Ignite Creation Date:
2025-12-24 @ 12:05 PM
Ignite Modification Date:
2025-12-24 @ 12:05 PM
Study NCT ID:
NCT00002061
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-11-02
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Multi-Center Randomized Double-Blind Placebo-Controlled Study To Investigate the Effect of Isoprinosine in Immunodepressed Patients With Uncomplicated Generalized Lymphadenopathy
Sponsor:
Newport Pharmaceuticals International
Organization:
Study Overview
Official Title:
A Multi-Center Randomized Double-Blind Placebo-Controlled Study To Investigate the Effect of Isoprinosine in Immunodepressed Patients With Uncomplicated Generalized Lymphadenopathy
Status:
COMPLETED
Status Verified Date:
1989-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 immunologic parameters:
* Increase in natural killer (NK) cell activity.
* Increase in total T-cells (OKT-11).
* Increases in absolute number and percentages of T-helper cells (OKT-4).
* Increase in natural killer (NK) cell activity.
* Increase in total T-cells (OKT-11).
* Increases in absolute number and percentages of T-helper cells (OKT-4).
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| ISO-105-USA | None | None | View |