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A randomized, dose-ranging study of Alferon LDO {low dose oral interferon ALFA-n3 (human leukocyte derived} in normal volunteers and/or asymptomatic subjects with exposure to a person known to have SARS [severe acute respiratory syndrome] or possible SARS

Trial Profile

A randomized, dose-ranging study of Alferon LDO {low dose oral interferon ALFA-n3 (human leukocyte derived} in normal volunteers and/or asymptomatic subjects with exposure to a person known to have SARS [severe acute respiratory syndrome] or possible SARS

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 23 Jan 2020

At a glance

  • Drugs Interferon alpha-n3 (Primary)
  • Indications Severe acute respiratory syndrome
  • Focus Pharmacogenomic; Therapeutic Use
  • Sponsors AIM ImmunoTech
  • Most Recent Events

    • 16 Nov 2005 New trial record.

Trial Overview

Purpose

This study is a randomized, dose-ranging study of Alferon LDO to evaluate the efficacy and tolerability of interferon alpha-n3 in normal volunteers and/or asymptomatic subjects with exposure to a person known to have SARS [severe acute respiratory syndrome] or possible SARS.

Primary Endpoints

Gene expression

Other Endpoints

SARS CoV Antibody

description: Development of clinical SARS-CoV symptomatology
time_frame: Days 0, 15, 20 and 40

SARS-CoV infection

description: Hospitalization for SARS-CoV infection and Death [1]

Diseases Treated

Indication Qualifiers Patient Segments
Severe acute respiratory syndrome treatment -

Subjects

  • Subject Type patients & volunteers
  • Number

    Planned: 10

    Actual: 10

  • Sex male & female
  • Age Group 18-80 years; adult; elderly

Patient Inclusion Criteria

1. 18-80 years of age. 2. Asymptomatic with close contact within the last 5 days with a person known to have possible SARS (SARS RUI-2 (SARS Report under investigation), RUI-3, RUI-4) or probable SARS or confirmed SARS using the Centers for Disease Control and Prevention (CDC) Supplement B: SARS Surveillance, Appendix B1: Revised Council of State and Territorial Epidemiologists (CSTE) SARS Surveillance Case Definition (Attachment II). 3. Oral temperature < 100.4°F (<38°C) 4. Subjects must be asymptomatic with regard to SARS related clinical symptoms including any signs of a respiratory illness. 5. Serum creatinine ≤ 1.5 x ULN (upper limit of normal); serum bilirubin ≤ 1.5 x ULN. 6. Total white blood cells (WBC) ≥ 3000/mm3, platelet count ≥ 100,000/mm3 and granulocytes ≥ 1500 mm3. 7. Hemoglobin > 10.0 g/dl. 8. ALT (alanine aminotransferase) and AST (aspartate aminotransferase) < 4 times upper normal limit. 9. C-reactive protein serum level in normal range 10. Serum albumin > 2.0 g/dl. 11. Written informed consent. 12. Females must either be of non-child bearing potential, or utilize an effective form of contraception and have a negative pregnancy test prior to randomization.

Patient Exclusion Criteria

1. Pregnant or nursing women, or women not using an effective form of contraception. 2. Less than 18 years of age. 3. Active intravenous (IV) drug users. 4. Receipt of any immunosuppressive agent, chemotherapy, or systemic steroids within 45 days of study entry. 5. Receipt of any immunomodulator such as BCG (bacille Calmette Guerin) vaccine, isoprinosine, or similar experimental agents within 45 days of study entry. 6. Evidence of HIV or other viral infections including chronic hepatitis, or other active gastrointestinal, renal, respiratory, endocrine, hematologic, cardiovascular, neurological, or psychiatric disorder that would limit the subject's ability to complete the study period. 7. Unlikely or unable to comply with the requirements of the protocol. 8. Patients unwilling or unable to give informed consent. 9. Patients on any other concurrent experimental medication. 10. Patients using any form of interferon therapy during the 6 weeks prior to study entry. 11. Hospitalized subjects, or those with an active viral infection other than possible SARS, within 2 weeks of study entry. 12. Transfusion dependent subjects (subjects requiring > 1 unit of packed RBC [red blood cells] per month within the 3 months prior to study entry).

Trial Details

Identifiers

Identifier Owner
NCT00215826 ClinicalTrials.gov: US National Institutes of Health
LDO102 -

Organisations

  • Sponsors AIM ImmunoTech
  • Affiliations AIM ImmunoTech; Hemispherx Biopharma

Trial Dates

  • Initiation Dates

    Actual : 01 Nov 2004

  • Primary Completion Dates

    Actual : 01 Apr 2006

  • End Dates

    Actual : 01 Apr 2006

Other Details

  • Design open; parallel; prospective; randomised
  • Phase of Trial Phase II
  • Location Hong Kong
  • Focus Pharmacogenomic; Therapeutic Use

Interventions

Drugs Route Formulation
Interferon alpha-n3Primary Drug Oral Solution

1

650 IU
Drug: Alferon LDO

2

1300 IU
Drug: Alferon LDO

Trial Centres

Investigators

Investigator Centre Name Trial Centre Country
Tong TR Kowloon West Cluster Clinical Research Ethics Committee
-

Centres

Centre Name Location Trial Centre Country
AIM ImmunoTech
-
-
Hemispherx Biopharma
-
-
Kowloon West Cluster Clinical Research Ethics Committee
-
-
Princess Margaret Hospital Lai Chi Kok Hong-Kong

Trial History

Event Date Event Type Comment
23 Jan 2020 Other trial event Last checked against ClinicalTrials.gov record. Updated 23 Jan 2020
23 Aug 2019 Other trial event According to an AIM ImmunoTech media release, the company has changed its name to AIM ImmunoTech, with effective from 3rd Sep 2019. Updated 16 Jan 2020
01 Apr 2006 Status change - completed Status changed from recruiting to completed as reported by ClinicalTrials.gov. Updated 20 Apr 2013
16 Nov 2005 New trial record New trial record. Updated 16 Nov 2005

References

  1. ClinicalTrials.gov: US National Institutes of Health. Trial-Reg 2016;.

    Available from: URL: http://clinicaltrials.gov
  2. Hemispherx Biopharma. Hemispherx Biopharma, Inc. Changes Name to AIM ImmunoTech Inc. Reflecting Ampligen's(Rm) Immuno Modulation Progress in Ongoing Oncology Clinical Trials and ME/CFS. Media-Rel 2019;.

    Media Release
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