Clinical Trial: Phase III Multicenter Double Blind Controlled Trial of Human Immune Globulin Therapy in Previously Untreated Patients With Chronic Inflammatory Demyelinating Neuropathy

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title:

Brief Summary:

OBJECTIVES:

I. Compare and evaluate the response to treatment with intravenous human immune globulin (IVIG) or placebo in previously untreated patients with chronic inflammatory demyelinating polyneuropathy.

Detailed Summary:

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.

Sponsor: National Center for Research Resources (NCRR)

Current Primary Outcome:

Original Primary Outcome:

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Office of Rare Diseases (ORD)

Dates:
Date Received: October 18, 1999
Date Started: February 1996
Date Completion: November 1999
Last Updated: June 23, 2005
Last Verified: January 2000