is warranted. In addition, activation of complement and the level of activated fragments in humans seem to correlate with the severity of the disease, making them an ideal therapeutic target.


Minimum age: 45 Years. Maximum age: 75 Years. Gender(s): Both.


Inclusion Criteria: 1. Onset of neurological symptoms between 4. 5 and 8 hours

2. Male or Female age 45 - 75 years old

3. Score of 10-15 points on the National Institutes of Health Stroke Scale (NIHSS) with clinical signs suggestive of ischemic stroke 4. Acute brain ischemia with a distinct penumbra (at least 20%), measured by magnetic resonance perfusion imaging (PI) and diffusion-weighted imaging (DWI), in the territory of the middle cerebral artery, anterior cerebral artery, or posterior cerebral artery with a hemispheric distribution 5. Ability and willingness to provide informed consent and comply with study requirements and procedures Exclusion Criteria: 1. Eligibility for acute thrombolytic (rtPA) treatment 2. Normal brain MRI 3. Transient ischemic attack or rapidly improving neurological symptoms 4. Previous disability 5. Hemorrhagic stroke on brain MRI (T2*/SWI) 6. Ongoing infection defined by clinical and laboratory signs: an evidence-based guideline will be followed to detect infectious complications (in short, physical and laboratory measures including WBC, ESR, hsCRP, PCT, fever, abnormal urine, chest X-ray or positive cultures) 7. Diagnosis of malignancy 8. Known sensitivity to any ingredients in the study drug or radiological contrast material 9. Participation in another clinical trial within the past 30 days 10. Stroke in the previous 3 months 11. Chronic liver, kidney or hematological disease

12. Contraindications to MRI - Brain aneurysm clip, implanted neural stimulator, implanted

cardiac pacemaker or defibrillator, cochlear implant, ocular foreign body e. g. metal shavings, other implanted medical devices: (e. g. Swan Ganz catheter) insulin pump, metal shrapnel or bullet. 13. Diabetes 14. Hypertension 15. Females who are pregnant or breastfeeding

Locations and Contacts

Inova Health Systems; Inova Fairfax Hospital, Falls Church, Virginia 22042, United States
Additional Information

Related publications:

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Starting date: March 2013
Last updated: November 7, 2013

Page last updated: August 23, 2015

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