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Immunomodulator
IGIV-C for Diabetic Neuropathy
Phase 2
Waitlist Available
Led By Christopher Gibbons, MD
Research Sponsored by Beth Israel Deaconess Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Individuals with a diagnosis of diabetes and treatment induced neuropathy (defined by the onset of neuropathic pain and signs of small fiber or autonomic neuropathy within 8 weeks of a change in HbA1C exceeding 3 points over 3 months).
Ages 18-60.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 7 weeks after first infusion
Awards & highlights
Study Summary
The Efficacy Of Intravenous Immunoglobulin Therapy In Treatment Induced Neuropathy Of Diabetes
Eligible Conditions
- Diabetic Neuropathy
- Diabetes
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 7 weeks after first infusion
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~7 weeks after first infusion
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Neuropathic Pain Severity as Measured by the Pain Visual Analogue Scores (VAS).
Change in Sensory Neuropathy as Measured by the Utah Early Neuropathy Score (UENS).
Secondary outcome measures
Change in Autonomic Neuropathy as Measured by Standardized Autonomic Nervous System Testing.
Change in Neuropathy Severity as Measured by Skin Biopsies.
Side effects data
From 2018 Phase 3 trial • 49 Patients • NCT0241358039%
Headache
16%
Pyrexia
8%
Urticaria
6%
Influenza like illness
6%
Vomiting
6%
Rash
100%
80%
60%
40%
20%
0%
Study treatment Arm
IGIV-C Treatment
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: IGIV-CExperimental Treatment1 Intervention
The study will include a total 20 individuals. Subjects will be randomized equally to treatment or placebo. The treatment will consist of IVIG administered at 2 grams/kg divided over 5 days, with a follow up treatment 3 weeks (+/-3 days) later of IVIG 1gram/kg administered over 2 day (or placebo).
Group II: 0.9% Sodium ChloridePlacebo Group1 Intervention
The study will include a total 20 individuals. Subjects will be randomized equally to treatment or placebo. The placebo will consist of 0.9% Sodium Chloride per day over 5 days. Participants who are randomized to placebo will receive the same volume as they would if they were randomized to IVIG (i.e.: as if receiving IVIG at 2gm/kg) through a peripheral IV line.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Human immunoglobulin G
FDA approved
Find a Location
Who is running the clinical trial?
Beth Israel Deaconess Medical CenterLead Sponsor
835 Previous Clinical Trials
13,006,517 Total Patients Enrolled
Grifols Biologicals, LLCIndustry Sponsor
32 Previous Clinical Trials
9,443 Total Patients Enrolled
Christopher Gibbons, MDPrincipal Investigator - Beth Israel Deaconess Medical Cednter
Beth Israel Deaconess Medical Center-Departmet of Neurology
1 Previous Clinical Trials
20 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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