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The Efficacy Of Intravenous Immunoglobulin Therapy In Treatment Induced Neuropathy Of Diabetes

NCT02915263 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2024-05-07

Study results available
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Summary

The goal of this pilot study is to obtain preliminary data on the magnitude of the treatment effect of IVIG on the neuropathic pain and neuropathy severity associated with treatment induced neuropathy (TIND).

The investigators hypothesize that immune globulin, administered intravenously (IVIG), will reduce the pain associated with treatment induced neuropathy and reduce the neuropathy severity.

Treatment induced neuropathy in diabetes, is an iatrogenic complications of diabetes. The preliminary data will be used to power a larger treatment trial, and to aid the understanding of the mitigating factors in the treatment response.

Conditions

Interventions

DRUG

IGIV-C

Gamunex-C \[immune globulin injection (human) 10% caprylate/chromatography purified\] is a sterile solution of human immune globulin protein.

DRUG

0.9% Sodium Chloride

Sodium Chloride (also known as saline) is a solution of sodium chloride, or salt, and sterile water.

Sponsors & Collaborators

Principal Investigators

  • Christopher Gibbons, MD · Beth Israel Deaconess Medical Cednter

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-11
Primary Completion
2022-02-01
Completion
2022-02-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02915263 on ClinicalTrials.gov