Phase III Multicenter Double Blind Controlled Trial of Human Immune Globulin Therapy in Previously Untreated Patients With Chronic Inflammatory Demyelinating Neuropathy
|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.|
|ClinicalTrials.gov Identifier: NCT00004286|
Recruitment Status : Completed
First Posted : October 19, 1999
Last Update Posted : June 24, 2005
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.
|Condition or disease||Intervention/treatment||Phase|
|Polyradiculoneuropathy, Chronic Inflammatory Demyelinating||Drug: immune globulin||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||120 participants|
|Study Start Date :||February 1996|
|Study Completion Date :||November 1999|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004286
|Study Chair:||Rup Tandan||University of Vermont|