Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00002296
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-11-02
Brief Title:
The Safety and Effectiveness of Isoprinosine in Patients With Weakened Immune Systems and Lymph Node Disease
Sponsor:
Newport Pharmaceuticals International
Organization:
NIH AIDS Clinical Trials Information Service
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 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
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
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 IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| ISO-106-USA | None | None | None |