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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00004286
First Posted: October 19, 1999
Last Update Posted: June 24, 2005
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
University of Vermont
Information provided by:
Office of Rare Diseases (ORD)
October 18, 1999
October 19, 1999
June 24, 2005
February 1996
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No Changes Posted
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Phase III Multicenter Double Blind Controlled Trial of Human Immune Globulin Therapy in Previously Untreated Patients With Chronic Inflammatory Demyelinating Neuropathy
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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.

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.

Interventional
Phase 3
Allocation: Randomized
Masking: Double
Primary Purpose: Treatment
Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
Drug: immune globulin
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
120
November 1999
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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
Sexes Eligible for Study: All
12 Years and older   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
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NCT00004286
199/11713
UVT-535
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National Center for Research Resources (NCRR)
University of Vermont
Study Chair: Rup Tandan University of Vermont
Office of Rare Diseases (ORD)
January 2000

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP