The Safety and Effectiveness of Isoprinosine in Patients With Weakened Immune Systems and Lymph Node Disease
The objective of this Phase III, randomized, double-blind, placebo-controlled study in patients with immunologic deficiency is to determine the effect of Isoprinosine in producing an immuno-restorative response within the study observation period (including the 2-month period following cessation of the 28 days of treatment), measured by one or more of the following immunological parameters:
- Increase in natural killer (NK) cell activity.
- Increase in total T-cells (OKT-11).
- Increases in absolute number and percentage of T-helper cells (OKT-4).
|Study Design:||Masking: Double
Primary Purpose: Treatment
|Official Title:||A Multi-Center Randomized Double-Blind Placebo-Controlled Study to Investigate the Effect of Isoprinosine in Immunodepressed Patients With Uncomplicated Generalized Lymphadenopathy|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002296
|United States, California|
|Newport Pharmaceuticals International Inc|
|Laguna Hills, California, United States, 92656|