Ignite Creation Date:
2024-05-05 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00215826
Status:
COMPLETED
Last Update Posted:
2013-04-17
First Post:
2005-09-16
Brief Title:
Study of Alferon LDO Low Dose Oral in Normal Volunteers
Sponsor:
AIM ImmunoTech Inc
Organization:
AIM ImmunoTech Inc
Study Overview
Official Title:
A Randomized Dose-ranging Study of Alferon LDO Low Dose Oral Interferon Alfa-n3 Human Leukocyte Derived in Normal Volunteers andor Asymptomatic Subjects With Exposure to a Person Known to Have SARS or Possible SARS
Status:
COMPLETED
Status Verified Date:
2013-04
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 purpose of this trial is to conduct a randomized dose-ranging study to evaluate the safety and activity of orally administered low dose interferon alfa-n3 as an antiviral and immunomodulator in asymptomatic subjects with recent exposure to a person with severe acute respiratory syndrome SARS or possible SARS The primary objective of this pilot study is to determine an Alferon LDO dose level that increases or upregulates genes known to be mediators of interferon response Secondary endpoints include the development of SARS symptomatology rate of hospitalization and mortality rate In the event that no subjects with recent exposure to a person with SARS or possible SARS are available this study will be conducted with 10 normal volunteers
Detailed Description:
This study will be an open-label randomized outpatient study in subjects potentially infected with the SARS-CoV SARS-associated coronavirus or normal volunteers using two dose levels of LDO interferon
Subjects will be randomized to receive Alferon LDO natural interferon alfa-n3 in a buffer solution once each day for 10 consecutive days at doses equal to 650 IU or 1300 IUday
Pretherapy baseline evaluations will be performed prior to randomization
Subjects will be randomly assigned to each dose level and both dosage levels will be started concurrently Drug will be dispensed for a ten day treatment period during which time any clinical symptoms and adverse events will be evaluated Laboratory samples 25 ml blood for microarray analysis evaluations will be made twice during baseline and 12-14 hours following doses 1 5 and 10 on study days 2 6 and 11 respectively
The conduct of this study will comply with International Conference on Harmonisation - Good Clinical Practice ICH - GCP and the 1996 or later version of the Declaration of Helsinki
Subjects will be randomized to receive Alferon LDO natural interferon alfa-n3 in a buffer solution once each day for 10 consecutive days at doses equal to 650 IU or 1300 IUday
Pretherapy baseline evaluations will be performed prior to randomization
Subjects will be randomly assigned to each dose level and both dosage levels will be started concurrently Drug will be dispensed for a ten day treatment period during which time any clinical symptoms and adverse events will be evaluated Laboratory samples 25 ml blood for microarray analysis evaluations will be made twice during baseline and 12-14 hours following doses 1 5 and 10 on study days 2 6 and 11 respectively
The conduct of this study will comply with International Conference on Harmonisation - Good Clinical Practice ICH - GCP and the 1996 or later version of the Declaration of Helsinki
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None