Completed

Human Immune Globulin Therapy for Untreated Chronic Inflammatory Demyelinating Neuropathy

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Study Aim

This phase 3 study aims to evaluate the effectiveness of Human Immune Globulin Therapy as a treatment for untreated Chronic Inflammatory Demyelinating Neuropathy.

What is being tested

immune globulin

Drug
Who is being recruted

Autoimmune Diseases+15

+ Chronic Disease

+ Demyelinating Diseases

Over 12 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 3
Interventional
Study Start: February 1996
See protocol details

Summary

Principal SponsorNational Center for Research Resources (NCRR)
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

Study start date: February 1, 1996

Actual date on which the first participant was enrolled.

PROTOCOL OUTLINE: This is a double blind, randomized, controlled study. Patients receive either intravenous human immune globulin (IVIG) or placebo infused at a rate of 40 mL/hr, increasing every 30 min to a maximum of 100 mL/hr daily over 6 to 8 hours for 2 days. On day 2, infusions of IVIG or placebo are delivered at the highest dose tolerated on day 1. On day 21, patients receive another IVIG or placebo infusion. Following day 42, patients may choose to continue infusions of IVIG every 21 days for 2 doses. Patients not receiving additional treatment are released from study. Patients are evaluated on days 10, 21, and 43.

NCT00004286
Principal SponsorNational Center for Research Resources (NCRR)
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

120 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 12 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Autoimmune DiseasesChronic DiseaseDemyelinating DiseasesImmune System DiseasesNervous System DiseasesNeuromuscular DiseasesPathologic ProcessesPeripheral Nervous System DiseasesPolyneuropathiesPolyradiculoneuropathySigns and SymptomsPathological Conditions, Signs and SymptomsAutoimmune Diseases of the Nervous SystemDisease AttributesMental DisordersNeurologic ManifestationsPolyradiculoneuropathy, Chronic Inflammatory DemyelinatingRare Diseases

Criteria

PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Chronic inflammatory demyelinating polyneuropathy (CIDP) characterized by: Progressive or relapsing disease or chronic stable course with elevated cerebrospinal fluid protein with normal cell counts Acquired demyelination on electrophysiologic studies Segmental demyelination on nerve histology --Patient Characteristics-- Not pregnant No significant medical disorders

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
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CompletedNo study centers